PHENTOLAMINE MESYLATE injection, powder, for solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

PHENTOLAMINE MESYLATE (UNII: Y7543E5K9T) (PHENTOLAMINE - UNII:Z468598HBV)

Disponible depuis:

Hikma Pharmaceuticals USA Inc.

DCI (Dénomination commune internationale):

PHENTOLAMINE MESYLATE

Composition:

PHENTOLAMINE MESYLATE 5 mg in 1 mL

Mode d'administration:

INTRAMUSCULAR

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Phentolamine Mesylate for Injection 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 is indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine. Phentolamine Mesylate for Injection is also indicated for the diagnosis of pheochromocytoma by the phentolamine 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.

Descriptif du produit:

Phentolamine Mesylate for Injection, USP, 5 mg, for intramuscular or intravenous use, is supplied as follows: NDC 0143-9564-01 - 2 mL vials packaged individually. NDC 0143-9564-10 - 2 mL vials packaged in cartons of 10 vials. The reconstituted solution should be used upon preparation and should not be stored. Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised May 2022 PIN385-WES/5

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

PHENTOLAMINE MESYLATE- PHENTOLAMINE MESYLATE INJECTION, POWDER, FOR
SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
PHENTOLAMINE MESYLATE
FOR INJECTION, USP
RX ONLY
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 is
_m_-[_N_-(2-Imidazolin-2-ylmethyl)-_p_-toluidino]phenol
monomethanesulfonate (salt), and its structural formula is:
Molecular Formula
C
H
N O•CH O S
M.W. 377.47
Phentolamine mesylate, USP is a white or off-white, odorless
crystalline powder. 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 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 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 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.
17
19
3
4
3
Phentolamine Mesylate for Injection is indicated for the prevention or
treatment of
dermal necrosis and sloughing following intravenous administration or
extravasation of
norepinephrine.
Phentolamine Mesylate for Injection is also indicated for the
diagnosis of
pheochromocytoma by the phentolamine blocking test.
CONTRAINDICATIONS
Myocardial infarction, history of myocardial infarction, coronary
insufficiency, angina, or
other evidence suggestive of coronary artery disease; hypersensitivity
t