Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Cipla USA Inc.
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
PHENYLEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE INJECTION CIPLA USA INC. ---------- 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 Leggi il documento completo