Ictammolo Zeta

Ictammolo Zeta may be available in the countries listed below.

Ingredient matches for Ictammolo Zeta

Ichthammol

Ichthammol is reported as an ingredient of Ictammolo Zeta in the following countries:

• Italy

International Drug Name Search

androgen Oral, Parenteral, Subcutaneous, Topical application, Transdermal

Class Name: androgen (Oral route, Parenteral route, Subcutaneous route, Topical application route, Transdermal route)

Commonly used brand name(s)

In the U.S.

• Anadrol-50


• Androderm


• Androgel


• Android


• Androxy


• Axiron


• Danocrine


• DHEA


• First-Testosterone


• First-Testosterone MC


• Fortesta


• Methitest


• Teslac


• Testopel Pellets


• Testred

In Canada

• Andriol


• Androplex

Available Dosage Forms:

• Patch, Extended Release


• Gel/Jelly


• Solution


• Implant


• Capsule


• Kit


• Tablet


• Tablet, Extended Release


• Capsule, Extended Release


• Cream

Uses For This Medicine

Androgens are male hormones. Some androgens are naturally produced in the body and are necessary for the normal sexual development of males.

Androgens are used for several reasons, such as:

• To replace the hormone when the body is unable to produce enough on its own.


• To stimulate the beginning of puberty in certain boys who are late starting puberty naturally.


• To treat certain types of breast cancer in females.

In addition, some of these medicines may be used for other conditions as determined by your doctor.

Androgens are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, androgens are used in certain patients with the following medical conditions:

• Anemias (blood problems)


• Delayed growth spurt


• Development of male features in transsexuals


• Lichen sclerosus (a skin problem of the vulva)


• Microphallus (underdevelopment of the penis)

Before Using This Medicine

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Androgens may cause children to stop growing. In addition, androgens may make male children develop too fast sexually and may cause male-like changes in female children

Geriatric

When older male patients are treated with androgens, they may have an increased risk of enlarged prostate (a male gland) or their existing prostate cancer may get worse. For these reasons, a prostate examination and a blood test to check for prostate cancer is often done before androgens are prescribed for men over 50 years of age. These examinations may be repeated during treatment.

Pregnancy

Androgens are not recommended during pregnancy. When given to pregnant women, the medicine has caused male features to develop in female babies.

Breast Feeding

Use is not recommended in nursing mothers, since androgens may pass into the breast milk and may cause unwanted effects in the nursing baby, such as premature (too early) sexual development in males and development of male features in female babies.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Simvastatin

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol


• Anisindione


• Atorvastatin


• Bupropion


• Dicumarol


• Fluvastatin


• Lovastatin


• Paclitaxel


• Paclitaxel Protein-Bound


• Phenindione


• Phenprocoumon


• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Breast cancer (in males) or


• Prostate cancer—Androgens can cause growth of these tumors.

• Breast cancer (in females)—Androgens may cause high calcium levels in the blood to become worse.

• Diabetes mellitus (sugar diabetes)—Androgens can increase or decrease blood sugar levels. Careful monitoring of blood glucose should be done.

• Edema (swelling of face, hands, feet, or lower legs) or


• Kidney disease or


• Liver disease—These conditions can be worsened by the fluid retention (keeping too much water in the body) that can be caused by androgens. Also, liver disease can prevent the body from removing the medicine from the bloodstream as fast as it normally would. This could increase the chance of side effects occurring

• Enlarged prostate—Androgens can cause further enlargement of the prostate.

• Heart or blood vessel disease—Androgens can make these conditions worse because androgens may increase blood cholesterol levels. Also, androgens can cause fluid retention (keeping too much water in the body), which also can worsen heart or blood vessel disease.

Proper Use of This Medicine

Take this medicine only as directed. Do not take more of it and do not take it more often than your doctor ordered . Doing so may increase the chance of side effects.

There are two types of testosterone skin patches. The matrix-type is applied to skin of the scrotum. The reservoir-type is never applied to the skin of the scrotum. It is applied to other parts of the body. Be sure you know which type you are using so that you will apply it properly. These skin patches come with patient directions. Read them carefully before using the patch.

For patients taking fluoxymesterone or methyltestosterone:

• Take this medicine with food to lessen possible stomach upset, unless otherwise directed by your doctor.

For patients using the matrix-type skin patch of testosterone (Testoderm or Testoderm with Adhesives):

• You must apply the patch to the scrotum because the medicine easily passes into your body at this area. Other areas of your skin are too thick for the medicine to work properly.


• Wash and dry your hands thoroughly before and after handling the patch.
  
  • Before applying the patch:
    
    • Clean and dry your scrotum.
    
    
    • You should also dry-shave this area once a week by using a shaver only (no soap or water). To dry-shave, stretch the skin of your scrotum with your fingers. Use short gentle strokes with no pressure on the razor to remove the hair. Do not use shaving cream or hair-removing creams (e.g., Nair).
    
    
    • You may sit with your legs apart or stand while applying the patch.
    
    
  
  
  • To apply the patch:
    
    • Open the wrapper containing the patch at the point shown on the package.
    
    
    • Carefully remove the patch from its protective plastic liner by peeling the patch from the liner starting at the corner.
    
    
    • Warm your scrotum for a few seconds before applying the patch to achieve the best results. Stretch the skin of your scrotum gently to remove the folds by pulling the penis up and to the side. Another way is to pull your scrotum down. Use your first and middle fingers to stretch the skin of your scrotum.
    
    
    • Place the shiny side of the patch onto the warm stretched skin of your scrotum.
    
    
    • Press the shiny side of the patch firmly in place with the palm of your hand for about 10 seconds. Make sure there is good contact, especially around the edges. The patch should stick to your scrotum and show the natural wrinkles of your scrotum.
    
    
    • Put on comfortable, close-fitting briefs (underwear) after applying the patch.
    
    
    • If a patch becomes loose or falls off, you may reapply it or discard it and apply a new patch.
    
    
  
  
  • To remove the skin patch:
    
    • Gently peel the patch from the skin.
    
    
    • You may reuse the patch after removing it for swimming, bathing, showering, or sexual activity. First, remove the patch and place the shiny (sticky) side up on a counter. Before you reapply the patch, be sure the skin on your scrotum is dry. Then, follow the directions to reapply the patch.
    
    
    • When the wearing period is over, fold the patch in half with the sticky sides together. Place the folded, used patch in its protective pouch or in aluminum foil. Be sure to throw it away out of the reach of children and pets.
    
    
  
  

For patients using the reservoir-type skin patch of testosterone (Androderm or Testoderm TTS):

• Apply the patch called Androderm to the abdomen, back, thighs, or arms. Apply the patch called Testoderm TTS to the back, arms, or upper buttocks. Do not apply these patches to the scrotum.


• Do not apply the patch to areas of the body that seem bony, such as the top of the shoulders or near the elbows, or to areas that may have to support your body while sleeping or sitting, such as the hips or shoulder blades. Apply each new patch to a different place. Do not reapply a patch to the same area of skin for 7 days.


• Wash and dry your hands thoroughly before and after handling the patch.
  
  • Before applying the patch, clean and dry the application site.
  
  
  • To apply the patch:
    
    • Open the wrapper containing the patch at the point shown on the package.
    
    
    • Carefully remove the patch from its protective plastic liner by peeling the patch from the liner, starting at the corner.
    
    
    • Place the shiny side of the patch onto the skin.
    
    
    • Press the shiny side of the patch firmly in place with the palm of your hand for about 10 seconds. Be sure there is good contact, especially around the edges.
    
    
    • If a patch becomes loose or falls off, you may reapply it or discard it and apply a new patch.
    
    
  
  
  • To remove the skin patch:
    
    • Gently peel the patch from the skin.
    
    
    • You do not need to remove this patch for swimming, bathing, showering, or sexual activity.
    
    
    • When the wearing period is over, fold the patch in half with the sticky sides together. Place the folded, used patch in its protective pouch or in aluminum foil. Be sure to throw it away out of the reach of children and pets.
    
    
  
  

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For fluoxymesterone


• For oral dosage form (tablets):
  
  • For androgen hormone replacement in men:
    
    • Adults—5 milligrams (mg) one to four times a day.
    
    
  
  
  • For treatment of breast cancer in women:
    
    • Adults—10 to 40 mg a day in divided doses.
    
    
  
  
  • For treatment of delayed sexual development in boys:
    
    • Children—2.5 to 10 mg a day for four to six months.
    
    
  
  

• For methyltestosterone


• For oral dosage forms (capsules or tablets):
  
  • For androgen hormone replacement in men:
    
    • Adults—10 to 50 milligrams (mg) a day.
    
    
  
  
  • For treatment of breast cancer in women:
    
    • Adults—50 mg one to four times a day. Your doctor may decrease your dose to 50 mg two times a day after two to four weeks.
    
    
  
  
  • For treatment of delayed sexual development in boys:
    
    • Children—5 to 25 mg a day for four to six months.
    
    
  
  

• For testosterone


• For injection dosage form:
  
  • For androgen hormone replacement in men:
    
    • Adults—25 to 50 milligrams (mg) injected into a muscle two or three times a week.
    
    
  
  
  • For treatment of breast cancer in women:
    
    • Adults—50 to 100 mg injected into a muscle three times a week.
    
    
  
  
  • For treatment of delayed sexual development in boys:
    
    • Children—Up to 100 mg injected into a muscle once a month for four to six months.
    
    
  
  


• For subcutaneous dosage form (implants):
  
  • For androgen hormone replacement in men:
    
    • Adults—150 to 450 milligram (mg) (two to six implants) inserted into the skin every three to six months.
    
    
  
  
  • For treatment of delayed sexual development in boys:
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For topical dosage forms:
  
  • For androgen hormone replacement in men:
    
    • When using the brand name AndroGel 1% testosterone gel
    
    
    • Adults—The recommended starting dose is 5 grams applied once daily (preferably in the morning) to clean, dry , intact skin of the shoulders and upper arms and/or abdomen. Allow the application sites to dry prior to dressing and wash hands with soap and water after application.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
    • When using the brand name Testoderm or Testoderm with Adhesives patches (matrix-type)
    
    
    • Adults—4 or 6 mg (one patch) applied to your scrotum once a day at about 8 a.m. The patch should be worn at least twenty-two of the twenty-four hours in a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
    • When using the brand name Androderm patches (reservoir-type)
    
    
    • Adults and teenagers 15 years of age and older—2.5 to 7.5 mg (one to three patches) applied to the abdomen, back, thighs, or upper arms once a day at about 10 p.m. The patch(es) should be worn for twenty-four hours a day.
    
    
    • Children up to 15 years of age—Use and dose must be determined by your doctor.
    
    
    • When using the brand name Testoderm TTS patches (reservoir-type)
    
    
    • Adults—5 mg (one patch) applied to the back, arms, or upper buttocks once a day at about 8 a.m. Your doctor may increase your dose if necessary. The patch should be worn at least twenty-two of the twenty-four hours in a day.
    
    
    • Children up to 18 years of age—Use and dose must be determined by your doctor.
    
    
  
  

• For testosterone cypionate or testosterone enanthate


• For injection dosage form:
  
  • For androgen hormone replacement in men:
    
    • Adults—50 to 400 milligrams (mg) injected into a muscle every two to four weeks.
    
    
  
  
  • For treatment of breast cancer in women:
    
    • Adults—200 to 400 mg injected into a muscle every two to four weeks.
    
    
  
  
  • For treatment of delayed sexual development in boys:
    
    • Children—Up to 100 mg injected into a muscle once a month for four to six months.
    
    
  
  

• For testosterone propionate


• For injection dosage form:
  
  • For androgen hormone replacement in men:
    
    • Adults—25 to 50 milligrams (mg) injected into a muscle two or three times a week.
    
    
  
  
  • For treatment of breast cancer in women:
    
    • Adults—50 to 100 mg injected into a muscle three times a week.
    
    
  
  
  • For treatment of delayed sexual development in boys:
    
    • Children—Up to 100 milligrams injected into a muscle once a month for four to six months.
    
    
  
  

• For testosterone undecanoate


• For oral dosage form (capsules):
  
  • For androgen hormone replacement in men:
    
    • Adults—120 to 160 milligrams (mg) divided into two doses a day taken with meals for two to three weeks. Then dose is reduced to 40 to 120 mg a day, taken with meals, and divided into 2 doses a day when possible.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

For topical dosage forms (patches): If you miss a dose of this medicine or your patch falls off within 12 hours after applying it and cannot be reapplied, skip the rest of the dose and go back to your regular dosing schedule. Do not double doses.

If you have any questions about this, check with your doctor.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine

Your doctor should check your progress at regular visits to make sure this medicine does not cause unwanted effects.

For patients with diabetes mellitus (sugar diabetes):

• This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

For patients using the brand name Androgel:

• Wait 5 or 6 hours after applying the gel before showering or swimming.


• Gel contains alcohol which is flammable- avoid fire, flame or smoking until the gel is dried.

Side Effects of This Medicine

Discuss these possible effects with your doctor:

Tumors of the liver, liver cancer, or peliosis hepatis (a form of liver disease) have occurred during long-term, high-dose therapy with androgens. Although these effects are rare, they can be very serious and may cause death.

Androgens can stimulate existing prostate cancer in men who already have it but have not yet been diagnosed. Also, the prostate (a male gland) may become enlarged. Enlargement of the prostate does not mean that cancer will develop. If enlargement occurs and you have difficulty in urinating, it is a good idea to be checked by your doctor.

When androgens are used in women, especially in high doses, male-like changes may occur, such as hoarseness or deepening of the voice, unnatural hair growth, or unusual hair loss. Most of these changes will go away if the medicine is stopped as soon as the changes are noticed. However, some changes, such as voice changes or enlarged clitoris, may not go away.

When androgens are used in high doses in males, they interfere with the production of sperm. This effect is usually temporary and only happens during the time you are taking the medicine. However, discuss this possible effect with your doctor if you are planning on having children.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More commonFor females only

These symptoms may occur in females whose male sexual partner uses a scrotal patch.

• Acne or oily skin


• decreased breast size


• irregular menstrual cycles


• hoarseness or deepening of voice


• increase in size of female genitals


• increase in unnatural hair growth or male pattern baldness

For males only

• Blistering of skin under patch (especially when the nonscrotal patch is applied to bony areas of the skin)


• breast soreness or enlargement


• frequent or continuing erection of penis lasting up to 4 hours or painful penile erections lasting longer than 4 hours


• frequent urge to urinate


• itching or redness of skin under patch (less likely with nonscrotal patch) or at site of implants, mild to severe

For prepubertal boys only

• Acne


• early growth of pubic hair


• enlargement of penis


• frequent or continuing erections

Less commonFor males or females

• Dizziness


• frequent or continuing headache


• lack or loss of strength


• nausea


• overall body flushing, redness, or itching of skin


• rapidly changing moods, such as depersonalization, dysphoria, euphoria, depression, paranoia, and quick to react or overreact emotionally


• swelling of feet or lower legs


• unusual bleeding


• unusual tiredness


• yellow skin or eyes (occurring with fluoxymesterone or methyltestosterone more often than with testosterone)

For females with breast cancer or bedridden males or females—in addition to the side effects listed above

• Confusion or mental depression


• constipation


• increased thirst


• increased urge to urinate or increased amount of urine

For males only

• Black, tarry stools


• burning sensation or hardening or thickening of skin under patch


• chills


• continuing pain at site of implants


• difficulty in urinating


• itching, skin redness, or rash under patch, severe (less likely with nonscrotal patch)


• pain in scrotum or groin


• vomiting of blood or material that looks like coffee grounds

RareFor males or females—more likely with oral androgens or long-term or high doses of androgens

• Abdominal or stomach pain, continuing


• bad breath odor, continuing


• black, tarry or light-colored stools or dark urine


• fever


• hives


• loss of appetite, continuing


• mood or mental changes


• purple or red spots on body or inside the mouth or nose


• sore throat


• swelling, pain, or tenderness of abdomen


• vomiting of blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less commonFor males and females

• Acne, mild


• decrease or increase in sexual desire or drive


• diarrhea


• hair loss or thinning of hair


• increase in pubic hair growth


• infection, pain, redness, or other irritation at site of injection


• nervousness


• stomach pain


• trouble in sleeping

For males only

• Decrease in testicle size


• infection, pain, redness, swelling, sores, or other skin irritation underneath patch

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.

Immunine Stim Plus

Immunine Stim Plus may be available in the countries listed below.

Ingredient matches for Immunine Stim Plus

Coagulation Factor IX, Human

Coagulation Factor IX, Human is reported as an ingredient of Immunine Stim Plus in the following countries:

• Germany


• Spain

International Drug Name Search

topotecan

toe-poe-TEE-kan

Oral route(Capsule)

Topotecan hydrochloride should be administered only to patients with baseline neutrophil counts of at least 1500 cells/mm(3) and a platelet count of at least 100,000 cells/mm(3). In order to assess the occurrence of bone marrow suppression, blood cell counts should be monitored .

Commonly used brand name(s)

In the U.S.

• Hycamtin

Available Dosage Forms:

• Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Topoisomerase I Inhibitor

Uses For topotecan

Topotecan is used to treat small cell lung cancer that has relapsed or gotten worse. It belongs to the group of medicines known as antineoplastics or cancer medicines.

Topotecan interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other unwanted effects may occur. Some of these may be serious and must be reported to your doctor. Some effects, like hair loss, may not be serious but may cause concern. Some unwanted effects may occur after treatment with topotecan has stopped.

topotecan is available only with your doctor's prescription.

Before Using topotecan

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For topotecan, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to topotecan or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of topotecan in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of topotecan in the elderly. However, elderly patients are more likely to have diarrhea and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving topotecan.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking topotecan, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using topotecan with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using topotecan with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Bacillus of Calmette and Guerin Vaccine, Live


• Carboplatin


• Cisplatin


• Cyclosporine


• Filgrastim


• Influenza Virus Vaccine, Live


• Ketoconazole


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Ritonavir


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Saquinavir


• Smallpox Vaccine


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of topotecan. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow depression, severe—Should not be used in patients with this condition.

• Interstitial lung disease (a serious lung problem), history of—Use with caution. May make this condition worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of topotecan

Medicines used to treat cancer are very strong and can have many side effects. Before receiving topotecan, make sure you understand all of the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take topotecan only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Swallow the capsule whole with water. Do not open, crush, break, or chew it.

You may take topotecan with or without food.

Be careful not to handle broken or leaking capsules. If you get the contents from the capsule on your skin, wash the area with soap and water and call your doctor right away. If the medicine gets in your eyes, rinse them immediately with gently flowing water for at least 15 minutes and call your doctor right away.

Topotecan often causes nausea and vomiting. It is very important that you continue to receive the medicine even if it makes you feel ill. Ask your doctor for ways to lessen these effects.

Dosing

The dose of topotecan will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of topotecan. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  
  • For small cell lung cancer:
    
    • Adults—Dose is based on body size and must be determined by your doctor. The dose is 2.3 milligrams per square meter of body surface area once a day for 5 days. Your dose will be repeated every 21 days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of topotecan, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you vomit after taking your medicine, call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using topotecan

It is very important that your doctor check your progress at regular visits to make sure topotecan is working properly. Blood tests are needed to check for unwanted effects.

Using topotecan while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Topotecan can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor right away if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

Topotecan may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

topotecan may cause some people to become more tired or weaker than they are normally. If either of these side effects occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert.

Stop using topotecan and check with your doctor right away if you have breathing problems, a cough, a fever, a fast heartbeat, or shortness of breath. These could be symptoms of a serious lung problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

topotecan Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Black, tarry stools


• bleeding gums


• blood in the urine or stools


• chest pain


• chills


• cough


• fever


• lower back or side pain


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


• shortness of breath


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• swollen glands


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea


• hair loss or thinning of the hair


• lack or loss of strength


• loss of appetite


• nausea


• vomiting


• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: topotecan side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More topotecan resources

• Topotecan Side Effects (in more detail)
• Topotecan Dosage
• Topotecan Use in Pregnancy & Breastfeeding
• Topotecan Drug Interactions
• Topotecan Support Group
• 0 Reviews for Topotecan - Add your own review/rating

• topotecan Concise Consumer Information (Cerner Multum)


• Topotecan Prescribing Information (FDA)


• Topotecan MedFacts Consumer Leaflet (Wolters Kluwer)


• Hycamtin Monograph (AHFS DI)


• Hycamtin Prescribing Information (FDA)

Compare topotecan with other medications

• Cancer
• Cervical Cancer
• Ovarian Cancer
• Small Cell Lung Cancer

Iopathek

Iopathek may be available in the countries listed below.

Ingredient matches for Iopathek

Iopamidol

Iopamidol is reported as an ingredient of Iopathek in the following countries:

• Germany

International Drug Name Search

Ictammolo Nova Argentia

Ictammolo Nova Argentia may be available in the countries listed below.

Ingredient matches for Ictammolo Nova Argentia

Ichthammol

Ichthammol is reported as an ingredient of Ictammolo Nova Argentia in the following countries:

• Italy

International Drug Name Search

Ibuprofeno Marfan

Ibuprofeno Marfan may be available in the countries listed below.

Ingredient matches for Ibuprofeno Marfan

Ibuprofen

Ibuprofen is reported as an ingredient of Ibuprofeno Marfan in the following countries:

• Peru

International Drug Name Search

Azo-Gesic

Generic Name: phenazopyridine (fen AY zoe PIR i deen)

Brand Names: Azo-Gesic, Azo-Standard, Baridium, Phenazo, Prodium, Pyridiate, Pyridium, Re-Azo, Uricalm, Uristat

What is Azo-Gesic (phenazopyridine)?

Phenazopyridine is a pain reliever that affects the lower part of your urinary tract (bladder and urethra).

Phenazopyridine is used to treat pain, burning, increased urination, and increased urge to urinate. These symptoms are usually caused by infection, injury, surgery, catheter, or other conditions that irritate the lower urinary tract.

Phenazopyridine will treat the symptoms of a urinary tract infection, but this medication does not treat the actual infection. Take any antibiotic that your doctor prescribes to treat your infection.

Phenazopyridine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Azo-Gesic (phenazopyridine)?

Do not take this medication if you are allergic to phenazopyridine, or if you have kidney disease. Phenazopyridine will treat the symptoms of a urinary tract infection, but this medication does not treat the actual infection. Take any antibiotic that your doctor prescribes to treat your infection. To avoid stomach upset, take phenazopyridine with food.

Phenazopyridine will most likely darken the color of your urine to an orange or red color. This is a normal effect and is not cause for alarm unless you have other symptoms such as pale or yellowed skin, fever, stomach pain, nausea, and vomiting. Darkened urine may also cause stains to your underwear, which may or may not be removed by laundering.

Phenazopyridine can also permanently stain soft contact lenses, and you should not wear them while taking this medicine.

Do not use phenazopyridine for longer than 2 days unless your doctor has told you to.

Stop taking this medication and call your doctor at once if you have pale skin, fever, confusion, yellowing of your skin or eyes, increased thirst, swelling, or if you urinate less than usual or not at all.

What should I discuss with my health care provider before taking Azo-Gesic (phenazopyridine)?

Do not take this medication if you are allergic to phenazopyridine, or if you have kidney disease.

Before using phenazopyridine, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  liver disease;

  
  


• 
  

  diabetes; or

  
  


• 
  

  a condition called G6PD (glucose-6-phosphate dehydrogenase) deficiency.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take phenazopyridine.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether phenazopyridine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Azo-Gesic (phenazopyridine)?

Take phenazopyridine exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medicine with a full glass of water. To avoid stomach upset, take phenazopyridine with food.

Phenazopyridine will most likely darken the color of your urine to an orange or red color. This is a normal effect and is not cause for alarm unless you have other symptoms such as pale or yellowed skin, fever, stomach pain, nausea, and vomiting. Darkened urine may also cause stains to your underwear, which may or may not be removed by laundering.

Phenazopyridine can also permanently stain soft contact lenses, and you should not wear them while taking this medicine.

Do not use phenazopyridine for longer than 2 days unless your doctor has told you to.

This medication can cause you to have false results with glucose or ketone urine tests. Tell any doctor who treats you that you are using phenazopyridine.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include yellowed skin, fever, confusion, weakness, urinating less than usual, nausea, vomiting, swelling, numbness, or blue-colored skin.

What should I avoid while taking Azo-Gesic (phenazopyridine)?

Avoid wearing soft contact lenses while you are taking phenazopyridine. The medication can cause permanent staining of soft contact lenses.

Azo-Gesic (phenazopyridine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using phenazopyridine and call your doctor at once if you have any of these serious side effects:

• 
  

  pale skin, fever, confusion or weakness;

  
  


• 
  

  jaundice (yellowing of your skin or eyes);

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

  
  


• 
  

  swelling, weight gain, feeling short of breath; or

  
  


• 
  

  blue or purple coloring in your skin.

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  dizziness;

  
  


• 
  

  stomach pain, upset stomach; or

  
  


• 
  

  skin itching.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Azo-Gesic (phenazopyridine)?

There may be other drugs that can interact with phenazopyridine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Azo-Gesic resources

• Azo-Gesic Side Effects (in more detail)
• Azo-Gesic Use in Pregnancy & Breastfeeding
• Azo-Gesic Drug Interactions
• Azo-Gesic Support Group
• 0 Reviews for Azo-Gesic - Add your own review/rating

• Azo-Gesic Advanced Consumer (Micromedex) - Includes Dosage Information


• Azo-Gesic MedFacts Consumer Leaflet (Wolters Kluwer)


• Phenazopyridine Hydrochloride Monograph (AHFS DI)


• Pyridium Consumer Overview

Compare Azo-Gesic with other medications

• Dysuria
• Interstitial Cystitis

Where can I get more information?

• Your pharmacist can provide more information about phenazopyridine.

See also: Azo-Gesic side effects (in more detail)

Otrivine Adult Measured Dose Sinusitis Spray

1. Name Of The Medicinal Product

Otrivine^® Adult Measured Dose Sinusitis Spray

Otrivine^® Adult Metered Dose 0.1% Nasal Spray

2. Qualitative And Quantitative Composition

Active ingredient: 0.1% w/v Xylometazoline Hydrochloride

For excipients see 6.1

3. Pharmaceutical Form

Nasal spray, solution

A clear, colourless solution

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of nasal congestion, perennial and allergic rhinitis (including hay fever), sinusitis.

4.2 Posology And Method Of Administration

Adults and elderly: One application in each nostril 1 to 3 times daily.

Not suitable for children under 12 years.

Route of administration: Application to the nasal passages.

4.3 Contraindications

Known hypersensitivity to xylometazoline.

Patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater.

4.4 Special Warnings And Precautions For Use

Patients are advised not to take decongestants for more than seven consecutive days. Otrivine, like other preparations belonging to the same class of active substances, should be used only with caution in patients showing a strong reaction to sympathomimetic agents as evidenced by signs of insomnia, dizziness etc.

Label warnings and precautions

• Do not exceed the stated dose

• Do not use continuously for more than seven consecutive days. If symptoms persist, consult your doctor

• If you are pregnant or taking other medicines, or are under a doctor's care, consult your doctor before using Otrivine

• Not to be used for infants or children under 12 years

• Each Otrivine pack should be used by one person only to prevent any cross infection

• For reasons of hygiene do not use this bottle for more than 28 days after first opening it

• Keep medicines out of the reach of children

Additional leaflet warnings and precautions

• Do not use if you are sensitive to any of the ingredients of Otrivine

• Do not use if you have had recent neurosurgery

• Consult your doctor before using Otrivine if you have heart or circulatory disease

• Some patients who have sensitive nasal passages may feel some local discomfort when applying the product. Other side effects such as palpitations, nausea and headache are very rare

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None

4.6 Pregnancy And Lactation

No foetal toxicity or fertility studies have been carried out in animals. In view of its potential systemic vasoconstrictor effect, it is advisable to take the precaution of not using Otrivine during pregnancy.

Label warning: If you are pregnant or taking any other medicines, or are under a doctor's care, consult him before using Otrivine.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

The following side effects have occasionally been encountered: A burning sensation in the nose and throat, local irritation, nausea, headache, and dryness of the nasal mucosa.

Systemic cardiovascular effects have occurred, and this should be kept in mind when giving Otrivine to people with cardiovascular disease.

4.9 Overdose

No cases of overdosage in adults have yet been reported. In rare instances of accidental poisoning in children, the clinical picture has been marked chiefly by signs such as acceleration and irregularity of the pulse, elevated blood pressure, drowsiness, respiratory depression or irregularity. There is no specific treatment and appropriate supportive treatment should be initiated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Otrivine Adult Measured Dose Sinusitis Spray is a sympathomimetic agent with marked alpha-adrenergic activity, and is intended for use in the nose. It constricts the nasal blood vessels, thereby decongesting the mucosa of the nose and neighbouring regions of the pharynx. This enables patients suffering from colds to breathe more easily through the nose. The effect of Otrivine Adult Measured Dose Sinusitis Spray begins within a few minutes and lasts for up to 10 hours. Otrivine Adult Measured Dose Sinusitis Spray is generally well tolerated and does not impair the function of ciliated epithelium.

In a double-blind, saline solution (Otrisal) controlled study in patients with common cold, the decongestant effect of Otrivin was significantly superior (p<0.0001) to Otrisal saline solution based on rhinomanometry measurement at 1 hour after administration of the study drugs.

5.2 Pharmacokinetic Properties

Systemic absorption may occur following nasal application of xylometazoline hydrochloride solutions. It is not used systemically.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Benzalkonium chloride

Disodium phosphate dodecahydrate (Sodium phosphate)

Disodium edetate

Sodium dihydrogen phosphate dihydrate (Sodium acid phosphate)

Sodium chloride

Sorbitol

Hypromellose

Purified water

6.2 Incompatibilities

None

6.3 Shelf Life

Unopened: 36 months

Opened: 28 days

6.4 Special Precautions For Storage

No special precautions.

6.5 Nature And Contents Of Container

High density polyethylene bottle with a polypropylene/polyethylene metered dose pump in a cardboard carton.

Pack size 10 ml.

6.6 Special Precautions For Disposal And Other Handling

Medicines should be kept out of the reach of children.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

Trading as: Novartis Consumer Health

8. Marketing Authorisation Number(S)

PL 00030/0117

9. Date Of First Authorisation/Renewal Of The Authorisation

First Authorisation: 1^st October 1997

10. Date Of Revision Of The Text

4 March 2010

LEGAL STATUS

GSL

Intelence

In the US, Intelence (etravirine systemic) is a member of the drug class NNRTIs and is used to treat HIV Infection.

US matches:

• Intelence

Ingredient matches for Intelence

Etravirine

Etravirine is reported as an ingredient of Intelence in the following countries:

• Australia


• Austria


• Canada


• France


• Germany


• Ireland


• Luxembourg


• Spain


• Sweden


• Switzerland


• United Kingdom


• United States

International Drug Name Search

Henoch-Schonlein Purpura Medications

There are currently no drugs listed for "Henoch-Schonlein Purpura".

Definition of Henoch-Schonlein Purpura: A group of conditions including purpura (purple spots on the skin), joint pain, gastrointestinal symptoms, and glomerulonephritis (a type of kidney disorder).

Learn more about Henoch-Schonlein Purpura

Medical Encyclopedia:

• Henoch-Schonlein purpura

Drug List:

Ilaten

Ilaten may be available in the countries listed below.

Ingredient matches for Ilaten

Atenolol

Atenolol is reported as an ingredient of Ilaten in the following countries:

• Argentina

International Drug Name Search

ProQuad

Generic Name: measles, mumps, rubella and varicella virus vaccine (MEE zels, MUMPS, roo BEL a, var i SEL a)

Brand Names: ProQuad

What is measles, mumps, rubella, and varicella virus vaccine?

Measles, mumps, rubella, and varicella are serious diseases caused by viruses. They are spread from person to person through the air.

Measles virus can cause minor symptoms such as skin rash, cough, runny nose, eye irritation, or mild fever. It can also cause more serious symptoms such as ear infection, pneumonia, seizures, permanent brain damage, or death.

Mumps virus causes fever, headache, and swollen glands, but more serious symptoms include hearing loss, and painful swelling of the testicles or ovaries. Mumps can cause breathing problems or meningitis, and these infections can be fatal.

Rubella virus (also called German Measles) causes skin rash, mild fever, and joint pain. Becoming infected with rubella during pregnancy can result in a miscarriage or serious birth defects.

Varicella (commonly known as chickenpox) is a common childhood disease that causes fever, skin rash, and a breakout of fluid-filled blisters on the skin. Most people who receive this vaccine will not get chickenpox, or will get only a mild case and will recover faster. Chickenpox is usually mild, but it can be serious or even fatal in young infants and in adults. It can lead to severe skin infection, breathing problems, brain damage, or death. A person who has had chickenpox can develop herpes zoster (also called shingles) later in life, which causes severe nerve pain, and hearing or vision problems, which may last for months or years.

Measles, mumps, rubella, and varicella are spread from person to person.

The measles, mumps, rubella, and varicella vaccine is used to help prevent these diseases in children. This vaccine works by exposing your child to a small dose of the virus or a protein from the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Measles, mumps, rubella, and varicella vaccine is for use in children between the ages of 12 months and 12 years old.

Like any vaccine, the measles, mumps, rubella, and varicella vaccine may not provide protection from disease in every person.

What is the most important information I should know about this vaccine?

The measles, mumps, rubella, and varicella vaccine is usually given only once when the child is between 12 months and 12 years old. If a booster dose is needed, At least 3 months should pass between the first and second doses of this vaccine.

Your child should not receive a booster vaccine if he or she had a life threatening allergic reaction after the first shot. Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine. Keep track of any and all side effects your child has after receiving this vaccine. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, rubella, or varicella is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Do not give your child salicylates such as aspirin, Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others for at least 6 weeks after receiving this vaccine. A serious condition called Reye's Syndrome has been reported in patients with chickenpox who take aspirin or salicylates.

What should I discuss with my healthcare provider before receiving this vaccine?

Your child should not receive this vaccine if he or she is allergic to eggs, gelatin, or neomycin (Mycifradin, Neo-Fradin, Neo-Tab), or if the child has ever had a life-threatening allergic reaction to any vaccine containing measles, mumps, rubella, or varicella.

Your child should also not receive this vaccine if he or she has:

• 
  

  active tuberculosis infection;

  
  


• 
  

  a cancer such as leukemia or lymphoma;

  
  


• 
  

  a history of Guillain-Barré syndrome;

  
  


• 
  

  a chronic disease such as asthma or other breathing disorder, diabetes, kidney disease, or a blood cell disorder such as anemia;

  
  


• 
  

  severe immune suppression caused by disease (such as cancer, HIV, or AIDS), or by receiving certain medicines such as steroids, chemotherapy or radiation;

  
  


• 
  

  if the child has recently taken aspirin or other similar medicines such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others;

  
  


• 
  

  if the child has recently received a stem cell transplant;

  
  


• 
  

  if someone in the child's household has a weak immune system; or

  
  


• 
  

  if the child is pregnant.

  
  

If your child has any of these other conditions, this vaccine may need to be postponed or not given at all:

• 
  

  thrombocytopenia purpura (easy bruising or bleeding);

  
  


• 
  

  a history of seizures;

  
  


• 
  

  a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);

  
  


• 
  

  a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments;

  
  


• 
  

  if the child has received an immune globulin or other blood product within the past year; or

  
  


• 
  

  if the child has received a measles, mumps, and rubella (MMR) vaccine within the past 28 days (4 weeks).

  
  

Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Pregnant women should wait to get this vaccine until after they have given birth. Women should not get pregnant for 3 months after getting the vaccine. A woman should not receive this vaccine without telling the doctor if she is breast-feeding a baby.

How is this vaccine given?

This vaccine is given as an injection under the skin. You will receive this injection in a doctor's office or clinic setting.

The measles, mumps, rubella, and varicella vaccine is usually given only once when the child is between 12 months and 12 years old. If a booster dose is needed, At least 3 months should pass between the first and second doses of this vaccine.

Your child's booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.

Your doctor may recommend treating fever and pain with an aspirin free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

This vaccine can cause false results on a skin test for tuberculosis for up to 6 weeks. Tell any doctor who treats you if you have received this vaccine within the past 4 to 6 weeks.

What happens if I miss a dose?

Since this vaccine is usually given only once, you are not likely to miss a dose. Contact your doctor if you do not receive all recommended doses.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine?

Your child should not receive another "live" vaccine for at least 4 weeks after receiving the measles, mumps, rubella, and varicella vaccine. The other live vaccine may not work as well during this time, and may not fully protect your child from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Do not give your child salicylates such as aspirin, Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others for at least 6 weeks after receiving this vaccine. A serious condition called Reye's Syndrome has been reported in patients with chickenpox who take aspirin or salicylates.

This vaccine side effects

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects your child has after receiving this vaccine. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, rubella, or varicella is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if your child has any of these serious side effects:

• 
  

  problems with hearing or vision;

  
  


• 
  

  extreme drowsiness, fainting;

  
  


• 
  

  fussiness, irritability, crying for an hour or longer;

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  seizure (black-out or convulsions); or

  
  


• 
  

  high fever (within a few hours or a few days after the vaccine).

  
  

Less serious side effects include:

• 
  

  redness, pain, swelling, or a lump where the shot was given;

  
  


• 
  

  headache, dizziness;

  
  


• 
  

  low fever, joint or muscle pain; or

  
  


• 
  

  nausea, vomiting, diarrhea.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What other drugs will affect measles, mumps, rubella, and varicella virus vaccine?

Before receiving this vaccine, tell the doctor about all other vaccines your child has recently received.

Also tell the doctor if your child has recently received drugs or treatments that can weaken the immune system, including:

• 
  

  an oral, nasal, inhaled, or injectable steroid medicine;

  
  


• 
  

  medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), etanercept (Enbrel), leflunomide (Arava), and others; or

  
  


• 
  

  medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

  
  

If your child is receiving any of these medications, he or she may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

This list is not complete and other drugs may interact with this vaccine. Tell your doctor about all medications your child receives. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More ProQuad resources

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• Your doctor or pharmacist can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.

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Indapamide SR

Indapamide SR may be available in the countries listed below.

Ingredient matches for Indapamide SR

Indapamide

Indapamide is reported as an ingredient of Indapamide SR in the following countries:

• Lithuania


• Netherlands

Indapamide hemihydrate (a derivative of Indapamide) is reported as an ingredient of Indapamide SR in the following countries:

• Estonia

International Drug Name Search

Impromen decanoas

Impromen decanoas may be available in the countries listed below.

Ingredient matches for Impromen decanoas

Bromperidol

Bromperidol decanoate (a derivative of Bromperidol) is reported as an ingredient of Impromen decanoas in the following countries:

• Luxembourg


• Netherlands

International Drug Name Search

Losartan potassium 25mg film-coated tablets

1. Name Of The Medicinal Product

Losartan potassium 25 mg film-coated tablets

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 25 mg losartan potassium, equivalent to 22.9 mg losartan

Excipient:

Losartan 25 mg film-coated tablets: lactose

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablets

White, oval-shaped, film-coated tablet with score line on both sides. The film-coated tablet can be divided into equal halves.

4. Clinical Particulars

4.1 Therapeutic Indications

• Treatment of essential hypertension in adults and in children and adolescents 6-18 years of age.

• Treatment of chronic heart failure (in patients especially cough, or contraindication. Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan. The patients should have a left ventricular ejection fraction

4.2 Posology And Method Of Administration

Losartan tablets should be swallowed with a glass of water

Losartan tablets may be administered with or without food.

Hypertension

The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy. Some patients may receive an additional benefit by increasing the dose to 100 mg once daily (in the morning). Losartan may be administered with other antihypertensive agents, especially with diuretics (e.g. hydrochlorothiazide).

Heart Failure

The usual initial dose of Losartan in patients with heart failure is 12.5 mg once daily. The dose should generally be titrated at weekly intervals (i.e. 12.5 mg daily, 25 mg daily, 50 mg daily) to the usual maintenance dose of 50 mg once daily, as tolerated by the patient.

Special populations:

Use in patients with intravascular volume depletion:

For patients with intravascular volume-depletion (e.g. those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered (see section 4.4).

Use in patients with renal impairment and haemodialysis patients:

No initial dosage adjustment is necessary in patients with renal impairment and in haemodialysis patients.

Use in patients with hepatic impairment

A lower dose should be considered for patients with a history of hepatic impairment. There is no therapeutic experience in patients with severe hepatic impairment. Therefore, losartan is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).

Use in paediatric patients

There are limited data on the efficacy and safety of losartan in children and adolescents aged 6-18 years old for the treatment of hypertension (see section 5.1). Limited pharmacokinetic data are available in hypertensive children above one month of age (see section 5.2).

For patients who can swallow tablets, the recommended dose is 25 mg once daily in patients>20 to <50 kg. In exceptional cases the dose can be increased to a maximum of 50 mg once daily. Dosage should be adjusted according to blood pressure response.

In patients>50 kg, the usual dose is 50 mg once daily. In exceptional cases the dose can be adjusted to a maximum of 100 mg once daily. Doses above 1.4 mg/kg (or in excess of 100 mg) daily have not been studied in paediatric patients.

Losartan is not recommended for use in children under 6 years old, as limited data are available in these patient groups.

It is not recommended in children with glomerular filtration rate < 30 ml/min / 1.73 m², as no data are available (see also section 4.4).

Losartan is also not recommended in children with hepatic impairment (see also section 4.4).

Use in the elderly

Although consideration should be given to initiating therapy with 25 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients (see section 4.4 and 6.1)

Second and third trimesters of pregnancy (see section 4.4 and 4.6)

Severe hepatic impairment

4.4 Special Warnings And Precautions For Use

Hypersensitivity

Angiooedema. Patients with a history of angiooedema (swelling of the face, lips, throat, and/or tongue) should be closely monitored (see section 4.8).

Hypotension and Electrolyte/Fluid Imbalance

Symptomatic hypotension, especially after the first dose and after increasing of the dose, may occur in patients who are volume- and/or sodium-depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. These conditions should be corrected prior to administration of Losartan; or a lower starting dose should be used (see section 4. 2). This also applies to children.

Electrolyte imbalances

Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed. In a clinical study conducted in type 2 diabetic patients with nephropathy, the incidence of hyperkalemia was higher in the group treated with Losartan as compared to the placebo group (see section 4.8) Therefore, the plasma concentrations of potassium as well as creatinine clearance values should be closely monitored, in particular, patients with heart failure and a creatinine Clearance between 30-50 ml/min should be closely monitored.

The concomitant use of potassium sparing diuretics, potassium supplements and potassium containing salt substitutes with losartan is not recommended (sec section 4.5).

Liver HepaticImpairment

Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, a lower dose should be considered for patients with a history of hepatic impairment. There is no therapeutic experience with losartan in patients with severe hepatic impairment. Therefore losartan must not be administered in patients with severe hepatic impairment (see sections 4.2, 4.3 and 5.2).

Losartan is also not recommended in children with hepatic impairment (see section 4.2).

Renal Impairment

As a consequence of inhibiting the renin-angiotensin system, changes in renal function including renal failure have been reported (in particular, in patients whose renal function is dependent on the renin angiotensin aldosterone system such as those with severe cardiac insufficiency or pre-existing renal dysfunction). As with other drugs that affect the renin-angiotensin-aldosterone system, increases in blood urea and serum creatinine have also been reported in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; these changes in renal function may be reversible upon discontinuation of therapy. Losartan should be used with caution in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney.

Use in paediatric patients with renal function impairment

Losartan is not recommended in children with glomerular filtration rate < 30ml/min/1.73 m² as no data are available (see section 4.2).

Renal function should be regularly monitored during treatment with losartan as it may deteriorate. This applies particularly when losartan is given in the presence of other conditions (fever, dehydration) likely to impair renal function.

Concomitant use of losartan and ACE-inhibitors has shown to impair renal function. Therefore, concomitant use is not recommended.

Renal transplantation

There is no experience in patients with recent kidney transplantation.

Primary hyperaldosteronism

Patients with primary aldosteronism generally will not respond to antihypertensive medicinal productsacting through inhibition of the renin-angiotensin system. Therefore, the use of Losartan tablets is not recommended.

Coronary heart disease and cerebrovascular disease

As with any antihypertensive agents, excessive blood pressure decrease in patients with ischaemic cardiovascular and cerebrovascular disease could result in a myocardial infarction or stroke.

Heart failure

In patients with heart failure, with or without renal impairment, there is - as with other medicinal products acting on the renin-angiotensin system - a risk of severe arterial hypotension, and (often acute) renal impairment.

There is no sufficient therapeutic experience with losartan in patients with heart failure and concomitant severe renal impairment, in patients with severe heart failure (NYHA class IV) as well as in patients with heart failure and symptomatic life threatening cardiac arrhythmias. Therefore, losartan should be used with caution in these patient groups. The combination of losartan with a beta-blocker should be used with caution (see section 5.1).

Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy

As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.

Excipients

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Pregnancy

AIIRAs should not be initiated during pregnancy. Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).

Other warnings and precautions:

As observed for antiotensin converting enzyme inhibitors, losartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Other antihypertensive agents may increase the hypotensive effects of losartan. Concomitant use withother substances inducing hypotension (like tricyclic antidepressants, antipsychotics, baclofen, and amifostine), may increase the risk of hypotension.

Losartan is predominantly metabolised by cytochrome P450 (CYP) 2C9 to the active carboxy-acid metabolite. In a clinical trial it was found that fluconazole (inhibitor of CYP2C9) decreases the exposure to the active metabolite by approximately 50%. It was found that concomitant treatment of losartan with rifampicine (inducer of metabolism enzymes) gave a 40% reduction in plasma concentration of the active metabolite. The clinical relevance of this effects is unknown. No difference in exposure was found with concomitantly treatment with fluvastatin (weak inhibitor of CYP2C9).

As with other drugs that block angiotensin II or its effects, concomitant use of other drugs which retain potassium (e.g. potassium-sparing diuretics: amiloride, triamteren, spironolactone) or may increase potassium levels (e.g. heparin), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium. Co-medication is not advisable.

Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors. Very rare cases have also been reported with angiotensin II receptor antagonists. Co-administration of lithium and losartan should be undertaken with caution. If this combination proves essential, serum lithium level monitoring is recommended during concomitant use.

When angiotensin II antagonists are administered simultaniously with NSAIDs (i.e. selective COX-2 inhibitors, acetylsalicylic acid at anti-inflammatory dosesand non-selective NSAIDs), attenuation of the antihypertensive effect may occur. Concomitant use of angiotensin II antagonists or diuretics and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function. The combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.

4.6 Pregnancy And Lactation

Pregnancy

The use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4).The use of AIIRAs is contra-indicated during the 2nd and 3rd trimesters of pregnancy (see section 4.3 and 4.4).

Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors ( AIIRAs), similar risks may exist for this class of drugs. Unless continued AIIRA-therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.

Exposure to AIIRA therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).

Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.

Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see section 4.3 and 4.4).

Lactation

Because no information is availabel regarding the use of Losartan during breastfeeding, Losartan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed.

However, when driving vehicles or operating machinery it must be borne in mind that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy, in particular during initiation of treatment or when the dose is increased.

4.8 Undesirable Effects

Losartan has been evaluated in clinical studies as follows:

• In controlled clinical trials in approximately 3300 adult patients 18 years of age and older for essential hypertension

• In a controlled clinical trial in 9193 hypertensive patients 55 to 80 years of age with left ventricular hypertrophy

• In a controlled clinical trial in approximately 3900 patients 20 years of age and older with chronic heart failure

• In a controlled clinical trial in 1513 type 2 diabetic patients 31 years of age and older with proteinuria

• In a controlled clinical trial in 177 hypertensive pediatric patients 6 to 16 years of age

In these clinical trials, the most common adverse event was dizziness.

The frequency of adverse events listed below is defined using the following convention:

very common (

In controlled clinical trials for essential hypertension , hypertensive patients with left ventricular hypertrophy, chronic heart failure as well as for hypertension and type 2 diabetes mellitus with renal disease, the most common adverse event was dizziness.

Hypertension

In controlled clinical trials, of approximately 3300 adult patients 18 years of age and older, for essential hypertension with losartan the following adverse events were reported

Nervous system disorders:

Common: dizziness, vertigo

Uncommon: somnolence, headache, sleep disorders

Cardiac disorders:

Uncommon: palpitations, angina pectoris

Vascular disorders:

Uncommon: symptomatic hypotension (especially in patients with intravascular volume depletion, e.g. patients with severe heart failure or under treatment with high dose diuretics), dose-related orthostatic effects, rash

Gastrointestinal disorders:

Uncommon: abdominal pain, obstipation

General disorders and administration site conditions:

Uncommon: asthenia, fatigue, oedema

Investigations:

In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Losartan tablets. Elevations of ALT occurred rarely and usually resolved upon discontinuation of therapy. Hyperkalaemia (serum potassium>5.5 mmol/l) occurred in 1.5 % of patients in hypertension clinical trials.

Hypertensive patients with left ventricular hypertrophy

In a controlled clinical trial in 9193 hypertensive patients 55 to 80 years of age with left ventricular hypertrophy the following adverse events were reported:

Nervous system disorders:

common: dizziness

Ear and labyrinth disorders:

common: vertigo

General disorders and administration site conditions:

common: asthenia/fatigue

Chronic heart failure

In a controlled clinical trial in approximately 3900 patients 20 years of age and older with cardiac insufficiency the following adverse events were reported:

Nervous system disorders:

uncommon: dizziness, headache

rare: paraesthesia

Cardiac disorders:

rare: syncope, artrial fibrillation, cerebrovascular accident

Vascular disorders;

uncommon: hypotension, including orthostatic hypotension

Respiratory, thoracic and mediastinal disorders;

uncommon: dyspnoea

Gastrointestinal disorders;

uncommon: diarrhoea, nausea, vomiting

Skin and subcutanous tissue disorders;

uncommon: urticaria, pruritus, rash

General disorders and administration site conditions:

uncommon: asthenia/fatigue

Investigations:

uncommon: increase in blood urea, serum creatinine and serum potassium has been reported.

Hypertension and type 2 diabetes with renal disease

In a controlled clinical trial in 1513 type 2 diabetic patients 31 years of age and older with proteinuria (RENAAL study, see section 5.1) the most common drug-related adverse events which were reported for losartan are as follows:

Nervous system disorders:

common: dizziness

Vascular disorders:

common: hypotension

General disorders and administration site conditions:

common: asthenia/fatigue

Investigations:

common: hypoglycaemia, hyperkalaemia

The following adverse events occured more often in patients receiving losartan than placebo:

Blood and lymphatic system disorders:

not known: anaemia

Cardiac disorders:

not known: syncope, palpitations

Vascular disorders:

not known: orthostatic hypotension

Gastrointestinal disorders:

not known: diarrhoea

Muscoskeletal and connective tissue disorders:

not known: back pain

Renal and urinary disorders

not known: urinary tract infections

General disorders and administration site conditions:

not known: flu-like symptoms

Investigations:

In a clinical study conducted in type 2 diabetic patients with nephropathy, 9.9 % of patients treated with Losartan tablets developed hyperkalaemia>5.5 mEq/l and 3.4 % of patients treated with placebo

Post-marketing experience

The following adverse events have been reported in post-marketing experience:

Blood and lymphatic system disorders

not known: Anaemia, thrombocytopenia

Ear and labyrinth disorders:

not known: tinnitus

Immune system disorders:

rare: hypersensitivity: anaphylactic reactions, angiooedema including swelling of the larynx and glottis causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue; in some of these patients angiooedema had been reported in the past in connection with the administration of other medicines, including ACE inhibitors; vasculitis, including Henoch-Schonlein purpura.

Nervous system disorders:

not known: migraine

Respiratory, thoracic and mediastinal disorders:

not known: cough

Gastrointestinal disorders:

not known: diarrhoea, pancreatitis

General disorders and administration site conditions:

not known: malaise

Hepatobiliary disorders:

rare: hepatitis

not known: liver function abnormalities

Skin and subcutaneous tissue disorders:

not known: urticaria, pruritus, rash, photosenstivity

Muscoskeletal and connective tissue disorders:

not known: myalgia, arthralgia

Reproductive system and breast disorders:

not known: erectile dysfunction/impotence

Renal and urinary disorders:

As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function including renal failure have been reported in patients at risk; these changes in renal function may be reversible upon discontinuation of therapy (see section 4.4)

Investigations:

not known: hyponatraemia

Psychiatric disorders:

not known: depression

Paediatric population

The adverse experience profile for paediatric patients appears to be similar to that seen in adult patients. Data in the paediatric population are limited.

4.9 Overdose

Symptoms of intoxication

Limited data are available with regard to overdose in humans. The most likely symptoms, depending on the extent of overdose, are hypotension, tachycardia, possibly bradycardia.

Treatment of intoxications

If symptomatic hypotension should occur, supportive treatment should be instituted. Measures are depending on the time of drug intake and kind and severity of symptoms. Stabilisation of the circulatory system should be given priority. After oral intake the administration of a sufficient dose of activated charcoal is indicated. Afterwards, close monitoring of the vital parameters should be performed. Vital parameters should be corrected if necessary.

Neither losartan nor the active metabolite can by removed by haemodialysis.

5. Pharmacological Properties

Pharmacotherapeutic group: Angiotensin II Receptor Antagonists, ATC code: C09CA01

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Angiotensin II antagonists, plain, ATC code: C09CA01

Losartan is a synthetic oral angiotensin-II receptor (type AT₁) antagonist. Angiotensin II, a potent vasoconstrictor, is the primary active hormone of the renin-angiotensin system and an important determinant of the pathophysiology of hypertension. Angiotensin II binds to the AT₁ receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys, and the heart) and elicits several important biological actions, including vasoconstriction and the release of aldosterone. Angiotensin II also stimulates smooth-muscle cell proliferation.

Losartan selectively blocks the AT1 receptor. In vitro and in vivo, both losartan and its pharmacologically active carboxylic acid metabolite E-3174 block all physiologically relevant actions of angiotensin II, regardless of its source or route of synthesis.

Losartan does not have an agonist effect, nor does it block other hormone receptors or ion channels important in cardiovascular regulation. Furthermore, losartan does not inhibit ACE (kininase II), the enzyme that degrades bradykinin. Consequently, there is no potentiation of undesirable bradykinin-mediated effects.

During administration of losartan, removal of angiotensin II negative feedback on renin secretion leads to increased plasma-renin activity (PRA). Increases in PRA lead to increases in angiotensin II in plasma. Despite these increases, antihypertensive activity and suppression of plasma aldosterone concentration are maintained, indicating effective angiotensin II receptor blockade. After discontinuation of losartan, PRA and angiotensin II values fell within three days to baseline values.

Both losartan and its principal active metabolite have a far greater affinity for the AT1 receptor than for the AT2 receptor. The active metabolite is 10 to 40 times more effective than losartan on a weight for weight basis.

Hypertension studies

In controlled clinical studies, once-daily administration of losartan to patients with mild to moderate essential hypertension produced statistically significant reductions in systolic and diastolic blood pressure. Measurement of blood pressure 24 hours post-dose relative to 5-6 hours post-dose demonstrated blood pressure reduction over 24 hours; the natural diurnal rhythm was retained. Blood-pressure reduction at the end of the dosing interval was approximately 70-80% of the effect seen 5-6 hours post-dose.

Discontinuation of losartan in hypertensive patients did not result in an abrupt rise in blood pressure (rebound). Despite the marked decrease in blood pressure, losartan had no clinically significant effect on heart rate.

Losartan is equally effective in males and females, and in younger (below the age of 65 years) and older hypertensive patients.

ELITE I and ELITE II Study

In the ELITE Study carried out over 48 weeks in 722 patients with heart failure (NYHA Class II-IV, no difference was observed between the patients treated with Losartan and those treated with captopril was observed with regard to the primary endpoint of a long-term change in renal function. The observation of the ELITE I Study was that, compared with captopril, Losartan reduced the mortality risk, was not confirmed in the subsequent ELITE II Study.

In the ELITE II Study Losartan 50 mg once daily (starting dose 12.5 mg, increased to 25 mg, then 50 mg once daily) was compared with captopril 50 mg three times daily (starting dose 12.5 mg, increased to 25 mg and then to 50 mg three times daily). The primary endpoint of this prospective study was the all-cause mortality.

In this study 3152 patients with heart failure (NYHA Class Il-IV) were followed for almost two years (median: 1.5 years) in order to determine whether Losartan is superior to captopril in reducing all cause mortality. The primary endpoint did not show any statistically significant difference between Losartan and captopril in reducing all-cause mortality.

In both comparator-controlled (not placebo-controlled) clinical studies on patients with heart failure the tolerability of Losartan was superior to that of captopril, measured on the basis of a significantly lower rate of discontinuations of therapy on account of adverse events and a significantly lower frequency of cough.

An increased mortality was observed in ELITE II in the small subgroup (22% of all HF patients) taking beta-blockers at baseline.

Paediatric Population

The antihypertensive effect of Losartan was established in a clinical study involving 177 hypertensive paediatric patients 6 to 16 years of age with a body weight> 20 kg and a glomerular filtration rate> 30 ml/min/1.73 m². Patients who weighed>20kg to < 50 kg received either 2.5, 25 or 50 mg of losartan daily and patients who weighed> 50 kg received either 5, 50 or 100 mg of losartan daily. At the end of three weeks, losartan administration once daily lowered trough blood pressure in a dose-dependent manner.

Overall, there was a dose-response. The dose-response relationship became very obvious in the low dose group compared to the middle dose group (period I: -6.2 mmHg vs. -11.65 mmHg), but was attenuated when comparing the middle dose group with the high dose group (period I: -11.65 mmHg vs. -12.21 mmHg). The lowest doses studied, 2.5 mg and 5 mg, corresponding to an average daily dose of 0.07 mg/kg, did not appear to offer consistent antihypertensive efficacy.

These results were confirmed during period II of the study where patients were randomized to continue losartan or placebo, after three weeks of treatment. The difference in blood pressure increase as compared to placebo was largest in the middle dose group (6.70 mm Hg middle dose vs. 5.38 mmHg high dose). The rise in trough diastolic blood pressure was the same in patients receiving placebo and in those continuing losartan at the lowest dose in each group, again suggesting that the lowest dose in each group did not have significant antihypertensive effect.

Long-term effects of losartan on growth, puberty and general development have not been studied. The long-term efficacy of antihypertensive therapy with losartan in childhood to reduce cardiovascular morbidity and mortality has also not been established.

In hypertensive (N=60) and normotensive (N=246) children with proteinuria, the effect of losartan on proteinuria was evaluated in a 12-week placebo- and active-controlled (amlodipine) clinical study. Proteinuria was defined as urinary protein/creatinine ratio of

Overall, after 12 weeks of treatment, patients receiving losartan experienced a statistically significant reduction from baseline in proteinuria of 36% versus 1% increase in placebo/amlodipine group (p

5.2 Pharmacokinetic Properties

Absorption

Following oral administration, losartan is well absorbed and undergoes first-pass metabolism, forming an active carboxylic acid metabolite and other inactive metabolites.

The systemic bioavailability of Losartan tablets is approx. 33%. Mean peak concentrations of losartan and its active metabolite are reached in 1 hour and in 3-4 hours, respectively.

Distribution

Both losartan and its active metabolite are

Biotransformation

About 14% of an intravenously or orally administered dose of losartan is converted to its active metabolite. Following oral and intravenous administration of 14C-labelled losartan potassium, circulating plasma radioactivity primarily is attributed to losartan and its active metabolite. Minimal conversion of losartan to its active metabolite was seen in about one percent of individuals studied.

In addition to the active metabolite, inactive metabolites are formed.

Elimination

Plasma clearance of losartan and its active metabolite is about 600 ml/minute and 50 ml/minute, respectively. Renal clearance of losartan and its active metabolite is about 74 ml/minute and 26 ml/minute, respectively. When losartan is administered orally, about 4% of the dose is excreted unchanged in the urine, and about 6% of the dose is excreted in the urine as active metabolite. The pharmacokinetics of losartan and its active metabolite are linear with oral losartan potassium doses up to 200 mg.

Following oral administration, plasma concentrations of losartan and its active metabolite decline polyexponentially with a terminal half-life of about 2 hours and 6-9 hours, respectively. During once-daily dosing with 100 mg, neither losartan nor its active metabolite accumulates significantly in plasma.

Both biliary and urinary excretion contribute to the elimination of losartan and its metabolites. Following an oral dose/intravenous administration of ¹⁴C-labeled losartan in man, about 35% / 43% of radioactivity is recovered in the urine and 58%/50% in the faeces.

Characteristics in patients

In elderly hypertensive patients the plasma concentrations of losartan and its active metabolite do not differ essentially from those found in young hypertensive patients.

In female hypertensive patients the plasma levels of losartan were up to twice as high as in male hypertensive patients, while the plasma levels of the active metabolite did not differ between men and women.

In patients with mild to moderate alcohol-induced hepatic cirrhosis, the plasma levels of losartan and its active metabolite after oral administration were respectively 5 and 1.7 times higher than in young male volunteers (see section 4.2 and 4.4).

Plasma concentrations of losartan are not altered in patients with creatinine clearance above 10 ml/minute. Compared to patients with normal renal function, the AUC for losartan is about two times higher in haemodialysis patients.

The plasma concentrations of the active metabolite are not altered in patients with renal impairment or in haemodialysis patients.

Neither losartan nor the active metabolite can be removed by haemodialysis.

Pharmacokinetics in paediatric patients

The pharmacokinetics of losartan have been investigated in 50 hypertensive paediatric patients> 1 month to < 16 years of age following once daily oral administration of approximately 0.54 to 0.77 mg/ kg of losartan (mean doses).

The results showed that the active metabolite is formed from losartan in all age groups. The results showed roughly similar pharmacokinetic parameters of losartan following oral administration in infants and toddlers, preschool children, school age children and adolescents. The pharmacokinetic parameters for the metabolite differed to a greater extent between the age groups. When comparing preschool children with adolescents these differences became statistically significant. Exposure in infants/toddlers was comparatively high.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of general pharmacology, genotoxicity and carcinogenic potential. In repeated dose toxicity studies, the administration of losartan induced a decrease in red blood cell parameters (erythrocytes, haemoglobin, haematocrit), a rise in urea-N in the serum and occasional rises in serum creatinine, a decrease in heart weight (without a histological correlate) and gastrointestinal changes (mucous membrane lesions, ulcers, erosions, haemorrhages). Like other substances that directly affect the renin-angiotensin system, losartan has been shown to induce adverse effects on late fetal development, resulting in fetal death and malformations.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Core:

Lactose monohydrate

Cellulose microcrystalline

Maize starch

Croscarmellose sodium

Magnesium stearate

Film-Coat (OPADRY 20A58900 white):

Hydroxypropylcellulose

Hypromellose

Titanium dioxide E171

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months

In-use shelf life for plastic bottle (HDPE): 12 weeks

6.4 Special Precautions For Storage

Do not store above 30°C.

6.5 Nature And Contents Of Container

Plastic bottle (HDPE) or blister pack (PVC/PE/PVDC blisters with aluminium foil lidding)

blister pack: 7, 14, 15, 21, 28, 30, 50, 56, 98, 70 (10X7), 280 (10 x 28) tablets

plastic bottle: 30, 50, 100 tablets

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Winthrop Pharmaceuticals UK Limited

One Onslow Street

Guildford

Surrey

GU1 4YS, UK

8. Marketing Authorisation Number(S)

PL 17780/0325

9. Date Of First Authorisation/Renewal Of The Authorisation

03/06/2008

10. Date Of Revision Of The Text

28/08/2010

LEGAL STATUS

POM