Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
Terbutaline Sulfate (UNII: 576PU70Y8E) (Terbutaline - UNII:N8ONU3L3PG)
Rebel Distributors Corp
Terbutaline Sulfate
Terbutaline Sulfate 2.5 mg
ORAL
PRESCRIPTION DRUG
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. Terbutaline sulfate is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of this drug product.
Terbutaline sulfate tablets USP are packaged in bottles of 100 and 30 tablets. Descriptions of the 2.5 and 5 mg tablets follow: Tablets 2.5 mg—round, white, scored (imprinted LCI over 1318) Bottles of 30 NDC 21695-122-25 Tablets 5 mg—round, white, scored (imprinted LCI over 1311) Bottles of 100 NDC 21695-121-00 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.
Abbreviated New Drug Application
TERBUTALINE SULFATE- TERBUTALINE SULFATE TABLET REBEL DISTRIBUTORS CORP ---------- TERBUTALINE SULFATE TABLETS USP RX ONLY DESCRIPTION Terbutaline sulfate USP is a beta-adrenergic agonist bronchodilator available as tablets of 2.5 mg (2.05 mg of the free base) and 5 mg (4.1 mg of the free base) for oral administration. Terbutaline sulfate is ±- α-[(_tert_ –butylamino) methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1) (salt). The molecular 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 0.1N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. Its molecular weight is 548.65. _Inactive Ingredients:_ microcrystalline cellulose, anhydrous lactose, magnesium stearate, povidone, and pregelatinized corn starch. CLINICAL PHARMACOLOGY 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 receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta - receptors in the human heart, existing in a concentration between 10%-50%. The precise function of these receptors has not been established (see WARNINGS). In controlled clinical studies in patients given terbutaline sulfate orally, proportionally greater changes occurred in pulmonary function parameters than in heart rate or blood pressure. While this suggests a relative preference for the beta - receptors in man, the usual cardiovascular effects commonly associated with other sympathomimetic agents were also observed with terbutaline sulfate. The pharmacologic effects of beta-adrenergic agonists, including terbutaline, are at least in part attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme which catalyzes the conversion of adenosine triphosphate (ATP) Baca dokumen lengkapnya