Teveten HCT (Eprosartan Mesylate / Hydrochlorothiazide) - Indications and Dosage

INDICATIONS AND USAGE

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).

DOSAGE AND ADMINISTRATION

The usual recommended starting dose of eprosartan is 600 mg once daily when used as monotherapy in patients who are not volume-depleted (see WARNINGS, Hypotension in Volume- and/or Salt-Depleted Patients). 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 WARNINGS) 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.

Replacement Therapy

TEVETEN^® HCT may be substituted for the individual components. The usual recommended dose of TEVETEN^® HCT is 600 mg/12.5 mg once daily when used as combination therapy in patients who are not volume-depleted (see WARNINGS, Hypotension in Volume-and/or Salt-Depleted Patients). If the antihypertensive effect measured at trough using TEVETEN^® HCT 600/12.5 mg is inadequate, patients may be titrated to TEVETEN^® HCT 600/25 mg once daily. Higher doses have not been studied in combination. Achievement of maximum blood pressure reduction in most patients may take 2 to 3 weeks. If the patient under treatment with TEVETEN^® HCT requires additional blood pressure control at trough, or to maintain a twice a day dosing schedule of monotherapy, 300 mg TEVETEN^® may be added as evening dose. TEVETEN^® HCT may be used in combination with other antihypertensive agents such as calcium channel blockers if additional blood-pressure-loweringeffect is required. Discontinuation of treatment with eprosartan does not lead to a rapid rebound increase in blood pressure.

HOW SUPPLIED

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 100 tablets as follows:

Eprosartan (mg)	HCTZ (mg)	Color	NDC
600	12.5	Butterscotch	0074-3015-11
600	25	Brick red	0074-3020-11

STORAGE

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured by:

Solvay Pharmaceuticals, SAS

01400 Châtillon-sur-Chalaronne, France

Manufactured for:

Abbott Laboratories

North Chicago, IL 60064 U.S.A.

©2008 Abbott Laboratories

Rev. October, 2008