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Albuterol Extended Release (Albuterol Sulfate Extended Release) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Albuterol 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.

DOSAGE AND ADMINISTRATION

The following dosages of albuterol extended-release tablets are expressed in terms of albuterol base:

USUAL DOSAGE:

Adults and Children over 12 years of age:    The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient.

Children 6 to 12 years of age:    The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours.

Dosage adjustment in Adults and Children over 12 years of age:    In unusual circumstances, such as adults of low body weight, it may be desirable to use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 32 mg per day in divided doses (i.e., every 12 hours).

Dosage adjustment in Children 6 to 12 years of age:    If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 24 mg per day in divided doses (i.e., every 12 hours).

Switching from oral albuterol, USP products:    Patients currently maintained on albuterol tablets, USP or albuterol sulfate syrup can be switched to albuterol extended-release tablets. For example, the administration of one 4 mg albuterol extended-release tablet every 12 hours is comparable to one 2 mg albuterol tablet, USP every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply.

Albuterol extended-release tablets must be swallowed whole with the aid of liquids. DO NOT CHEW OR CRUSH THESE TABLETS.

HOW SUPPLIED

Albuterol Extended-Release Tablets, equivalent to 4 mg and 8 mg of Albuterol:

4 mg - Green, round, coated tablets in bottles of 100. Printed V on one side and
           4 on the other side in black ink.

8 mg - White, round, coated tablets in bottles of 100. Printed V on one side and
           8 on the other side in black ink.

Dispense in a well-closed, light-resistant container as defined in the USP. Replace cap securely after each opening. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Distributed by Odyssey Pharmaceuticals, Inc.

East Hanover, New Jersey 07936

Manufactured by:

PLIVA, Inc.

East Hanover, NJ 07936

2/04

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