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:

ANI Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

TERBUTALINE SULFATE- TERBUTALINE SULFATE TABLET
ANI PHARMACEUTICALS, INC.
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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