VERELAN PM- verapamil hydrochloride capsule, extended release

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29)

Доступно од:

Lannett Company, Inc.

INN (Међународно име):

verapamil hydrochloride

Састав:

verapamil hydrochloride 100 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Verelan® PM (verapamil hydrochloride extended-release capsules) for oral use is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs,

Резиме производа:

Verapamil Hydrochloride Extended-release Capsules (PM) (verapamil hydrochloride) extended-release pellet filled capsules are supplied in three dosage strengths: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight, light-resistant container as defined in USP.

Статус ауторизације:

New Drug Application

Карактеристике производа

VERELAN PM- VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
LANNETT COMPANY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VERELAN PM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VERELAN PM.
VERELAN PM (VERAPAMIL HYDROCHLORIDE) EXTENDED-RELEASE CAPSULES FOR
ORAL
USE INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Verelan PM is a calcium channel blocker indicated for the treatment of
hypertension, to lower blood
pressure. Lowering blood pressure reduces the risk of fatal and
nonfatal cardiovascular events, primarily
strokes and myocardial infarctions. (1)
DOSAGE AND ADMINISTRATION
Do not crush or chew capsule contents; swallow capsule whole or
sprinkle entire contents onto
applesauce (2.2, 17)
Usual dosage: 200 mg once daily at bedtime; if inadequate response,
titrate upward to 300 mg, then
400 mg once daily at bedtime (2.1)
Initial dose of 100 mg once daily at bedtime in patients with renal or
hepatic impairment, elderly or low-
weight patients (2.1)
DOSAGE FORMS AND STRENGTHS
Extended-release capsules controlled-onset: 100 mg, 200 mg, and 300 mg
(3)
CONTRAINDICATIONS
Severe left ventricular dysfunction (4)
Hypotension (<90 mmHg systolic pressure) or cardiogenic shock (4)
Sick sinus syndrome (except in patients with pacemaker) (4)
2nd- or 3rd-degree AV block (except in patients with pacemaker) (4)
Atrial flutter or atrial fibrillation and an accessory bypass tract
(4)
WARNINGS AND PRECAUTIONS
Congestive heart failure or pulmonary edema may develop (5.1)
Hypotension/dizziness may occur (5.2)
Elevated transaminases have occurred; monitor liver function (5.3)
Ventricular fibrillation has occurred in patients with atrial flutter
or atrial fibrillation and an accessory
bypass tract (5.4)
Reduce dose or discontinue therapy if marked first-degree AV block or
progression to second- or third-
degree AV block occurs (5.5)
Sinus bradycardia, pulmonary edema, severe hypotension, second-degree
AV block, sinus arrest, and
death occurr