"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
TENORETIC (atenolol and chlorthalidone) 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'sneeds, it may be more convenient than the separatecomponents.
DOSAGE AND ADMINISTRATION
DOSAGE MUST BE INDIVIDUALIZED. (See INDICATIONS.)
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 (atenolol and chlorthalidone) 50 tablet given once a day. If an optimal response is not achieved, the dosage should be increased to one TENORETIC (atenolol and chlorthalidone) 100 tablet given once a day.
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. Creatinine Clearance Atenolol Elimination (mL/min/1.73m2) Half-life (hrs) Maximum Dosage15-35 16-27 50 mg daily < 15 > 27 50 mg every other day
TENORETIC (atenolol and chlorthalidone) 50 Tablets (atenolol 50 mg and chlorthalidone 25 mg), NDC 0310-0115, (white, round, biconvex, uncoated tablets with TENORETIC (atenolol and chlorthalidone) on one side and 115 on the other side, bisected) are supplied in bottles of 100 tablets.
TENORETIC (atenolol and chlorthalidone) 100 Tablets (atenolol 100 mg and chlorthalidone 25 mg), NDC 0310-0117, (white, round, biconvex, uncoated tablets with TENORETIC (atenolol and chlorthalidone) on one side and 117 on the other side) are supplied in bottles of 100 tablets.
Store at controlled room temperature, 20-25°C (68-77°F) [see USP]. Dispense in well-closed, light-resistant containers.
Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. By: IPR Pharmaceuticals, Inc. Carolina, PR 00984. Rev 02/05. FDA Rev date: 10/29/2008This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/8/2009
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