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:

General Injectables & Vaccines, Inc

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Phenylephrine Hydrochloride is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia. The use of phenylephrine hydrochloride is contraindicated in patients with: - Hypersensitivity to it or any of its components Pregnancy Category C Animal reproduction studies have not been conducted with intravenous phenylephrine. It is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed. The most common maternal adverse reactions reported in studies of phenylephrine use during neuraxial anesthesia during cesarean delivery include nausea and vomiting, which are commonly associated with hypotension, bradycardia, reactive hypertension, and transient arrhythmias. Phenylephrine does not appear to cause a dec

Product summary:

Phenylephrine Hydrochloride Injection, USP, is supplied as follows: Store 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. Keep covered in carton until time of use. For single use only. Discard unused portion.

Authorization status:

New Drug Application

Summary of Product characteristics

PHENYLEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE INJECTION
GENERAL INJECTABLES & VACCINES, INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
PHENYLEPHRINE HCL INJECTION, USP
RX ONLY
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHENYLEPHRINE HYDROCHLORIDE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PHENYLEPHRINE
HYDROCHLORIDE.
PHENYLEPHRINE HYDROCHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2012
INDICATIONS AND USAGE
Phenylephrine Hydrochloride is an alpha-1 adrenergic receptor agonist
indicated for increasing blood pressure in adults
with clinically important hypotension resulting primarily from
vasodilation, in such settings as septic shock or anesthesia.
(1)
DOSAGE AND ADMINISTRATION
Dilute before administration. (2)
_Dosing for Perioperative Hypotension_ (2)
Intravenous bolus administration: 50 mcg to 250 mcg (2.4)
Intravenous continuous infusion: 0.5 mcg/kg/minute to 1.4
mcg/kg/minute titrated to effect (2.4)
_Dosing for Patients with Vasodilatory Shock_ (2)
Intravenous continuous infusion: 0.5 mcg/kg/minute to 6 mcg/kg/minute
titrated to effect (2.5)
DOSAGE FORMS AND STRENGTHS
Injection: 10 mg/mL supplied as a 1 mL single dose vial (3, 11, 16)
(3)
CONTRAINDICATIONS
Hypersensitivity to it or any of its components (4)
WARNINGS AND PRECAUTIONS
_Severe bradycardia and decreased cardiac output _(5.2)
_Extravasation: _
during intravenous administration may cause necrosis or sloughing of
tissue (5.4)
_Concomitant use with oxytocic drugs: _pressor effect of
sympathomimetic pressor amines is potentiated (5.5)
_Allergic-type reactions: _ Sulfite (5.6)
ADVERSE REACTIONS
Most common adverse reactions: nausea and vomiting, headache,
nervousness (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WEST-WARD
PHARMACEUTICAL CORP. AT 1-877-845-0689
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Agonistic effects with monoamine oxidase inhibitors (MAOI),
B-adrenergic blocking agents, a-2 adrenergic agonists,
steroids, tricyclic antidepressant