PHENYLEPHRINE HYDROCHLORIDE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Provepharm Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Phenylephrine hydrochloride Injection, 10 mg/mL 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 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 ]. The estimated background risk of ma

Product summary:

Phenylephrine hydrochloride Injection, 10 mg/mL is supplied as clear and colorless sterile solution for injection as follows: Vial stopper is not made with natural rubber latex. Store Phenylephrine hydrochloride Injection, 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 1 mL vials are for single use 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. Discard any unused portion.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PHENYLEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE INJECTION
PROVEPHARM INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHENYLEPHRINE
HYDROCHLORIDE 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)
Adjust the dose according to the pressor response (i.e., titrate to
effect). (2)
DOSAGE FORMS AND STRENGTHS
Injection (3)
1 mL single use 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 Visceral Ischemia: Phenylephrine hydrochloride
injection can cause excessive peripheral
and visceral vasoconstriction and ischemia to vital organs. (5.2)
Skin and Subcutaneous Necrosis: Extrav