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:

Medical Purchasing Solutions, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Pregnancy Category C Risk Summary There are no adequate or well-controlled studies with phenylephrine hydrochloride injection in pregnant women, nor have animal reproduction studies been conducted. Published studies in normotensive pregnant rabbits report early onset labor, increased fetal lethality, and adverse placental effects with subcutaneous phenylephrine administration during gestation at doses approximately 1.9-times the total daily human dose. Published studies in normotensive pregnant sheep report decreased uterine blood flow and decreased PaO 2 in the fetus with intravenous phenylephrine administration during late gestation at doses less than and similar to the human dose. It is not known whether phenylephrine hydrochloride, can cause fetal harm when administer

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PHENYLEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE INJECTION
MEDICAL PURCHASING SOLUTIONS, LLC
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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
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)
The dose should be adjusted 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)
CONTRAINDICATIONS
None. ( 4)
WARNINGS AND PRECAUTIONS
_Extravasation during intravenous administration may cause necrosis or
sloughing of tissue. _( 5.3)
_Severe bradycardia and decreased cardiac output. _( 5.4)
_Allergic-type reactions_: Sulfite. ( 5.5)
_Concomitant use with oxytocic drugs: _Pressor effect of
sympathomimetic pressor amines is
potentiated. ( 5.8)
ADVERSE REACTIONS
Most common adverse reactions during treatment: nausea, vomiting, and
headache. ( 6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AMNEAL BIOSCIENCES AT
1-855-266-3251
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Agonistic effects with monoamine oxidase inhibitors (MA