País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
EPHEDRINE SULFATE (UNII: U6X61U5ZEG) (EPHEDRINE - UNII:GN83C131XS)
Exela Pharma Sciences, LLC
INTRAVENOUS
PRESCRIPTION DRUG
AKOVAZ (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
AKOVAZ (ephedrine sulfate injection) is a clear, colorless, sterile solution for intravenous injection supplied as follows: NDC Strength How Supplied 50 mg/mL of ephedrine sulfate equivalent to 38 mg/mL of ephedrine base 1 mL clear glass vial; for single-dose (supplied in packages of 25) 51754-4250-3 25 mg/ 5 mL (5 mg/mL) of ephedrine sulfate equivalent to 19 mg/5 mL (3.8 mg/mL) of ephedrine base 5 mL single-dose prefilled syringe (supplied in packages of 10) Vial stoppers are not manufactured with natural rubber latex. Store AKOVAZ (ephedrine sulfate injection), at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in carton until time of use. For single dose only. Discard unused portion. The single-dose 5 mL prefilled syringe is intended for use in one patient during one surgical procedure. Manufactured for: Exela Pharma Sciences, LLC Lenoir, NC 28645
New Drug Application
AKOVAZ- EPHEDRINE SULFATE INJECTION EXELA PHARMA SCIENCES, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AKOVAZ® SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AKOVAZ. AKOVAZ (EPHEDRINE SULFATE INJECTION) FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2016 INDICATIONS AND USAGE AKOVAZ 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 • • • DOSAGE FORMS AND STRENGTHS Injection: 50 mg/mL ephedrine sulfate in single-dose vial (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS • • ADVERSE REACTIONS Most common adverse reactions during treatment: nausea, vomiting, and tachycardia. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT EXELA PHARMA SCIENCES, LLC AT 1-888- 451-4321 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_. DRUG INTERACTIONS • • • • • • • REVISED: 4/2021 Should be administered by trained healthcare providers (2.1) AKOVAZ 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) 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) 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. Monit Leer el documento completo