PHENYLEPHRINE HYDROCHLORIDE injection

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Cipla USA Inc.

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 injection 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

Rezumat produs:

Phenylephrine hydrochloride injection, USP 10 mg/ml, 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.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

PHENYLEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE INJECTION
CIPLA USA INC.
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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: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. (2.1)
_Dosing for Perioperative Hypotension_
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_
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)
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 CIPLA LTD AT
1-866-604-3268 OR FDA AT 1-800-FDA-
1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
Agonistic effects with monoamine oxidase inhibitors (MAOI),
β-adrenergic blocking agents, α-2 adrenergic agonists,
steroids, tricyclic antidepressants, norepinephrine transport
inhibitors, ergot alkaloids, centrally-acti