TENORETIC is indicated in the treatment of hypertension. This fixed dose combination drug is not indicated for initial therapy of hypertension. If the fixed dose combination represents the dose appropriate to the individual patient's needs, it may be more convenient than the separate components.

DOSAGE MUST BE INDIVIDUALIZED. (See INDICATIONS AND USAGE.)

Chlorthalidone is usually given at a dose of 25 mg daily; the usual initial dose of atenolol is 50 mg daily. Therefore, the initial dose should be one TENORETIC 50 tablet given once a day. If an optimal response is not achieved, the dosage should be increased to one TENORETIC 100 tablet given once a day.

When necessary, another antihypertensive agent may be added gradually beginning with 50 percent of the usual recommended starting dose to avoid an excessive fall in blood pressure.

Since atenolol is excreted via the kidneys, dosage should be adjusted in cases of severe impairment of renal function. No significant accumulation of atenolol occurs until creatinine clearance falls below 35 mL/min/1.73m² (normal range is 100-150 mL/min/1.73m²); therefore, the following maximum dosages are recommended for patients with renal impairment.

TENORETIC 50 Tablets (atenolol 50 mg and chlorthalidone 25 mg), NDC 0310-0115, (white, round, biconvex, uncoated tablets with TENORETIC on one side and 115 on the other side, bisected) are supplied in bottles of 100 tablets.

TENORETIC 100 Tablets (atenolol 100 mg and chlorthalidone 25 mg), NDC 0310-0117, (white, round, biconvex, uncoated tablets with TENORETIC on one side and 117 on the other side) are supplied in bottles of 100 tablets.

Storage:

Store at controlled room temperature, 20-25°C (68-77°F) [see USP]. Dispense in well-closed, light-resistant containers.

TENORETIC is a trademark of the AstraZeneca group of companies. Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. By: IPR Pharmaceuticals, Inc. Carolina, PR 00984. Rev 02/05. FDA rev date: 2/9/2005

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