Albuterol (Albuterol Sulfate) - Indications and Dosage

INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

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

Usual Dosage

Adults and Children Over 12 Years of Age

The usual starting dosage for adults and children 12 years and older is 2 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 older, 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.

HOW SUPPLIED

Albuterol Tablets, USP, contain albuterol sulfate equivalent to 2 mg or 4 mg of albuterol.

The tablets containing albuterol sulfate equivalent to 2 mg of albuterol are white, scored, round tablets debossed with M255 on the scored side. They are available as follows:

NDC 0378-0255-01
bottles of 100 tablets

NDC 0378-0255-05
bottles of 500 tablets

The tablets containing albuterol sulfate equivalent to 4 mg of albuterol are white, scored, round tablets debossed with M572 on the scored side. They are available as follows:

NDC 0378-0572-01
bottles of 100 tablets

NDC 0378-0572-05
bottles of 500 tablets

Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]

Protect from light.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

REVISED MARCH 2006
ALB:R14