not fda-approved nebulizer medication fda-approved nebulizer
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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
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levalbuterol hydrochloride0.31 mg0.63 mg1.25 mg
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ipratropium bromide0.5 mgno brand available
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ipratropium bromide andalbuterol sulfate
0.5 mg ipratropium bromideand 3.0 mg albuterol sulfate
—————————––––————––—budesonide
0.25 mg0.5 mg
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cromolyn sodium10 mg20 mgno brand available
arformoterol tartrateno generics available
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formoterol fumarateno generics available
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FDA-Approved Generics
No FDA-ApprovedGenerics Available