N-Lactase

N-Lactase may be available in the countries listed below.

Ingredient matches for N-Lactase

Tilactase

Tilactase is reported as an ingredient of N-Lactase in the following countries:

• Japan

International Drug Name Search

Talacen

In the US, Talacen (acetaminophen/pentazocine systemic) is a member of the drug class narcotic analgesic combinations and is used to treat Pain.

US matches:

• Talacen

Ingredient matches for Talacen

Paracetamol

Paracetamol is reported as an ingredient of Talacen in the following countries:

• United States

Pentazocine

Pentazocine hydrochloride (a derivative of Pentazocine) is reported as an ingredient of Talacen in the following countries:

• United States

International Drug Name Search

Prefest

In the US, Prefest (estradiol/norgestimate systemic) is a member of the drug class sex hormone combinations and is used to treat Atrophic Urethritis, Atrophic Vaginitis, Postmenopausal Symptoms and Prevention of Osteoporosis.

US matches:

• Prefest

Ingredient matches for Prefest

Estradiol

Estradiol is reported as an ingredient of Prefest in the following countries:

• Brazil

Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Prefest in the following countries:

• United States

Norgestimate

Norgestimate is reported as an ingredient of Prefest in the following countries:

• United States

International Drug Name Search

Fosinopril HCT Winthrop

Fosinopril HCT Winthrop may be available in the countries listed below.

Ingredient matches for Fosinopril HCT Winthrop

Fosinopril

Fosinopril sodium salt (a derivative of Fosinopril) is reported as an ingredient of Fosinopril HCT Winthrop in the following countries:

• Australia

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Fosinopril HCT Winthrop in the following countries:

• Australia

International Drug Name Search

Robinul

glycopyrrolate

Dosage Form: tablet
Robinul and Robinul Forte

Robinul® and Robinul® Forte

(Glycopyrrolate Tablets, USP)

Rx Only

Code: 883C00          Rev. 04/10

Robinul Description

Robinul® and Robinul® Forte tablets contain the synthetic anticholinergic, glycopyrrolate.  Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyacetyl)oxy]-1,1-dimethylpyrrolidinium bromide.

 

Robinul tablets are scored, compressed white tablets engraved HPC 200.  Each tablet contains:

Glycopyrrolate, USP………..1 mg

 

Robinul Forte tablets are scored, compressed white tablets engraved HORIZON 205.  Each tablet contains:

Glycopyrrolate, USP……….2 mg

 

Inactive Ingredients: Dibasic Calcium Phosphate, Lactose, Magnesium Stearate, Povidone, Sodium Starch Glycolate

ACTIONS

Glycopyrrolate, like other anticholinergic (antimuscarinic) agents, inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine by lack cholinergic innervation.  These peripheral cholinergic receptors are present in the autonomic effector cells of smooth muscle, cardiac muscle, the sino-atrial node, the atrioventricular node, exocrine glands, and, to a limited degree, in the autonomic ganglia.  Thus, it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal, and bronchial secretions.

 

Glycopyrrolate antagonizes muscarinic symptoms (e.g., bronchorrhea, bronchospasm, bradycardia, and intestinal hypermotility) induced by cholinergic drugs such as the anticholinesterases.

 

The highly polar quaternary ammonium group of glycopyrrolate limits its passage across lipid membranes, such as the blood-brain barrier, in contrast to atropine sulfate and scopolamine hydrobromide, which are non-polar tertiary amines which penetrate lipid barriers easily.

INDICATIONS

For use as adjunctive therapy in the treatment of peptic ulcer.

Contraindications

Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.  Robinul (glycopyrrolate) tablets are contraindicated in those patients with a hypersensitivity to glycopyrrolate.

Warnings

In the presence of a high environmental temperature, heal prostration (fever and heat stroke due to decreased sweating) can occur with the use of Robinul.

 

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy.  In this instance treatment with this drug would be inappropriate and possibly harmful.

 

Robinul (glycopyrrolate) may produce drowsiness or blurred vision.  In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug. 

 

Theoretically, with overdosage, a curare-like action may occur, i.e., neuro-muscular blockade leading to muscular weakness and possible paralysis.

Pregnancy

The safety of this drug during pregnancy has not been established.  The use of any drug during pregnancy requires that the potential benefits of the drug be weighed against possible hazards to mother and child.  Reproduction studies in rats revealed no teratogenic effects from glycopyrrolate; however, the potent anticholinergic action of this agent resulted in diminished rates of conception and of survival at weaning, in a dose-related manner.  Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate.  Information on possible adverse effects in the pregnant female is limited to uncontrolled data derived from marketing experience.  Such experience has revealed no reports of teratogenic or other fetus-damaging potential.  No controlled studies to establish the safety of the drug in pregnancy have been performed.

Nursing Mothers

It is not know whether this drug is excreted in human milk.  As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

Pediatric Use

Since there is no adequate experience in pediatric patients who have received this drug, safety and efficacy in pediatric patients have not been established.

Precautions

Use Robinul with caution in the elderly and in all patients with:

 

• Autonomic neuropathy.


• Hepatic or renal disease.


• Ulcerative colitis - large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason may precipitate or aggravate the "toxic megacolon," a serious complication of the disease.


• Hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, tachycardia, hypertension and prostatic hypertrophy.


• Hiatal hernia associated with reflux esophagitis, since anticholinergic drugs may aggravate this condition.

 

 

Adverse Reactions

Anticholinergics produce certain effects, most of which are extensions of their fundamental pharmacological actions.  Adverse reactions to anticholinergics in general may include xerostomia; decreased sweating; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; dilation of the pupil; cycloplegia; increased ocular tension; loss of taste; headaches; nervousness; mental confusion; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; constipation; bloated feeling; impotence; suppression of lactation; severe allergic reaction or drug idiosyncrasies including anaphylaxis, urticaria and other dermal manifestations.

 

Robinul (glycopyrrolate) is chemically a quaternary ammonium compound; hence, its passage across lipid membranes, such as the blood-brain barrier, is limited in contrast to atropine sulfate and scopolamine hydrobromide.  For this reason the occurrence of CNS related side effects is lower, in comparison to their incidence following administration of anticholinergics which are chemically tertiary amines that can cross this barrier readily.

Overdosage

The symptoms of overdosage of glycopyrrolate are peripheral in nature rather than central.

 

1. To guard against further absorption of the drug - use gastric lavage, cathartics, and/or enemas.


2. To combat peripheral anticholinergic effects (residual mydriasis, dry mouth, etc.) - utilize a quaternary ammonium anticholinesterase, such as neostigmine methylsulfate.


3. To combat hypotension - use pressor amines (norepinephrine, metaraminol) i.v.; and supportive care.


4. To combat respiratory depression - administer oxygen; utilize a respiratory stimulant such as Dopram® i.v.; artificial respiration.

Robinul Dosage and Administration

The dosage of Robinul® or Robinul® Forte should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions. The presently recommended maximum daily dosage of glycopyrrolate is 8 mg.

 

Robinul (glycopyrrolate, 1 mg) tablets.  The recommended initial dosage of Robinul for adults is one tablet three times daily (in the morning, early afternoon, and at bedtime).  Some patients may require two tablets at bedtime to assure overnight control of symptoms.  For maintenance, a dosage of one tablet twice a day is frequently adequate.

 

Robinul Forte (glycopyrrolate, 2 mg) tablets.  The recommended dosage of Robinul Forte for adults is one tablet two or three times daily at equally spaced intervals.

 

Robinul tablets are not recommended for use in pediatric patients under the age of 12 years.

Drug Interactions

There are no known drug interactions.

How is Robinul Supplied

Robinul® (glycopyrrolate, 1 mg) tablets in bottles of 100 (NDC 59630-200-10).

 

Robinul® Forte (glycopyrrolate, 2 mg) tablets in bottles of 100 (NDC 59630-205-10).

 

Store at controlled room temperature, 20˚C to 25˚C (68˚F to 77˚F); excursions permitted to 15˚C-30˚C (59˚F-86˚F) [See USP Controlled Room Temperature].  Keep out of reach of children.

 

Dispense in tight container.

 

Rx only

 

ROB-PI-2

Rev. 04 / 10                 Code 883C00                Printed in USA

 

Manufactured by:

MIKART, INC.

Atlanta, GA 30318

 

Manufactured for:

SHIONOGI PHARMA, INC.

Atlanta, GA 30328

PRINCIPAL DISPLAY PANEL - 1 mg Bottle Label

NDC 59630-200-10

100 Tablets

Robinul®

(glycopyrrolate tablets, USP)

1 mg

WHITE DYE-FREE

Manufactured for :

SHIONOGI PHARMA, INC.

Atlanta, GA 30328    U.S. Patent No. 7,091,236

PRINCIPAL DISPLAY PANEL - 2 mg Bottle Label

NDC 59630-205-10

100 Tablets

Robinul®

(glycopyrrolate

tablets, USP)

2 mg

WHITE DYE-FREE

Manufactured for :

SHIONOGI PHARMA, INC.

Atlanta, GA 30328

U.S. Patent No. 7,091,236

Robinul  glycopyrrolate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59630-200 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCOPYRROLATE (GLYCOPYRROLATE) GLYCOPYRROLATE 1 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE   LACTOSE   MAGNESIUM STEARATE   POVIDONE

Product Characteristics Color WHITE (white) Score 2 pieces Shape ROUND (ROUND) Size 8mm Flavor Imprint Code HPC;200 Contains

Packaging # NDC Package Description Multilevel Packaging 1 59630-200-10 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA012827	03/28/1961

Robinul FORTE  glycopyrrolate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59630-205 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCOPYRROLATE (GLYCOPYRROLATE) GLYCOPYRROLATE 2 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE   LACTOSE   MAGNESIUM STEARATE   POVIDONE

Product Characteristics Color WHITE (white) Score 2 pieces Shape ROUND (ROUND) Size 10mm Flavor Imprint Code HORIZON;205 Contains

Packaging # NDC Package Description Multilevel Packaging 1 59630-205-10 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA012827	03/28/1961

Labeler - Shionogi Pharma, Inc. (802728477)

Revised: 12/2010Shionogi Pharma, Inc.

More Robinul resources

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

• Robinul Monograph (AHFS DI)


• Robinul Advanced Consumer (Micromedex) - Includes Dosage Information


• Robinul MedFacts Consumer Leaflet (Wolters Kluwer)


• Glycopyrrolate Professional Patient Advice (Wolters Kluwer)


• Cuvposa Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Cuvposa Consumer Overview


• Robinul Forte MedFacts Consumer Leaflet (Wolters Kluwer)

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Zolazepam Hydrochloride may be available in the countries listed below.

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Zolazepam Hydrochloride (BAN, USAN) is also known as Zolazepam (Rec.INN)

International Drug Name Search

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BAN	British Approved Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

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Noxidem may be available in the countries listed below.

Ingredient matches for Noxidem

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Zolpidem tartrate (a derivative of Zolpidem) is reported as an ingredient of Noxidem in the following countries:

• South Africa

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Cerini

Cerini may be available in the countries listed below.

Ingredient matches for Cerini

Cetirizine

Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Cerini in the following countries:

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Gliclazid-Mepha may be available in the countries listed below.

Ingredient matches for Gliclazid-Mepha

Gliclazide

Gliclazide is reported as an ingredient of Gliclazid-Mepha in the following countries:

• Switzerland

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Paracetamol Lazar

Paracetamol Lazar may be available in the countries listed below.

Ingredient matches for Paracetamol Lazar

Paracetamol

Paracetamol is reported as an ingredient of Paracetamol Lazar in the following countries:

• Argentina

International Drug Name Search

Premaston

Premaston may be available in the countries listed below.

Ingredient matches for Premaston

Allylestrenol

Allylestrenol is reported as an ingredient of Premaston in the following countries:

• Indonesia


• Myanmar


• Sri Lanka

International Drug Name Search

Volequin

Volequin may be available in the countries listed below.

Ingredient matches for Volequin

Levofloxacin

Levofloxacin is reported as an ingredient of Volequin in the following countries:

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Paracetamol AL

Paracetamol AL may be available in the countries listed below.

Ingredient matches for Paracetamol AL

Paracetamol

Paracetamol is reported as an ingredient of Paracetamol AL in the following countries:

• Germany

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Budenofalk

Budenofalk may be available in the countries listed below.

UK matches:

• Budenofalk 3mg Capsules
• Budenofalk 2mg/dose rectal foam (SPC)
• Budenofalk 3mg gastro-resistant capsules (SPC)

Ingredient matches for Budenofalk

Budesonide

Budesonide is reported as an ingredient of Budenofalk in the following countries:

• Belgium


• Bulgaria


• Chile


• Czech Republic


• Denmark


• Finland


• Germany


• Greece


• Hungary


• Indonesia


• Ireland


• Latvia


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• Luxembourg


• Netherlands


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SPC	Summary of Product Characteristics (UK)

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Isox

Isox may be available in the countries listed below.

Ingredient matches for Isox

Itraconazole

Itraconazole is reported as an ingredient of Isox in the following countries:

• Dominican Republic


• El Salvador


• Guatemala


• Honduras


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• Panama

Meloxicam

Meloxicam is reported as an ingredient of Isox in the following countries:

• Chile


• Peru

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Sorbi

Sorbi may be available in the countries listed below.

Ingredient matches for Sorbi

Sorbitol

Sorbitol is reported as an ingredient of Sorbi in the following countries:

• New Zealand

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Alendronat Merck NM

Alendronat Merck NM may be available in the countries listed below.

Ingredient matches for Alendronat Merck NM

Alendronic Acid

Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Alendronat Merck NM in the following countries:

• Denmark

International Drug Name Search

Spyrocon

Spyrocon may be available in the countries listed below.

Ingredient matches for Spyrocon

Itraconazole

Itraconazole is reported as an ingredient of Spyrocon in the following countries:

• Indonesia

International Drug Name Search

Paracetamol Combix

Paracetamol Combix may be available in the countries listed below.

Ingredient matches for Paracetamol Combix

Paracetamol

Paracetamol is reported as an ingredient of Paracetamol Combix in the following countries:

• Spain

International Drug Name Search

Gastrolux

Gastrolux may be available in the countries listed below.

Ingredient matches for Gastrolux

Diatrizoic acid

Diatrizoic acid meglumine and sodium salt (a derivative of Diatrizoic acid) is reported as an ingredient of Gastrolux in the following countries:

• Germany

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Tussidrill

Tussidrill may be available in the countries listed below.

Ingredient matches for Tussidrill

Dextromethorphan

Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Tussidrill in the following countries:

• Poland


• Spain

International Drug Name Search

Phemiton

Phemiton may be available in the countries listed below.

Ingredient matches for Phemiton

Methylphenobarbital

Methylphenobarbital is reported as an ingredient of Phemiton in the following countries:

• Bosnia & Herzegowina


• Croatia (Hrvatska)


• Slovenia

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Nalbuphin Amomed

Nalbuphin Amomed may be available in the countries listed below.

Ingredient matches for Nalbuphin Amomed

Nalbuphine

Nalbuphine hydrochloride (a derivative of Nalbuphine) is reported as an ingredient of Nalbuphin Amomed in the following countries:

• Austria

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Cholerit

Cholerit may be available in the countries listed below.

Ingredient matches for Cholerit

Pravastatin

Pravastatin sodium salt (a derivative of Pravastatin) is reported as an ingredient of Cholerit in the following countries:

• Japan

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Uprima

In the US, Uprima is a member of the drug class dopaminergic antiparkinsonism agents and is used to treat Parkinson's Disease.

Ingredient matches for Uprima

Apomorphine

Apomorphine is reported as an ingredient of Uprima in the following countries:

• Slovenia

Apomorphine hydrochloride (a derivative of Apomorphine) is reported as an ingredient of Uprima in the following countries:

• Iceland


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Oncaspar

Pronunciation: peg-AS-par-jase
Generic Name: Pegaspargase
Brand Name: Oncaspar

Oncaspar is used for:

Treating acute lymphoblastic leukemia (ALL) in certain patients. It is used along with other cancer medicines.

Oncaspar is an antineoplastic agent. It works by decreasing the amount of asparagine in the body, which kills certain leukemia cells.

Do NOT use Oncaspar if:

• you are allergic to any ingredient in Oncaspar


• you have chickenpox, shingles, or inflammation of the pancreas (pancreatitis)


• you have ever had serious blood clots, serious bleeding, or inflammation of the pancreas after using Oncaspar or L-asparaginase

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

Before using Oncaspar:

Some medical conditions may interact with Oncaspar. 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 liver problems, bone marrow problems, diabetes, or an infection


• if you have a history of bleeding problems or blood clots


• if you are undergoing radiation therapy

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

• Anticoagulants (eg, warfarin), aspirin, dipyridamole, heparin, or nonsteroidal anti-inflammatory drugs (NSAIDs) because the risk of side effects such as bleeding may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Oncaspar 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 Oncaspar:

Use Oncaspar as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Oncaspar is usually given as an injection at your doctor's office, hospital, or clinic.


• Do not shake Oncaspar.


• Do not use Oncaspar if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• Oncaspar is usually not used more often than every 14 days. Do not use Oncaspar more often than every 14 days without first checking with your doctor.


• If you miss a dose of Oncaspar, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Oncaspar.

Important safety information:

• Tell your doctor or dentist that you take Oncaspar before you receive any medical or dental care, emergency care, or surgery.


• Oncaspar may reduce the ability of your blood to clot. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Oncaspar may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• Lab tests, including blood clotting tests or blood glucose, may be performed while you use Oncaspar. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Oncaspar should be used with extreme caution in CHILDREN younger than 1 year old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Oncaspar can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Oncaspar while you are pregnant. It is not known if Oncaspar is found in breast milk. Do not breast-feed while taking Oncaspar.

Possible side effects of Oncaspar:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Oncaspar. 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; trouble swallowing); blurred vision or other vision changes; calf or leg pain or swelling; chest pain; confusion; coughing up blood; dizziness; one-sided weakness; pain, redness, or swelling at the injection site; severe headache; shortness of breath; severe stomach pain; slurred speech; swelling of an arm or leg; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; drowsiness; flushing; rapid breathing; fruit-like breath odor); unusual bleeding or bruising; yellowing of 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: Oncaspar 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 rash.

Proper storage of Oncaspar:

Oncaspar is usually handled and stored by a health care provider. If you are using Oncaspar at home, store Oncaspar as directed by your pharmacist or health care provider. Keep Oncaspar out of the reach of children and away from pets.

General information:

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


• Oncaspar 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 Oncaspar. 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.

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• Oncaspar Side Effects (in more detail)
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• Oncaspar Drug Interactions
• Oncaspar Support Group
• 0 Reviews for Oncaspar - Add your own review/rating

• Oncaspar Prescribing Information (FDA)


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In some countries, this medicine may only be approved for veterinary use.

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Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Chlorexivet in the following countries:

• France


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Cyprostat may be available in the countries listed below.

UK matches:

• Cyprostat 100mg (SPC)
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Cyproterone

Cyproterone 17α-acetate (a derivative of Cyproterone) is reported as an ingredient of Cyprostat in the following countries:

• Australia


• Bahrain


• Egypt


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• Iraq


• Jordan


• Kuwait


• Lebanon


• Oman


• Qatar


• Saudi Arabia


• Syria


• United Arab Emirates


• United Kingdom


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Aklonil

Aklonil may be available in the countries listed below.

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Clonazepam

Clonazepam is reported as an ingredient of Aklonil in the following countries:

• Tunisia

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Cefalotin Sandoz

Cefalotin Sandoz may be available in the countries listed below.

Ingredient matches for Cefalotin Sandoz

Cefalotin

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• Australia

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Unalium

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Flunarizine

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Magion

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Ingredient matches for Magion

Magaldrate

Magaldrate is reported as an ingredient of Magion in the following countries:

• Spain

International Drug Name Search

Petty

Petty may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Petty

Dimpylate

Dimpylate is reported as an ingredient of Petty in the following countries:

• Portugal

Permethrin

Permethrin is reported as an ingredient of Petty in the following countries:

• Portugal

Piperonyl Butoxide

Piperonyl Butoxide is reported as an ingredient of Petty in the following countries:

• Portugal

International Drug Name Search

Sterinol

Sterinol may be available in the countries listed below.

Ingredient matches for Sterinol

Benzalkonium Chloride

Benzalkonium chloride (a derivative of Benzalkonium) is reported as an ingredient of Sterinol in the following countries:

• Poland

International Drug Name Search

Vetasept

Vetasept may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Vetasept

Chlorhexidine

Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Vetasept in the following countries:

• United Kingdom

Povidone Iodine

Povidone-Iodine is reported as an ingredient of Vetasept in the following countries:

• United Kingdom

International Drug Name Search

Hymecromome

Hymecromome may be available in the countries listed below.

Ingredient matches for Hymecromome

Hymecromone

Hymecromome (BAN) is also known as Hymecromone (Rec.INN)

International Drug Name Search

Glossary

BAN	British Approved Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

rituximab

Generic Name: rituximab (ri TUX i mab)

Brand Names: Rituxan

What is rituximab?

Rituximab is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Rituximab is used in combination with other cancer medicines to treat non-Hodgkin's lymphoma or chronic lymphocytic leukemia. Rituximab is also used in combination with another drug called methotrexate to treat symptoms of adult rheumatoid arthritis.

Rituximab is also used in combination with steroid medicines to treat certain rare disorders that cause inflammation of the blood vessels.

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

What is the most important information I should know about rituximab?

You should not receive this medication if you have ever had a severe allergic reaction to rituximab, or if you are allergic to mouse protein. Some people receiving a rituximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, weak, nauseated, light-headed, itchy, or if you have a fever, chills, muscle pain, sneezing, sore throat, trouble breathing, or pain in your chest or shoulders. Infusion reactions often occur within the first 24 hours after the start of your rituximab infusion.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

If you have hepatitis B you may develop liver symptoms after you stop using this medication, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop using rituximab. Visit your doctor regularly.

Rituximab increases the risk of a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines. Call your doctor right away if you have symptoms such as change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

What should I discuss with my healthcare provider before receiving rituximab?

You should not receive this medication if you have ever had a severe allergic reaction to rituximab, or if you are allergic to mouse protein.

To make sure you can safely use rituximab, tell your doctor if you have any of these other conditions:

• 
  

  liver disease or hepatitis B (or if you are a carrier of hepatitis B);

  
  


• 
  

  kidney disease;

  
  


• 
  

  systemic lupus erythematosus (SLE);

  
  


• 
  

  lung disease or a breathing disorder;

  
  


• 
  

  a weak immune system;

  
  


• 
  

  a history of heart disease, angina (chest pain), or heart rhythm disorder; or

  
  


• 
  

  a recent or active infection, including herpes, shingles, cytomegalovirus, chickenpox, West Nile virus, hepatitis C, or any infection that keeps coming back or does not clear up.

  
  

FDA pregnancy category C. It is not known whether rituximab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether rituximab passes into breast milk or if it could harm a nursing baby. Do not take rituximab without telling your doctor if you are breast feeding a baby. Older adults may be more likely to have side effects from rituximab, causing breathing difficulty or heart rhythm problems.

How is rituximab given?

Rituximab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.

Before you receive rituximab, you may be given other medications to prevent certain side effects that rituximab can cause.

The medicine is usually given once per week for 4 to 8 weeks. In the treatment of rheumatoid arthritis, you may receive only two injections of rituximab, with 2 weeks in between treatments.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

If you have hepatitis B you may develop liver symptoms after you stop using this medication, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop using rituximab. Do not miss any scheduled visits.

If you need surgery, tell the surgeon ahead of time that you are using rituximab.

What happens if I miss a dose?

Call your doctor if you miss an appointment for your rituximab injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving rituximab?

Do not receive a "live" vaccine while using rituximab, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. 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.

Rituximab side effects

Some people receiving a rituximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, weak, nauseated, light-headed, itchy, or if you have a fever, chills, muscle pain, sneezing, sore throat, trouble breathing, or pain in your chest or shoulders. Infusion reactions often occur within the first 24 hours after the start of your rituximab infusion.

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. Rituximab increases the risk of a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines. Call your doctor right away if you have symptoms such as change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly. Call your doctor at once if you have any of these other serious side effects, even if they occur several months after you receive rituximab, or after your treatment ends.

• 
  

  lower back pain, blood in your urine, numbness or tingly feeling around your mouth;

  
  


• 
  

  urinating less than usual;

  
  


• 
  

  muscle weakness, tightness, or contraction, overactive reflexes;

  
  


• 
  

  fast or slow heart rate, weak pulse, feeling short of breath, fainting;

  
  


• 
  

  uneven heartbeats, wheezing or trouble breathing;

  
  


• 
  

  confusion, dizziness, loss of balance, sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  fever, chills, cough, body aches, flu symptoms, ongoing cold symptoms such as stuffy nose, sneezing, sore throat;

  
  


• 
  

  easy bruising or bleeding;

  
  


• 
  

  pain or burning when you urinate;

  
  


• 
  

  earache, painful mouth ulcers, skin sores, warmth or swelling with skin redness;

  
  


• 
  

  a red, raised, blistering, scaly, itchy, or peeling skin rash;

  
  


• 
  

  severe constipation or stomach pain;

  
  


• 
  

  black, bloody, or tarry stools; or

  
  


• 
  

  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  pain where the IV needle is placed;

  
  


• 
  

  mild stomach pain, nausea, or diarrhea;

  
  


• 
  

  swelling in your hands or feet;

  
  


• 
  

  muscle or joint pain; or

  
  


• 
  

  night sweats.

  
  

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 side effects to FDA at 1-800-FDA-1088.

Rituximab Dosing Information

Usual Adult Dose for non-Hodgkin's Lymphoma:

Information for all healthcare professionals administering rituximab: Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion. Premedicate before each infusion with acetaminophen and an antihistamine. For RA patients, methylprednisolone 100 mg IV or its equivalent is recommended 30 minutes prior to each infusion. Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

First Infusion: Initiate infusion at a rate of 50 mg/hr. In the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.

Subsequent Infusions: Initiate infusion at a rate of 100 mg/hr. In the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30 minute intervals, to a maximum of 400 mg/hr.

Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

Relapsed or Refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's Lymphoma (NHL): 375 mg/m2 IV once weekly for 4 or 8 doses.

Retreatment for Relapsed or Refractory, low-grade or follicular, CD20-positive, B-cell NHL: 375 mg/m2 IV once weekly for 4 doses.

Previously untreated, follicular, CD20-positive, B-cell NHL: 375 mg/m2 IV, administered on Day 1 of each cycle of chemotherapy, for up to 8 doses. In patients with complete or partial response, initiate rituximab maintenance 8 weeks following completion of rituximab in combination with chemotherapy. Administer rituximab as a single agent every 8 weeks for 12 doses.

Non-progressing, Low-grade, CD20-positive, B-cell NHL, after first-line CVP chemotherapy: Following completion of 6 to 8 cycles of CVP chemotherapy, administer 375 mg/m2 IV once weekly for 4 doses at 6 month intervals to a maximum of 16 doses.

Diffuse large B-cell NHL: 375 mg/m2 IV given on day 1 of each cycle of chemotherapy for up to 8 doses.

Chronic Lymphocytic Leukemia (CLL): 375 mg/m2 the day prior to initiation of FC chemotherapy, then 500 mg/m2 on Day 1 of cycles 2 through 6 (every 28 days).

As a required component of ibritumomab tiuxetan therapeutic regimen: rituximab 250 mg/m2 should be infused within 4 hours prior to the administration of Indium-111- (In-111-) ibritumomab tiuxetan and within 4 hours prior to the administration of Yttrium-90- (Y-90-) ibritumomab tiuxetan. Administration of rituximab and In-111-ibritumomab tiuxetan should precede rituximab and Y-90-ibritumomab tiuxetan by 7 to 9 days. (Note: The ibritumomab tiuxetan therapeutic regimen is indicated for the treatment of patients with relapsed or refractory low-grade or follicular B-cell non-Hodgkin's lymphoma, including patients with rituximab refractory follicular non-Hodgkin's lymphoma.)

Usual Adult Dose for Rheumatoid Arthritis:

Information for all healthcare professionals administering rituximab: Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion. Premedicate before each infusion with acetaminophen and an antihistamine. For RA patients, methylprednisolone 100 mg IV or its equivalent is recommended 30 minutes prior to each infusion. Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

First Infusion: Initiate infusion at a rate of 50 mg/hr. In the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.

Subsequent Infusions: Initiate infusion at a rate of 100 mg/hr. In the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30 minute intervals, to a maximum of 400 mg/hr.

Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

Rheumatoid Arthritis: Rituximab is given in combination with methotrexate. Rituximab is given as two 1000 mg IV infusions separated by 2 weeks. Glucocorticoids administered as methylprednisolone 100 mg IV or its equivalent 30 minutes prior to each infusion are recommended to reduce the incidence and severity of infusion reactions. Subsequent courses should be administered every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks.

Usual Adult Dose for Chronic Lymphocytic Leukemia:

Information for all healthcare professionals administering rituximab: Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion. Premedicate before each infusion with acetaminophen and an antihistamine. For RA patients, methylprednisolone 100 mg IV or its equivalent is recommended 30 minutes prior to each infusion. Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

First Infusion: Initiate infusion at a rate of 50 mg/hr. In the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.

Subsequent Infusions: Initiate infusion at a rate of 100 mg/hr. In the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30 minute intervals, to a maximum of 400 mg/hr.

Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

Chronic Lymphocytic Leukemia (CLL): 375 mg/m2 IV the day prior to the initiation of fludarabine and cyclophosphamide (FC) chemotherapy, then 500 mg/m2 on Day 1 of cycles 2 to 6 (every 28 days).

Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

Usual Adult Dose for Wegener's Granulomatosus:

Information for all healthcare professionals administering rituximab: Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion. Premedicate before each infusion with acetaminophen and an antihistamine. For RA patients, methylprednisolone 100 mg IV or its equivalent is recommended 30 minutes prior to each infusion. Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

First Infusion: Initiate infusion at a rate of 50 mg/hr. In the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.

Subsequent Infusions: Initiate infusion at a rate of 100 mg/hr. In the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30 minute intervals, to a maximum of 400 mg/hr.

Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA): 375 mg/m2 IV administered once weekly for 4 weeks.

Glucocorticoids administered as methylprednisolone 1000 mg IV daily for 1 to 3 days followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day and tapered per clinical need) are recommended to treat severe vasculitis symptoms. This regimen should begin within 14 days prior to or with the initiation of rituximab and may continue during and after the 4 week course of rituximab treatment.

Safety and efficacy of treatment with subsequent courses of rituximab have not been established.

PCP prophylaxis is recommended for patients with WG and MPA during treatment and for at least 6 months following the last rituximab infusion.

Usual Adult Dose for Microscopic Polyangiitis:

Information for all healthcare professionals administering rituximab: Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion. Premedicate before each infusion with acetaminophen and an antihistamine. For RA patients, methylprednisolone 100 mg IV or its equivalent is recommended 30 minutes prior to each infusion. Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

First Infusion: Initiate infusion at a rate of 50 mg/hr. In the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.

Subsequent Infusions: Initiate infusion at a rate of 100 mg/hr. In the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30 minute intervals, to a maximum of 400 mg/hr.

Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA): 375 mg/m2 IV administered once weekly for 4 weeks.

Glucocorticoids administered as methylprednisolone 1000 mg IV daily for 1 to 3 days followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day and tapered per clinical need) are recommended to treat severe vasculitis symptoms. This regimen should begin within 14 days prior to or with the initiation of rituximab and may continue during and after the 4 week course of rituximab treatment.

Safety and efficacy of treatment with subsequent courses of rituximab have not been established.

PCP prophylaxis is recommended for patients with WG and MPA during treatment and for at least 6 months following the last rituximab infusion.

What other drugs will affect rituximab?

Tell your doctor about all other medicines you use, especially:

• 
  

  cisplatin (Platinol);

  
  


• 
  

  adalimumab (Humira);

  
  


• 
  

  auranofin (Ridaura);

  
  


• 
  

  azathioprine (Imuran);

  
  


• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


• 
  

  etanercept (Enbrel);

  
  


• 
  

  infliximab (Remicade);

  
  


• 
  

  leflunomide (Arava);

  
  


• 
  

  minocycline (Dynacin, Minocin, Vectrin);

  
  


• 
  

  sulfasalazine (Azulfidine);

  
  


• 
  

  blood pressure medications; or

  
  


• 
  

  medication to treat malaria, such as chloroquine (Aralen) or hydroxychloroquine (Plaquenil, Quineprox).

  
  

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

More rituximab resources

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

• rituximab Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Rituxan Prescribing Information (FDA)


• Rituxan Consumer Overview


• Rituximab Professional Patient Advice (Wolters Kluwer)


• Rituximab Monograph (AHFS DI)


• Rituximab MedFacts Consumer Leaflet (Wolters Kluwer)

Compare rituximab with other medications

• Bullous Pemphigoid
• Chronic Lymphocytic Leukemia
• Evan's Syndrome
• Focal Segmental Glomerulosclerosis
• Follicular Lymphoma
• Idiopathic Thrombocytopenic Purpura
• Microscopic polyangiitis
• Non-Hodgkin's Lymphoma
• Pemphigoid
• Pemphigus
• Rheumatoid Arthritis
• Wegener's Granulomatosus

Where can I get more information?

• Your doctor or pharmacist can provide more information about rituximab.

See also: rituximab side effects (in more detail)

Adrenalin-Braun

Adrenalin-Braun may be available in the countries listed below.

Ingredient matches for Adrenalin-Braun

Epinephrine

Epinephrine hydrochloride (a derivative of Epinephrine) is reported as an ingredient of Adrenalin-Braun in the following countries:

• Luxembourg

International Drug Name Search

Sotalol Merck

Sotalol Merck may be available in the countries listed below.

Ingredient matches for Sotalol Merck

Sotalol

Sotalol hydrochloride (a derivative of Sotalol) is reported as an ingredient of Sotalol Merck in the following countries:

• France

International Drug Name Search

Methotrexate Pfizer

Methotrexate Pfizer may be available in the countries listed below.

Ingredient matches for Methotrexate Pfizer

Methotrexate

Methotrexate is reported as an ingredient of Methotrexate Pfizer in the following countries:

• Denmark


• Iceland


• Philippines


• Singapore

International Drug Name Search

Oxycodon-HCl-CT

Oxycodon-HCl-CT may be available in the countries listed below.

Ingredient matches for Oxycodon-HCl-CT

Oxycodone

Oxycodone hydrochloride (a derivative of Oxycodone) is reported as an ingredient of Oxycodon-HCl-CT in the following countries:

• Germany

International Drug Name Search

Norepinefrina Northia

Norepinefrina Northia may be available in the countries listed below.

Ingredient matches for Norepinefrina Northia

Norepinephrine

Norepinephrine is reported as an ingredient of Norepinefrina Northia in the following countries:

• Argentina

International Drug Name Search

Trimipramin CT

Trimipramin CT may be available in the countries listed below.

Ingredient matches for Trimipramin CT

Trimipramine

Trimipramine maleate (a derivative of Trimipramine) is reported as an ingredient of Trimipramin CT in the following countries:

• Germany

International Drug Name Search

Spironolacton CF

Spironolacton CF may be available in the countries listed below.

Ingredient matches for Spironolacton CF

Spironolactone

Spironolactone is reported as an ingredient of Spironolacton CF in the following countries:

• Netherlands

International Drug Name Search

Acide méfénamique

Acide méfénamique may be available in the countries listed below.

Ingredient matches for Acide méfénamique

Mefenamic Acid

Acide méfénamique (DCF) is known as Mefenamic Acid in the US.

International Drug Name Search

Glossary

DCF	Dénomination Commune Française

Click for further information on drug naming conventions and International Nonproprietary Names.

Antichol

Antichol may be available in the countries listed below.

Ingredient matches for Antichol

Simvastatin

Simvastatin is reported as an ingredient of Antichol in the following countries:

• Greece

International Drug Name Search

Rifampicina Fabra

Rifampicina Fabra may be available in the countries listed below.

Ingredient matches for Rifampicina Fabra

Rifampicin

Rifampicin is reported as an ingredient of Rifampicina Fabra in the following countries:

• Argentina

International Drug Name Search

Nivelipol

Nivelipol may be available in the countries listed below.

Ingredient matches for Nivelipol

Simvastatin

Simvastatin is reported as an ingredient of Nivelipol in the following countries:

• Argentina

International Drug Name Search

Duraflu

Pronunciation: a-seet-a-MIN-oh-fen/dex-troe-meth-OR-fan/gwye-FEN-e-sin /sue-doe-eh-FED-rin
Generic Name: Acetaminophen/Dextromethorphan/Guaifenesin/Pseudoephedrine
Brand Name: Examples include Duraflu and Tylenol Cold

Duraflu is used for:

Relieving pain, congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Duraflu is an analgesic, decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, loosening mucus and lung secretions in the chest, and making coughs more productive. The analgesic and cough suppressant works in the brain to decrease pain and to help decrease the cough reflex to reduce a dry cough.

Do NOT use Duraflu if:

• you are allergic to any ingredient in Duraflu


• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)


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

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

Before using Duraflu:

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

• if you are pregnant, plan 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 history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, stroke, or liver problems, or if you consume more than 3 alcohol-containing drinks per day


• if you have a chronic cough, lung problems (eg, asthma, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

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

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Duraflu may be increased


• Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of side effects such as bleeding, irregular heartbeat or heart attack may be increased


• Bromocriptine because the risk of side effects may be increased by Duraflu


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Duraflu

This may not be a complete list of all interactions that may occur. Ask your health care provider if Duraflu 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 Duraflu:

Use Duraflu as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Duraflu may be taken with or without food.


• Drink plenty of water while taking Duraflu.


• If you miss a dose of Duraflu, 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 Duraflu.

Important safety information:

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


• Do not take appetite suppressants while you are taking Duraflu without checking with your doctor.


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


• Do NOT exceed the recommended dose or take Duraflu for longer than prescribed without checking with your doctor.


• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.


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


• Duraflu may interfere with certain lab test results. Make sure that all of your doctors and laboratory personnel know that you are taking Duraflu.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Duraflu.


• Use Duraflu with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Duraflu in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Duraflu, discuss with your doctor the benefits and risks of using Duraflu during pregnancy. It is unknown if Duraflu is excreted in breast milk. Do not breast-feed while taking Duraflu.

Possible side effects of Duraflu:

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; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; yellowing of 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: Duraflu 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; unusually fast, slow, or irregular heartbeat; vomiting; yellowing of skin or eyes.

Proper storage of Duraflu:

Store Duraflu at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Duraflu out of the reach of children and away from pets.

General information:

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


• Duraflu 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 Duraflu. 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.

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