PHENTOLAMINE MESYLATE injection

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

Phentolamine Mesylate (UNII: Y7543E5K9T) (Phentolamine - UNII:Z468598HBV)

Disponible desde:

TAGI Pharma, Inc.

Vía de administración:

INTRAMUSCULAR

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Phentolamine Mesylate for Injection, USP is indicated for the prevention or control of hypertensive episodes that may occur in a patient with pheochromocytoma as a result of stress or manipulation during preoperative preparation and surgical excision. Phentolamine Mesylate for Injection, USP is indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine. Phentolamine Mesylate for Injection, USP is also indicated for the diagnosis of pheochromocytoma by the Phentolamine Mesylate for Injection, USP blocking test. Myocardial infarction, history of myocardial infarction, coronary insufficiency, angina or other evidence suggestive of coronary artery disease; hypersensitivity to phentolamine or related compounds.

Resumen del producto:

Vials— each containing 5 mg of Phentolamine mesylate, USP, and 25 mg of mannitol, USP, in sterile, lyophilized form. Trays of 10 with NDC 51224-012-10 Cartons of 1 with NDC 51224-012-20 The reconstituted solution should be used upon preparation and should not be stored. Store at 20° to 25°C (68° - 77°F) with excursions between 15° to 30°C (59° to 86°F) [USP Controlled Room Temperature]

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

PHENTOLAMINE MESYLATE- PHENTOLAMINE MESYLATE INJECTION
TAGI PHARMA, INC.
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PHENTOLAMINE MESYLATE FOR INJECTION USP, 5MG
DESCRIPTION
Phentolamine Mesylate for Injection, USP is an antihypertensive,
available in vials for
intravenous and intramuscular administration. Each vial contains
phentolamine mesylate,
USP, 5 mg, and mannitol USP, 25 mg, in sterile, lyophilized form.
Phentolamine Mesylate, USP is
4,5-dihydro-2-[N-(_m_-hydroxyphenyl)-N-(_p_-methylphenyl)
aminomethyl]-1_H_-imidazole 1:1 methanesulfonate, and its structural
formula is
Phentolamine mesylate, USP is a white or off-white, odorless
crystalline powder with a
molecular weight of 377.46. Its solutions are acid to litmus. It is
freely soluble in water
and in alcohol, and slightly soluble in chloroform. It melts at about
178°C.
CLINICAL PHARMACOLOGY
Phentolamine Mesylate for Injection, USP produces an alpha-adrenergic
block of
relatively short duration. It also has direct, but less marked,
positive inotropic and
chronotropic effects on cardiac muscle and vasodilator effects on
vascular smooth
muscle.
Phentolamine Mesylate for Injection, USP has a half-life in the blood
of 19 minutes
following intravenous administration. Approximately 13% of a single
intravenous dose
appears in the urine as unchanged drug.
INDICATIONS AND USAGE
Phentolamine Mesylate for Injection, USP is indicated for the
prevention or control of
hypertensive episodes that may occur in a patient with
pheochromocytoma as a result
of stress or manipulation during preoperative preparation and surgical
excision.
Phentolamine Mesylate for Injection, USP is indicated for the
prevention or treatment of
dermal necrosis and sloughing following intravenous administration or
extravasation of
norepinephrine.
Phentolamine Mesylate for Injection, USP is also indicated for the
diagnosis of
pheochromocytoma by the Phentolamine Mesylate for Injection, USP
blocking test.
CONTRAINDICATIONS
Myocardial infarction, history of myocardial infarction, coronary
insufficiency, angina or
other evidence sug