Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
PHENTOLAMINE MESYLATE (UNII: Y7543E5K9T) (PHENTOLAMINE - UNII:Z468598HBV)
Hikma Pharmaceuticals USA Inc.
PHENTOLAMINE MESYLATE
PHENTOLAMINE MESYLATE 5 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
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.
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
Abbreviated New Drug Application
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 Lesen Sie das vollständige Dokument