TARKA- trandolapril and verapamil hydrochloride tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

trandolapril (UNII: 1T0N3G9CRC) (trandolapril - UNII:1T0N3G9CRC), verapamil hydrochloride (UNII: V3888OEY5R) (verapamil - UNII:CJ0O37KU29)

Available from:

Physicians Total Care, Inc.

INN (International Name):

trandolapril

Composition:

trandolapril 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TARKA is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE and ADMINISTRATION). 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 (see WARNINGS -Neutropenia/Agranulocytosis ). TARKA is contraindicated in patients who are hypersensitive to any ACE inhibitor or verapamil. Because of the verapamil component, TARKA is 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 pacemak

Product summary:

TARKA 2/180 mg tablets are supplied as pink, oval, film-coated tablets containing 2 mg trandolapril in an immediate release form and 180 mg verapamil hydrochloride in a sustained release form. The tablet is debossed with a triangle and 182 on one side and plain on the other side. TARKA 4/240 mg tablets are supplied as reddish-brown, oval, film-coated tablets containing 4 mg trandolapril in an immediate release form and 240 mg verapamil hydrochloride in a sustained release form. The tablet is debossed with a triangle and 244 on one side and plain on the other side. Dispense in well-closed container with safety closure. Store at 15°-25°C (59°-77°F) see USP. Abbott Laboratories North Chicago, IL 60064, U.S.A. Rev: 1/2012 Abbott Laboratories Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma       74146

Authorization status:

New Drug Application

Summary of Product characteristics

TARKA - TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED RELEASE
TARKA - TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
TARKA®
(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).
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.
VERAPAMIL COMPONENT
Verapamil hydrochloride is chemically described as
benzeneacetonitrile, α[3-[[2-(3,4-
dimethoxyphenyl)ethyl]methylamino]propyl]-3,
4-dimethoxy-α-(1-methylethyl) hydrochloride. Its
empirical formula is C
H N O 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 COMPONENT
Trandolapril is the ethyl ester prodrug of a nonsulfhydryl angiotensin
converting enzyme (ACE)
inhibitor, trandolaprilat. It is chemically described as
(2S,3aR,7aS)-1-[(S)-N-[(S)-1-Carboxy-3-
phenylpropyl]alanyl] hexahydro-2-indolinecarboxylic acid, 1-ethyl
ester. Its empirical formula is C
H N O and its structural formula is:
27
38
2
4
24
34
2
5
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 24