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

 
 



INDICATIONS & USAGE

VENTOLIN HFA is a beta2-adrenergic agonist indicated for:

•Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1)•Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2)

 

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

 

VENTOLIN HFA is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

 

DOSAGE & ADMINISTRATION

Administer VENTOLIN HFA by oral inhalation only. Shake VENTOLIN HFA well before each spray.

 

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.

 

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

 

Priming: Priming VENTOLIN HFA is essential to ensure appropriate albuterol content in each actuation. Prime VENTOLIN HFA 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, 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 has a dose counter attached to the canister that starts at 204 or 64 and counts down each time a spray is released [see Dosage Forms and Strengths (3)]. 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 comes in a moisture-protective foil pouch, which should be removed prior to use. Discard VENTOLIN HFA when the counter reads 000 or 12 months after removal from the moisture-protective foil pouch, whichever comes first [see Dosage Forms and Strengths (3)].

See Patient Information tear-off leaflet for instructions on how to prime and clean the inhaler to ensure proper dosing and to prevent actuator orifice blockage.

 

DOSAGE FORMS & STRENGTHS

VENTOLIN HFA is an inhalation aerosol. Each actuation contains 108 mcg albuterol sulfate (90 mcg albuterol base) from the mouthpiece. VENTOLIN HFA is supplied as an 18-g pressurized aluminum canister with dose counter fitted with a blue plastic actuator and a blue strapcap; this canister contains 200 actuations. VENTOLIN HFA is also supplied as an 8-g pressurized aluminum canister with dose counter fitted with a blue plastic actuator and a blue strapcap; this canister contains 60 actuations.

 

HOW SUPPLIED

VENTOLIN HFA (albuterol sulfate) Inhalation Aerosol is supplied in the following packs 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 that also contains a desiccant:

NDC 0173-0682-20 18-g canister containing 200 actuations

NDC 0173-0682-21 8-g canister containing 60 actuations

NDC 0173-0682-24 8-g institutional pack canister containing 60 actuations

Before using, VENTOLIN HFA should be removed from the moisture-protective foil pouch. The pouch and desiccant should be discarded. VENTOLIN HFA should be discarded 12 months after removal from the pouch.

Priming VENTOLIN HFA 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).

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 the Patient Information tear‑off leaflet].

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.

VENTOLIN HFA has a counter attached to the canister. The counter starts at 204 or 64 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 or 12 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 does not contain chlorofluorocarbons (CFCs) as the propellant.

 

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