TERBUTALINE SULFATE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

RedPharm Drug, Inc.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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.

Ürün özeti:

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—round, white, scored (imprinted LCI over 1318) Bottles of 100 NDC 0527-1318-01 Bottles of 1000 NDC 0527-1318-10 Tablets 5 mg—round, white, scored (imprinted LCI over 1311) Bottles of 100 NDC 0527-1311-01 Bottles of 1000 NDC 0527-1311-10 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 Distributed By: Lannett Company, Inc. Philadelphia, PA 19136 Made in the USA CIB70314B Rev. 02/16

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

TERBUTALINE SULFATE- TERBUTALINE SULFATE TABLET
REDPHARM DRUG, INC.
----------
BOXED WARNING
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.]
SPL UNCLASSIFIED SECTION
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
(C12H19NO3)2 •
H2SO4 and the structural formula is
[Chemical Structure]
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 beta2-adrenergic receptors. While it is
recognized that beta2-
adrenergic receptors are the predominant receptors in bronchial smooth
muscle, data
indicate that there is a population of beta2-receptors in the human
heart, existing in a
concentration between 10% to 50%. The precise function of these
receptors has