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:

Medical Purchasing Solutions. 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. 1. Prolonged Tocolysis Terbutaline sulfate has not been approved 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 ). 2. 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 amber 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. NDC 0143-9746-10 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: HIKMA FARMACÊUTICA (PORTUGAL), S.A.. Estrada do Rio da Mó, nº 8, 8A e 8B - Fervença, 2705 – 906 Terrugem SNT, PORTUGAL Distributed by: WEST-WARD PHARMACEUTICAL Corp. Eatontown, NJ 07724 USA Revised: April 2011

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TERBUTALINE SULFATE- TERBUTALINE SULFATE INJECTION
MEDICAL PURCHASING SOLUTIONS. LLC
----------
TERBUTALINE SULFATE INJECTION, USP
A sterile aqueous solution for subcutaneous injection
Rx Only
BOXED WARNING WARNING: PROLONGED
TOCOLYSIS
TERBUTALINE SULFATE HAS NOT BEEN APPROVED 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, USP, 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, 0.055% edetate disodium dihydrate as a stabilizing agent,
and hydrochloric
acid for adjustment to a target pH of 4. Terbutaline sulfate is
(±)-a-[(
_tert_
‑butylamino) methyl]-3,5-dihydroxybenzyI 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.
12
19
3
2
2
4
CLINICAL PHARMACOLOGY
Terbutaline sulfate injection is a beta-adrenergic receptor agonist.
_In vitro_ and _in vivo_
pharmacologic studies have demonstrated that terbutaline exerts a
pref