TERBUTALINE SULFATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

TERBUTALINE SULFATE

Composition:

TERBUTALINE SULFATE 1 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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 ). 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 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TERBUTALINE SULFATE - TERBUTALINE SULFATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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TERBUTALINE SULFATE INJECTION, USP
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 (±)-α-[(
_tert_-butyl-amino) methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1)
(salt). The structural
formula is:
(C
H NO ) • H SO
M.W. 548.65
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 beta
-
adrenergic receptors. While it is recognized that beta
-adrenergic receptors are the
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predominant receptors in bronchial smoo