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Tarka 2-240 Mg Tabs 100 By Abbvie Us.

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Tarka 2-240 Mg Tabs 100 By Abbvie Us.

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Tarka 2-240 Mg Tabs 100 By Abbvie Us. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD3258258/RXB10033673
Size : 100
Selling UoM : EA
NDC: 00074-3289-13
UPC Barcode : 300743289138
Supplier: 0050001088 ABBVIE US LLC
Supplier Material : 032890413
Generic Code : 029253 TRANDOLAPRIL/VERAPAMIL HCL ORAL TAB BP 2
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Branded RX

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Product Description.:

Logo and 242
tablet , film-coated , gold , oval oblong
Debossed

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, TARKA? should be discontinued as soon as possible. See WARNINGS, Fetal/ Neonatal Morbidity and Mortality.

DRUG DESCRIPTION

TARKA? (trandolapril/verapamil hydrochloride ER) combines a slow release formulation of a calcium channel blocker, verapamil hydrochloride, and an immediate release formulation of an angiotensin converting enzyme inhibitor, trandolapril.

Trandolapril is a colorless, crystalline substance with a molecular weight of 430.54. It is soluble ( > 100 mg/mL) in chloroform, dichloromethane, and methanol.

TARKA tablets are formulated for oral administration, containing verapamil hydrochloride as a controlled release formulation and trandolapril as an immediate release formulation. The tablet strengths are trandolapril 2 mg/verapamil hydrochloride ER 180 mg, trandolapril 1 mg/verapamil hydrochloride ER 240 mg, trandolapril 2 mg/verapamil hydrochloride ER 240 mg, and trandolapril 4 mg/verapamil hydrochloride ER 240 mg. The tablets also contain the following ingredients: corn starch, dioctyl sodium sulfosuccinate, ethanol, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, silicon dioxide, sodium alginate, sodium stearyl fumarate, synthetic iron oxides, talc, and titanium dioxide.

INDICATIONS

TARKA is indicated for the treatment of hypertension.

This fixed combination drug is not indicated for the initial therapy of hypertension. In using TARKA, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that trandolapril does not have similar risk

SIDE EFFECTS

TARKA has been evaluated in over 1,957 subjects and patients. Of these, 541 patients, including 23% elderly patients, participated in U.S. controlled clinical trials, and 251 were studied in foreign controlled clinical trials. In clinical trials with TARKA, no adverse experiences peculiar to this combination drug have been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with verapamil or trandolapril. TARKA has been evaluated for long-term safety in 272 patients treated for 1 year or more. Adverse experiences were usually mild and transient.

Discontinuation of therapy because of adverse events in U.S. placebo- controlled hypertension studies was required in 2.6% and 1.9% of patients treated with TARKA and placebo, respectively.