DESCRIPTION
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USE IN PREGNANCY
When used in pregnancy during the second and third trimesters,
drugs that act directly on the renin-angiotensin system can cause
injury and even death to the developing fetus. When pregnancy
is detected. TEVETEN Tablets should be discontinued as soon as
possible.
See WARNINGS: Fetal/ Neonatal
Morbidity and Mortality.
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TEVETEN (eprosartan mesylate) Tablet is a non-biphenyl non-tetrazole
angiotensin II receptor (AT1) antagonist.
A selective non-peptide molecule, TEVETEN Tablets are chemically described
as the monomethanesulfonate of (E)-2-butyl-1-(p-carboxybenzyl)-a-2-thienylmethylimidazole-5-acrylic
acid.
Its empirical formula is C23H24N2O4S
CH4O3S and molecular weight is 520.625.
Eprosartan mesylate is a white to off-white free-flowing crystalline
powder that is insoluble in water, freely soluble in ethanol, and melts
between 248 C and 250 C.
TEVETEN Tablets are available as aqueous film-coated tablets containing
eprosartan mesylate equivalent to 400 mg or 600 mg eprosartan zwitterion
(pink, scored Tiltab, oval or white capsule-shaped tablets, respectively).
Inactive Ingredients
The 400 mg tablet contains the following: croscarmellose sodium, hydroxypropyl
methylcellulose, iron oxide red, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized
starch, titanium dioxide.
The 600 mg tablet contains crospovidone, hydroxypropyl methylcellulose,
lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene
glycol, polysorbate 80, pregelatinized starch, titanium dioxide.
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