TERBUTALINE SULFATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

UBI Pharma Inc.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Terbutaline sulfate injection 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 for and should not be used for prolonged tocolysis (beyond 48-72 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.

Product summary:

Terbutaline Sulfate Injection USP; 1 mg/mL, is supplied at a volume of 1 mL contained in a 2 mL clear glass vial. Each vial contains 1 mg of terbutaline sulfate per 1 mL of solution; 0.25 mL of solution will provide the usual clinical dose of 0.25 mg. Vials are expiration-dated. NDC 72843-101-10; Carton of 10 vials. Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature. Protect from light by storing vials in original carton until dispensed. Do not use if solution is discolored. Discard unused portion after single patient use. Manufactured by: UBI Pharma Inc. Hsinchu, 30351 Taiwan Manufactured for: United Biomedical Inc. Hauppauge, NY 11788 Revised:01/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TERBUTALINE SULFATE- TERBUTALINE SULFATE INJECTION
UBI PHARMA INC.
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TERBUTALINE SULFATE INJECTION USP
Vials
A sterile aqueous solution for subcutaneous injection
Rx Only
Prescribing Information
WARNING: PROLONGED TOCOLYSIS
Terbutaline Sulfate has not been approved for and should not be used
for prolonged tocolysis
(beyond 48-72 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 USP, the active ingredient of terbutaline sulfate
injection, is a beta-adrenergic
agonist bronchodilator available as a sterile, nonpyrogenic, aqueous
solution in vials, for subcutaneous
administration. Each milliliter of solution contains 1 mg of
terbutaline sulfate USP (0.82 mg of the free
base), sodium chloride for isotonicity, and hydrochloric acid for
adjustment to a target pH of 4.
Terbutaline sulfate is (±)-α-[(
_tert_-butylamino)methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1)
(salt).
The molecular formula is (C
H
N0
)
•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.
CLINICAL PHARMACOLOGY
Terbutaline sulfate injection is a beta-adrenergic receptor agonist.
_In vitro_ and _in vivo_ pharmacologic
studies have demonstrated that terbutaline exerts a preferential
effect on beta
-adrenergic receptors.
While it is recognized that bet