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(trandolapril/verapamil hydrochloride ER) Tablets
WARNING: FETAL TOXICITY
- When pregnancy is detected, discontinue TARKA as soon as possible.
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (see WARNINGS: Fetal Toxicity).
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.
Verapamil hydrochloride is chemically described as benzeneacetonitrile, α[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3, 4-dimethoxy-α-(l-methylethyl) hydrochloride. Its empirical formula is C27H38N2O4 HCl and its structural formula is:
Verapamil hydrochloride is an almost white crystalline powder, with a molecular weight of 491.08. It is soluble in water, chloroform, and methanol. It is practically free of odor, with a bitter taste.
Trandolapril is the ethyl ester prodrug of a nonsulfhydryl angiotensin converting enzyme (ACE) inhibitor, trandolaprilat. It is chemically described as (2S,3aR,7aS)-l-[(S)-N-[(S)-l-Carboxy-3-phenylpropyl]alanyl] hexahydro-2-indolinecarboxylic acid, 1-ethyl ester. Its empirical formula is C24H34N2O5 and its structural formula is:
Trandolapril is a white or almost white powder 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 monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, silicon dioxide, sodium alginate, sodium stearyl fumarate, synthetic iron oxides, talc, and titanium dioxide.
What are the possible side effects of trandolapril and verapamil (Tarka)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- urinating less than usual or not at all;
- swelling, weight gain, feeling short of breath;
- feeling like you might pass out;
- anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus;
- chest pain, fast, slow, or uneven heart...
What are the precautions when taking trandolapril and verapamil er (Tarka)?
Before taking this product, tell your doctor or pharmacist if you are allergic to trandolapril or verapamil; or to other ACE inhibitors (such as benazepril, lisinopril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain types of heart rhythm problems (such as second- or third-degree atrioventricular block, sick sinus syndrome unless you have a pacemaker, Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome), a history of an allergic reaction that included swelling of the...
Last reviewed on RxList: 9/24/2012
This monograph has been modified to include the generic and brand name in many instances.
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