מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
TERBUTALINE SULFATE (UNII: 576PU70Y8E) (TERBUTALINE - UNII:N8ONU3L3PG)
ANI Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Terbutaline Sulfate Tablets USP are 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. Oral terbutaline sulfate is contraindicated for the treatment of acute or maintenance tocolysis [see Boxed Warning: Tocolysis] . 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 available as: 2.5 mg: White to faintly yellow, oval, biconvex tablets debossed with ‘ANI’ and ‘721’ on one side and bisected on the reverse side. They are packaged in high density polyethylene (HDPE) bottles of 100 tablets (NDC 62559-721-01). 5 mg: White to faintly yellow, round, biconvex tablets debossed with ‘ANI’ and ‘722’ on one side and bisected on the reverse side. They are packaged in high density polyethylene (HDPE) bottles of 100 tablets (NDC 62559-722-01). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container (as defined in the USP). Manufactured by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 10141 Rev 09/18
New Drug Application Authorized Generic
TERBUTALINE SULFATE- TERBUTALINE SULFATE TABLET ANI PHARMACEUTICALS, INC. ---------- TERBUTALINE SULFATE TABLETS USP RX ONLY DESCRIPTION Terbutaline sulfate USP, the active ingredient of Terbutaline Sulfate Tablets 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 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 0.1N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. Its molecular weight is 548.65. Inactive Ingredients: Microcrystalline cellulose, lactose monohydrate, magnesium stearate, povidone, and corn starch. WARNING: TOCOYSIS ORAL TERBUTALINE SULFATE HAS NOT BEEN APPROVED FOR 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. DURING PREGNANCY, 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]_ 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% to 50 קרא את המסמך השלם