Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
EPHEDRINE SULFATE (UNII: U6X61U5ZEG) (EPHEDRINE - UNII:GN83C131XS)
Par Pharmaceutical, Inc.
EPHEDRINE SULFATE
EPHEDRINE SULFATE 50 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
CORPHEDRA is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. None R isk 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. C linical 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 reports descri
CORPHEDRA (ephedrine sulfate injection), 50 mg/mL, is supplied as follows: NDC S tre n gth How Supplied 42023-196-01 50 mg/mL 1 mL clear glass vial; for single use (supplied in packages of 25) 42023-233-01 500 mg/10 mL (50 mg/mL) 10 mL clear glass vial; multi-dose Vial stoppers are not manufactured with natural rubber latex. Store CORPHEDRA, 50 mg/mL, at 20° to 25°C (68° to 77°F), with excursions permitted to 15°C to 30°C (59°F 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.
New Drug Application
CORPHEDRA- EPHEDRINE SULFATE INJECTION, SOLUTION PAR PHARMACEUTICAL, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CORPHEDRA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CORPHEDRA. CORPHEDRA (EPHEDRINE SULFATE INJECTION, USP) FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2016 INDICATIONS AND USAGE CORPHEDRA is an alpha- and beta- adrenergic agonist and a norepinephrine-releasing agent indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. (1) DOSAGE AND ADMINISTRATION Treatment of hypotension developing during anesthesia: 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 single-dose vial (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS • Pressor Effect with Concomitant 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 PAR PHARMACEUTICAL AT 1-800-828-9393 OR FDA AT 1- 800-FDA-1088 OR _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 pre Lees het volledige document