PHENYLEPHRINE HYDROCHLORIDE injection

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

General Injectables and Vaccines, Inc.

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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]

Tuoteyhteenveto:

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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

PHENYLEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE INJECTION
GENERAL INJECTABLES AND VACCINES, INC.
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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: nau