Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
EPROSARTAN MESYLATE (UNII: 8N2L1NX8S3) (EPROSARTAN - UNII:2KH13Z0S0Y)
Mylan Pharmaceuticals Inc.
EPROSARTAN MESYLATE
EPROSARTAN 600 mg
ORAL
PRESCRIPTION DRUG
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).
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
Abbreviated New Drug Application
EPROSARTAN MESYLATE- EPROSARTAN MESYLATE TABLET, FILM COATED MYLAN PHARMACEUTICALS INC. ---------- PRESCRIBING INFORMATION WARNING: FETAL TOXICITY _See full prescribing information for complete boxed warning._ • • 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. 1 24 28 2 7 2 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 Pročitajte cijeli dokument