AKOVAZ- ephedrine sulfate injection

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Exela Pharma Sciences, LLC

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

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

Autorisasjon status:

New Drug Application

Preparatomtale

AKOVAZ- EPHEDRINE SULFATE INJECTION
EXELA PHARMA SCIENCES, LLC
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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
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DOSAGE FORMS AND STRENGTHS
Injection: 50 mg/mL ephedrine sulfate in single-dose vial (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
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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
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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