PHENYLEPHRINE HYDROCHLORIDE injection

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Cipla USA Inc.

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 PaO2 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 administered to a pregn

leaflet_short:

Phenylephrine hydrochloride injection, USP 10 mg/mL is supplied as follows: Vial stoppers are not manufactured with natural rubber latex. Store phenylephrine hydrochloride injection, USP 10 mg/mL 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. Store in carton until time of use. The 5 and 10 mL vials are pharmacy bulk packages. 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.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

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:1954
INDICATIONS AND USAGE
Phenylephrine hydrochloride 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 1-2 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)
5 mL pharmacy bulk package vials containing 50 mg phenylephrine
hydrochloride (10 mg/mL) (3)
10 mL pharmacy bulk package vials containing 100 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 bradycardiaand 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 CIPLA LTD AT
1-866-604-3268 OR FDA AT 1-800-FDA-
1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
Agonisti