Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
terbutaline sulfate (UNII: 576PU70Y8E) (terbutaline - UNII:N8ONU3L3PG)
Akorn
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. 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 .] Terbutaline sulfate injection is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of this drug product.
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
Abbreviated New Drug Application
TERBUTALINE SULFATE- TERBUTALINE SULFATE INJECTION AKORN ---------- TERBUTALINE SULFATE INJECTION, USP Ampules A sterile aqueous solution for subcutaneous injection R only 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, 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 H NO ) • 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 0.1 N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. Its molecular weight is 548.65. CLINICAL PHARMACOLOGY x 12 19 3 2 2 4 Terbutaline Sulfate Injection, USP is a beta-adrenergic receptor agonist. _In vitro_ and _in_ _vivo_ pharmacologic studies have demonstrated that terbutaline exerts a preferential effect on beta -adrenergic receptors. While it is recognized that beta -adrenergic Lire le document complet