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Terbutaline (Terbutaline Sulfate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Terbutaline sulfate is 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 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 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

Terbutaline sulfate tablets USP are packaged in bottles of 100 and 1000 tablets. Descriptions of the 2.5 and 5 mg tablets follow:

Tablets 2.5 mg—round, white, scored (imprinted LCI over 1318)

Bottles of 100       NDC 0527-1318-01
Bottles of 1000     NDC 0527-1318-10

Tablets 5 mg—round, white, scored (imprinted LCI over 1311)

Bottles of 100       NDC 0527-1311-01
Bottles of 1000     NDC 0527-1311-10

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

Dispense in tight, light-resistant container as defined in the USP.

Manufactured By:
Lannett Company, Inc.
Philadelphia, PA 19136

Revised 3/08

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