VERAPAMIL HYDROCHLORIDE capsule, delayed release pellets

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Teva Pharmaceuticals Inc

Designació comuna internacional (DCI):

VERAPAMIL HYDROCHLORIDE

Composición:

VERAPAMIL HYDROCHLORIDE 120 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Verapamil hydrochloride sustained-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 Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacolo

Resumen del producto:

Verapamil hydrochloride sustained-release capsules are supplied in four dosage strengths: Store at Controlled Room Temperature 20° to 25°C (68° to 77°F). [See USP]. Avoid excessive heat. Brief digressions above 25°C, while not detrimental, should be avoided. Protect from moisture. Dispense in tight, light-resistant container as defined in USP.

Estat d'Autorització:

New Drug Application

Fitxa tècnica

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED
RELEASE PELLETS
TEVA PHARMACEUTICALS INC
----------
VERAPAMIL HYDROCHLORIDE
SUSTAINED-RELEASE CAPSULES
DESCRIPTION
Verapamil hydrochloride sustained-release capsules are calcium ion
influx inhibitors
(slow channel blockers or calcium ion antagonists). Verapamil
hydrochloride sustained-
release capsules are available for oral administration as a 360 mg
hard gelatin capsule
(lavender cap/yellow body), a 240 mg hard gelatin capsule (dark blue
cap/yellow body), a
180 mg hard gelatin capsule (light grey cap/yellow body), and a 120 mg
hard gelatin
capsule (yellow cap/yellow body). These pellet-filled capsules provide
a sustained-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: Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-
ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl)
monohydrochloride.
Verapamil HCl is an 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
sustained-release capsules
contain the following inactive ingredients: fumaric acid, talc, sugar
spheres, povidone,
shellac, gelatin, FD&C red #40, yellow iron oxide, titanium dioxide,
methylparaben,
propylparaben, silicon dioxide, and sodium lauryl sulfate. In
addition, the verapamil
hydrochloride sustained-release capsules 240 mg and 360 mg capsules
contain FD&C
blue #1 and D&C red #28; and the verapamil hydrochloride
sustained-release capsules
27
38
2
4
180 mg contain black iron oxide.
CLINICAL PHARMACOLOGY
Verapamil hydrochloride sustained-release capsules are a calcium ion
influx inhibitor
(slow channel blockers or calcium ion antagonists) which exerts its
pharmacologic
effects by modulating the influx of ionic calcium across the cell
membrane of the arterial
smooth muscle as