Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29)
Physicians Total Care, Inc.
VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE 360 mg
ORAL
PRESCRIPTION DRUG
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.
Verapamil Hydrochloride Sustained-Release Capsules are supplied in 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.
New Drug Application
VERAPAMIL HYDROCHLORIDE - VERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS PHYSICIANS TOTAL CARE, INC. ---------- 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 smo Przeczytaj cały dokument