Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29)
Physicians Total Care, Inc.
VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE 120 mg
ORAL
PRESCRIPTION DRUG
Verapamil hydrochloride extended-release tablets are indicated for the management of essential hypertension. Verapamil hydrochloride extended-release tablets are contraindicated in: - Severe left ventricular dysfunction (see WARNINGS) - Hypotension (systolic pressure less than 90 mmHg) 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.
Verapamil Hydrochloride Extended-release Tablets, USP are available containing 120 mg, 180 mg or 240 mg of verapamil hydrochloride, USP. The 120 mg tablets are blue film-coated, oval, unscored tablets debossed with MYLAN on one side of the tablet and 244 on the other side. They are available as follows: NDC 54868-4432-0 bottles of 30 tablets The 180 mg tablets are blue film-coated, oval tablets debossed with M to the left of the score and 312 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 54868-3300-2 bottles of 30 tablets NDC 54868-3300-3 bottles of 60 tablets NDC 54868-3300-4 bottles of 90 tablets NDC 54868-3300-1 bottles of 100 tablets The 240 mg tablets are blue film-coated, modified capsule-shaped tablets debossed with M to the left of the score and 411 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 54868-2207-6 bottles of 10 tablets NDC 54868-2207-2 bottles of 30 tablets NDC 54868-2207-0 bottles of 60 tablets NDC 54868-2207-5 bottles of 90 tablets NDC 54868-2207-3 bottles of 100 tablets NDC 54868-2207-7 bottles of 180 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED AUGUST 2010 VERAT:R5 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146
Abbreviated New Drug Application
VERAPAMIL HYDROCHLORIDE - VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE PHYSICIANS TOTAL CARE, INC. ---------- DESCRIPTION Verapamil hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). The tablets are designed for extended-release of the drug in the gastrointestinal tract; extended-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil hydrochloride is given below: C H N O • HCL M.W. = 4 91.07 (±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile monohydrochloride Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil hydrochloride is not chemically related to other cardioactive drugs. Each extended-release tablet, for oral administration, contains 120 mg, 180 mg or 240 mg of verapamil hydrochloride. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium alginate, sodium lauryl sulfate, talc, and titanium dioxide. Verapamil Hydrochloride Extended-release Tablets USP, 120 mg meet _USP Dissolution Test 1_. Verapamil Hydrochloride Extended-release Tablets USP, 180 mg and 240 mg meet _USP Dissolution_ _Test 3_. CLINICAL PHARMACOLOGY Verapamil hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist) that exerts its pharmacologic effects by modulating the influx of ionic calcium across the cell membrane of the arterial smooth muscle as well as in conductile and contractile myocardial cells. MECHANISM OF ACTION Essential Hypertension Verapamil exerts antihypertensive effects by decreasing systemic vascular resistance, usually without orthostatic decreases in blood pressure or reflex tachycardia; bradycardia (rate less than 50 beats/min) is uncommon (1.4%). Baca dokumen lengkap