VENTOLIN HFA- albuterol sulfate aerosol, metered
1 INDICATIONS AND USAGE
VENTOLIN® HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease.
1.2 Exercise-Induced Bronchospasm
VENTOLIN HFA is indicated for the prevention of exercise-induced bronchospasm in patients aged 4 years and older.
2 DOSAGE AND ADMINISTRATION
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 greater number of inhalations is not recommended.
2.2 Exercise-Induced Bronchospasm
For prevention of exercise-induced bronchospasm, the usual dosage for adults and children aged 4 years and older is 2 inhalations 15 to 30 minutes before exercise.
2.3 Administration Information
VENTOLIN HFA should be administered by the orally inhaled route only.
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.
3 DOSAGE FORMS AND STRENGTHS
Inhalation Aerosol. Blue plastic inhaler with a blue strapcap containing a pressurized metered-dose aerosol canister containing 60 or 200 metered inhalations and fitted with a counter. Each actuation delivers 108 mcg of albuterol sulfate (90 mcg of albuterol base) from the mouthpiece.
VENTOLIN HFA is contraindicated in patients with a history of hypersensitivity to any of the ingredients [see Warnings and Precautions (5.6), Description (11)].
5 WARNINGS AND PRECAUTIONS
5.1 Paradoxical Bronchospasm
VENTOLIN HFA can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with VENTOLIN HFA, it should be discontinued immediately and alternative therapy should be instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.
5.2 Deterioration of Asthma
Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of VENTOLIN HFA than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
5.3 Use of Anti-inflammatory Agents
The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids, to the therapeutic regimen.
5.4 Cardiovascular Effects
VENTOLIN HFA, like all other beta2 -adrenergic agonists, can produce clinically significant cardiovascular effects in some patients such as changes in pulse rate or blood pressure. If such effects occur, VENTOLIN HFA may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical relevance of these findings is unknown. Therefore, VENTOLIN HFA, like all other sympathomimetic amines, should be used with caution in patients with underlying cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
5.5 Do Not Exceed Recommended Dose
Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.
5.6 Immediate Hypersensitivity Reactions
Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of VENTOLIN HFA [see Contraindications (4)].
5.7 Coexisting Conditions
VENTOLIN HFA, like other sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines. Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.
Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects [see Clinical Pharmacology (12.1)]. The decrease in serum potassium is usually transient, not requiring supplementation.
6 ADVERSE REACTIONS
Use of VENTOLIN HFA may be associated with the following:
Paradoxical bronchospasm [see Warnings and Precautions (5.1)]
Cardiovascular effects [see Warnings and Precautions (5.4)]
Immediate hypersensitivity reactions [see Warnings and Precautions (5.6)]
Hypokalemia [see Warnings and Precautions (5.8)]
The active component of VENTOLIN HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2 -adrenergic bronchodilator. Albuterol sulfate has the chemical name α1 -[(tert -butylamino)methyl]-4-hydroxy-m -xylene-α, α′-diol sulfate (2:1)(salt)
Albuterol sulfate is a white crystalline powder with a molecular weight of 576.7, and the empirical formula is (C13 H21 NO3 )2 •H2 SO4 . It is soluble in water and slightly soluble in ethanol.
The World Health Organization recommended name for albuterol base is salbutamol.
VENTOLIN HFA is a blue plastic inhaler with a blue strapcap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients.
After priming, each actuation of the inhaler 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).
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.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta2 -adrenergic receptors compared with isoproterenol. Although beta2 -adrenoceptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1 -adrenoceptors are the predominant receptors in the heart, there are also beta2 -adrenoceptors in the human heart comprising 10% to 50% of the total beta-adrenoceptors. The precise function of these receptors has not been established, but their presence raises the possibility that even selective beta2 -agonists may have cardiac effects.
HOW SUPPLIED/STORAGE AND HANDLING
VENTOLIN HFA Inhalation Aerosol is supplied in the following boxes of 1 as a pressurized aluminum canister fitted with a counter and supplied with a blue plastic actuator with a blue strapcap:
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
Each inhaler is sealed in a moisture-protective foil pouch with a desiccant that should be discarded when the pouch is opened. Each inhaler is packaged with a Patient Information 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 actuation cannot be assured after the counter reads 000, even though the canister is not completely empty and will continue to operate. The inhaler should be discarded when the counter reads 000 or 12 months after removal from the moisture-protective foil pouch, whichever comes first.
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 canister into fire or incinerator.
Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use. SHAKE WELL BEFORE EACH SPRAY.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Frequency of Use: Inform patients that the action of VENTOLIN HFA should last up to 4 to 6 hours. Do not use VENTOLIN HFA more frequently than recommended. Instruct patients not to increase the dose or frequency of doses of VENTOLIN HFA without consulting the physician. Instruct patients to seek medical attention immediately if treatment with VENTOLIN HFA becomes less effective for symptomatic relief, symptoms become worse, and/or they need to use the product more frequently than usual.
Priming: Instruct patients to 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, instruct patients to wash the actuator with warm water and let it air-dry completely at least once a week. Inform patients that detailed cleaning instructions are included in the Patient Information leaflet.
Paradoxical Bronchospasm: Inform patients that VENTOLIN HFA can produce paradoxical bronchospasm. Instruct them to discontinue VENTOLIN HFA if paradoxical bronchospasm occurs.
Concomitant Drug Use: Advise patients that while they are using VENTOLIN HFA, other inhaled drugs and asthma medications should be taken only as directed by the physician.
Common Adverse Effects:Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, and nervousness.
Pregnancy: Advise patients who are pregnant or nursing to contact their physicians about the use of VENTOLIN HFA.
VENTOLIN is a registered trademark of the GSK group of companies. The other brands listed are trademarks of their respective owners and are not trademarks of the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.