TERBUTALINE SULFATE injection, solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

General Injectables & Vaccines, Inc

INN (Nama Internasional):

Terbutaline Sulfate

Komposisi:

Terbutaline Sulfate 1 mg in 1 mL

Rute administrasi :

SUBCUTANEOUS

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Terbutaline Sulfate Injection, USP 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. Prolonged Tocolysis Terbutaline sulfate has not been approved and should not be used for prolonged tocolysis (beyond 48 to 72 hours). In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting (see BOXED WARNING: PROLONGED TOCOLYSIS). Hypersensitivity Terbutaline sulfate injection is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of this drug product.

Ringkasan produk:

Discard unused portion after single patient use. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Do not use if solution is discolored. Vial stoppers do not contain natural rubber latex. APP APP Pharmaceuticals, LLC Schaumburg, IL 60173 451001D Revised: February 2011

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

TERBUTALINE SULFATE- TERBUTALINE SULFATE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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TERBUTALINE SULFATE INJECTION, USP 1MG/ML 1ML SINGLE DOSE VIAL
DESCRIPTION
Rx only
A sterile aqueous solution for subcutaneous injection.
WARNING: PROLONGED TOCOLYSIS
Terbutaline sulfate has not been approved and should not be used for
prolonged
tocolysis (beyond 48 to 72 hours). 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, Prolonged
Tocolysis).
DESCRIPTION
Terbutaline Sulfate Injection, USP, is a beta-adrenergic agonist
bronchodilator available
as a sterile, nonpyrogenic, aqueous solution in vials, for
subcutaneous administration.
Each mL of solution contains: 1 mg of terbutaline sulfate USP (0.82 mg
of the free
base), and Water for Injection, USP. Sodium chloride is used for
isotonicity, and
hydrochloric acid for adjustment to a pH of 3.0 to 5.0. Terbutaline
sulfate is (±)-a-[(tert-
butyl-amino) methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1) (salt).
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.
CLINICAL PHARMACOLOGY
Terbutaline is a beta-adrenergic receptor agonist. 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 musc