TERBUTALINE SULFATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TERBUTALINE SULFATE (UNII: 576PU70Y8E) (TERBUTALINE - UNII:N8ONU3L3PG)

Available from:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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