RVP

Drug Catalog - Product Detail

TERBUTALINE SULFATE FOR INJECTION INJECT. 1MG/ML 10X1ML

NDC Mfr Size Str Form
17478-0933-01 AKORN NA NA NA
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Description
DESCRIPTION Terbutaline sulfate USP, the active ingredient, is a beta-adrenergic agonist bronchodilator available as a sterile, nonpyrogenic, aqueous solution in ampules, for subcutaneous administration. Each milliliter of solution contains 1 mg of terbutaline sulfate USP (0.82 mg of the free base); sodium chloride USP, for isotonicity; hydrochloric acid NF, for adjustment to a target pH of 4; and water for injection. Terbutaline sulfate is (±)-α-[( tert -butylamino) methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1) (salt). The empirical formula is (C 12 H 19 NO 3 ) 2 • H 2 SO 4 and the structural formula is: Terbutaline sulfate USP is a white to gray-white crystalline powder. It is odorless or has a faint odor of acetic acid. It is soluble in water and in 0.1 N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. Its molecular weight is 548.65. structural formula
How Supplied
HOW SUPPLIED Ampules 1 mg/mL – The drug is supplied at a volume of 1 mL contained in a 2 mL clear glass ampule. Each ampule contains 1 mg of terbutaline sulfate per 1 mL of solution; 0.25 mL of solution will provide the clinical dose of 0.25 mg. Ampules are expiration-dated Discard unused portion after single patient use. Terbutaline Sulfate Injection, USP, 1 mg/mL is available as a 1 mL ampule in packs of 10. NDC 17478-933-01 STORAGE: Store at 20° to 25° C (68º to 77°F). [See USP Controlled Room Temperature]. Protect from light by storing ampules in original carton until dispensed. Do not use if solution is discolored. Akorn Manufactured by: Akorn, Inc. Lake Forest, IL 60045 TB00N Rev. 03/11
Indications & Usage
INDICATIONS AND USAGE Terbutaline Sulfate Injection, USP 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
DOSAGE AND ADMINISTRATION Ampules should be used only for subcutaneous administration and not intravenous infusion. Sterility and accurate dosing cannot be assured if the ampules are not used in accordance with DOSAGE AND ADMINISTRATION . The usual subcutaneous dose of Terbutaline Sulfate Injection, USP is 0.25 mg injected into the lateral deltoid area. If significant clinical improvement does not occur within 15-30 minutes, a second dose of 0.25 mg may be administered. If the patient then fails to respond within another 15-30 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.