Teveten hct (Eprosartan mesylate,hydrochlorothiazide) 600/12.5 mg and Teveten hct (Eprosartan mesylate,hydrochlorothiazide) 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 ()-2-butyl-1-(p-carboxybenzyl)-α-2-thienylmethylimidazole-5-acrylic acid. Its empirical formula is CHNOS•CHOS 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 CHClNOS 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 (Eprosartan mesylate,hydrochlorothiazide) is available for oral administration in film-coated, non-scored, capsule-shaped tablet combinations of eprosartan mesylate and hydrochlorothiazide. Teveten hct (Eprosartan mesylate,hydrochlorothiazide) 600/12.5 mg contains 735.8 mg of eprosartan mesylate (equivalent to 600 mg eprosartan) and 12.5 mg hydrochlorothiazide in a butterscotch-colored tablet. Teveten hct (Eprosartan mesylate,hydrochlorothiazide) 600/25 mg contains 735.8 mg of eprosartan mesylate (equivalent to 600 mg eprosartan) and 25 mg hydrochlorothiazide in a brick-red tablet. Inactive ingredients of both tablets: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, crospovidone, magnesium stearate, and purified water. Ingredients of the OPADRY 85F27320 butterscotch film coating: polyethylene glycol 3350, talc, polyvinyl alcohol, titanium dioxide, iron oxide black, and iron oxide yellow. Ingredients of the OPADRY II 85F24297 pink film coating: polyethylene glycol 3350, titanium dioxide, talc, polyvinyl alcohol, iron oxide red, and iron oxide yellow.
Teveten hct (Eprosartan mesylate,hydrochlorothiazide) 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 (Eprosartan mesylate,hydrochlorothiazide) 600/12.5 mg has been evaluated for safety in 268 patients in double-blind, controlled clinical trials. Most of these patients were treated with Teveten hct (Eprosartan mesylate,hydrochlorothiazide) 600/12.5 mg for 29 to 60 days. Eprosartan/hydrochlorothiazide combination therapy has been evaluated for safety in 890 patients in open-label, long-term clinical trials. Approximately 50% of these patients were treated with eprosartan/hydrochlorothiazide for over 2 years. Eprosartan/hydrochlorothiazide combination therapy was well tolerated. Most adverse events were of mild or moderate severity and did not require discontinuation of therapy. Adverse experiences were similar in patients regardless of age, gender, or race. In the controlled clinical trials, about 3% of the 268 patients treated with Teveten hct (Eprosartan mesylate,hydrochlorothiazide) 600/12.5 mg discontinued therapy due to clinical adverse experiences.
The following table lists adverse events that occurred at an incidence of >3% among Teveten hct (Eprosartan mesylate,hydrochlorothiazide) 600/12.5 mg- or monotherapy-treated patients who participated in the controlled clinical trials. Of the 268 patients who received Teveten hct (Eprosartan mesylate,hydrochlorothiazide) 600/12.5 mg during the double-blind treatment period in the controlled trials, 110 patients were reported to have adverse events.
The adverse events reported in over 600 patients that received TEVETEN/hydrochlorothiazide combination therapy for at least 1 year in the open-label, long-term clinical trials were comparable to those reported in the controlled trials.
The usual recommended starting dose of eprosartan is 600 mg once daily when used as monotherapy in patients who are not volume-depleted (see ). Eprosartan can be administered once or twice daily and total daily doses ranging from 400 mg to 800 mg. There is limited experience with doses beyond 800 mg/day. If the antihypertensive effect measured at trough using once-daily monotherapy dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response. Achievement of maximum blood pressure reduction in most patients may take 2 to 3 weeks. Hydrochlorothiazide is effective in doses of 12.5 mg to 50 mg once daily. To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy. The side effects (see ) of eprosartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent (e.g., pancreatitis) phenomena, the former much more common than the latter. Therapy with any combination of eprosartan and hydrochlorothiazide will be associated with both sets of dose-independent side effects.
Teveten hct (Eprosartan mesylate,hydrochlorothiazide) 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 100 tablets as follows:
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbott Laboratories
North Chicago, IL 60064 U.S.A.
©2010 Abbott Laboratories
Rev. April, 2011
