EPHEDRINE SULFATE injection

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Gland Pharma Limited

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 Risk Summary Available data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, there are clinical considerations due to underlying conditions (see Clinical Considerations) . In animal reproduction studies, decreased fetal survival and fetal body weights were observed in the presence of maternal toxicity after normotensive pregnant rats were administered 60 mg/kg intravenous ephedrine sulfate (12 times the maximum recommended human dose (MRHD) of 50 mg/day). No malformations or embryofetal adverse effects were observed when pregnant rats or rabbits were treated with intravenous bolus doses of ephedrine sulfate during organogenesis at doses 1.9 and 7.7 times the MRHD, respectively [See data] . The esti

Produkt oppsummering:

Ephedrine Sulfate Injection USP, 50 mg/mL is a clear, colorless solution and supplied in 1 mL single-dose glass vials. Each mL contains 50 mg of ephedrine sulfate USP, equivalent to 38 mg ephedrine base and it is available as follows: Vial stoppers are not manufactured with natural rubber latex. Store Ephedrine Sulfate Injection USP, 50 mg/mL, at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Store in carton until time of use. For single dose only. Discard unused portion. Manufactured by: Gland Pharma Limited D.P.Pally, Dundigal Post Hyderabad - 500 043, India January 2022

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

EPHEDRINE SULFATE - EPHEDRINE SULFATE INJECTION
GLAND PHARMA LIMITED
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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 FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
Ephedrine Sulfate Injection is an alpha- and beta-adrenergic agonist
and a norepinephrine-releasing agent
that is indicated for the treatment of clinically important
hypotension occurring in the setting of
anesthesia. (1)
DOSAGE AND ADMINISTRATION
Should be administered by trained healthcare providers. (2.1)
Ephedrine Sulfate injection, 50 mg/mL, must be diluted before
administration as an intravenous bolus
dose. (2.1)
Bolus intravenous injection: 5 mg to 10 mg as needed, not to exceed 50
mg. (2.1)
DOSAGE FORMS AND STRENGTHS
Injection: 50 mg/mL ephedrine sulfate in single-dose vial (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
• Pressor Effects with Concomitant Use with 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 GLAND PHARMA AT
609-250-7990 OR FDA
AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
Interactions that Augment 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 effectiveness. Monitor blood pres