TERBUTALINE SULFATE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

Terbutaline Sulfate (UNII: 576PU70Y8E) (Terbutaline - UNII:N8ONU3L3PG)

זמין מ:

Rebel Distributors Corp

INN (שם בינלאומי):

Terbutaline Sulfate

הרכב:

Terbutaline Sulfate 2.5 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of this drug product.

leaflet_short:

Terbutaline sulfate tablets USP are packaged in bottles of 100 and 30 tablets. Descriptions of the 2.5 and 5 mg tablets follow: Tablets 2.5 mg—round, white, scored (imprinted LCI over 1318) Bottles of 30       NDC 21695-122-25 Tablets 5 mg—round, white, scored (imprinted LCI over 1311) Bottles of 100       NDC 21695-121-00 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

TERBUTALINE SULFATE- TERBUTALINE SULFATE TABLET
REBEL DISTRIBUTORS CORP
----------
TERBUTALINE SULFATE TABLETS USP
RX ONLY
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:_ microcrystalline cellulose, anhydrous lactose,
magnesium stearate, povidone, and
pregelatinized corn 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, existing in a concentration between
10%-50%. The precise function of
these receptors has not been established (see WARNINGS). In controlled
clinical studies in patients
given terbutaline sulfate orally, proportionally greater changes
occurred in pulmonary function
parameters than in heart rate or blood pressure. While this suggests a
relative preference for the beta -
receptors in man, the usual cardiovascular effects commonly associated
with other sympathomimetic
agents were also observed with terbutaline sulfate.
The pharmacologic effects of beta-adrenergic agonists, including
terbutaline, are at least in part
attributable to stimulation through beta-adrenergic receptors of
intracellular adenyl cyclase, the enzyme
which catalyzes the conversion of adenosine triphosphate (ATP)