Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Medical Purchasing Solutions, LLC
INTRAVENOUS
PRESCRIPTION DRUG
Phenylephrine hydrochloride injection, 10 mg/mL is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. None Pregnancy Category C Risk Summary There are no adequate or well-controlled studies with phenylephrine hydrochloride injection in pregnant women, nor have animal reproduction studies been conducted. Published studies in normotensive pregnant rabbits report early onset labor, increased fetal lethality, and adverse placental effects with subcutaneous phenylephrine administration during gestation at doses approximately 1.9-times the total daily human dose. Published studies in normotensive pregnant sheep report decreased uterine blood flow and decreased PaO 2 in the fetus with intravenous phenylephrine administration during late gestation at doses less than and similar to the human dose. It is not known whether phenylephrine hydrochloride, can cause fetal harm when administer
Phenylephrine Hydrochloride Injection, USP is a sterile, clear, colorless solution and supplied in 1 mL single-dose glass vials. Each mL contains phenylephrine hydrochloride USP, 10 mg . 10 mg/mL (1 mL) 1 mL Single - dose Vial: NDC 70121-1577-1 25 Vials in a Carton: NDC 70121-1577-5 Store phenylephrine hydrochloride injection USP, 10 mg/mL at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Store in carton until time of use. Vial stoppers are not manufactured with natural rubber latex. The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions. Discard any unused portion.
Abbreviated New Drug Application
PHENYLEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE INJECTION MEDICAL PURCHASING SOLUTIONS, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PHENYLEPHRINE HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PHENYLEPHRINE HYDROCHLORIDE INJECTION. PHENYLEPHRINE HYDROCHLORIDE INJECTION FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1954 INDICATIONS AND USAGE Phenylephrine hydrochloride injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. ( 1) DOSAGE AND ADMINISTRATION Phenylephrine hydrochloride injection, 10 mg/mL, is injected intravenously either as a bolus or in a dilute solution as a continuous infusion. Dilute before administration. ( 2) _ _ _Dosing for treatment of hypotension during anesthesia_ Bolus intravenous injection: 40 mcg to 100 mcg every 1 to 2 minutes as needed, not to exceed 200 mcg. ( 2) Intravenous infusion: 10 mcg/min to 35 mcg/min, titrating to effect, not to exceed 200 mcg/min. ( 2) The dose should be adjusted according to the pressor response (i.e. titrate to effect). ( 2) DOSAGE FORMS AND STRENGTHS Injection. ( 3) 1 mL single-dose vials containing 10 mg phenylephrine hydrochloride (10 mg/mL). ( 3) CONTRAINDICATIONS None. ( 4) WARNINGS AND PRECAUTIONS _Extravasation during intravenous administration may cause necrosis or sloughing of tissue. _( 5.3) _Severe bradycardia and decreased cardiac output. _( 5.4) _Allergic-type reactions_: Sulfite. ( 5.5) _Concomitant use with oxytocic drugs: _Pressor effect of sympathomimetic pressor amines is potentiated. ( 5.8) ADVERSE REACTIONS Most common adverse reactions during treatment: nausea, vomiting, and headache. ( 6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AMNEAL BIOSCIENCES AT 1-855-266-3251 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS Agonistic effects with monoamine oxidase inhibitors (MA Citiți documentul complet