VERAPAMIL HYDROCHLORIDE- verapamil hydrochloride capsule, delayed release pellets

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

VERAPAMIL HYDROCHLORIDE

Composition:

VERAPAMIL HYDROCHLORIDE 360 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Verapamil Hydrochloride Sustained-Release Capsules are indicated for the management of essential hypertension. Verapamil HCl is contraindicated in: - Severe left ventricular dysfunction. (See WARNINGS. ) - Hypotension (less than 90 mm Hg 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 erapamil hydrochloride.

Product summary:

Verapamil Hydrochloride Sustained-Release Capsules are supplied in four dosage strengths: Store at Controlled Room Temperature 20°-25°C (68°-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.

Authorization status:

New Drug Application

Summary of Product characteristics

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED
RELEASE PELLETS
BRYANT RANCH PREPACK
----------
VERAPAMIL HYDROCHLORIDE
SUSTAINED-RELEASE CAPSULES
R ONLY
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 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
X
27
38
2
4
ionic calcium across the cell membrane of the arterial smooth musc