Keratol HC

Generic Name: hydrocortisone and urea topical (HYE droe KOR ti sone and yoo REE a TOP ik al)

Brand Names: Carmol HC (obs), Keratol HC (obsolete)

What is Keratol HC (hydrocortisone and urea topical)?

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Urea is a skin softener. It is used to moisturize the skin.

Hydrocortisone and urea topical is used to treat inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, or psoriasis.

Hydrocortisone and urea topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Keratol HC (hydrocortisone and urea topical)?

Use this medication exactly as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone and urea topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone and urea topical.

Hydrocortisone and urea topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

What should I discuss with my healthcare provider before using Keratol HC (hydrocortisone and urea topical)?

Do not use this medication if you are allergic to hydrocortisone.

Hydrocortisone and urea topical will not treat a bacterial, fungal, or viral skin infection.

FDA pregnancy category C. This medication may 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 hydrocortisone and urea topical 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. Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone and urea topical.

How should I use Keratol HC (hydrocortisone and urea topical)?

Use this medication exactly as it has been prescribed by your doctor. Do not use the medication in larger or smaller amounts, or use it for longer than recommended.

Wash your hands before and after each application, unless you are using this medication to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone and urea topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use hydrocortisone and urea topical regularly to get the most benefit. Store the medicine at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use 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, or if anyone has accidentally swallowed it. An overdose of hydrocortisone and urea topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using Keratol HC (hydrocortisone and urea topical)?

Do not use plastic bandages, dressings, or diapers that do not allow air to circulate to the area (occlusive dressings), unless your doctor directs you to do so. The use of occlusive dressings can greatly increase the amount of drug the body absorbs. Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use hydrocortisone and urea topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Keratol HC (hydrocortisone and urea topical) 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 this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  blurred vision, or seeing halos around lights;

  
  


• 
  

  uneven heartbeats;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  weight gain, puffiness in your face; or

  
  


• 
  

  feeling tired.

  
  

Less serious side effects may include:

• 
  

  skin redness, burning, itching, or peeling;

  
  


• 
  

  thinning of your skin;

  
  


• 
  

  blistering skin; or

  
  


• 
  

  stretch marks.

  
  

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 Keratol HC (hydrocortisone and urea topical)?

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

More Keratol HC resources

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

• Keratol HC Advanced Consumer (Micromedex) - Includes Dosage Information


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• U-cort Prescribing Information (FDA)


• Westcort Prescribing Information (FDA)

Compare Keratol HC with other medications

• Dermatological Disorders

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone and urea topical.

See also: Keratol HC side effects (in more detail)

Valvular Heart Disease Medications

Definition of Valvular Heart Disease: A general term that applies to any abnormality of one of the heart valves, tricuspid, mitral, aortic or pulmonic valves.

Topics under Valvular Heart Disease

• Aortic Insufficiency (0 drugs)

• Aortic Stenosis (2 drugs)

• Mitral Stenosis (0 drugs)

• Mitral Valve Prolapse (12 drugs)

• Prosthetic Heart Valves (77 drugs in 3 topics)

Learn more about Valvular Heart Disease

Micromedex Care Notes:

• Aortic Regurgitation
• Mitral Regurgitation
• Mitral Stenosis
• Mitral Valve Prolapse

Medical Encyclopedia:

• Aortic insufficiency
• Congenital heart disease
• Endocarditis
• Mitral regurgitation - chronic
• Mitral stenosis
• Mitral valve prolapse
• Pulmonary valve stenosis
• Rheumatic fever
• Tricuspid regurgitation

Drug List:

Trelstar LA

Generic Name: triptorelin (Intramuscular route)

trip-toe-REL-in

Commonly used brand name(s)

In the U.S.

• Trelstar


• Trelstar Depot


• Trelstar LA

Available Dosage Forms:

• Powder for Suspension

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Luteinizing Hormone Releasing Hormone Agonist

Uses For Trelstar LA

Triptorelin is used to treat advanced prostate cancer in men. It is a hormone that is similar to the one normally released from the hypothalamus gland in the brain. When given on a regular basis to men, triptorelin decreases testosterone levels which helps treat prostate cancer.

This medicine is to be given only by or under the supervision of a doctor.

Before Using Trelstar LA

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 triptorelin 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 triptorelin in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bladder blockage or


• Diabetes or


• Heart or blood vessel disease or


• Hyperglycemia (high blood sugar) or


• Spinal cord problems—Use with caution. May make these conditions worse.

• Kidney disease or


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

Proper Use of triptorelin

This section provides information on the proper use of a number of products that contain triptorelin. It may not be specific to Trelstar LA. Please read with care.

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into your muscle (usually in the buttocks). This medicine needs to be given on a fixed schedule. Make sure you keep all of your appointments.

Precautions While Using Trelstar LA

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive the medicine.

When you first start using this medicine, some of your symptoms might get worse or you might have new symptoms for a short time. Tell your doctor right away if you have bone pain, back pain, a tingling or numbness in the body, blood in the urine, or trouble urinating.

This medicine may cause changes in your blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.

This medicine may increase your risk of having a heart attack or stroke. Call your doctor right away if you have chest pain or discomfort; pain or discomfort in the arms, jaw, back, or neck; shortness of breath; nausea; sweating; or vomiting.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Trelstar LA 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 or nurse immediately if any of the following side effects occur:

Less common

• Bladder pain


• bloating or swelling of the face, arms, hands, lower legs, or feet


• bloody or cloudy urine


• blurred vision


• burning while urinating


• chest pain


• cough producing mucus


• decrease in urine volume or frequency of urination


• difficult or labored breathing


• difficult, burning, or painful urination


• difficulty in passing urine


• dizziness


• dry mouth


• flushed, dry skin


• frequent urge to urinate


• fruit-like breath odor


• headache


• high blood pressure


• increased hunger


• increased thirst


• increased urination


• loss of consciousness


• lower back or side pain


• nausea


• nervousness


• pale skin


• pounding in the ears


• rapid weight gain


• shortness of breath


• slow or fast heartbeat


• stomachache


• sweating


• tightness in the chest


• tingling of the hands or feet


• troubled breathing


• troubled breathing with exertion


• unexplained weight loss


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss


• vomiting


• wheezing

Incidence not known

• Anxiety


• changes in skin color


• changes in vision


• chest discomfort


• cold, clammy, or pale skin


• confusion


• dizziness or lightheadedness


• fainting


• inability to speak


• irregular heartbeats


• numbness or tingling in the face, arms, or legs


• pain


• pain or discomfort in the arms, jaw, back, or neck


• pain, redness, or swelling in the arm or leg


• seizures


• severe or sudden headache


• slow heart rate


• slurred speech


• sudden shortness of breath or troubled breathing


• temporary blindness


• tenderness


• trouble speaking, thinking, or walking


• weakness in the arm or leg on one side of the body, sudden and severe

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

• Bone pain


• chills


• decrease in testicle size


• diarrhea


• fever


• decreased interest in sexual intercourse


• feeling of warmth or redness of the face, neck, arms, and occasionally, upper chest


• general feeling of discomfort or illness


• inability to have or keep an erection


• joint pain


• leg pain


• loss in sexual ability, desire, drive, or performance


• loss of appetite


• muscle aches and pains


• redness of the face, neck, arms, and occasionally, upper chest


• runny nose


• shivering


• sore throat


• sudden sweating


• trouble sleeping

Less common

• Acid or sour stomach


• back pain


• belching


• body aches or pain


• breast pain


• burning, dry, or itching eyes


• congestion


• crying


• depersonalization


• difficulty having a bowel movement (stool)


• difficulty with moving


• discharge or excessive tearing


• dysphoria


• euphoria


• eye pain


• heartburn


• hoarseness


• indigestion


• injection site pain


• itching


• lack or loss of strength


• leg cramps


• loss of appetite


• mental depression


• muscle aching or cramping


• muscle pains or stiffness


• pain


• paranoia


• quick to react or overreact emotionally


• rapidly changing moods


• rash


• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid


• runny nose


• sleeplessness


• stomach discomfort, upset, or pain


• swelling of the breasts or breast soreness in both females and males


• swollen joints


• tender, swollen glands in the neck


• trouble with swallowing


• voice changes


• 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: Trelstar LA 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 Trelstar LA resources

• Trelstar LA Side Effects (in more detail)
• Trelstar LA Use in Pregnancy & Breastfeeding
• Trelstar LA Drug Interactions
• Trelstar LA Support Group
• 1 Review for Trelstar LA - Add your own review/rating

• Trelstar LA Prescribing Information (FDA)


• Trelstar LA MedFacts Consumer Leaflet (Wolters Kluwer)


• Trelstar LA Concise Consumer Information (Cerner Multum)


• Trelstar Depot Prescribing Information (FDA)


• Triptorelin Pamoate Monograph (AHFS DI)

Compare Trelstar LA with other medications

• Prostate Cancer

Kytril Tablets 1mg and 2mg

1. Name Of The Medicinal Product

Kytril Tablets 1mg and 2mg.

2. Qualitative And Quantitative Composition

Each tablet contains 1mg or 2mg granisetron (as hydrochloride).

Excipients include lactose (see section 4.3 Contraindications).

For full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated Tablet.

White triangular film-coated tablets marked 'K1' or 'K2' on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Kytril tablets are indicated for the prevention of nausea and vomiting induced by cytostatic therapy.

4.2 Posology And Method Of Administration

Adults

The dose of Kytril is 1mg twice a day or 2mg once a day during cytostatic therapy.

The first dose of Kytril should be administered within one hour before the start of cytostatic therapy.

Concomitant use of dexamethasone: The efficacy of Kytril may be enhanced by the addition of dexamethasone.

Maximum Dose and Duration of Treatment

Kytril is also available as ampoules for intravenous administration. The maximum dose of Kytril administered orally and/or intravenously over 24 hours should not exceed 9mg.

Children

There is insufficient evidence on which to base appropriate dosage regimens for children under 12 years old. Kytril Tablets are therefore not recommended in this age group.

Elderly

As for adults.

Renally Impaired

As for adults.

Hepatically Impaired

As for adults.

4.3 Contraindications

Hypersensitivity to granisetron, related substances, or the excipients (see section 6.1).

Owing to the presence of lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.4 Special Warnings And Precautions For Use

As Kytril may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following administration of Kytril.

As for other 5-HT₃ antagonists, cases of ECG modifications including QT prolongation have been reported with Kytril. These ECG changes with Kytril were minor and generally not of clinical significance, specifically with no evidence of proarrhythmia. However, in patients with pre-existing arrhythmias or cardiac conduction disorders, this might lead to clinical consequences. Therefore, caution should be exercised in patients with cardiac co-morbidities, on cardio-toxic chemotherapy and/or with concomitant electrolyte abnormalities.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In studies in healthy subjects, no evidence of any interaction has been indicated between Kytril and cimetidine or lorazepam. No evidence of drug interactions has been observed in clinical studies.

As for other 5-HT₃ antagonists, cases of ECG modifications including QT prolongation have been reported with Kytril. These ECG changes with Kytril were minor and generally not of clinical significance, specifically with no evidence of proarrhythmia. However, in patients concurrently treated with drugs known to prolong QT interval and/or are arrhythmogenic, this may lead to clinical consequences.

4.6 Pregnancy And Lactation

Whilst animal studies have shown no teratogenic effects, there is no experience of Kytril in human pregnancy. Therefore Kytril should not be administered to women who are pregnant unless there are compelling clinical reasons. There are no data on the excretion of Kytril in breast milk. Breast feeding should therefore be discontinued during therapy.

4.7 Effects On Ability To Drive And Use Machines

There has been no evidence from human studies that Kytril has any adverse effect on alertness.

4.8 Undesirable Effects

Kytril has been generally well tolerated in human studies. As reported with other drugs of this class, headache and constipation have been the most frequently noted adverse events, but the majority have been mild or moderate in nature. Rare cases of hypersensitivity reaction, occasionally severe (e.g. anaphylaxis), have been reported. Other allergic reactions including minor skin rashes have also been reported. In clinical trials, transient increases in hepatic transaminases, generally within the normal range, have been seen.

Dystonias and dyskinesias have been reported with medicines in the 5-HT₃ antagonist class. Such events have been reported rarely with Kytril.

As for other 5-HT₃ antagonists, cases of ECG modifications including QT prolongation have been reported with Kytril. These ECG changes with Kytril were minor and generally not of clinical significance, specifically with no evidence of proarrhythmia. (See section 4.4 Special Warnings and Precautions for Use and 4.5 Interactions with other Medicinal Products and other Forms of Interaction)

4.9 Overdose

There is no specific antidote for Kytril. In the case of overdosage, symptomatic treatment should be given. One patient has received 30mg of Kytril intravenously. The patient reported a slight headache but no other sequelae were observed.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Kytril is a potent anti-emetic and highly selective antagonist of 5-hydroxytryptamine (5-HT₃) receptors. Radioligand binding studies have demonstrated that Kytril has negligible affinity for other receptor types including 5-HT and dopamine D₂ binding sites.

Kytril is effective orally prophylactically in abolishing the retching and vomiting evoked by cytostatic therapy.

5.2 Pharmacokinetic Properties

General Characteristics

Absorption

Absorption of Kytril is rapid and complete, though oral bioavailability is reduced to about 60% as a result of first pass metabolism. Oral bioavailability is generally not influenced by food.

Distribution

Kytril is extensively distributed, with a mean volume of distribution of approximately 3 l/kg; plasma protein binding is approximately 65%.

Biotransformation

Biotransformation pathways involve N-demethylation and aromatic ring oxidation followed by conjugation.

Elimination

Clearance is predominantly by hepatic metabolism. Urinary excretion of unchanged Kytril averages 12% of dose whilst that of metabolites amounts to about 47% of dose. The remainder is excreted in faeces as metabolites. Mean plasma half-life in patients is approximately nine hours, with a wide inter-subject variability.

The pharmacokinetics of Kytril demonstrate no marked deviations from linear pharmacokinetics at oral doses up to 2.5-fold of the recommended clinical dose.

Characteristics in Patients

The plasma concentration of Kytril is not clearly correlated with anti-emetic efficacy. Clinical benefit may be conferred even when Kytril is not detectable in plasma.

In elderly subjects after single intravenous doses, pharmacokinetic parameters were within the range found for non-elderly subjects. In patients with severe renal failure, data indicate that pharmacokinetic parameters after a single intravenous dose are generally similar to those in normal subjects. In patients with hepatic impairment due to neoplastic liver involvement, total plasma clearance of an intravenous dose was approximately halved compared to patients without hepatic involvement. Despite these changes, no dosage adjustment is necessary.

5.3 Preclinical Safety Data

Data from two-year carcinogenicity studies have shown an increase in hepatocellular carcinoma and/or adenoma in rats and mice of both sexes given 50mg/kg (rat dosage reduced to 25mg/kg/day at week 59). Increases in hepatocellular neoplasia were also detected at 5mg/kg in male rats. In both species, drug-induced effects (hepatocellular neoplasia) were not observed in the low-dose group (1mg/kg).

In several in vitro and in vivo assays, Kytril was shown to be non-genotoxic in mammalian cells.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Microcrystalline Cellulose (E460)

Sodium Starch Glycolate

Hypromellose (E464)

Lactose monohydrate

Magnesium Stearate (E572)

Film coat :

Hypromellose (E464)

Titanium dioxide (E171)

Macrogol 400

Polysorbate 80 (E433)

6.2 Incompatibilities

None.

6.3 Shelf Life

Kytril Tablets have a shelf-life of three years.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Opaque PVC/aluminium foil blister packs packed in cartons containing 10 tablets (1mg) or 5 tablets (2mg).

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom.

8. Marketing Authorisation Number(S)

PL 00031/0591 (1mg)

PL 00031/0592 (2mg)

9. Date Of First Authorisation/Renewal Of The Authorisation

15 September 2001

10. Date Of Revision Of The Text

23 December 2009

Legal STATUS

POM

Kytril is a registered trade mark

Acetaminophen/Chlorpheniramine/Pseudoephedrine

Pronunciation: ah-seet-ah-MIN-oh-fen/klor-fen-EER-a-meen/soo-doe-e-FED-rin
Generic Name: Acetaminophen/Chlorpheniramine/Pseudoephedrine
Brand Name: Examples include Alka-Seltzer Plus Cold and Comtrex Sinus and Nasal

Acetaminophen/Chlorpheniramine/Pseudoephedrine is used for:

Relieving symptoms of colds, hay fever, and allergies such as headache, sinus pain, nasal and sinus congestion, sneezing, watery eyes, runny nose, fever, and itching of the nose or throat. It may also be used for other conditions as determined by your doctor.

Acetaminophen/Chlorpheniramine/Pseudoephedrine is an antihistamine, decongestant, and pain reliever combination. It works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. It also relieves nasal congestion and pain associated with sinus pressure, and dries the nose and chest.

Do NOT use Acetaminophen/Chlorpheniramine/Pseudoephedrine if:

• you are allergic to any ingredient in Acetaminophen/Chlorpheniramine/Pseudoephedrine


• you are taking sodium oxybate (GHB) or you have taken furazolidone a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using Acetaminophen/Chlorpheniramine/Pseudoephedrine:

Some medical conditions may interact with Acetaminophen/Chlorpheniramine/Pseudoephedrine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a fast, slow, or irregular heartbeat


• if you have a history of asthma; lung problems (eg, emphysema); heart problems; diabetes; difficulty urinating; an enlarged prostate or other prostate problems; glaucoma; high blood pressure; an overactive thyroid; liver problems (eg, hepatitis) or severe kidney problems; adrenal gland problems (eg, pheochromocytoma); sleep apnea; trouble sleeping; stomach problems; ulcers; seizures; heart blood vessel problems; stroke; or a blockage of your stomach, intestines, or bladder


• if you consume more than 3 alcoholic drinks per day

Some MEDICINES MAY INTERACT with Acetaminophen/Chlorpheniramine/Pseudoephedrine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), droxidopa, isoniazid, sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects may be increased


• Blood thinners (eg, warfarin), bromocriptine, furazolidone, MAO inhibitors (eg, phenelzine), or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the actions and side effects may be increased


• Certain high blood pressure medicines such as beta-blockers (eg, atenolol) and guanethidine because these medicines may be less effective

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Chlorpheniramine/Pseudoephedrine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Acetaminophen/Chlorpheniramine/Pseudoephedrine:

Use Acetaminophen/Chlorpheniramine/Pseudoephedrine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Acetaminophen/Chlorpheniramine/Pseudoephedrine may be taken with food if it upsets your stomach.


• If you miss a dose of Acetaminophen/Chlorpheniramine/Pseudoephedrine and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen/Chlorpheniramine/Pseudoephedrine.

Important safety information:

• Acetaminophen/Chlorpheniramine/Pseudoephedrine may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Acetaminophen/Chlorpheniramine/Pseudoephedrine. Using Acetaminophen/Chlorpheniramine/Pseudoephedrine alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Acetaminophen/Chlorpheniramine/Pseudoephedrine will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.


• Do not exceed the recommended dose of Acetaminophen/Chlorpheniramine/Pseudoephedrine. Doing so will not improve your condition faster and may increase your risk for side effects.


• If your symptoms do not improve within a few days or if they become worse, check with your doctor.


• Acetaminophen/Chlorpheniramine/Pseudoephedrine contains acetaminophen, chlorpheniramine, and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen, chlorpheniramine, or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• Do not take diet or appetite control medicines while you are taking Acetaminophen/Chlorpheniramine/Pseudoephedrine without checking with your doctor.


• If you consume 3 or more alcohol-containing drinks every day, ask your doctor whether you should take Acetaminophen/Chlorpheniramine/Pseudoephedrine or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Alcohol use combined with Acetaminophen/Chlorpheniramine/Pseudoephedrine may increase your risk for liver damage.


• If you are scheduled for allergy skin testing, do not take Acetaminophen/Chlorpheniramine/Pseudoephedrine for several days before the test because it may decrease your response to the skin tests.


• If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take Acetaminophen/Chlorpheniramine/Pseudoephedrine.


• Caution is advised when using Acetaminophen/Chlorpheniramine/Pseudoephedrine in the ELDERLY because they may be more sensitive to its effects.


• Use Acetaminophen/Chlorpheniramine/Pseudoephedrine with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is unknown if Acetaminophen/Chlorpheniramine/Pseudoephedrine can cause harm to the fetus. If you become pregnant while taking Acetaminophen/Chlorpheniramine/Pseudoephedrine, discuss with your doctor the benefits and risks of using Acetaminophen/Chlorpheniramine/Pseudoephedrine during pregnancy. Some of the ingredients in Acetaminophen/Chlorpheniramine/Pseudoephedrine are excreted in breast milk. If you are or will be breast-feeding while you are using Acetaminophen/Chlorpheniramine/Pseudoephedrine, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Acetaminophen/Chlorpheniramine/Pseudoephedrine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; dry mouth, nose, or throat; headache; nausea; nervousness; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine or pale stools; difficulty urinating; excessive sweating; frequent urination; hallucinations; pounding in the chest; rapid pulse; severe nervousness; stomach pain; tremors; unusual fatigue; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Acetaminophen/Chlorpheniramine/Pseudoephedrine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fast or irregular heartbeat; fever; hallucinations; nausea; seizures; sweating; tremors; trouble breathing; unusual drowsiness or dizziness; vomiting.

Proper storage of Acetaminophen/Chlorpheniramine/Pseudoephedrine:

Store Acetaminophen/Chlorpheniramine/Pseudoephedrine at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen/Chlorpheniramine/Pseudoephedrine out of the reach of children and away from pets.

General information:

• If you have any questions about Acetaminophen/Chlorpheniramine/Pseudoephedrine, please talk with your doctor, pharmacist, or other health care provider.


• Acetaminophen/Chlorpheniramine/Pseudoephedrine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Acetaminophen/Chlorpheniramine/Pseudoephedrine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Acetaminophen/Chlorpheniramine/Pseudoephedrine resources

• Acetaminophen/Chlorpheniramine/Pseudoephedrine Side Effects (in more detail)
• Acetaminophen/Chlorpheniramine/Pseudoephedrine Use in Pregnancy & Breastfeeding
• Acetaminophen/Chlorpheniramine/Pseudoephedrine Drug Interactions
• Acetaminophen/Chlorpheniramine/Pseudoephedrine Support Group
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