PHENYLEPHRINE HYDROCHLORIDE injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)

Dostopno od:

Sagent Pharmaceuticals

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Phenylephrine Hydrochloride Injection is 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 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]. The estimated background risk of major birth defects and mis

Povzetek izdelek:

Phenylephrine Hydrochloride Injection, USP is supplied as follows: Phenylephrine Hydrochloride Injection, USP is a clear, colorless solution. Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] The 1 mL vials are for single-dose only; 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. Protect from light. Retain in carton until time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative -free. The container closure is not made with natural rubber latex.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

PHENYLEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE INJECTION,
SOLUTION
SAGENT PHARMACEUTICALS
----------
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 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)
Adjust the dose according to the pressor response (i.e., titrate to
effect). (2)
DOSAGE FORMS AND STRENGTHS
Phenylephrine Hydrochloride Injection (3)
1 mL single-dose vials containing 10 mg phenylephrine hydrochloride
(10 mg per mL) (3)
5 mL pharmacy bulk package vials containing 50 mg phenylephrine
hydrochloride (10 mg per mL) (3)
10 mL pharmacy bulk package vials containing 100 mg phenylephrine
hydrochloride (10 mg per mL) (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Exacerbation of Angina, Heart Failure, or Pulmonary Arterial
Hypertension: Phenylephrine hydrochloride 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 Visceral Ischemia: Phenylephrine hydrochloride can
cause excessive peripheral and visceral
vasoconstriction and ischemia to vital organs. (5.2)
S