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Ventolin HFA

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Ventolin HFA

INDICATIONS

Bronchospasm

VENTOLIN HFA (albuterol sulfate inhalation aerosol) is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

Exercise-Induced Bronchospasm

VENTOLIN HFA (albuterol sulfate inhalation aerosol) is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

DOSAGE AND ADMINISTRATION

Administer VENTOLIN HFA (albuterol sulfate inhalation aerosol) by oral inhalation only. Shake VENTOLIN HFA (albuterol sulfate inhalation aerosol) well before each spray.

Bronchospasm

For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children 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.

Exercise-Induced Bronchospasm

The usual dosage for adults and children 4 years of age and older is 2 inhalations 15 to 30 minutes before exercise.

Administration Information

Priming: Priming VENTOLIN HFA (albuterol sulfate inhalation aerosol) is essential to ensure appropriate albuterol content in each actuation. Prime VENTOLIN HFA (albuterol sulfate inhalation aerosol) before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA (albuterol sulfate inhalation aerosol) , release 4 sprays into the air away from the face, shaking well before each spray.

Cleaning: To ensure proper dosing and to prevent actuator orifice blockage, wash the actuator with warm water and let it air-dry completely at least once a week.

Dose Counter: VENTOLIN HFA (albuterol sulfate inhalation aerosol) has a dose counter attached to the canister that starts at 204 and counts down each time a spray is released. When the counter reads 020, the patient should contact the pharmacist for a refill of medication or consult the physician to determine whether a prescription refill is needed.

VENTOLIN HFA (albuterol sulfate inhalation aerosol) comes in a moisture-protective foil pouch, which should be removed prior to use. Discard VENTOLIN HFA (albuterol sulfate inhalation aerosol) when the counter reads 000 (after 200 sprays have been used) or 6 months after removal from the moisture-protective foil pouch, whichever comes first.

See FDA-Approved Patient Labeling for instructions on how to prime and clean the inhaler to ensure proper dosing and to prevent actuator orifice blockage.

HOW SUPPLIED

Dosage Forms And Strengths

VENTOLIN HFA (albuterol sulfate inhalation aerosol) is an inhalation aerosol. Each actuation contains 108 mcg albuterol sulfate (90 mcg albuterol base) from the mouthpiece. VENTOLIN HFA (albuterol sulfate inhalation aerosol) is supplied as an 18-g pressurized aluminum canister with dose counter fitted with a blue plastic actuator and a blue strapcap. Each canister contains 200 actuations.

Storage And Handling

VENTOLIN HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister fitted with a counter with a blue plastic actuator and a blue strapcap packaged within a moisture-protective foil pouch, each in boxes of 1 (NDC 0173-0682-20). The moisture-protective foil pouch also contains a desiccant.

Before using, VENTOLIN HFA (albuterol sulfate inhalation aerosol) should be removed from the moisture-protective foil pouch. The pouch and dessicant should be discarded. VENTOLIN HFA (albuterol sulfate inhalation aerosol) should be discarded 6 months after removal from the pouch.

Priming VENTOLIN HFA (albuterol sulfate inhalation aerosol) is essential to ensure appropriate albuterol content in each actuation. To prime the inhaler, release 4 sprays into the air away from the face, shaking well before each spray. The inhaler should be primed before using it for the first time, when the inhaler has not been used for more than 2 weeks, or when it has been dropped.

After priming, 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.

To ensure proper dosing and to prevent actuator orifice blockage, wash the actuator with warm water and let it air-dry completely at least once a week [see FDA-Approved Patient Labeling].

The blue actuator supplied with VENTOLIN HFA (albuterol sulfate inhalation aerosol) should not be used with any other product canisters, and actuators from other products should not be used with a VENTOLIN HFA (albuterol sulfate inhalation aerosol) canister.

VENTOLIN HFA (albuterol sulfate inhalation aerosol) has a counter attached to the canister. The counter starts at 204 and counts down each time a spray is released. The correct amount of medication in each inhalation cannot be assured after the counter reads 000, even though the canister is not completely empty and will continue to operate. VENTOLIN HFA should be discarded when the counter reads 000 (after 200 sprays have been used) or 6 months after removal from the moisture-protective foil pouch, whichever comes first. Never immerse the canister in water to determine the amount of drug remaining in the canister.

Keep out of reach of children. Avoid spraying in eyes.

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.

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

VENTOLIN HFA (albuterol sulfate inhalation aerosol) does not contain chlorofluorocarbons (CFCs) as the propellant.

VENTOLIN is a registered trademark of GlaxoSmithKline., AeroChamber Plus is a registered trademark of Monaghan Medical Inc. OptiChamber is a registered trademark of Respironics Inc., GlaxoSmithKline, Research Triangle Park, NC 27709. FDA revision date: 3/25/2008

Last reviewed on RxList: 4/17/2008
This monograph has been modified to include the generic and brand name in many instances.

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