VERAPAMIL HYDROCHLORIDE capsule, extended release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Mylan Pharmaceuticals Inc.

INN (Nome Internazionale):

VERAPAMIL HYDROCHLORIDE

Composizione:

VERAPAMIL HYDROCHLORIDE 120 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 pharmacol

Dettagli prodotto:

Verapamil Hydrochloride Extended-Release Capsules, USP are available containing 120 mg, 180 mg or 240 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 0378-6320-01 bottles of 100 capsules The 180 mg capsules are hard-shell gelatin capsules with a bluish green opaque cap and light green opaque body filled with white to off-white beads. The capsules are radially printed with MYLAN over 6380 in black ink on both the cap and the body. They are available as follows: NDC 0378-6380-01 bottles of 100 capsules The 240 mg capsules are hard-shell gelatin capsules with a bluish green opaque cap and bluish green opaque body filled with white to off-white beads. The capsules are radially printed with MYLAN over 6440 in black ink on both the cap and the body. They are available as follows: NDC 0378-6440-01 bottles of 100 capsules 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 moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. 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 75080580 Revised: 6/2021 MX:CVERER:R1

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
MYLAN PHARMACEUTICALS INC.
REFERENCE LABEL SET ID: 04A149A5-7153-4CFE-949F-8889669CDD2B
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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:
C
H
N O • HCL M.W. 491.07
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.
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CLINICAL PHARMACOLOGY
Verapamil hydrochloride extended-release capsules are a calci