Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
TERBUTALINE SULFATE (UNII: 576PU70Y8E) (TERBUTALINE - UNII:N8ONU3L3PG)
Proficient Rx LP
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 - White to off-white, oval tablets, scored on one side and engraved with “T132” on the other side Bottles of 30 NDC 71205-938-30 Bottles of 60 NDC 71205-938-60 Bottles of 90 NDC 71205-938-90 Bottles of 100 NDC 71205-938-00 Bottles of 500 NDC 71205-938-55 Tablets 5 mg - White to off-white, round, scored and engraved “T” above and “133” below the score on the scored side. Bottles of 30 NDC 71205-939-30 Bottles of 60 NDC 71205-939-60 Bottles of 90 NDC 71205-939-90 Bottles of 100 NDC 71205-939-00 Bottles of 500 NDC 71205-939-55 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 Manufactured for: TWi Pharmaceuticals USA, Inc. Paramus, NJ 07652 Manufactured by: TWi Pharmaceuticals, Inc. Taoyuan City, 32063, Taiwan Rev. 07/19 Repackaged and Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320
Abbreviated New Drug Application
TERBUTALINE SULFATE- TERBUTALINE SULFATE TABLET PROFICIENT RX LP ---------- TERBUTALINE SULFATE TABLETS, USP RX ONLY 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._] 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:_ lactose monohydrate, pregelatinized starch, microcrystalline cellulose, povidone, and magnesium stearate. CLINICAL PHARMACOLOGY _In vitro _and _in vivo _pharmacologic studies have demonstrated that terbutaline exerts a 12 19 3 2 2 4 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%. The precise function of these receptors has not been est Прочитать полный документ