AKOVAZ- ephedrine sulfate injection

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Avadel Legacy Pharmaceuticals, LLC

INN (nemzetközi neve):

EPHEDRINE SULFATE

Összetétel:

EPHEDRINE SULFATE 50 mg in 1 mL

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Termék összefoglaló:

AKOVAZ (ephedrine sulfate injection), 50 mg/mL, is supplied as follows: Vial stoppers are not manufactured with natural rubber latex. Store AKOVAZ (ephedrine sulfate injection), 50 mg/mL, 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. Manufactured for: Avadel Avadel Legacy Pharmaceuticals, LLC Chesterfield, MO 63005 Rev. 04/20

Engedélyezési státusz:

New Drug Application

Termékjellemzők

AKOVAZ- EPHEDRINE SULFATE INJECTION
AVADEL LEGACY PHARMACEUTICALS, 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, USP) 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
AKOVAZ 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 AVADEL AT
1-877-638-4579 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 accordingly.
Rocuronium: Ephedrine may reduce the ons