EPROSARTAN MESYLATE- eprosartan mesylate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

EPROSARTAN MESYLATE (UNII: 8N2L1NX8S3) (EPROSARTAN - UNII:2KH13Z0S0Y)

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

EPROSARTAN MESYLATE

Composition:

EPROSARTAN 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Eprosartan mesylate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensives such as diuretics and calcium channel blockers. Eprosartan mesylate tablets are contraindicated in patients who are hypersensitive to this product or any of its components. Do not co-administer aliskiren with eprosartan in patients with diabetes (see PRECAUTIONS: Drug Interactions).

Product summary:

Eprosartan Mesylate Tablets are available containing eprosartan mesylate equivalent to 600 mg of eprosartan. The 600 mg tablets are white to off-white film-coated, capsule shaped, unscored tablets imprinted with M EN3 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6629-93 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured in India by: Mylan Laboratories Limited Hyderabad — 500 034, India Code No.: MH/DRUGS/25/NKD/89 75055504 REVISED NOVEMBER 2014 MX:EPRS:R4

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

EPROSARTAN MESYLATE- EPROSARTAN MESYLATE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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PRESCRIBING INFORMATION
WARNING: FETAL TOXICITY
_See full prescribing information for complete boxed warning._
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•
DESCRIPTION
Eprosartan mesylate is a non-biphenyl non-tetrazole angiotensin II
receptor (AT ) antagonist. A
selective non-peptide molecule, eprosartan mesylate is chemically
described as (E)-[2-Butyl]-1-[(4-
carboxyphenyl)-methyl]imidazol-5yl]-2-(2-thienylmethyl)-2-propenoic
acid monomethane sulfonate.
Its molecular formula is C
H N O S and molecular weight is 520.62. Its structural formula is:
Eprosartan mesylate is a white to off-white crystalline powder that is
insoluble in water, freely soluble
in ethanol, and melts between 248°C and 250°C.
Eprosartan mesylate tablets are available as film-coated tablets
containing eprosartan mesylate
equivalent to 600 mg eprosartan zwitterion (white to off-white capsule
shaped, unscored tablets).
INACTIVE INGREDIENTS
The 600 mg tablets contain the following: ammonium hydroxide, black
iron oxide, colloidal silicon
dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose
monohydrate, magnesium
stearate, microcrystalline cellulose, polyethylene glycol, polysorbate
80, povidone, pregelatinized
starch (corn), propylene glycol, shellac glaze and titanium dioxide.
WHEN PREGNANCY IS DETECTED, DISCONTINUE EPROSARTAN MESYLATE TABLETS AS
SOON AS
POS S IBLE.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO
THE DEVELOPING FETUS. SEE WARNINGS: FETAL TOXICITY.
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7
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CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Angiotensin II (formed from angiotensin I in a reaction catalyzed by
angiotensin-converting enzyme
[kininase II]), a potent vasoconstrictor, is the principal pressor
agent of the renin-angiotensin system.
Angiotensin II also stimulates aldosterone synthesis and secretion by
the adrenal cortex, cardiac
contraction, renal resorption of sodium, activity of the sympathetic
nervous system, and smooth muscle
cell growth