VERAPAMIL HYDROCHLORIDE capsule, extended release

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Bryant Ranch Prepack

INN (nume internaţional):

VERAPAMIL HYDROCHLORIDE

Compoziție:

VERAPAMIL HYDROCHLORIDE 300 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Verapamil Hydrochloride Extended-release Capsules (PM) 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, from a var

Rezumat produs:

NDC: 63629-7233-1: 30 Capsules in a BOTTLE NDC: 63629-7233-2: 90 Capsules in a BOTTLE

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VERAPAMIL
HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (PM) SAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FOR VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE
CAPSULES
(PM).
VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (PM) FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Verapamil Hydrochloride Extended-release Capsules (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-
deg