PHENYLEPHRINE HCI injection

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

HF Acquisition Co LLC, DBA HealthFirst

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 8.1 Pregnancy 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. 8.2 Labor and Delivery 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 decrease in placental perfusion sufficient to alter either the neonate Apgar scores or blood-gas status. 8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of phenylephrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 8.6 Hepatic Impairment In patients with liver cirrhosis [Child Pugh Class A (n=3), Class B (n=5) and Class C (n=1)], dose-response data indicate decreased responsiveness to phenylephrine. Consider using larger doses than usual in hepatic impaired subjects. 8.7 Renal Impairment In patients with end stage renal disease (ESRD) undergoing hemodialysis, dose-response data indicates increased responsiveness to phenylephrine. Consider using lower doses of phenylephrine hydrochloride in ESRD patients.

Tuoteyhteenveto:

PHENYLEPHRINE HCI INJECTION, USP is supplied in the following dosage forms. NDC 51662-1249-1 PHENYLEPHRINE HCI INJECTION, USP 10mg/mL 1mL VIAL NDC 51662-1249-2 Pouch of 1 PHENYLEPHRINE HCI INJECTION, USP 10mg/mL 1mL VIAL NDC 51662-1249-3 Case of 25 pouches of PHENYLEPHRINE HCI INJECTION, USP 10mg/mL 1mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Phenylephrine Hydrochloride Injection, USP, is supplied as follows: NDC 0641-6142-25: 1 mL single dose vials packaged in cartons containing 25 vials per carton. 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.

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

PHENYLEPHRINE HCI- PHENYLEPHRINE HCI INJECTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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PHENYLEPHRINE HCI INJECTION, USP 10MG/ML 1ML VIAL
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.
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 SECT 2.1).
Dosing for Perioperative Hypotension
• Intravenous bolus administration: 50 mcg to 250 mcg ( 2 SECT 2.4)
• Intravenous continuous infusion: 0.5 mcg/kg/minute to 1.4
mcg/kg/minute titrated to effect ( 2 SECT 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 SECT 2.5)
DOSAGE FORMS AND STRENGTH
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 SECT 5.2)
Extravasation: during intravenous administration may cause necrosis or
sloughing of tissue ( 5 SECT 5.4)
Concomitant use with oxytocic drugs: pressor effect of sympathomimetic
pressor amines is potentiated ( 5
SECT 5.5)
Allergic-type reactions: Sulfite ( 5 SECT 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),
β-adrenergic blocking agents, α-2 adren