Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Henry Schein, Inc.
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 8.1 Pregnancy Risk Summary Data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride use in pregnant women during Cesarean section have not established a drug-associated risk of major birth defects and miscarriage. These studies have not identified an adverse effect on maternal outcomes or infant Apgar scores [see Data]. There are no data on the use of phenylephrine during the first or second trimester. In animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine was administered during organogenesis via a 1-hour infusion at 1.2 times the human daily dose (HDD) of 10 mg/60 kg/day. Decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the HDD [See Data]
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 HENRY SCHEIN, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION PHENYLEPHRINE HYDROCHLORIDE 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 INTRAVENOUSE 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) (1) DOSAGE AND ADMINISTRATION Phenylephrine hydrochloride injection, 10 mg/mL, is injected intravenously either as ab olus or in a dilute solution as a continuous infusion. Dilute before administration. (2) (2) _Dosing for treatment of hypotension during anesthesia_ (2) 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) Adjust the dose according to the pressor response (i.e. titrate to effect). (2) WARNINGS AND PRECAUTIONS Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension: Phenylephrine hydrochloride can precipitate angina in patients with severe arterioschlerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure. (5.1) (5) Peripheral and Visceral Ischemia: PHenylephrine hydrochloride can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs. (5.2) (5) Skin and Subcutaneous Necrosis: Extravasation during intravenous administration may cause necrosis or sloughing of tissue. (5.3) (5) Bradycardia: Phenylephrine hydrochloride can cause severe bradycardia and decreased cardiac output. (5.4) (5) ADVERSE REACTIONS Most common adverse reactions during treatment: nausea, vomiting, and h Soma hati kamili