VERAPAMIL HYDROCHLORIDE capsule, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Mylan Institutional Inc.

INN (International Name):

VERAPAMIL HYDROCHLORIDE

Sammensetning:

VERAPAMIL HYDROCHLORIDE 120 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Verapamil hydrochloride extended-release capsules 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 variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Verapamil HCl is contraindicated in: - Severe left ventricular dysfunction. (See WARNINGS.) - Hypotension (less than 90 mmHg systolic pressure) or cardiogenic shock. - Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker). - Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker). - Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes). (See WARNINGS.) - Patients with known hypersensitivity to verapamil hydrochloride.

Produkt oppsummering:

Verapamil Hydrochloride Extended-Release Capsules, USP are available containing 120 mg of verapamil hydrochloride, USP. The 120 mg capsules are hard-shell gelatin capsules with a bluish green opaque cap and white opaque body filled with white to off-white beads. The capsules are radially printed with MYLAN over 6320 in black ink on both the cap and the body. They are available as follows: NDC 51079-917-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Brief digressions above 25°C while not detrimental, should be avoided. Avoid excessive heat. Protect from light and moisture. Call your doctor for medical advice about side effects. You may report side effects to Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12770 1/22

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
MYLAN INSTITUTIONAL INC.
----------
DESCRIPTION
Verapamil hydrochloride extended-release capsules, USP are a calcium
ion influx inhibitor
(slow channel blocker or calcium ion antagonist). Verapamil
hydrochloride extended-
release capsules are available for oral administration as a 120 mg
hard gelatin capsule
(bluish green opaque cap and white opaque body), a 180 mg hard gelatin
capsule (bluish
green opaque cap and light green opaque body) and a 240 mg hard
gelatin capsule
(bluish green opaque cap and bluish green opaque body). These bead
filled capsules
provide an extended-release of the drug in the gastrointestinal tract.
The structural formula of verapamil HCl is given below:
Chemical name: (±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-
dimethoxyphenyl)-2-isopropylvaleronitrile monohydrochloride.
Verapamil HCl, USP is a white or almost white, crystalline powder,
practically free of
odor, with a bitter taste. It is soluble in water, chloroform and
methanol. Verapamil HCl is
not structurally related to other cardioactive drugs.
In addition to verapamil HCl the verapamil hydrochloride
extended-release capsules
contain the following inactive ingredients: ammonium hydroxide,
dibutyl sebacate, diethyl
phthalate, ethylcellulose, FD&C Green No. 3, gelatin, hypromellose,
maltodextrin,
methacrylic acid copolymer Type A and B, oleic acid, polyethylene
glycol, povidone,
silicon dioxide, sodium lauryl sulfate, sugar spheres (which contain
cornstarch and
sucrose), talc and titanium dioxide, the 180 mg capsules also contain
D&C Yellow No.
10.
In addition, the black imprinting ink contains black iron oxide, D&C
Yellow No. 10
Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum
Lake,
FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.
CLINICAL PHARMACOLOGY
Verapamil hydrochloride extended-release capsules are a calcium ion
influx inhibitor
(slow channel blocker or calcium ion antagonist) which exert its
pharmacologi