TERBUTALINE SULFATE injection

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

terbutaline sulfate (UNII: 576PU70Y8E) (terbutaline - UNII:N8ONU3L3PG)

Disponible des:

Akorn

Designació comuna internacional (DCI):

terbutaline sulfate

Composición:

terbutaline sulfate 1 mg in 1 mL

Vía de administración:

SUBCUTANEOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 -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.

Resumen del producto:

Ampules 1 mg/mL – The drug is supplied at a volume of 1 mL contained in a 2 mL clear glass ampule. Each ampule contains 1 mg of terbutaline sulfate per 1 mL of solution; 0.25 mL of solution will provide the clinical dose of 0.25 mg. Ampules are expiration-dated Discard unused portion after single patient use. Terbutaline Sulfate Injection, USP, 1 mg/mL is available as a 1 mL ampule in packs of 10. NDC 17478-933-01 STORAGE: Store at 20° to 25° C (68º to 77°F). [See USP Controlled Room Temperature]. Protect from light by storing ampules in original carton until dispensed. Do not use if solution is discolored. Akorn Manufactured by: Akorn, Inc. Lake Forest, IL 60045 TB00N Rev. 03/11

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

TERBUTALINE SULFATE- TERBUTALINE SULFATE INJECTION
AKORN
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TERBUTALINE SULFATE INJECTION, USP
Ampules
A sterile aqueous solution for subcutaneous injection
R only
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, is a beta-adrenergic
agonist bronchodilator
available as a sterile, nonpyrogenic, aqueous solution in ampules, for
subcutaneous
administration. Each milliliter of solution contains 1 mg of
terbutaline sulfate USP (0.82
mg of the free base); sodium chloride USP, for isotonicity;
hydrochloric acid NF, for
adjustment to a target pH of 4; and water for injection.
Terbutaline sulfate is (±)-α-[(_tert_-butylamino)
methyl]-3,5-dihydroxybenzyl alcohol
sulfate (2:1) (salt). The empirical formula is (C
H
NO ) • 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 0.1 N
hydrochloric acid, slightly
soluble in methanol, and insoluble in chloroform. Its molecular weight
is 548.65.
CLINICAL PHARMACOLOGY
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12
19
3 2
2
4
Terbutaline Sulfate Injection, USP 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