TERBUTALINE SULFATE tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

PD-Rx Pharmaceuticals, Inc.

INN（国際名）:

TERBUTALINE SULFATE

構図:

TERBUTALINE SULFATE 5 mg

処方タイプ:

PRESCRIPTION DRUG

認証ステータス:

Abbreviated New Drug Application

製品の特徴

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