TERBUTALINE SULFATE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Marlex Pharmaceuticals Inc

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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. Oral terbutaline sulfate has not been approved and should not be used for 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.

Ապրանքի ամփոփագիր:

Terbutaline sulfate tablets, USP are packaged in bottles of 100, 180 and 1000 tablets. Descriptions of the 2.5 and 5 mg tablets follow: Tablets 2.5 mg—round, white, scored (imprinted LCI over 1318) Bottles of 100 NDC 10135-0579-01 Bottles of 180 NDC 10135-0579-32 Bottles of 1000 NDC 10135-0579-10 Tablets 5 mg—round, white, scored (imprinted LCI over 1311) Bottles of 100 NDC 10135-0580-01 Bottles of 180 NDC 10135-0580-32 Bottles of 1000 NDC 10135-0580-10 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 By:                      Distributed By: Lannett Company, Inc.              Marlex Pharmaceuticals, Inc. Philadelphia, PA 19136             New Castle, DE 19720 Made in the USA Rev. 10/14 LAN

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

TERBUTALINE SULFATE- TERBUTALINE SULFATE TABLET
MARLEX PHARMACEUTICALS INC
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TERBUTALINE SULFATE TABLETS, USP
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.
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%. The precise function of