TERBUTALINE SULFATE- terbutaline sulfate injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Athenex Pharmaceutical Division, LLC.

INN (שם בינלאומי):

terbutaline sulfate

הרכב:

terbutaline sulfate 1 mg in 1 mL

מסלול נתינה (של תרופות):

SUBCUTANEOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 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.

leaflet_short:

Terbutaline Sulfate Injection, USP is supplied as follows: 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. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Do not use if solution is discolored. Discard unused portion after single patient use. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. PETERSON PHARMACEUTICALS         Athenex Mfd. for Peterson Athenex Dist. by Athenex Schaumburg, IL 60173 (USA) Made in Taiwan ©2017 Athenex. January 2017

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

TERBUTALINE SULFATE- TERBUTALINE SULFATE INJECTION, SOLUTION
ATHENEX PHARMACEUTICAL DIVISION, LLC.
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TERBUTALINE SULFATE INJECTION, USP
A sterile aqueous solution for subcutaneous injection
PETERSON
PHARMACEUTICALS ATHENEX
RX ONLY
WARNING: PROLONGED TOCOLYSIS
TERBUTALINE SULFATE HAS NOT BEEN APPROVED FOR 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, 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 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 0.1N 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