Country: United States
Language: English
Source: NLM (National Library of Medicine)
TERBUTALINE SULFATE (UNII: 576PU70Y8E) (TERBUTALINE - UNII:N8ONU3L3PG)
Chartwell RX, LLC.
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 tablets, USP are packaged in bottles of 90 tablets. Descriptions of the 2.5 and 5 mg tablets follow: Tablets 2.5 mg—round, white, scored (imprinted LCI over 1318) Bottles of 90 NDC 62135-524-90 Tablets 5 mg—round, white, scored (imprinted LCI over 1311) Bottles of 90 NDC 62135-525-90 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: Chartwell RX, LLC. Congers, NY 10920 L71336 Revised 02/2023
Abbreviated New Drug Application
TERBUTALINE SULFATE- TERBUTALINE SULFATE TABLET CHARTWELL RX, LLC. ---------- 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:_ anhydrous lactose, pregelatinized corn starch, microcrystalline cellulose, povidone, and magnesium stearate. 12 19 3 2 2 4 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 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 not bee Read the complete document