EPHEDRINE SULFATE injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

EPHEDRINE SULFATE (UNII: U6X61U5ZEG) (EPHEDRINE - UNII:GN83C131XS)

Tilgjengelig fra:

Par Pharmaceutical, Inc.

INN (International Name):

EPHEDRINE SULFATE

Sammensetning:

EPHEDRINE SULFATE 50 mg in 1 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. None R isk Summary Limited published data on the use of ephedrine sulfate are insufficient to determine a drug associated risk of major birth defects or miscarriage. However, there are clinical considerations [see Clinical Considerations] . Animal reproduction studies have not been conducted with ephedrine sulfate. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.  All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.  In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. C linical Considerations Fetal/Neonatal adverse reactions Cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature. Th

Produkt oppsummering:

Ephedrine Sulfate Injection, USP, 50 mg/mL, is supplied as follows: NDC S tre n gth How Supplied 42023-216-25 50 mg/mL 1 mL clear glass vial; for single use (supplied in packages of 25) Vial stoppers are not manufactured with natural rubber latex. Store ephedrine sulfate injection, 50 mg/mL, at 20° to 25°C (68° to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature.]  Protect from light. Store in carton until time of use. For single use only. Discard unused portion.

Autorisasjon status:

New Drug Application

Preparatomtale

EPHEDRINE SULFATE- EPHEDRINE SULFATE INJECTION, SOLUTION
PAR PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EPHEDRINE SULFATE INJECTION SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EPHEDRINE
SULFATE INJECTION.
EPHEDRINE SULFATE INJECTION, USP, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
Ephedrine Sulfate Injection, USP is an alpha- and beta- adrenergic
agonist and a norepinephrine-releasing agent indicated
for the treatment of clinically important hypotension occurring in the
setting of anesthesia. (1)
DOSAGE AND ADMINISTRATION
Treatment of hypotension developing during anesthesia: Bolus
intravenous injection: 5 to 10 mg as needed, not to
exceed 50 mg. Dilute before use. See Full Prescribing Information for
instructions on administration and preparation
for injection. (2)
DOSAGE FORMS AND STRENGTHS
Injection: 50 mg/mL ephedrine sulfate in single-dose vial (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
• Pressor Effect with Concomitant Oxytocic Drugs: Pressor effect of
sympathomimetic pressor amines is potentiated
(5.1)
• Tachyphylaxis and Tolerance: Repeated administration of ephedrine
may cause tachyphylaxis (5.2)
ADVERSE REACTIONS
Most common adverse reactions during treatment: nausea, vomiting, and
tachycardia.(6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PAR PHARMACEUTICAL AT
1-800-828-9393 OR FDA AT 1-
800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._
DRUG INTERACTIONS
• Interactions that Augment the Pressor Effect: clonidine, oxytocin
and oxytocic drugs, propofol, monoamine oxidase
inhibitors (MAOIs), and atropine. Monitor blood pressure. (7)
• Interactions that Antagonize the Pressor Effect: Antagonistic
effects with α-adrenergic antagonists, β-adrenergic
antagonists, reserpine, quinidine, mephentermine. Monitor blood
pressure. (7)
• Guanethidine: Ephedrine may inhibit the neuron blockage produced
by guanethidine, resulting in loss of
antihypertensive effectiven