Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
EPROSARTAN MESYLATE (UNII: 8N2L1NX8S3) (Eprosartan - UNII:2KH13Z0S0Y), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (hydrochlorothiazide - UNII:0J48LPH2TH)
Physicians Total Care, Inc.
EPROSARTAN MESYLATE
Eprosartan 600 mg
ORAL
PRESCRIPTION DRUG
TEVETEN® HCT is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensives such as calcium channel blockers. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION ). TEVETEN® HCT is contraindicated in patients who are hypersensitive to this product or any of its components. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
TEVETEN® HCT is available as film-coated, capsule-shaped tablets, debossed with “SOLVAY” on one side and “5147” or “5150” on the other, supplied as bottles of 30 tablets as follows:
New Drug Application
TEVETEN HCT - EPROSARTAN MESYLATE AND HYDROCHLOROTHIAZIDE TABLET PHYSICIANS TOTAL CARE, INC. ---------- TEVETEN HCT (EPROSARTAN MESYLATE/HYDROCHLOROTHIAZIDE)600/12.5MG 600/25MG RX ONLY PRESCRIBING INFORMATION 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 HCT Tablets should be discontinued as soon as possible. See WARNINGS: FETAL/NEONATAL MORBIDITY AND MORTALITY. DESCRIPTION TEVETEN HCT 600/12.5 mg and TEVETEN HCT 600/25 mg (eprosartan mesylate- hydrochlorothiazide) combine an angiotensin II receptor (AT subtype) antagonist and a diuretic, hydrochlorothiazide. TEVETEN (eprosartan mesylate) is a non-biphenyl non-tetrazole angiotensin II receptor (AT ) antagonist. A selective non-peptide molecule, TEVETEN is chemically described as the monomethanesulfonate of (_E_)-2-butyl-1-(p-carboxybenzyl)-α-2-thienylmethylimidazole-5-acrylic acid. Its empirical formula is C H N O S•CH O S and molecular weight is 520.625. Its structural formula is: 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. Hydrochlorothiazide is 6-chloro-3,4- dihydro-2 H 1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C H ClN O S and its structural formula is: Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. TEVETEN HCT is available for oral administration in film-coated, non-scored, capsule-shaped tablet combinations of eprosartan mesylate and hydrochlorothiazide. TEVETEN HCT 600/12.5 mg contains ® ® ® ® 1 ® 1 ® 23 24 2 4 4 3 7 8 3 4 2 ® ® 735.8 mg of eprosartan mesylate (equivalent to 600 mg eprosartan) and 12.5 mg hydrochlorothiazide in a butterscotch-colored tablet. TEVETEN HCT Olvassa el a teljes dokumentumot