Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
TERBUTALINE SULFATE (UNII: 576PU70Y8E) (TERBUTALINE - UNII:N8ONU3L3PG)
PD-Rx Pharmaceuticals, Inc.
TERBUTALINE SULFATE
TERBUTALINE SULFATE 5 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
TERBUTALINE SULFATE- TERBUTALINE SULFATE TABLET PD-RX PHARMACEUTICALS, INC. ---------- TERBUTALINE SULFATE TABLETS USP, 5 MG 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, 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 ±-alpha-[( _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. 12 19 3 2 2 4 _Inactive Ingredients. _Hydroxypropyl methylcellulose, microcrystalline cellulose, anhydrous lactose, magnesium stearate, povidone, and pregelatinized 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, existin Baca dokumen lengkap