Albuterol immediate-release tablets and extended-release tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

Albuterol syrup is indicated for the relief of bronchospasm in adults and in children 2 years of age and older with reversible obstructive airway disease.

The following dosages of albuterol immediate-release tablets and extended-release tablets are expressed in terms of albuterol base.

Extended-Release Tablets

Usual Dose: Pediatric Patients 6 to 11 Years of Age: The usual starting dosage of albuterol extended-release tablets is 2 mg (one tablet) every 12 hours. Adults and Pediatric Patients 12 Years and Over: The usual starting dosage of albuterol extended-release tablets is 4 or 8 mg (one or two tablets) every 12 hours.

Dosage Adjustment in Pediatric Patients Aged 6 to 11 Years: Doses of albuterol extended-release tablets above 4 mg twice a day should be used only when the patient fails to respond to this dose while on otherwise optimized asthma therapy. In such instances, the albuterol extended-release tablets dose may be increased cautiously stepwise as tolerated if a favorable response does not occur with the 4 mg twice daily initial dose. The maximum recommended dose of albuterol extended-release tablets in pediatric patients aged 6 to 11 years is 12 mg twice a day.

Dosage Adjustment in Adults and Pediatric Patients 12 Years of Age and Over: Doses of albuterol extended-release tablets above 8 mg twice a day should be used only when the patient fails to this dose while on otherwise optimized asthma therapy. The albuterol extended-release dose may be increased cautiously stepwise as tolerated if a favorable response does not occur with the twice daily initial dose. The maximum recommended dose of albuterol extended-release tablets in adults and pediatric patients over 12 years of age is 16 mg twice daily.

Switching to Albuterol Extended-Release Tablets: Patients currently maintained on albuterol immediate-release tablets can be switched to albuterol extended-release tablets. For example, the administration of a 4 mg albuterol extended-release tablet every 12 hours is clinically comparable to one 2 mg albuterol immediate-release tablet every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply.

Immediate-Release Tablets

Usual Dosage: Adults and Children Over 12 Years of Age: The usual starting dosage for adults and children 12 years and over is 2 mg or 4 mg three or four times a day. Children 6 to 12 Years of Age: The usual starting dosage for children 6 to 12 years of age is 2 mg three or four times a day.

Dosage Adjustment: Adults and Children Over 12 Years of Age: For adults and children 12 years and over, a dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4-mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated. Children 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day: For children from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).

Elderly Patients and Those Sensitive to Beta-Adrenergic Stimulators: An initial dosage of 2 mg three or four times a day is recommended for elderly patients and for those with a history of unusual sensitivity to beta-adrenergic stimulators. If adequate bronchodilation is not obtained, dosage may be increased gradually to as much as 8 mg three or four times a day.

The total daily dose should not exceed 32 mg in adults and children 12 years and older.

Syrup

The following dosages of albuterol syrup are expressed in terms of albuterol base.

Usual Dosage: The usual starting dosage for adults and children over 14 years of age is 2 mg (1 teaspoonful) or 4 mg (2 teaspoonfuls) three or four times a day.

The usual starting dosage for children 6 to 14 years of age is 2 mg (1 teaspoonful) three or four times a day.

For children 2 to 6 years of age, dosing should be initiated at 0.1 mg/kg of body weight three times a day. This starting dosage should not exceed 2 mg (1 teaspoonful) three times a day.

Dosage Adjustment: For adults and children over age 14, a dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur, the dosage may be cautiously increased stepwise, but the dosage should not exceed 8 mg four times a day.

For children from 6 to 14 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg per day (given in divided doses).

For children 2 to 6 years of age who do not respond satisfactorily to the initial dosage, the dosage may be increased stepwise to 0.2 mg/kg of body weight three times a day, but not to exceed a maximum of 4 mg (2 teaspoonfuls) given three times a day.

For elderly patients and those sensitive to beta-adrenergic stimulation, the initial dosage should be restricted to 2 mg three or four times a day and individually adjusted thereafter.

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