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Terbutaline (Terbutaline Sulfate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Terbutaline sulfate tablets, USP are indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.

DOSAGE AND ADMINISTRATION

Adults

The usual oral dose of terbutaline sulfate tablets, USP for adults is 5 mg administered at approximately six-hour intervals, three times daily, during the hours the patient is usually awake. If side effects are particularly disturbing, the dose may be reduced to 2.5 mg three times daily, and still provide a clinically significant improvement in pulmonary function. The total dose within 24 hours should not exceed 15 mg.

Children

Terbutaline sulfate tablets, USP is not recommended for use in children below the age of 12 years. A dosage of 2.5 mg three times daily is recommended for children 12-15 years of age. The total dose within 24 hours should not exceed 7.5 mg.

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.

HOW SUPPLIED

Tablets 2.5 mg—Each off-white, oval convex tablet debossed with G on one side and 2611 on the other side

Bottles of 100 NDC 0115-2611-01
Bottles of 500 NDC 0115-2611-02
Bottles of 1000 NDC 0115-2611-03

Tablets 5 mg—Each off-white, round, convex tablet debossed with G on one side and 2622 on the other side

Bottles of 100 NDC 0115-2622-01
Bottles of 500 NDC 0115-2622-02
Bottles of 1000 NDC 0115-2622-03

Store at controlled room temperature 15° to 30°C (59° to 86°F) (see USP).

Dispense in tightly-closed, light-resistant container (USP).

Mfg. by:
IMPAX Laboratories, Inc.
Hayward, California 94544

Dist by:
Global Pharmaceuticals
Division of IMPAX Laboratories, Inc.
Philadelphia, PA 19124

192-02
Rev. 4/01

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