Albuterol Sulfate (Page 5 of 8)

14 CLINICAL STUDIES

14.1 Bronchospasm Associated with Asthma

Adult and Adolescent Patients 12 Years of Age and Older: In a 6-week, randomized, double-blind, placebo-controlled trial, albuterol sulfate inhalation aerosol (58 patients) was compared to a matched placebo HFA inhalation aerosol (58 patients) in asthmatic patients 12 to 76 years of age at a dose of 180 mcg albuterol four times daily. An evaluator-blind marketed active comparator HFA-134a albuterol inhaler arm (56 patients) was included.

Serial FEV1 measurements, shown below as percent change from test-day baseline at Day 1 and at Day 43, demonstrated that two inhalations of albuterol sulfate inhalation aerosol produced significantly greater improvement in FEV1 over the pre-treatment value than the matched placebo, as well as a comparable bronchodilator effect to the marketed active comparator HFA-134a albuterol inhaler.

FEV1 as Mean Percent Change from Test-Day Pre-Dose in a 6-Week Clinical Trial

figure-graphs
(click image for full-size original)

In this study, 31 of 58 patients treated with albuterol sulfate inhalation aerosol achieved a 15% increase in FEV1 within 30 minutes post-dose on Day 1. In these patients, the median time to onset, median time to peak effect, and median duration of effect were 8.2 minutes, 47 minutes, and approximately 3 hours, respectively. In some patients, the duration of effect was as long as 6 hours.

In a placebo-controlled, single-dose, crossover study, albuterol sulfate inhalation aerosol, administered at albuterol doses of 90, 180 and 270 mcg, produced bronchodilator responses significantly greater than those observed with a matched placebo HFA inhalation aerosol and comparable to a marketed active comparator HFA-134a albuterol inhaler.

Pediatric Patients 4 to 11 Years of Age: In a 3-week, randomized, double-blind, placebo-controlled trial, the same formulation of albuterol as in albuterol sulfate inhalation aerosol (50 patients) was compared to a matched placebo HFA inhalation aerosol (45 patients) in asthmatic children 4 to 11 years of age at a dose of 180 mcg albuterol four times daily. Serial FEV1 measurements, expressed as the maximum percent change from test-day baseline in percent predicted FEV1 at Day 1 and at Day 22 observed within two hours post-dose, demonstrated that two inhalations of HFA albuterol sulfate produced significantly greater improvement in FEV1 over the pre-treatment value than the matched placebo.

In this study, 21 of 50 pediatric patients treated with the same formulation of albuterol as in albuterol sulfate inhalation aerosol achieved a 15% increase in FEV1 within 30 minutes post-dose on Day 1. In these patients, the median time to onset, median time to peak effect and median duration of effect were 10 minutes, 31 minutes, and approximately 4 hours, respectively. In some pediatric patients, the duration of effect was as long as 6 hours.

In a placebo-controlled, single-dose, crossover study in 55 pediatric patients 4 to 11 years of age, albuterol sulfate inhalation aerosol, administered at albuterol doses of 90 and 180 mcg, was compared with a matched placebo HFA inhalation aerosol. Serial FEV1 measurements, expressed as the baseline-adjusted percent predicted FEV1 observed over 6 hours post-dose, demonstrated that one and two inhalations of albuterol sulfate inhalation aerosol produced significantly greater bronchodilator responses than the matched placebo.

14.2 Exercise-Induced Bronchospasm

In a randomized, single-dose, crossover study in 24 adults and adolescents with exercise-induced bronchospasm (EIB), two inhalations of albuterol sulfate inhalation aerosol taken 30 minutes before exercise prevented EIB for the hour following exercise (defined as maintenance of FEV1 within 80% of post-dose, pre-exercise baseline values) in 83% (20 of 24) of patients as compared to 25% (6 of 24) of patients when they received placebo.

Some patients who participated in these clinical trials were using concomitant steroid therapy.

16 HOW SUPPLIED/STORAGE & HANDLING

Albuterol sulfate inhalation aerosol is supplied as a pressurized aluminum canister with a white plastic actuator with a dose counter and red dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 45802-088 -01). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

SHAKE WELL BEFORE USE. Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120°F may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.

See FDA-Approved Patient Labeling (17.9) for priming and cleaning instructions.

The white actuator supplied with albuterol sulfate inhalation aerosol should not be used with the canister from any other inhalation aerosol products. The albuterol sulfate inhalation aerosol canister should not be used with the actuator from any other inhalation aerosol products.

Albuterol sulfate inhalation aerosol inhaler has a dose counter attached to the actuator. Patients should never try to alter the numbers for the dose counter or tamper with the parts inside the actuator. Discard the albuterol sulfate inhalation aerosol inhaler when the counter displays 0 or after the expiration date on the product, whichever comes first. The labeled amount of medication in each actuation cannot be assured after the counter displays 0, even though the canister is not completely empty and will continue to operate. Never immerse the canister into water to determine how full the canister is (“float test”).

Albuterol sulfate inhalation aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (17.9)

Patients should be given the following information:

17.1 Frequency of Use

The action of albuterol sulfate inhalation aerosol should last for 4 to 6 hours. Do not use albuterol sulfate inhalation aerosol more frequently than recommended. Instruct patients to not increase the dose or frequency of doses of albuterol sulfate inhalation aerosol without consulting the physician. If patients find that treatment with albuterol sulfate inhalation aerosol becomes less effective for symptomatic relief, symptoms become worse, and/or they need to use the product more frequently than usual, they should seek medical attention immediately.

17.2 Priming and Cleaning

Priming: Priming is essential to ensure appropriate albuterol content in each actuation. Instruct patients to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face.

Cleaning: To ensure proper dosing and prevent actuator orifice blockage, instruct patients to wash the white plastic actuator mouthpiece and dry thoroughly at least once a week. Instruct patients that if they have more than one albuterol sulfate inhalation aerosol inhaler, they should wash each one at separate times to prevent attaching the wrong canister to the wrong plastic actuator. In this way, they can be sure they will always know the correct number of remaining doses. Patients should be instructed to never attach a canister of medicine from any other inhaler to the albuterol sulfate inhalation aerosol actuator and never attach the albuterol sulfate inhalation aerosol canister to an actuator from any other inhaler. Patients should not remove the canister from the actuator except during cleaning because reattachment may release a dose into the air and the dose counter will count down each time a spray is released. Detailed cleaning instructions are included in the illustrated Information for the Patient leaflet.

17.3 Dose Counter

Patients should be informed that albuterol sulfate inhalation aerosol has a dose counter attached to the actuator. When the patient receives the inhaler, the number 203 will appear in the viewing window and will count down during each of three priming sprays, at which point the number 200 will be displayed. The dose counter will count down each time a spray is released. The dose-counter window displays the number of sprays left in the inhaler. When the counter displays 20, the patient should contact their pharmacist for a refill of medication or consult their physician for a prescription refill. When it is time to obtain a new inhaler a red flag will begin to show in the window, getting larger as the number of doses remaining approaches 0. The red flag will remind the patient that a new inhaler is needed. When the dose counter reaches 0, a very large 0 with a solid red background will appear in the window. Patients should be informed to discard albuterol sulfate inhalation aerosol inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first.

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