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albuterol sulfate
Overview
What is PROAIR?
The active ingredient of PROAIR HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate has the chemical name α-[(-butylamino) methyl]-4-hydroxy--xylene-α,α'-diol sulfate (2:1) (salt), and has the following chemical structure:
The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (CHNO)•HSO. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official generic name in the United States, and salbutamol sulfate is the World Health Organization recommended generic name. PROAIR HFA Inhalation Aerosol is a pressurized metered-dose aerosol unit with a dose counter. PROAIR HFA is for oral inhalation only. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1, 1, 1, 2-tetrafluoroethane) and ethanol.
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 three sprays into the air, away from the face. After priming, each actuation delivers 108 mcg albuterol sulfate, from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). Each canister provides 200 actuations (inhalations).
This product does not contain chlorofluorocarbons (CFCs) as the propellant.
What does PROAIR look like?
What are the available doses of PROAIR?
Inhalation Aerosol: Each actuation delivers 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). Supplied in 8.5-g canister containing 200 actuations. ()
What should I talk to my health care provider before I take PROAIR?
How should I use PROAIR?
PROAIR HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.
For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children 4 years and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient.
What interacts with PROAIR?
Sorry No Records found
What are the warnings of PROAIR?
Sorry No Records found
What are the precautions of PROAIR?
Sorry No Records found
What are the side effects of PROAIR?
Sorry No records found
What should I look out for while using PROAIR?
PROAIR HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other PROAIR HFA Inhalation Aerosol components. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate .
What might happen if I take too much PROAIR?
The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia.
Hypokalemia may also occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of PROAIR HFA Inhalation Aerosol.
Treatment consists of discontinuation of PROAIR HFA Inhalation Aerosol together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of PROAIR HFA Inhalation Aerosol.
The oral median lethal dose of albuterol sulfate in mice is greater than 2,000 mg/kg (approximately 6,800 times the maximum recommended daily inhalation dose for adults on a mg/m basis and approximately 3,200 times the maximum recommended daily inhalation dose for children on a mg/m basis). In mature rats, the subcutaneous median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 3,000 times the maximum recommended daily inhalation dose for adults on a mg/m basis and approximately 1,400 times the maximum recommended daily inhalation dose for children on a mg/m basis). In young rats, the subcutaneous median lethal dose is approximately 2,000 mg/kg (approximately 14,000 times the maximum recommended daily inhalation dose for adults on a mg/m basis and approximately 6,400 times the maximum recommended daily inhalation dose for children on a mg/m basis). The inhalation median lethal dose has not been determined in animals.
How should I store and handle PROAIR?
Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator with a dose counter and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 68788-9900-2). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120°F may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.Seefor priming and cleaning instructions.The red actuator supplied with PROAIR HFA Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.PROAIR HFA inhaler has a dose counter attached to the actuator. Patients should never try to alter the numbers for the dose counter or tamper with the pin mechanism inside the actuator. Discard the PROAIR HFA inhaler when the counter displays 0 or after the expiration date on the product, whichever comes first. The labeled amount of medication in each actuation cannot be assured after the counter displays 0, even though the canister is not completely empty and will continue to operate. Never immerse the canister into water to determine how full the canister is ("float test").PROAIR HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator with a dose counter and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 68788-9900-2). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120°F may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.Seefor priming and cleaning instructions.The red actuator supplied with PROAIR HFA Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.PROAIR HFA inhaler has a dose counter attached to the actuator. Patients should never try to alter the numbers for the dose counter or tamper with the pin mechanism inside the actuator. Discard the PROAIR HFA inhaler when the counter displays 0 or after the expiration date on the product, whichever comes first. The labeled amount of medication in each actuation cannot be assured after the counter displays 0, even though the canister is not completely empty and will continue to operate. Never immerse the canister into water to determine how full the canister is ("float test").PROAIR HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator with a dose counter and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 68788-9900-2). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120°F may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.Seefor priming and cleaning instructions.The red actuator supplied with PROAIR HFA Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.PROAIR HFA inhaler has a dose counter attached to the actuator. Patients should never try to alter the numbers for the dose counter or tamper with the pin mechanism inside the actuator. Discard the PROAIR HFA inhaler when the counter displays 0 or after the expiration date on the product, whichever comes first. The labeled amount of medication in each actuation cannot be assured after the counter displays 0, even though the canister is not completely empty and will continue to operate. Never immerse the canister into water to determine how full the canister is ("float test").PROAIR HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator with a dose counter and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 68788-9900-2). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120°F may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.Seefor priming and cleaning instructions.The red actuator supplied with PROAIR HFA Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.PROAIR HFA inhaler has a dose counter attached to the actuator. Patients should never try to alter the numbers for the dose counter or tamper with the pin mechanism inside the actuator. Discard the PROAIR HFA inhaler when the counter displays 0 or after the expiration date on the product, whichever comes first. The labeled amount of medication in each actuation cannot be assured after the counter displays 0, even though the canister is not completely empty and will continue to operate. Never immerse the canister into water to determine how full the canister is ("float test").PROAIR HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator with a dose counter and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 68788-9900-2). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120°F may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.Seefor priming and cleaning instructions.The red actuator supplied with PROAIR HFA Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.PROAIR HFA inhaler has a dose counter attached to the actuator. Patients should never try to alter the numbers for the dose counter or tamper with the pin mechanism inside the actuator. Discard the PROAIR HFA inhaler when the counter displays 0 or after the expiration date on the product, whichever comes first. The labeled amount of medication in each actuation cannot be assured after the counter displays 0, even though the canister is not completely empty and will continue to operate. Never immerse the canister into water to determine how full the canister is ("float test").PROAIR HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator with a dose counter and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 68788-9900-2). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120°F may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.Seefor priming and cleaning instructions.The red actuator supplied with PROAIR HFA Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.PROAIR HFA inhaler has a dose counter attached to the actuator. Patients should never try to alter the numbers for the dose counter or tamper with the pin mechanism inside the actuator. Discard the PROAIR HFA inhaler when the counter displays 0 or after the expiration date on the product, whichever comes first. The labeled amount of medication in each actuation cannot be assured after the counter displays 0, even though the canister is not completely empty and will continue to operate. Never immerse the canister into water to determine how full the canister is ("float test").PROAIR HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Albuterol sulfate is a beta-adrenergic agonist. The pharmacologic effects of albuterol sulfate are attributable to activation of beta-adrenergic receptors on airway smooth muscle. Activation of beta-adrenergic receptors leads to the activation of adenylcyclase and to an increase in the intracellular concentration of cyclic-3', 5'-adenosine monophosphate (cyclic AMP). This increase of cyclic AMP is associated with the activation of protein kinase A, which in turn inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in muscle relaxation. Albuterol relaxes the smooth muscle of all airways, from the trachea to the terminal bronchioles. Albuterol acts as a functional antagonist to relax the airway irrespective of the spasmogen involved, thus protecting against all bronchoconstrictor challenges. Increased cyclic AMP concentrations are also associated with the inhibition of release of mediators from mast cells in the airway. While it is recognized that beta-adrenergic receptors are the predominant receptors on bronchial smooth muscle, data indicate that there are beta-receptors in the human heart, 10% to 50% of which are cardiac beta-adrenergic receptors. The precise function of these receptors has not been established .
Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects. However, inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes .
Non-Clinical Toxicology
PROAIR HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other PROAIR HFA Inhalation Aerosol components. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate .With potassium supplements and potassium-sparing diuretics:
With lithium:
With antacids:
Gold:
Non-steroidal anti-inflammatory agents including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors):
The antihypertensive effect of ACE inhibitors, including fosinopril may be attenuated by NSAIDs.
Agents that inhibit mTOR:
Dual Blockade of the Renin-Angiotensin System (RAS):
Do not co-administer aliskiren with fosinopril in patients with diabetes. Avoid use of aliskiren with fosinopril in patients with renal impairment (GFR <60 ml/min).
Other:
In a pharmacokinetic interaction study with warfarin, bioavailability parameters, the degree of protein binding, and the anticoagulant effect (measured by prothrombin time) of warfarin were not significantly changed.
PROAIR HFA Inhalation Aerosol can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, PROAIR HFA Inhalation Aerosol should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.
Use of PROAIR HFA may be associated with the following:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
Review
Professional
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Tips
Interactions
Interactions
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