Dizziness, headache, lightheadedness, heartburn, loss of appetite, altered taste sensation, restlessness, anxiety, nervousness, trembling or sweating may occur but should subside as your body adjust to the medication.

If these symptoms persist or worsen, inform your doctor.

Notify your doctor if you experience chest pain, palpitations, vomiting or breathing difficulties while taking this medication.

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Precautions:

Tell your doctor if you have heart disease, high blood pressure, an overactive thyroid gland, epilepsy or diabetes.

Tell your doctor if you ever had a bad reaction to bitolterol, ephedrine, epinephrine, metaproterenol, phenylephrine, phenylpropanolamine, pseudoephedrine, or terbutaline.

Many nonprescription products contain these drugs (e.g., diet pills and medication for colds and asthma), so check the labels carefully.

Do not take any of these medications without consulting your doctor (even if you never had a problem taking them before).

Do not allow anyone else to take this medication.

Before you use this drug, tell your doctor if you are pregnant or breast-feeding.

This drug should not be used unless clearly needed if you are pregnant.

For information on Medic Alert(TM) call 1-800-854-1166. In Canada call 1-800-668-1507.

Generic Name: Albuterol Sulfate

Albuterol Sulfate 2 mg Tablet - Prescription

Proventil 2 mg Tablet - Prescription

Albuterol Sulfate 4 mg Tablet - Prescription

Proventil 4 mg Tablet - Prescription

Albuterol Sulfate 2 mg/5 ml Syrup - Prescription

Proventil 2 mg/5 ml Syrup - Prescription

Ventolin 2 mg/5 ml Syrup - Prescription

Ventolin Rotacaps 200 mcg Capsule, Enteric Coated - Prescription

Ventolin Rotacaps 200 mcg Capsule - Prescription

Proventil HFA 105 mcg Aerosol w/Adapter - Prescription

Albuterol Sulfate 5 mg/ml Solution, Topical/EENT - Prescription

Albuterol Sulfate 0.83 mg/ml Solution, Topical/EENT - Prescription

Airet 0.83 mg/ml Solution, Topical/EENT - Prescription

Proventil 4 mg Tablet, Sustained Action - Prescription

Volmax 4 mg Tablet, Osmotic Laser-Drilled Form - Prescription

Volmax 8 mg Tablet, Osmotic Laser-Drilled Form - Prescription

PROVENTILHFA

albuterol sulfate, inhalation aerosol, Proventil HFA, bronchospasm, mouthpiece, patients, inhaler, water, NDA, medication, drug.

DESCRIPTION The active component of PROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, USP racemic "1[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-", "'-diol sulfate (2:1) (salt), a relatively selective beta2-adrenergic bronchodilator having the following chemical structure: Albuterol sulfate is the official generic name in the United States.

In another clinical study in adults, two inhalations of Proventil HFA (albuterol sulfate) Inhalation Aerosol taken 30 minutes before exercise prevented exercise-induced bronchospasm as demonstrated by the maintenance of FEV1 within 80% of baseline values in the majority of patients.

Adverse events reported by less than 3% of the patients receiving PROVENTIL HFA (albuterol sulfate) Inhalation Aerosol, and by a greater proportion of PROVENTIL HFA (albuterol sulfate) Inhalation Aerosol patients than placebo patients, which have the potential to be related to PROVENTIL HFA (albuterol sulfate) Inhalation Aerosol include: dysphonia, increased sweating, dry mouth, chest pain, edema, rigors, ataxia, leg cramps, hyperkinesia, eructation, flatulence, tinnitus, diabetes mellitus, anxiety, depression, somnolence, rash.

593

http://allergy.edoc.com/1998_archives/pdf/dec_98/593.pdf

albuterol, patients, FEV, dose, albuterol sulfate, predose, serum potassium, safety, treatment, asthma, protocol.

Objectives: This cumulative dose response study compared the safety and bronchodilator efficacy of 16 cumulative inhalations of albuterol sulfate in an HFA-134a, CFC-free propellant system (108 mg of albuterol sulfate, equivalent to 90 mg of albuterol base) with that of equivalent doses of albuterol in a conventional CFC propellant system.

90 mg albuterol base equivalent per actuation, during study period 1 and CFC albuterol (Proventil ® Inhalation Aerosol), 90 mg albuterol base per actuation, during study period 2, or CFC albuterol during study period 1 and HFA-134a albuterol sulfate during study period 2.

Both HFA-134a albuterol sulfate and CFC albuterol demonstrated statistically significant dose-related decreases in serum potassium (P 5 .001; Fig 3), and doserelated increases in heart rate (P, .001; Fig 4) and systolic blood pressure (P, .001; Fig 5).

oei-03-97-00292

http://oig.hhs.gov/oei/reports/oei-03-97-00292.pdf

Medicare, albuterol sulfate, drug, prices, reimbursement, payments, report, pharmacies, Medicare allowances, HCFA, purchasing.

To determine if the current Medicare allowance for albuterol sulfate is reasonable.

On January 1, 1998, as a result of the Balanced Budget Act of 1997, Medicare Part B began reimbursing prescription drugs at 95 percent of average wholesale prices.

We previously recommended, and HCFA concurred, that HCFA reexamine its Medicare drug reimbursement methodologies, with the goal of reducing payments as appropriate.

The Office of Inspector General has issued several reports addressing the appropriateness of Medicare allowances for albuterol sulfate 0.083%.

Medicare and its beneficiaries would have saved $11 million in payments for albuterol sulfate between January 1, 1994 and February 28, 1995 if reimbursement had been based on Medicaid's payment methodology in the 17 States reviewed.