Terbutaline Injection (Terbutaline Sulfate Injection) - Indications and Dosage

INDICATIONS AND USAGE

Terbutaline sulfate injection 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

Vials should be used only for subcutaneous administration and not intravenous infusion. Sterility and accurate dosing cannot be assured if the vials are not used in accordance with DOSAGE AND ADMINISTRATION.

Discard unused portion after single patient use.

The usual subcutaneous dose of terbutaline sulfate injection is 0.25 mg injected into the lateral deltoid area. If significant clinical improvement does not occur within 15 to 30 minutes, a second dose of 0.25 mg may be administered. If the patient then fails to respond within another 15 to 30 minutes, other therapeutic measures should be considered. The total dose within 4 hours should not exceed 0.5 mg.

Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Terbutaline Sulfate Injection USP; 1 mg/mL, is supplied at a volume of 1 mL contained in a 2 mL amber glass vial. Each vial contains 1 mg of terbutaline sulfate per 1 mL of solution; 0.25 mL of solution will provide the usual clinical dose of 0.25 mg.

Vials are expiration-dated.

NDC 55390-101-10; Carton of 10 vials.

Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature.

Protect from light by storing vials in original carton until dispensed.

Do not use if solution is discolored.

Discard unused portion after single patient use.

Manufactured by: Manufactured for:

Ben Venue Laboratories, Inc. Bedford Laboratories™

Bedford, OH 44146 Bedford, OH 44146

March 2004 Div-TBT-P00