Ventolin HFA (Albuterol Sulfate HFA Inhalation) - Indications and Dosage

INDICATIONS AND USAGE

VENTOLIN HFA is indicated for the treatment or prevention of bronchospasm in adults and children 4 years of age and older with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

DOSAGE AND ADMINISTRATION

Adult and Pediatric Asthma:    For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual dosage for adults and children 4 years of age and older is 2 inhalations repeated every 4 to 6 hours; in some patients, 1 inhalation every 4 hours may be sufficient. More frequent administration or a larger number of inhalations is not recommended. It is recommended 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 4 test sprays into the air, away from the face.

VENTOLIN HFA can also be used to relieve acute symptoms of asthma. The use of VENTOLIN HFA can be continued as medically indicated to control recurring bouts of bronchospasm. If a previously effective dosage regimen fails to provide the usual response, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

Safe usage of albuterol for periods extending over several years has been documented.

Exercise-Induced Bronchospasm Prevention:    The usual dosage for adults and children 4 years and older is 2 inhalations 15 to 30 minutes before exercise. For treatment, see above.

Cleaning:    To maintain proper use of this product, it is important that the actuator be washed and dried thoroughly at least once a week. The inhaler may cease to deliver medication if not properly cleaned and dried thoroughly. See Information for Patients. Keeping the plastic actuator clean is very important to prevent medication build-up and blockage. If the actuator becomes blocked with drug, washing the actuator will remove the blockage.

HOW SUPPLIED

VENTOLIN HFA (albuterol sulfate HFA inhalation aerosol) is supplied as a pressurized aluminum canister with a blue plastic actuator and a blue strapcap packaged within a moisture-protective foil pouch, each in boxes of 1 with patient's instructions (NDC 0173-0682-00). The moisture-protective foil pouch also contains a desiccant that should be discarded when the pouch is opened.

It is recommended 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 4 test sprays into the air, away from the face. After priming with 4 actuations, each actuation delivers 120 mcg of albuterol sulfate, USP in 75 mg of suspension from the valve and 108 mcg of albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). The canister is labeled with a net weight of 18 g and contains 200 metered inhalations.

The blue actuator supplied with VENTOLIN HFA should not be used with any other product canisters, and actuators from other products should not be used with a VENTOLIN HFA canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when 200 actuations have been used or 3 months after removal from the moisture-protective foil pouch, whichever comes first. Never immerse the canister into water to determine how full the canister is ("float test").

Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children. Avoid spraying in eyes.

Store between 15° and 25°C (59° and 77°F). Store canister with mouthpiece down. For best results, the canister should be at room temperature before use. SHAKE WELL BEFORE USING.

VENTOLIN HFA does not contain chlorofluorocarbons (CFCs) as the propellant.

GlaxoSmithKline, Research Triangle Park, NC 27709

June 2002/RL-970