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INDICATIONS
Inhalation Aerosol and Capsules for Inhalation: Albuterol inhalation aerosol is indicated for the prevention and relief of bronchospasm in patients 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. The capsules for inhalation formulation is particularly useful in patients who are unable to properly use the pressurized aerosol form of albuterol or who prefer an alternative formulation.
Albuterol inhalation aerosol can be used with or without concomitant steroid therapy.
Inhalation Solution: Albuterol inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age or older with reversible obstructive airway disease and acute attacks of bronchospasm.
DOSAGE AND ADMINISTRATION
Inhalation Aerosol
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 two inhalations repeated every 4 to 6 hours; in some patients, one inhalation every 4 hours may be sufficient. More frequent administration or a larger number of inhalations are not recommended. It is recommended to "test spray" albuterol inhalation aerosol. Do this by spraying four times into the air before using for the first time and when the inhaler has not been used for a prolonged period of time (i.e., more than 4 weeks).
The use of albuterol inhalation aerosol can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimal benefit from regular use of the inhaler. Safe usage for periods extending over several years has been documented.
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).
Exercise-Induced Bronchospasm Prevention: The usual dosage for adults and children 4 years and older is two inhalations 15 minutes before exercise.
For treatment, see above.
Inhalation Solution, 0.5%
To avoid microbial contamination, proper aseptic techniques should be used each time the bottle is opened. Precautions should be taken to prevent contact of the dropper tip of the bottle with any surface, including the nebulizer reservoir and associated ventilatory equipment. In addition, if the solution changes color or becomes cloudy, it should not be used.
Children 2 to 12 Years of Age: For children 2 to 12 years of age, initial dosing should be based upon body weight (0.1 to 0.15 mg/kg per dose), with subsequent dosing triated to achieve the desired clinical response. Dosing should not exceed 2.5 mg three to four times daily by nebulization. TABLE 5 outlines approximate dosing according to body weight.
TABLE 5
Approximate Weight (kg) Approximate Weight (lb) Dose (mg) Volume of Inhalation Solution
10-15 22-33 1.25 0.25 ml
>15 >33 2.5 0.5 ml
The appropriate volume of the 0.5% inhalation solution should be diluted in sterile normal saline solution to a total volume of 3 ml prior to administration via nebulization.
Adults and Children Over 12 Years of Age: The usual dosage for adults and children 12 years of age and older is 2.5 mg of albuterol administered three to four times daily by nebulization. More frequent administration or higher doses are not recommended. To administer 2.5 mg of albuterol, dilute 0.5 ml of the 0.5% inhalation solution with 2.5 ml of sterile normal saline solution. The wflow rate is regulated to suit the particular nebulizer so that albuterol inhalation solution will be delivered over approximately 5 to 15 minutes.
The use of albuterol sulfate inhalation solution 0.5% can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimal benefit from regular use of the inhalation solution.
If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma that would require reassessment of therapy.
Drug compatibility (physical and chemical), efficacy, and safety of albuterol inhalation solution 0.5% when mixed with other drugs in a nebulizer have not been established.
Inhalation Solution, 0.083%
Adults and Children 2 to 12 Years of Age: The usual dosage for adults and children wei***ng at least 15 kg is 2.5 mg of albuterol (one Ventolin Nebule) administered three to four times daily by nebulization. Children wei***ng less than 15 kg who require less than 2.5 mg/dose (i.e., less than a full Ventolin Nebule) should use albuterol inhalation solution 0.5% instead of 0.083%. More frequent administration or higher doses are not recommended. To administer 2.5 mg of albuterol, administer the contents of one sterile unit dose Nebule (3 ml of 0.083% inhalation solution) by nebulization. The wflow rate is regulated to suit the particular nebulizer so that albuterol inhalation solution 0.083% will be delivered over approximately 5 to 15 minutes.
The use of albuterol inhalation solution 0.083% can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimal benefit from regular use of the inhalation solution.
If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma that would require reassessment of therapy.
Drug compatibility (physical and chemical), efficacy, and safety of albuterol inhalation solution 0.083% when mixed with other drugs in a nebulizer have not been established.
Capsules for Inhalation
The usual dosage of capsules for inhalation for adults and children 4 years of age and older is the contents of one 200-mcg capsule inhaled every 4 to 6 hours using a Rotahaler inhalation device. In some patients, the contents of two 200 mcg capsules inhaled every 4 to 6 hours may be required. Larger doses or more frequent administration is not recommended.
The use of albuterol capsules for inhalation can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimal benefit from regular use of the albuterol capsules for inhalation formulation.
If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma that would require reassessment of therapy.
Exercise-Induced Bronchospasm Prevention: The usual dosage of albuterol capsules for inhalation for adults and children 4 years of age and older is the contents of one 200-mcg capsule inhaled using a Rotahaler 15 minutes before exercise.
HOW SUPPLIED
Ventolin Inhalation Aerosol
Supplied in 6.8-g canisters containing 80 metered inhalations and in 17-g canisters containing 200 metered inhalations. Each actuation delivers 100 mcg of albuterol from the valve and 90 mcg of albuterol from the mouthpiece. Each canister is supplied with a blue oral adapter and patient's instructions. Also available, Ventolin inhalation aerosol refill 17-g canister only with patient's instructions.
The blue adapter supplied with Ventolin inhalation aerosol should not be used with any other product canisters, and adapters from other products should not be used with Ventolin inhalation aerosol canister. The correct amount of medication in each canister cannot be assured after 80 actuations from the 6.8-g canister and 200 actuations from the 17.0-g canister, even though the canister is not completely empty. The canister should be discarded when the labelled number of actuations have been used.
Storage: Store between 15-30°C (59-86°F). As with most inhaled medications in aerosol canisters, the therapeutic effect of this medication may decrease when the canister is cold, for best results, the canister should be at room temperature before use. Shake well before using.
Note the indented statement below is required by the Federal government Clean Air Act for all products containing chlorofluorocarbons.
WARNING: This product contains trichloromonofluoromethane and dichlorod***uoromethane, substances which harm public health and environment by destroying ozone in the upper atmosphere.
A notice similar to the above warning has been placed in the patient instruction leaflet pursuant to regulations of the U.S. Environmental Protection Agency (EPA). The patient's warning states that the patient should consult his or her physician if there are questions about alternatives.
Ventolin Inhalation Solution, 0.5%
Supplied as 20 ml with accompanying calibrated dropper.
Storage: Store between 2-25°C (36-77°F).
Ventolin Nebules Inhalation Solution, 0.083%
Contained in sterile, plastic dose nebules of 3 ml each.
Storage: Protect from light. Store in refrigerator between 2-8°C (36-46°F). Ventolin Nebules Inhalation Solution may be held at room temperature for up to 2 weeks before use. (Nebules must be used within 2 weeks of removal from refrigerator; record date the nebules are removed from the refrigerator in the space provided on the product carton.) Discard if solution becomes discolored. (Note:Ventolin Nebules inhalation solution is colorless.)
Ventolin Rotacaps for Inhalation
The 200-mcg capsule is light blue and clear with "VENTOLIN 200" printed on the blue cap and "GLAXO" printed on the clear body.
Ventolin Rotacaps for inhalation are supplied in a kit containing 100 capsules and one Rotahaler inhalation device with patient's instructions. Also available, Ventolin Rotacaps for inhalation refill with patient's instructions.
Storage: Store between 2-30°C (36-86°F). Replace cap securely after each opening.
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