USE IN PREGNANCY
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.
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
Verapamil Component: Verapamil hydrochloride is chemically
described as benzeneacetonitrile, a[3-[[2-(3,4-dimethoxyphenyl)
ethyl] methylamino] propyl]-3,4-dimethoxy-a-(1-methylethyl)
hydrochloride. Its empirical formula is C27H38N2O4HCl.
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)-Carboxy-3-phenylpropyl]alanyl]hexahydro-2-indo-linecarboxylic
acid, 1-ethyl ester. Its empirical formula is C24H34N2O5.
Trandolapril is a colorless, crystalline substance with a molecular weight
of 430.54. It is soluble (>100 mg/mL) in chloroform, dichloromethane,
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, hydroxypropyl methylcellulose, lactose, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, povidone, purified water,
silicon dioxide, sodium alginate, sodium stearyl fumarate, synthetic iron
oxides, talc, and titanium dioxide.