PHENYLEPHRINE HYDROCHLORIDE injection PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE- phenylephrine hydrochloride inje

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

थमां उपलब्ध:

Gland Pharma Limited

प्रशासन का मार्ग:

INTRAVENOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 Risk Summary Data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection 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]

उत्पाद समीक्षा:

Phenylephrine hydrochloride injection USP, 10 mg/mL is available as a clear, colorless solution and supplied as follows: Vial stoppers are not manufactured with natural rubber latex. Store Phenylephrine hydrochloride Injection USP, 10 mg/mL at 20°C to 25°C (68°F to 77°F) 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. The 5 and  10 mL vials are pharmacy bulk packages. 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.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

PHENYLEPHRINE HYDROCHLORIDE - PHENYLEPHRINE HYDROCHLORIDE INJECTION
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE-
PHENYLEPHRINE HYDROCHLORIDE INJECTION
GLAND PHARMA LIMITED
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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
PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION
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 1-2 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)
DOSAGE FORMS AND STRENGTHS
Injection (3)
• 1 mL single-dose vials containing 10 mg phenylephrine
hydrochloride (10 mg/mL) (3)
• 5 mL pharmacy bulk package vials containing 50 mg phenylephrine
hydrochloride (10 mg/mL) (3)
• 10 mL pharmacy bulk package vials containing 100 mg phenylephrine
hydrochloride (10 mg/mL) (3)
CONTRAINDICATIONS
• None (4)
WARNINGS AND PRECAUTIONS
Exacerbation of Angina, Heart Failure, or Pulmonary Arterial
Hypertension: Phenylephrine hydrochloride
injection can precipitate angina in patients with severe
arteriosclerosis or history of angina, exacerbate
underlying heart failure, and increase pulmonary arterial pressure.
(5.1)
Peripheral and Viscera