Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
TERBUTALINE SULFATE (UNII: 576PU70Y8E) (TERBUTALINE - UNII:N8ONU3L3PG)
Medical Purchasing Solutions. LLC
TERBUTALINE SULFATE
TERBUTALINE SULFATE 1 mg in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
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. 1. Prolonged Tocolysis Terbutaline sulfate has not been approved and should not be used for prolonged tocolysis (beyond 48-72 hours). In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting (see BOXED WARNING: Prolonged Tocolysis ). 2. Hypersensitivity Terbutaline sulfate injection is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of this drug product.
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. NDC 0143-9746-10 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: HIKMA FARMACÊUTICA (PORTUGAL), S.A.. Estrada do Rio da Mó, nº 8, 8A e 8B - Fervença, 2705 – 906 Terrugem SNT, PORTUGAL Distributed by: WEST-WARD PHARMACEUTICAL Corp. Eatontown, NJ 07724 USA Revised: April 2011
Abbreviated New Drug Application
TERBUTALINE SULFATE- TERBUTALINE SULFATE INJECTION MEDICAL PURCHASING SOLUTIONS. LLC ---------- TERBUTALINE SULFATE INJECTION, USP A sterile aqueous solution for subcutaneous injection Rx Only BOXED WARNING WARNING: PROLONGED TOCOLYSIS TERBUTALINE SULFATE HAS NOT BEEN APPROVED AND SHOULD NOT BE USED FOR PROLONGED TOCOLYSIS (BEYOND 48-72 HOURS). IN PARTICULAR, TERBUTALINE SULFATE SHOULD NOT BE USED FOR MAINTENANCE TOCOLYSIS IN THE OUTPATIENT OR HOME SETTING. SERIOUS ADVERSE REACTIONS, INCLUDING DEATH, HAVE BEEN REPORTED AFTER ADMINISTRATION OF TERBUTALINE SULFATE TO PREGNANT WOMEN. IN THE MOTHER, THESE ADVERSE REACTIONS INCLUDE INCREASED HEART RATE, TRANSIENT HYPERGLYCEMIA, HYPOKALEMIA, CARDIAC ARRHYTHMIAS, PULMONARY EDEMA AND MYOCARDIAL ISCHEMIA. INCREASED FETAL HEART RATE AND NEONATAL HYPOGLYCEMIA MAY OCCUR AS A RESULT OF MATERNAL ADMINISTRATION (SEE CONTRAINDICATIONS: PROLONGED TOCOLYSIS). DESCRIPTION Terbutaline Sulfate, USP, the active ingredient of Terbutaline Sulfate Injection, USP, is a beta‑adrenergic agonist bronchodilator available as a sterile, nonpyrogenic, aqueous solution in vials, for subcutaneous administration. Each milliliter of solution contains 1 mg of Terbutaline Sulfate, USP (0.82 mg of the free base), sodium chloride for isotonicity, 0.055% edetate disodium dihydrate as a stabilizing agent, and hydrochloric acid for adjustment to a target pH of 4. Terbutaline sulfate is (±)-a-[( _tert_ ‑butylamino) methyl]-3,5-dihydroxybenzyI alcohol sulfate (2:1) (salt). The molecular formula is (C H N0 ) •H SO 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 0.1N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. Its molecular weight is 548.65. 12 19 3 2 2 4 CLINICAL PHARMACOLOGY Terbutaline sulfate injection is a beta-adrenergic receptor agonist. _In vitro_ and _in vivo_ pharmacologic studies have demonstrated that terbutaline exerts a pref Lees het volledige document