देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29)
Lannett Company, Inc.
verapamil hydrochloride
verapamil hydrochloride 100 mg
ORAL
PRESCRIPTION DRUG
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,
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.
New Drug Application
VERELAN PM- VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE LANNETT COMPANY, INC. ---------- 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 पूरा दस्तावेज़ पढ़ें