EPHEDRINE SULFATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lifestar Pharma LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 estimate

Product summary:

Ephedrine sulfate injection, USP, 50 mg/mL, is a clear, colorless, sterile solution for intravenous injection supplied as follows: 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); [see USP Controlled Room temperature]. Store in carton until time of use. For single dose only. Discard unused portion. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Made in India Revised: December 2021, V-03

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

EPHEDRINE SULFATE - EPHEDRINE SULFATE INJECTION
LIFESTAR PHARMA LLC
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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 LIFESTAR PHARMA LLC AT
1-888-995-4337
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 p