not fda-approved nebulizer medication fda-approved nebulizer

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FDA-Approved Asthma and COPD Nebulizer Medications aanma.org • 800.878.4403 May 2009 albuterol sulfate brand available: AccuNeb — Dey, L.P. 0.63 mg 1.25 mg arformoterol tartrate brand available: Brovana — Sepracor Inc. 15 mcg budesonide brand available: Pulmicort Respules — AstraZeneca 0.25 mg 0.5 mg 1 mg ipratropium bromide and albuterol sulfate brand available: DuoNeb — Dey, L.P. 0.5 mg ipratropium bromide and 3.0 mg albuterol sulfate Development of this poster was supported by formoterol fumarate brand available: Perforomist — Dey, L.P. 20 mcg Expiration date embossed onto vial Medication lot number embossed onto vial Medication name and dosage embossed onto vial Pharmaceutical manufacturer name embossed onto vial Imposters come in all shapes and sizes. The plastic “wings” and paper labels are clues to question the safety, source, potency, sterility and inactive ingredients. The source of ingredients in your nebulizer vial may be unknown — and untraceable. Do not use a nebulizer medication that smells foul, rotten or spoiled, or like it may contain rub- bing alcohol. Stop the nebulizer treatment if the medication becomes foamy or bubbly during nebulization. Don’t assume a patent number applies to a medication. This one refers to the plastic vial. For more information: aanma.org/advocacy Paper labels leach toxins into nebulizer solutions; all lack FDA-mandated infor- mation such as dose, expiration date and lot number. Not FDA-Approved Nebulizer Medication Use only Food and Drug Administration ap- proved brand-name or generic medications in- tended for use in nebulizers. Ask your prescriber to write “Do not compound; do not substitute” on your prescription. Make sure that the prescrip- tion is filled with the medication your doctor prescribed. Nebulizer medications are prescribed in unit- dose vials (usually packaged in sealed foil pouches) and multidose bottles. Unit-dose vials are a snap to use; simply open and pour premeasured and mixed solution or suspension into the nebulizer medication cup. Multidose bottles are usually less expensive but require careful handling to avoid contaminating the solution. Wash your hands before opening the medicine. Use a sterile metered syringe to measure out medication; mix with sterile saline solution in the nebulizer medication cup. NOTE: Some multidose bottles contain preservatives, such as benzalkonium chloride (BAC) and disodium ethylene diamine tetraacetic acid (EDTA), which can sometimes irritate sensitive airways. Talk with your healthcare provider if your symptoms are not responding to the medication the way you expect them to. FDA-Approved Nebulizer Medication Combination Short-Acting Corticosteroid Beta-2 Agonists Short-Acting Beta-2 Agonists Long-Acting Actavis Mid Atlantic Llc Apotex Inc. Bausch & Lomb Breath Ltd Cardinal Health Cobalt Laboratories Inc. Dey, L.P. Hi-Tech Pharmacal Co., Inc. Holopack International TEVA Pharmaceutical Morton Grove Nephron Pharmaceuticals Corporation Novex Pharmascience Inc. Respirare RxElite Holdings, Inc. Sandoz Watson Pharmaceuticals, Inc. Manufacturers of FDA-Approved Generic Medications for Nebulizers levalbuterol hydrochloride brand available: Xopenex — Sepracor Inc. 0.31 mg 0.63 mg 1.25 mg albuterol sulfate 0.63 mg 1.25 mg 2.5 mg —————————––––————––— levalbuterol hydrochloride 0.31 mg 0.63 mg 1.25 mg —————————––––————––— ipratropium bromide 0.5 mg no brand available —————————––––————––— ipratropium bromide and albuterol sulfate 0.5 mg ipratropium bromide and 3.0 mg albuterol sulfate —————————––––————––— budesonide 0.25 mg 0.5 mg —————————––––————––— cromolyn sodium 10 mg 20 mg no brand available arformoterol tartrate no generics available —————————––––————––— formoterol fumarate no generics available —————————––––————––— FDA-Approved Generics No FDA-Approved Generics Available

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Page 1: Not FDA-Approved Nebulizer Medication FDA-Approved Nebulizer

FDA-Approved Asthma andCOPD Nebulizer Medicationsaanma.org • 800.878.4403 May 2009

albuterol sulfatebrand available:AccuNeb—Dey, L.P.0.63 mg1.25 mg

arformoterol tartratebrand available:Brovana— Sepracor Inc.15 mcg

budesonidebrand available:

Pulmicort Respules —AstraZeneca0.25 mg0.5 mg1 mg

ipratropium bromide andalbuterol sulfatebrand available:

DuoNeb —Dey, L.P.0.5 mg ipratropium bromideand 3.0 mg albuterol sulfate

Development ofthis poster wassupported by

formoterol fumaratebrand available:

Perforomist — Dey, L.P.20 mcg

Expiration dateembossedonto vial

Medication lotnumber embossed

onto vial

Medication name anddosage embossed

onto vial

Pharmaceuticalmanufacturer nameembossed onto vial

Imposters come in all shapes and sizes. Theplastic “wings” and paper labels are clues toquestion the safety, source, potency, sterilityand inactive ingredients.The source of ingredients in your nebulizer vial

may be unknown — and untraceable.

Do not use a nebulizer medication that smellsfoul, rotten or spoiled, or like it may contain rub-bing alcohol. Stop the nebulizer treatment if themedication becomes foamy or bubbly duringnebulization.

Don’t assume apatent numberapplies to amedication. Thisone refers tothe plastic vial.

For more information: aanma.org/advocacy

Paper labels leachtoxins into nebulizersolutions; all lackFDA-mandated infor-mation such as dose,expiration date andlot number.

Not FDA-Approved Nebulizer Medication

Use only Food and Drug Administration ap-proved brand-name or generic medications in-tended for use in nebulizers. Ask your prescriberto write “Do not compound; do not substitute”on your prescription. Make sure that the prescrip-tion is filled with the medication your doctorprescribed.Nebulizer medications are prescribed in unit-

dose vials (usually packaged in sealed foilpouches) and multidose bottles.• Unit-dose vials are a snap to use; simply openand pour premeasured and mixed solution orsuspension into the nebulizer medication cup.

• Multidose bottles are usually less expensive butrequire careful handling to avoid contaminatingthe solution. Wash your hands before openingthe medicine. Use a sterile metered syringe tomeasure out medication; mix with sterile salinesolution in the nebulizer medication cup.

NOTE: Some multidose bottles containpreservatives, such as benzalkoniumchloride (BAC) and disodium ethylenediamine tetraacetic acid (EDTA), which cansometimes irritate sensitive airways. Talkwith your healthcare provider if yoursymptoms are not responding to themedication the way you expect them to.

FDA-Approved Nebulizer Medication

Combination

Short-Acting

Corticosteroid

Beta-2AgonistsShort-Acting

Beta-2AgonistsLong-Acting

Actavis Mid Atlantic LlcApotex Inc.Bausch & LombBreath LtdCardinal HealthCobalt Laboratories Inc.Dey, L.P.Hi-Tech Pharmacal Co., Inc.Holopack InternationalTEVA PharmaceuticalMorton GroveNephron Pharmaceuticals CorporationNovexPharmascience Inc.RespirareRxElite Holdings, Inc.SandozWatson Pharmaceuticals, Inc.

Manufacturers ofFDA-Approved GenericMedications for Nebulizers

levalbuterol hydrochloridebrand available:Xopenex— Sepracor Inc.0.31 mg0.63 mg1.25 mg

albuterol sulfate0.63 mg1.25 mg2.5 mg

—————————––––————––—

levalbuterol hydrochloride0.31 mg0.63 mg1.25 mg

—————————––––————––—

ipratropium bromide0.5 mgno brand available

—————————––––————––—

ipratropium bromide andalbuterol sulfate

0.5 mg ipratropium bromideand 3.0 mg albuterol sulfate

—————————––––————––—budesonide

0.25 mg0.5 mg

—————————––––————––—

cromolyn sodium10 mg20 mgno brand available

arformoterol tartrateno generics available

—————————––––————––—

formoterol fumarateno generics available

—————————––––————––—

FDA-Approved Generics

No FDA-ApprovedGenerics Available