Maxair Autohaler (Pirbuterol Acetate) - Indications and Dosage

INDICATIONS AND USAGE

MAXAIR AUTOHALER 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.

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.

HOW SUPPLIED

MAXAIR AUTOHALER, box of one, is supplied in a pressurized aluminum canister with a light blue plastic breath-activated actuator and a light blue mouthpiece cover. DO NOT USE WITH OTHER CANISTERS OR MOUTHPIECES. Each actuation delivers 253 mcg of pirbuterol (as pirbuterol acetate) from the valve and 200 mcg of pirbuterol (as pirbuterol acetate) from the mouthpiece.

Canister net content weight 14.0 g, 400 inhalations (NDC 29336-815-21) and canister net content weight 2.8 g, 80 inhalations (Sample Pack: NDC 29336-815-08).

The correct amount of medication in each canister cannot be assured after 80 actuations from the 2.8 g canister and 400 actuations from the 14.0 g canister, even though the canister is not completely empty. The canister should be discarded when the labeled numbers of actuations have 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 AUTOHALER 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 AUTOHALER should not be used with any other product canisters, and actuators from other product should not be used with MAXAIR AUTOHALER canister.

Distributed by:

Graceway Pharmaceuticals, LLC

Bristol, TN 37620

Manufactured by:

3M Drug Delivery Systems

Northridge, CA 91324

634000 Rev 01/08