Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
TERBUTALINE SULFATE (UNII: 576PU70Y8E) (TERBUTALINE - UNII:N8ONU3L3PG)
RedPharm Drug, Inc.
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. 1. Tocolysis Oral terbutaline sulfate has not been approved and should not be used for acute or maintenance tocolysis. [see BOXED WARNING: TOCOLYSIS.] 2. Hypersensitivity 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 1000 tablets. Descriptions of the 2.5 and 5 mg tablets follow: Tablets 2.5 mg—round, white, scored (imprinted LCI over 1318) Bottles of 100 NDC 0527-1318-01 Bottles of 1000 NDC 0527-1318-10 Tablets 5 mg—round, white, scored (imprinted LCI over 1311) Bottles of 100 NDC 0527-1311-01 Bottles of 1000 NDC 0527-1311-10 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure Distributed By: Lannett Company, Inc. Philadelphia, PA 19136 Made in the USA CIB70314B Rev. 02/16
Abbreviated New Drug Application
TERBUTALINE SULFATE- TERBUTALINE SULFATE TABLET REDPHARM DRUG, INC. ---------- BOXED WARNING WARNING: TOCOLYSIS Oral terbutaline sulfate has not been approved and should not be used for acute or maintenance tocolysis. 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, TOCOLYSIS.] SPL UNCLASSIFIED SECTION 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 (C12H19NO3)2 • H2SO4 and the structural formula is [Chemical Structure] 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: anhydrous lactose, pregelatinized corn starch, microcrystalline cellulose, povidone, and magnesium stearate. CLINICAL PHARMACOLOGY In vitro and in vivo pharmacologic studies have demonstrated that terbutaline exerts a preferential effect on beta2-adrenergic receptors. While it is recognized that beta2- adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta2-receptors in the human heart, existing in a concentration between 10% to 50%. The precise function of these receptors has Lestu allt skjalið