Epilepax

Epilepax may be available in the countries listed below.

Ingredient matches for Epilepax

Lamotrigine

Lamotrigine is reported as an ingredient of Epilepax in the following countries:

• Argentina

International Drug Name Search

Biclin

Biclin may be available in the countries listed below.

Ingredient matches for Biclin

Amikacin

Amikacin sulfate (a derivative of Amikacin) is reported as an ingredient of Biclin in the following countries:

• Mexico


• Portugal


• Spain

International Drug Name Search

Spironolactone Altizide RPG

Spironolactone Altizide RPG may be available in the countries listed below.

Ingredient matches for Spironolactone Altizide RPG

Altizide

Altizide is reported as an ingredient of Spironolactone Altizide RPG in the following countries:

• France

Spironolactone

Spironolactone is reported as an ingredient of Spironolactone Altizide RPG in the following countries:

• France

International Drug Name Search

Siznil

Siznil may be available in the countries listed below.

Ingredient matches for Siznil

Aripiprazole

Aripiprazole is reported as an ingredient of Siznil in the following countries:

• Bangladesh

International Drug Name Search

Sannax

Sannax may be available in the countries listed below.

Ingredient matches for Sannax

Diclofenac

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

• Japan

International Drug Name Search

Simvastatina Stada

Simvastatina Stada may be available in the countries listed below.

Ingredient matches for Simvastatina Stada

Simvastatin

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

• Spain

International Drug Name Search

Simvastatine Arrow

Simvastatine Arrow may be available in the countries listed below.

Ingredient matches for Simvastatine Arrow

Simvastatin

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

• France


• Netherlands

International Drug Name Search

Sulton

Sulton may be available in the countries listed below.

Ingredient matches for Sulton

Calcium Folinate

Calcium Folinate pentahydrate (a derivative of Calcium Folinate) is reported as an ingredient of Sulton in the following countries:

• Italy

International Drug Name Search

Noctor

Noctor may be available in the countries listed below.

Ingredient matches for Noctor

Diphenhydramine

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

• Austria

International Drug Name Search

Sorbidin

Sorbidin may be available in the countries listed below.

Ingredient matches for Sorbidin

Isosorbide Dinitrate

Isosorbide Dinitrate is reported as an ingredient of Sorbidin in the following countries:

• Australia


• Thailand


• Vietnam

International Drug Name Search

Simvarcana

Simvarcana may be available in the countries listed below.

Ingredient matches for Simvarcana

Simvastatin

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

• Austria

International Drug Name Search

Sutril Neo

Sutril Neo may be available in the countries listed below.

Ingredient matches for Sutril Neo

Torasemide

Torasemide is reported as an ingredient of Sutril Neo in the following countries:

• Spain

International Drug Name Search

Avalide

In the US, Avalide (hydrochlorothiazide/irbesartan systemic) is a member of the drug class antihypertensive combinations and is used to treat High Blood Pressure.

US matches:

• Avalide

Ingredient matches for Avalide

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Avalide in the following countries:

• Canada


• United States

Irbesartan

Irbesartan is reported as an ingredient of Avalide in the following countries:

• Canada


• United States

International Drug Name Search

Oflocollyre

Oflocollyre may be available in the countries listed below.

Ingredient matches for Oflocollyre

Ofloxacin

Ofloxacin is reported as an ingredient of Oflocollyre in the following countries:

• Greece

International Drug Name Search

Sanomigran

Sanomigran may be available in the countries listed below.

UK matches:

• Sanomigran Elixir 0.25 mg/5 ml
• Sanomigran Tablets 1.5 mg and 0.5 mg
• SANOMIGRAN 0.5mg Tablets (SPC)
• SANOMIGRAN 1.5mg Tablets (SPC)
• SANOMIGRAN Elixir (SPC)

Ingredient matches for Sanomigran

Pizotifen

Pizotifen malate (a derivative of Pizotifen) is reported as an ingredient of Sanomigran in the following countries:

• Argentina


• Ireland


• United Kingdom

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

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

Syntofulvin

Syntofulvin may be available in the countries listed below.

Ingredient matches for Syntofulvin

Griseofulvin

Griseofulvin is reported as an ingredient of Syntofulvin in the following countries:

• Sri Lanka

International Drug Name Search

Rocuronium-Mepha

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

Ingredient matches for Rocuronium-Mepha

Rocuronium

Rocuronium Bromide is reported as an ingredient of Rocuronium-Mepha in the following countries:

• Switzerland

International Drug Name Search

Enalapril HCT-1a Pharma

Enalapril HCT-1a Pharma may be available in the countries listed below.

Ingredient matches for Enalapril HCT-1a Pharma

Enalapril

Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Enalapril HCT-1a Pharma in the following countries:

• Hungary

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Enalapril HCT-1a Pharma in the following countries:

• Hungary

International Drug Name Search

Syncomet

Syncomet may be available in the countries listed below.

Ingredient matches for Syncomet

Cimetidine

Cimetidine is reported as an ingredient of Syncomet in the following countries:

• Hong Kong

International Drug Name Search

Sulop

Sulop may be available in the countries listed below.

Ingredient matches for Sulop

Sulfacetamide Sodium

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

• Peru

International Drug Name Search

Sanpilo

Sanpilo may be available in the countries listed below.

Ingredient matches for Sanpilo

Pilocarpine

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

• Japan

International Drug Name Search

Sapridate

Sapridate may be available in the countries listed below.

Ingredient matches for Sapridate

Trimebutine

Trimebutine maleate (a derivative of Trimebutine) is reported as an ingredient of Sapridate in the following countries:

• Algeria

International Drug Name Search

Nevirapina

Nevirapina may be available in the countries listed below.

Ingredient matches for Nevirapina

Nevirapine

Nevirapine is reported as an ingredient of Nevirapina in the following countries:

• Argentina


• Peru

International Drug Name Search

Betanol

Betanol may be available in the countries listed below.

Ingredient matches for Betanol

Atenolol

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

• Bangladesh

Metipranolol

Metipranolol is reported as an ingredient of Betanol in the following countries:

• Monaco

International Drug Name Search

Santa-E

Santa-E may be available in the countries listed below.

Ingredient matches for Santa-E

Tocopherol, α-

Tocopherol, α- is reported as an ingredient of Santa-E in the following countries:

• Indonesia

International Drug Name Search

Mucoangin

Mucoangin may be available in the countries listed below.

Ingredient matches for Mucoangin

Ambroxol

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

• Austria


• Belgium


• Denmark


• Germany


• Hungary


• Luxembourg


• Mexico


• Netherlands


• Poland


• Romania


• Sweden


• Venezuela

International Drug Name Search

Sarasilt

Sarasilt may be available in the countries listed below.

Ingredient matches for Sarasilt

Miconazole

Miconazole is reported as an ingredient of Sarasilt in the following countries:

• Japan

International Drug Name Search

Adversuten

Adversuten may be available in the countries listed below.

Ingredient matches for Adversuten

Prazosin

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

• Germany

International Drug Name Search

Sanocef

Sanocef may be available in the countries listed below.

Ingredient matches for Sanocef

Cefaclor

Cefaclor monohydrate (a derivative of Cefaclor) is reported as an ingredient of Sanocef in the following countries:

• Turkey

International Drug Name Search

Athlikan

Athlikan may be available in the countries listed below.

Ingredient matches for Athlikan

Hyaluronic Acid

Hyaluronic Acid sodium salt (a derivative of Hyaluronic Acid) is reported as an ingredient of Athlikan in the following countries:

• Japan

International Drug Name Search

Saprox

Saprox may be available in the countries listed below.

Ingredient matches for Saprox

Naproxen

Naproxen is reported as an ingredient of Saprox in the following countries:

• Bangladesh

International Drug Name Search

Sanset

Sanset may be available in the countries listed below.

Ingredient matches for Sanset

Ciprofloxacin

Ciprofloxacin is reported as an ingredient of Sanset in the following countries:

• Turkey

International Drug Name Search

Feraheme

Generic Name: Ferumoxytol
Class: Iron Preparations
VA Class: TN410
Molecular Formula: Fe₅₈₇₄O₈₇₅₂C₁₁₇₁₉H₁₈₆₈₂O₉₉₃₃Na₄₁₄
CAS Number: 1309-38-2

Introduction

Hematinic agent: a superparamagnetic iron oxide nanoparticle with a polyglucose sorbitol carboxymethylether coating.^{1 2 3}

Uses for Feraheme

Iron Deficiency Anemia in Patients with Chronic Kidney Disease

Treatment of iron deficiency anemia in adults with chronic kidney disease (CKD).^{1 2 3}

National Kidney Foundation guidelines recommend use of IV iron in patients undergoing hemodialysis and either oral or IV iron in patients undergoing peritoneal dialysis and in those with chronic kidney disease not on dialysis.⁴

Feraheme Dosage and Administration

General

Goal of iron therapy in patients with chronic renal failure not undergoing dialysis or undergoing peritoneal dialysis is to achieve and maintain a transferrin saturation (TSAT) of >20% and a serum ferritin concentration of >100 ng/mL.⁴

Goal of iron therapy in patients with chronic renal failure undergoing hemodialysis is to achieve and maintain a TSAT of >20% (or content of hemoglobulin in reticulocytes [CHr] >29 pg/cell) and a serum ferritin concentration of >200 ng/mL.⁴

Evaluate hematologic response (e.g., serum ferritin concentration, hemoglobin level, iron and transferrin saturation) at least one month after the second dose of ferumoxytol.¹

Monitor for hypersensitivity reactions for at least 30 minutes after each injection.¹ Appropriate agents and personnel for the treatment of hypersensitivity reactions should be readily available.¹

Monitor for hypotension.¹

Administration

IV Administration

Administer undiluted by IV injection.¹

Hemodialysis patients: Administer after first hour of dialysis, when patient is hemodynamically stable.¹

Rate of Administration

1 mL/second.¹

Dosage

Dosage expressed in terms of mg of elemental iron.¹ Ferumoxytol injection contains the equivalent of 30 mg of elemental iron per mL.¹

Adults

Iron Deficiency Anemia in Patients with Chronic Kidney Disease

IV

Initial dose is 510 mg; second dose is 510 mg administered 3–8 days after initial dose.¹

Course of ferumoxytol may be repeated.¹

Special Populations

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.¹

Cautions for Feraheme

Contraindications

• 
  

  Known hypersensitivity to ferumoxytol or any ingredient in the formulation.¹

  
  


• 
  

  Evidence of iron overload.¹

  
  


• 
  

  Anemias not associated with iron deficiency.¹

  
  

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity reactions (e.g., anaphylaxis, anaphylactoid reactions) reported; serious reactions reported in 0.2% of patients; other potential hypersensitivity reactions (e.g., pruritus, rash, urticaria, wheezing) reported in 3.7% of patients.¹ Monitor patient for hypersensitivity reactions for at least 30 minutes after each injection.¹

Cardiovascular Effects

Hypotension reported in 1.9% of patients; serious hypotensive reactions reported in a few patients.¹ Monitor patient for hypotension.¹

Iron Toxicity

Withhold iron administration in patients with evidence of iron overload.¹ Excessive administration of parenteral iron preparations may cause excess storage of iron with the possibility of iatrogenic hemosiderosis.¹

Evaluate hematologic response at least 1 month after second dose.¹ Laboratory assays may overestimate serum iron and transferrin-bound iron in the 24 hours following injection of ferumoxytol.¹

Magnetic Resonance Imaging

May temporarily affect magnetic resonance imaging (MRI) studies; alteration in MRI studies may persist for up to 3 months after the last dose of ferumoxytol.¹

Schedule MRI studies before administration of ferumoxytol.¹ If MRI studies are needed within 3 months of ferumoxytol administration, use of T1- or proton density-weighted pulse sequences minimizes the effects of the drug.¹ Do not perform MRI studies using T2-weighted pulse sequences earlier than 4 weeks after drug administration.¹ Maximum alteration in vascular MRI studies is expected for 1–2 days following drug administration.¹

Does not interfere with radiography, computed tomography (CT), positron emission tomography (PET), single photon emission computed tomography (SPECT), ultrasound, or nuclear imaging.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Not know whether ferumoxytol is distributed into human milk.¹ Discontinue nursing or the drug, taking into account the importance of the drug to the woman and the benefits of nursing.¹

Pediatric Use

Safety and efficacy not established in pediatric patients.¹

Geriatric Use

No overall differences in efficacy or safety relative to younger adults; possibility of increased sensitivity cannot be ruled out.¹ Use caution in dosage selection.¹ (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Diarrhea, nausea, dizziness, hypotension, constipation, peripheral edema.¹

Interactions for Feraheme

No formal drug interaction studies to date.¹

Oral Iron Preparations

Ferumoxytol injection expected to reduce absorption of concomitantly administered oral iron.¹

Feraheme Pharmacokinetics

Absorption

Bioavailability

Time to peak plasma concentrations is 0.32 hours.¹

Elimination

Elimination Route

Not removed by dialysis.^{1 3}

Half-life

15 hours.¹

Stability

Storage

Parenteral

Injection

20–25°C (may be exposed to 15–30°C).¹

ActionsActions

• 
  

  Ferumoxytol is taken up by the reticuloendothelial system.¹ Subsequently, iron is released from ferumoxytol into macrophages.¹ Iron enters the intracellular storage pool or is bound to plasma transferrin for transport to erythroid precursor cells where it is incorporated into hemoglobin.¹

  
  

Advice to Patients

• 
  

  Risk of hypersensitivity reactions.¹

  
  


• 
  

  Risk of hypotension.¹

  
  


• 
  

  Importance of informing clinician of prior hypersensitivity reactions to parenteral iron preparations.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Ferumoxytol

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for IV use	equivalent to elemental iron 30 mg/mL	Feraheme	AMAG Pharmaceuticals

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. AMAG Pharmaceuticals. Feraheme (ferumoxytol) injection prescribing information. Lexington, MA; 2009 Jun.

2. Spinowitz BS, Kausz AT, Baptista J et al. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol. 2008; 19:1599-1605. [PubMed 18525001]

3. Provenzano R, Schiller B, Rao M et al. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Clin J Am Soc Nephrol. 2009; 4:386-93. [PubMed 19176796]

4. National Kidney Foundation. K/DOQI clinical practice guidelines and clinical practice recommendations for anemia of chronic kidney disease. Am J Kidney Dis. 2006; 47 (Suppl 3);S1-S146.

More Feraheme resources

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

• Feraheme Prescribing Information (FDA)


• Feraheme Consumer Overview


• Feraheme Advanced Consumer (Micromedex) - Includes Dosage Information


• Feraheme MedFacts Consumer Leaflet (Wolters Kluwer)


• Ferumoxytol Professional Patient Advice (Wolters Kluwer)

Compare Feraheme with other medications

• Anemia Associated with Chronic Renal Failure
• Iron Deficiency Anemia

Santo

Santo may be available in the countries listed below.

Ingredient matches for Santo

Tetryzoline

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

• Indonesia

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Nomégestrol Teva

Nomégestrol Teva may be available in the countries listed below.

Ingredient matches for Nomégestrol Teva

Nomegestrol

Nomegestrol acetate (a derivative of Nomegestrol) is reported as an ingredient of Nomégestrol Teva in the following countries:

• France

International Drug Name Search

Sapimol

Sapimol may be available in the countries listed below.

Ingredient matches for Sapimol

Ipratropium

Ipratropium Bromide monohydrate (a derivative of Ipratropium Bromide) is reported as an ingredient of Sapimol in the following countries:

• Sweden

Salbutamol

Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Sapimol in the following countries:

• Sweden

International Drug Name Search

Sarcop

Sarcop may be available in the countries listed below.

Ingredient matches for Sarcop

Permethrin

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

• Spain

International Drug Name Search

Metformin Pfizer

Metformin Pfizer may be available in the countries listed below.

Ingredient matches for Metformin Pfizer

Metformin

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

• Sweden

International Drug Name Search

Tifomycine

Tifomycine may be available in the countries listed below.

Ingredient matches for Tifomycine

Chloramphenicol

Chloramphenicol is reported as an ingredient of Tifomycine in the following countries:

• Ethiopia

International Drug Name Search

Tensen

Tensen may be available in the countries listed below.

Ingredient matches for Tensen

Finasteride

Finasteride is reported as an ingredient of Tensen in the following countries:

• Taiwan

International Drug Name Search

Siblix

Siblix may be available in the countries listed below.

Ingredient matches for Siblix

Aripiprazole

Aripiprazole is reported as an ingredient of Siblix in the following countries:

• Argentina

International Drug Name Search

Sporanox

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

In the US, Sporanox (itraconazole systemic) is a member of the drug class azole antifungals and is used to treat Aspergillosis - Aspergilloma, Blastomycosis, Candida Infections - Systemic, Candida Urinary Tract Infection, Coccidioidomycosis, Cryptococcosis, Dermatophytosis, Esophageal Candidiasis, Febrile Neutropenia, Histoplasmosis, Onychomycosis - Fingernail, Onychomycosis - Toenail, Oral Thrush, Paracoccidioidomycosis, Sporotrichosis, Tinea Capitis, Tinea Versicolor and Vaginal Yeast Infection.

US matches:

• Sporanox


• Sporanox Capsules


• Sporanox PulsePak


• Sporanox Solution


• Sporanox injection

UK matches:

• Sporanox -Pulse (SPC)
• Sporanox 10 mg/ml Oral Solution (SPC)
• Sporanox Capsules (SPC)
• Sporanox I.V. 10 mg/ml concentrate and solvent for solution for infusion (SPC)

Ingredient matches for Sporanox

Itraconazole

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

• Antigua & Barbuda


• Argentina


• Aruba


• Australia


• Austria


• Bahamas


• Belgium


• Bermuda


• Brazil


• Canada


• Cayman Islands


• Chile


• Colombia


• Costa Rica


• Cyprus


• Czech Republic


• Denmark


• Dominican Republic


• Ecuador


• Egypt


• El Salvador


• Ethiopia


• Finland


• France


• Greece


• Grenada


• Guatemala


• Guyana


• Honduras


• Hong Kong


• Iceland


• Indonesia


• Ireland


• Israel


• Italy


• Jamaica


• Jordan


• Lebanon


• Lithuania


• Luxembourg


• Malaysia


• Mexico


• Netherlands Antilles


• New Zealand


• Nicaragua


• Norway


• Oman


• Panama


• Peru


• Philippines


• Portugal


• Saint Lucia


• Saint Vincent & The Grenadines


• Saudi Arabia


• Serbia


• Singapore


• Slovakia


• Slovenia


• South Africa


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• Sri Lanka


• Sudan


• Suriname


• Sweden


• Switzerland


• Taiwan


• Trinidad & Tobago


• United Arab Emirates


• United Kingdom


• United States


• Venezuela


• Yemen

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

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

Salbutal

Salbutal may be available in the countries listed below.

Ingredient matches for Salbutal

Salbutamol

Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Salbutal in the following countries:

• Bangladesh

International Drug Name Search

Guaifenesin Tablets

Dosage Form: tablet
Professional Labeling Information and Directions for Use

These products labeled for sale on prescription only.

Guaifenesin Tablets

Guaifenesin Tablets Description

Guaifenesin (glyceryl guaiacolate) has the chemical name 3-(2-methoxyphenoxy)-1,2-propanediol. Its molecular formula is C10H14O4 with a molecular weight of 198.21. It is a white or slightly gray crystalline substance with a slightly bitter aromatic taste. One gram dissolves in 20 mL water at 25°C; it is freely soluble in ethanol. Guaifenesin is readily absorbed from the GI tract and is rapidly metabolized and excreted in the urine. Guaifenesin has a plasma half-life of one hour. The major urinary metabolite is β-(2-methoxyphenoxy) lactic acid.

Guaifenesin is an expectorant available for oral administration as:

Tablets — each containing 200 mg guaifenesin, USP.

Other ingredients: crospovidone, D&C red #30 aluminum lake, magnesium stearate, microcrystalline cellulose, polysaccharides, pregelatinized starch, silicon dioxide, sodium starch glycolate, and stearic acid.

Guaifenesin Tablets - Clinical Pharmacology

Guaifenesin is an expectorant, the action of which promotes or facilitates the removal of secretions from the respiratory tract. By increasing sputum volume and making sputum less viscous, guaifenesin facilitates expectoration of retained secretions.

Indications and Usage for Guaifenesin Tablets

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes and make coughs more productive. Helps loosen phlegm and thin bronchial secretions in patients with stable chronic bronchitis.

Contraindications

Hypersensitivity to any of the ingredients.

Precautions

Carcinogenesis, Mutagenesis, Impairment of Fertility: Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans have not been performed.

Pregnancy:

Teratogenic Effects—Pregnancy Category C: Animal reproduction studies have not been conducted. Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore, these products should not be used in pregnant patients unless, in the judgment of the physician, the potential benefits outweigh possible hazards.

Nursing Mothers: It is not known whether guaifenesin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when these products are administered to a nursing woman and a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Laboratory Test Interactions: Guaifenesin or its metabolites may cause color interference with the VMA (vanillylmandelic acid) test for catechols. It may also falsely elevate the level of urinary 5-HIAA (5-hydroxyindoleacetic acid) in certain serotonin metabolite chemical tests because of color interference.

Adverse Reactions

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Guaifenesin is well tolerated and has a wide margin of safety. Side effects have been generally mild and infrequent. Nausea and vomiting are the side effects that occur most commonly. Dizziness, headache, and rash (including urticaria) have been reported rarely.

Overdosage

In massive overdosage the stomach should be emptied (emesis and/or gastric lavage) and further absorption prevented. Treatment is symptomatic and supportive.

The acute toxicity of guaifenesin is low and overdosage is unlikely to produce serious toxic effects. In laboratory animals no toxicity resulted when guaifenesin was administered by stomach tube in doses up to 5 grams/kg.

Guaifenesin Tablets Dosage and Administration

Adults and children 12 years of age and older: One to 2 tablets (200 mg to 400 mg) every four hours, not to exceed 2400 mg (12 tablets) in 24 hours.

PATIENTS SHOULD BE ADVISED TO KEEP THESE AND ALL DRUGS OUT OF THE REACH OF CHILDREN AND TO SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY IN CASE OF ACCIDENTAL OVERDOSE.

How is Guaifenesin Tablets Supplied

Guaifenesin

Tablets — Each round, scored, rose-colored tablet contains 200 mg guaifenesin USP—available in blisters of 30 (NDC 67046-250-30)

STORAGE — Store at controlled room temperature 20°-25°C (68°-77°F). Protect tablets from moisture. Keep bottle tightly closed.

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Qualitest PHARMACEUTICALS®

Huntsville, AL 35811

8180142 Rev 5/08

Blister of 30 Tablets

GUAIFENESIN  guaifenesin  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 67046-250 (0603-4886) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE   D&C RED NO. 30   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   SILICON DIOXIDE   SODIUM STARCH GLYCOLATE TYPE A POTATO   STEARIC ACID

Product Characteristics Color PINK Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 4740;V Contains

Packaging # NDC Package Description Multilevel Packaging 1 67046-250-30 30 TABLET In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		10/06/2010

Labeler - Contract Pharmacy Services-PA (945429777)

Revised: 10/2010Contract Pharmacy Services-PA

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Sumatriptan Pliva

Sumatriptan Pliva may be available in the countries listed below.

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Sumatriptan

Sumatriptan succinate (a derivative of Sumatriptan) is reported as an ingredient of Sumatriptan Pliva in the following countries:

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International Drug Name Search

Maxair

pirbuterol acetate

Dosage Form: Inhalation Aerosol

For Oral Inhalation Only

Maxair Description

The active component of Maxair Inhaler (pirbuterol acetate) is (R,S)a6-{ [(1,1-dimethylethyl)amino]methyl}-3-hydroxy-2,6-pyridine-dimethanol monoacetate salt, a beta-2 adrenergic bronchodilator, having the following chemical structure:

Pirbuterol acetate is a white, crystalline racemic mixture of two optically active isomers. It is a powder, freely soluble in water, with a molecular weight of 300.3 and empirical formula of C12H20N2O3•C2H4O2.

Maxair Inhaler is a pressurized metered-dose aerosol unit for oral inhalation. It provides a fine-particle suspension of pirbuterol acetate in the propellant mixture of trichloromonofluoromethane and dichlorodifluoromethane, with sorbitan trioleate. Each actuation delivers 256 mcg of pirbuterol (as pirbuterol acetate) from the valve and 200 mcg of pirbuterol (as pirbuterol acetate) from the mouthpiece. Each canister provides 300 inhalations.

As with all aerosol medications, it is recommended to prime (test) Maxair Inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks. Prime by releasing three “test sprays” into the air away from yourself and other people.

Maxair - Clinical Pharmacology

In vitro studies and in vivo pharmacologic studies have demonstrated that pirbuterol has a preferential effect on beta-2 adrenergic receptors compared with isoproterenol. While it is recognized that beta-2 adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta-2 receptors in the human heart, existing in a concentration between 10-50%. The precise function of these receptors has not been established (see WARNINGS section).

The pharmacologic effects of beta adrenergic agonist drugs, including pirbuterol, are at least in part attributable to stimulation through beta adrenergic receptors of intracellular adenyl cyclase, the enzyme which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3′,5′-adenosine monophosphate (c-AMP). Increased c-AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.

Bronchodilator activity of pirbuterol was manifested clinically by an improvement in various pulmonary function parameters (FEV1, MMF, PEFR, airway resistance [RAW] and conductance [GA/Vtg]).

Clinical Trials: In controlled, double-blind, single-dose clinical trials, the onset of improvement in pulmonary function occurred within 5 minutes in most patients as determined by forced expiratory volume in one second (FEV1). FEV1 and MMF measurements also showed that maximum improvement in pulmonary function generally occurred 30-60 minutes following one (1) or two (2) inhalations of pirbuterol (200-400 mcg). The duration of action of pirbuterol is maintained for 5 hours (the time at which the last observations were made) in a substantial number of patients, based on a 15% or greater increase in FEV1. In controlled repetitive-dose studies of 12 weeks' duration, 74% of 156 patients on pirbuterol and 62% of 141 patients on metaproterenol showed a clinically significant improvement based on a 15% or greater increase in FEV1 on at least half of the days. Onset and duration were equivalent to that seen in single-dose studies. Continued effectiveness was demonstrated over the 12-week period in the majority (94%) of responding patients; however, chronic dosing was associated with the development of tachyphylaxis (tolerance) to the bronchodilator effect in some patients in both treatment groups.

A placebo-controlled, double-blind, single-dose study (24 patients per treatment group), utilizing continuous Holter monitoring for 5 hours after drug administration, showed no significant difference in ectopic activity between the placebo control group and pirbuterol at the recommended dose (200-400 mcg), and twice the recommended dose (800 mcg). As with other inhaled beta adrenergic agonists, supraventricular and ventricular ectopic beats have been seen with pirbuterol (see WARNINGS).

Preclinical: Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta-agonists and methylxanthines were administered concurrently. The clinical significance of these findings when applied to humans is unknown.

Pharmacokinetics: As expected by extrapolation from oral data, systemic blood levels of pirbuterol are below the limit of assay sensitivity (2-5 ng/ml) following inhalation of doses up to 800 mcg (twice the maximum recommended dose). A mean of 51% of the dose is recovered in urine as pirbuterol plus its sulfate conjugate following administration by aerosol. Pirbuterol is not metabolized by catechol-O-methyltransferase. The percent of administered dose recovered as pirbuterol plus its sulfate conjugate does not change significantly over the dose range of 400 mcg to 800 mcg and is not significantly different from that after oral administration of pirbuterol. The plasma half-life measured after oral administration is about two hours.

Indications and Usage for Maxair

Maxair Inhaler is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with reversible bronchospasm including asthma. It may be used with or without concurrent theophylline and/or corticosteroid therapy.

Contraindications

Maxair Inhaler is contraindicated in patients with a history of hypersensitivity to pirbuterol or any of its ingredients.

Warnings

Cardiovascular: Maxair Inhaler, like other inhaled beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of Maxair Inhaler at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, Maxair Inhaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Paradoxical Bronchospasm: Maxair Inhaler can produce paradoxical bronchospasm, which can be life threatening. If paradoxical bronchospasm occurs, Maxair Inhaler should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial.

Use of Anti-Inflammatory Agents: The use of beta adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids.

Deterioration of Asthma: Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Maxair Inhaler than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

Precautions

General: Since pirbuterol is a sympathomimetic amine, it should be used with caution in patients with cardiovascular disorders, including ischemic heart disease, hypertension, or cardiac arrhythmias, in patients with hyperthyroidism or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines or who have convulsive disorders. Significant changes in systolic and diastolic blood pressure could be expected to occur in some patients after use of any beta adrenergic aerosol bronchodilator.

Beta adrenergic agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.

Information for Patients: The action of Maxair Inhaler should last up to five hours or longer. Maxair Inhaler should not be used more frequently than recommended. Do not increase the dose or frequency of Maxair Inhaler without consulting your physician. If you find that treatment with Maxair Inhaler becomes less effective for symptomatic relief, or your symptoms become worse, and/or you need to use the product more frequently than usual, you should seek medical attention immediately. While you are using Maxair Inhaler, other inhaled drugs and asthma medications should be taken only as directed by your physician. Common adverse effects include palpitations, chest pain, rapid heart rate, tremor or nervousness. If you are pregnant or nursing, contact your physician about use of Maxair Inhaler. Effective and safe use includes an understanding of the way the medication should be administered. As with all aerosol medications, it is recommended to prime (test) Maxair Inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks. Prime by releasing three “test sprays” into the air away from yourself and other people. (See “Patient's Instructions for Use” portion of this package insert.)

Drug Interactions: Other short-acting beta adrenergic aerosol bronchodilators should not be used concomitantly with Maxair Inhaler because they may have additive effects.

Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: Pirbuterol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of pirbuterol on the vascular system may be potentiated.

Beta Blockers: Beta adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as Maxair Inhaler, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta blockers could be considered, although they should be administered with caution.

Diuretics: The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics.

Carcinogenicity, Mutagenesis and Impairment of Fertility: In a 2-year study in Sprague-Dawley rats, pirbuterol hydrochloride administered at dietary doses of 1.0, 3.0, and 10 mg/kg (approximately 3, 10, and 35 times the maximum recommended daily inhalation dose for adults and children on a mg/m2 basis) showed no evidence of carcinogenicity. In an 18-month study in mice at dietary doses of 1.0, 3.0, and 10 mg/kg (approximately 2, 5, and 15 times the maximum recommended daily inhalation dose for adults and children on a mg/m2 basis) no evidence of tumorigenicity was seen. Reproduction studies in rats administered pirbuterol hydrochloride at oral doses of 1, 3, and 10 mg/kg (approximately 3, 10, and 35 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis) revealed no evidence of impaired fertility.

Pirbuterol dihydrochloride showed no evidence of mutagenicity in in vitro assays and host-mediated microbial (Ames) assays for point mutations and in vivo tests for somatic or germ cell effects following acute and subchronic treatment in mice (cytogenicity assays).

Teratogenic Effects – Pregnancy Category C: Pirbuterol was not teratogenic in rats administered oral doses of 30, 100, and 300 mg/kg (approximately 100, 340, and 1000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis). Pirbuterol was not teratogenic in rabbits administered oral doses of 30 and 100 mg/kg (approximately 200 and 680 times the maximum recommended inhalation dose for adults on a mg/m2 basis). However, pirbuterol at an oral dose of 300 mg/kg (approximately 2000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis) caused abortions and fetal death.

There are no adequate and well-controlled studies in pregnant women. Pirbuterol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery: Because of the potential for beta-agonist interference with uterine contractility, use of Maxair Inhaler for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.

Nursing Mothers: It is not known whether pirbuterol is excreted in human milk. Therefore, Maxair Inhaler should be used during nursing only if the potential benefit justifies the possible risk to the newborn.

Pediatric Use: Maxair Inhaler is not recommended for patients under the age of 12 years because of insufficient clinical data to establish safety and effectiveness.

Adverse Reactions

The following rates of adverse reactions to pirbuterol are based on single- and multiple-dose clinical trials involving 761 patients, 400 of whom received multiple doses (mean duration of treatment was 2.5 months and maximum was 19 months).

The following were the adverse reactions reported more frequently than 1 in 100 patients:

CNS: nervousness (6.9%), tremor (6.0%), headache (2.0%), dizziness (1.2%).

Cardiovascular: palpitations (1.7%), tachycardia (1.2%).

Respiratory: cough (1.2%).

Gastrointestinal: nausea (1.7%).

The following adverse reactions occurred less frequently than 1 in 100 patients and there may be a causal relationship with pirbuterol:

CNS: depression, anxiety, confusion, insomnia, weakness, hyperkinesia, syncope.

Cardiovascular: hypotension, skipped beats, chest pain.

Gastrointestinal: dry mouth, glossitis, abdominal pain/cramps, anorexia, diarrhea, stomatitis, nausea and vomiting.

Ear, Nose and Throat: smell/taste changes, sore throat.

Dermatological: rash, pruritus.

Other: numbness in extremities, alopecia, bruising, fatigue, edema, weight gain, flushing.

Other adverse reactions were reported with a frequency of less than 1 in 100 patients but a causal relationship between pirbuterol and the reaction could not be determined: migraine, productive cough, wheezing, and dermatitis.

The following rates of adverse reactions during three-month controlled clinical trials involving 310 patients are noted. The table does not include mild reactions.

PERCENT OF PATIENTS WITH MODERATE TO SEVERE ADVERSE REACTIONS

Reaction	Pirbuterol	Metaproterenol
	N=157	N=153
Central Nervous System
tremors	1.3%	3.3%
nervousness	4.5%	2.6%
headache	1.3%	2.0%
weakness	.0%	1.3%
drowsiness	.0%	0.7%
dizziness	0.6%	.0%
Cardiovascular
palpitations	1.3%	1.3%
tachycardia	1.3%	2.0%
Respiratory
chest pain/tightness	1.3%	.0%
cough	.0%	0.7%
Gastrointestinal
nausea	1.3%	2.0%
diarrhea	1.3%	0.7%
dry mouth	1.3%	1.3%
vomiting	.0%	0.7%
Dermatological
skin reaction	.0%	0.7%
rash	.0%	1.3%
Other
bruising	0.6%	.0%
smell/taste change	0.6%	.0%
backache	.0%	0.7%
fatigue	.0%	0.7%
hoarseness	.0%	0.7%
nasal congestion	.0%	0.7%

Electrocardiograms: Electrocardiograms, obtained during a randomized, double-blind, cross-over study in 57 patients, showed no observations or findings considered clinically significant, or related to drug administration. Most electrocardiographic observations, obtained during a randomized, double blind, cross-over study in 40 patients, were judged not clinically significant or related to drug administration. One patient was noted to have some changes on the one hour postdose electrocardiogram consisting of ST and T wave abnormality suggesting possible inferior ischemia. This abnormality was not observed on the predose or the six hours postdose ECG. A treadmill was subsequently performed and all the findings were normal.

Overdosage

The expected symptoms with overdosage are those of excessive beta-stimulation and/or any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Hypokalemia may also occur. As with all sympathomimetic aerosol medication, cardiac arrest and even death may be associated with abuse of Maxair Inhaler.

Treatment consists of discontinuation of pirbuterol together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage.

The oral median lethal dose of pirbuterol dihydrochloride in mice and rats is greater than 2000 mg/kg (approximately 3400 and 6800 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis).

Maxair Dosage and Administration

The usual dose for adults and children 12 years and older is two inhalations (400 mcg) repeated every 4-6 hours. One inhalation (200 mcg) repeated every 4-6 hours may be sufficient for some patients.

A total daily dose of 12 inhalations should not be exceeded. If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

As with all aerosol medications, it is recommended to prime (test) Maxair Inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks. Prime by releasing three “test sprays” into the air away from yourself and other people.

How is Maxair Supplied

Maxair Inhaler, box of one, is supplied in a pressurized aluminum canister with a light blue plastic actuator and attached white mouthpiece. Each actuation delivers pirbuterol acetate equivalent to 256 mcg of pirbuterol (as pirbuterol acetate) from the valve and 200 mcg of pirbuterol (as pirbuterol acetate) from the mouthpiece.

Net content weight 25.6 g, 300 metered inhalations (NDC 0089-0790-21).

The correct amount of medication in each canister cannot be assured after 300 actuations even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations has been used.

Note: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFC's).

 

WARNING: Contains trichloromonofluoromethane and dichlorodifluoromethane, substances which harm public health and environment by destroying ozone in the upper atmosphere.

A notice similar to the above WARNING has been placed in the “Patient's Instructions for Use” portion of this package insert under the Environmental Protection Agency's (EPA's) regulations. The patient's warning states that the patient should consult his or her physician if there are questions about alternatives.

Rx only

Store between 15° and 30°C (59° to 86°F). Failure to use this product within this temperature range may result in improper dosing. For optimal results, the canister should be at room temperature before use. Shake well before using.

The contents of Maxair Inhaler are under pressure. Do not puncture. Do not use or store near heat or open flame. Exposure to temperature above 120°F may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children. Avoid spraying in eyes.

The light blue plastic actuator supplied with Maxair Inhaler should not be used with any other product canisters, and actuators from other products should not be used with Maxair Inhaler canister.

3M Pharmaceuticals

Northridge, CA 91324

654500

3M

SEPTEMBER 2000

Maxair™ Inhaler

pirbuterol acetate inhalation aerosol

PATIENT'S INSTRUCTIONS FOR USE

Before using your Maxair Inhaler, read the following instructions carefully.

NOTE: Your Maxair Inhaler is assembled with a special one-piece light blue plastic actuator and attached white mouthpiece/cap that protects your Inhaler from dust during shipping and in between use (see Figure A).

The Actuator Is Readily Prepared For Use As Follows:

1. Grasp the base of the actuator with one hand and pull the mouthpiece/cap with the other hand (see Figure B). The light blue plastic actuator supplied with Maxair Inhaler should not be used with any other product canisters, and actuators from other products should not be used with Maxair Inhaler canister.
   
   
   

   As with all aerosol medications, it is recommended to prime (test) Maxair Inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks. Prime by releasing three “test sprays” into the air away from yourself and other people.

   
   


2. While holding the base, turn the mouthpiece/cap as shown. Inspect mouthpiece for foreign objects (see Figure C).
   
   
   


3. Just prior to use, SHAKE the Inhaler.


4. Hold the Inhaler so that the base of the canister is UP as shown (see Figure D). Avoid spraying in eyes.
   
   
   


5. Breathe normally, do not exhale deeply.


6. Place the mouthpiece well into the mouth. Press down firmly and fully on the canister with your index finger (see Figure D) to release one dose. Breathe in deeply while doing this. Hold your breath for 5 seconds. Remove the Inhaler from your mouth, then breathe normally.


7. Wait one minute and SHAKE the Inhaler again. Repeat steps 4 through 6 for each inhalation if necessary as prescribed by your physician. No more than 12 inhalations should be taken in one day.


8. After use, the mouthpiece/cap should be turned back, then pushed into the CLOSED POSITION to protect from dust or foreign objects (see Figure E).
   
   
   


9. Cleanse the Inhaler thoroughly at least once a day. Remove the canister and rinse the mouthpiece/cap section with warm running water. If soap is used, rinse thoroughly with plain water. Allow the actuator to dry before reuse (do not expose to excessive heat; see CAUTION below), then reassemble.

Dosage: Use only as directed by your physician. The correct amount of medication in each canister cannot be assured after 300 actuations even though the canister is not completely empty. You should keep track of the number of actuations used from each Maxair Inhaler and discard the canister after 300 actuations. The canister should be discarded when the labeled number of actuations has been used. Before you reach the specified number of actuations, you should consult your physician to determine whether a refill is needed. Just as you should not take extra doses without consulting your physician, you should not stop using Maxair Inhaler without consulting your physician.

WARNINGS: The effects of Maxair Inhaler may last up to five hours or longer. Therefore, it should not be used more frequently than recommended. Do not increase the number or frequency of doses without speaking with the prescribing physician. If the recommended dosage does not provide relief of symptoms, or your symptoms get worse, speak with your physician. While taking Maxair Inhaler, other inhaled medicines should not be used unless prescribed.

Note: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFC's).

 

This product contains trichloromonofluoromethane and dichlorodifluoromethane, substances which harm the environment by destroying ozone in the upper atmosphere.

Your physician has determined that this product is likely to help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO DO OTHERWISE BY YOUR PHYSICIAN. If you have any questions about alternatives, consult with your physician.

Caution: CONTENTS UNDER PRESSURE. Do not puncture. Do not use or store near heat or open flame. Exposure to temperature above 120°F may cause bursting. Never throw canister into fire or incinerator. Avoid spraying in eyes. KEEP OUT OF REACH OF CHILDREN.

Store between 15° and 30°C (59° to 86°F). Failure to use this product within this temperature range may result in improper dosing. For optimal results, the canister should be at room temperature before use. Shake well before using.

3M Pharmaceuticals

Northridge, CA 91324

3M

Maxair  pirbuterol acetate  aerosol, metered

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0089-0790 Route of Administration RESPIRATORY (INHALATION) DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength pirbuterol acetate (pirbuterol) Active 200 MICROGRAM  In 1 INHALATION trichloromonofluoromethane Inactive   dichlorodifluoromethane Inactive   sorbitan trioleate Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0089-0790-21 300 INHALATION In 1 INHALER None

Revised: 03/20063M Pharmaceuticals

More Maxair resources

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

• Maxair Concise Consumer Information (Cerner Multum)


• Maxair Advanced Consumer (Micromedex) - Includes Dosage Information


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