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:

Akorn

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 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. Clinical Considerations Fetal/Neonatal adverse reactions Cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature. These

Product summary:

Ephedrine Sulfate Injection, USP, 50 mg/mL, is a clear, colorless, sterile solution supplied as follows: NDC 17478-415-10 1 mL clear, glass ampules supplied in packages of 10 (NDC 17478-415-01). NDC 17478-517-01 1 mL single-dose Vials supplied in packages of 10. This container closure is not made with natural rubber latex. Store at 20° to 25°C (68° to 77°F), with excursions permitted from 15° to 30 °C (59° 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.

Authorization status:

New Drug Application

Summary of Product characteristics

EPHEDRINE SULFATE- EPHEDRINE SULFATE INJECTION
AKORN
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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
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 an ampule (3)
Injection: 50 mg/mL ephedrine sulfate in a vial (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Pressor Effect with Concomitant Oxytocic Drugs: Pressor effect of
sympathomimetic pressor amines is
potentiated. (5.1)
Tolerance and Tachyphylaxis: 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 AKORN, INC. AT
1-800-932-5676 OR FDA AT
1-800-FDA-1088 OR_ HTTP://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 effectiveness. Monitor blood pressure and adjust the
dosage of pres