VERAPAMIL HYDROCHLORIDE PM- verapamil hydrochloride capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

VERAPAMIL HYDROCHLORIDE

Composition:

VERAPAMIL HYDROCHLORIDE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Verapamil hydrochloride extended-release capsules (PM) for oral use are 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 va

Product summary:

Verapamil Hydrochloride Extended-Release Capsules, USP (PM) are available containing 100 mg, 200 mg or 300 mg of verapamil hydrochloride, USP. The 100 mg capsule is a hard-shell gelatin capsule with a red opaque cap and a white opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 6201 in black ink on both the cap and the body. They are available as follows: NDC 0378-6201-77 bottles of 90 capsules NDC 0378-6201-01 bottles of 100 capsules The 200 mg capsule is a hard-shell gelatin capsule with a red opaque cap and a light orange opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 6202 in black ink on both the cap and the body. They are available as follows: NDC 0378-6202-77 bottles of 90 capsules NDC 0378-6202-01 bottles of 100 capsules NDC 0378-6202-05 bottles of 500 capsules The 300 mg capsule is a hard-shell gelatin capsule with a red opaque cap and a red opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 6203 in black ink on both the cap and the body. They are available as follows: NDC 0378-6203-77 bottles of 90 capsules NDC 0378-6203-01 bottles of 100 capsules NDC 0378-6203-05 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VERAPAMIL HYDROCHLORIDE PM- VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
MYLAN PHARMACEUTICALS INC.
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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 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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 3% and more common than
in patients treated with placebo) are headache,
infection, constipation, flu syndrome, peripheral edema, dizziness,
pharyngitis, and sinusitis (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
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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)
Extended-release capsules controlled-onset: 100 mg, 200 mg, and 300 mg
(3)
Severe left ventricular dysfunction (4)
Hypotension (< 90 mm Hg 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)