Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
EPHEDRINE SULFATE (UNII: U6X61U5ZEG) (EPHEDRINE - UNII:GN83C131XS)
Sandoz Inc
EPHEDRINE SULFATE
EPHEDRINE SULFATE 50 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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 estimated
Ephedrine sulfate injection, USP, 50 mg/mL, is supplied as follows: NDC Strength How Supplied 0781-3269-95 50 mg/mL 1 mL fill in 2 mL amber vial; for single-dose (supplied in packages of 10) Vial stoppers are not manufactured with natural rubber latex. Store ephedrine sulfate injection, USP, 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. 46269329 Distributed by Sandoz Inc., Princeton, NJ 08540
Abbreviated New Drug Application
EPHEDRINE SULFATE- EPHEDRINE SULFATE INJECTION SANDOZ 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, 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 Ephedrine sulfate injection, 50 mg/mL, (equivalent to 38 mg ephedrine base) is injected intravenously as a bolus. Dilute before administration. ( 2) Bolus intravenous injection: 5 to 10 mg as needed, not to exceed 50 mg. ( 2) 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 SANDOZ INC. AT 1-800-525-8747 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 pressure and adjust the dosage of pressor ac Прочитайте повний документ