isoptin sr- Verapamil hydrochloride tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Verapamil hydrochloride (UNII: V3888OEY5R) (Verapamil - UNII:CJ0O37KU29)

Available from:

Ranbaxy Laboratories Inc.

INN (International Name):

Verapamil hydrochloride

Pharmaceutical form:

TABLET, COATED

Composition:

120 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ISOPTIN SR (verapamil HCI) is indicated for the management of essential hypertension. Verapamil HCI is contraindicated in: 1. Severe left ventricular dysfunction (see WARNINGS) 2. Hypotension (systolic pressure less than 90 mmHg) or cardiogenic shock 3. Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker) 4. Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker). 5. Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes). (see WARNINGS). 6. Patients with known hypersensitivity to verapamil hydrochloride.

Product summary:

ISOPTIN® SR 240 mg tablets are supplied as light green, capsule shaped, scored, film-coated tablets containing 240 mg of verapamil hydrochloride. The tablet is embossed with “pp” on one side and “ST” on the other side. ISOPTIN® SR 180 mg tablets are supplied as light pink, oval shaped, scored, film-coated tablets containing 180 mg of verapamil hydrochloride. The tablet is embossed with “pp” on one side, and “SK” on the other side. The ISOPTIN® SR 120 mg tablets are supplied as light violet, oval shaped, film-coated tablets containing 120 mg of verapamil hydrochloride. The tablet is embossed with “p” on one side and “SC” on the other side. 240 mg (light green) -Bottle of 100-NDC # 10631-490-01 Bottle of 500- NDC # 10631-490-05 180 mg (light pink) -Bottle of 100- NDC # 10631-489-01 120 mg (light violet) -Bottle of 100- NDC # 10631-488-01 Storage: Store at 25 ° C (77 ° F); excursions permitted to 15 °–30 ° C (59 °–86 ° F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Abbott Laboratories North Chicago, IL 60064 USA Manufactured for: FSC Laboratories, Inc. Charlotte, NC 28210 USA January 2005

Summary of Product characteristics

ISOPTIN SR- VERAPAMIL HYDROCHLORIDE TABLET, COATED
RANBAXY LABORATORIES INC.
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DESCRIPTION
ISOPTIN SR (verapamil hydrochloride) is a calcium ion influx inhibitor
(slow channel blocker or
calcium ion antagonist). ISOPTIN SR is available for oral
administration as light green, capsule shaped,
scored, film-coated tablets containing 240 mg verapamil hydrochloride,
as light pink, oval shaped,
scored, film-coated tablets containing 180 mg verapamil hydrochloride,
and as light violet, oval shaped,
film-coated tablets containing 120 mg verapamil hydrochloride. The
tablets are designed for sustained
release of the drug in the gastrointestinal tract, sustained release
characteristics are not altered when the
tablet is divided in half.
The structural formula of verapamil HCI is given below:
C
H N O •HCl M.W. 491.08
Benzeneacetronitrile, α [3-[[2-(3, 4-dimethoxyphenyl) ethyl]
methylamino] propyl]-3, 4- dimethoxy-α-(1-
methylethyl) hydrochloride
Verapamil HCI is an almost white, crystalline powder, practically free
of odor, with a bitter taste.
It is soluble in water, chloroform and methanol. Verapamil HCI is not
chemically related to other
cardioactive drugs.
In addition to verapamil HCI, the ISOPTIN SR tablet contains the
following ingredients: alginate,
hypromellose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polyvinyl
pyrrolidone, talc, and titanium dioxide. The following are the color
additives per tablet strength:
Strength (mg) Color Additive(s)
120 Iron Oxide
180 Iron Oxide
240 D&C yellow #10 Lake dye, and FD&C blue #2 Lake dye
CLINICAL PHARMACOLOGY
ISOPTIN (verapamil HCl) 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_
®
27
38
2
4
ISOPTIN exerts antihypertensive effects by decreasing systemic
vascular resistan