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Clorpres (Clonidine Hydrochloride / Chlorthalidone) - Indications and Dosage

 



INDICATIONS AND USAGE

CLORPRES® (clonidine hydrochloride USP/chlorthalidone USP) is indicated in the treatment of hypertension. This fixed combination drug is not indicated for initial therapy of hypertension. Hypertension requires therapy titrated to the individual patient. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management. The treatment of hypertension is not static, but must be reevaluated as conditions in each patient warrant.

DOSAGE AND ADMINISTRATION

The dosage must be determined by individual titration. (See INDICATIONS AND USAGE.)

Chlorthalidone is usually initiated at a dose of 25 mg once daily and may be increased to 50 mg if the response is insufficient after a suitable trial.

Clonidine hydrochloride is usually initiated at a dose of 0.1 mg twice daily. Elderly patients may benefit from a lower initial dose. Further increments of 0.1 mg/day may be made if necessary until the desired response is achieved. The therapeutic doses most commonly employed have ranged from 0.2 to 0.6 mg per day in divided doses.

One CLORPRES® (clonidine hydrochloride/chlorthalidone) Tablet administered once or twice daily can be used to administer a minimum of 0.1 mg clonidine hydrochloride and 15 mg chlorthalidone to a maximum of 0.6 mg clonidine hydrochloride and 30 mg chlorthalidone.

HOW SUPPLIED

CLORPRES® (clonidine hydrochloride and chlorthalidone) Tablets, USP are available containing:

0.1 mg clonidine hydrochloride, USP and 15 mg chlorthalidone, USP
or
0.2 mg clonidine hydrochloride, USP and 15 mg chlorthalidone, USP
or
0.3 mg clonidine hydrochloride, USP and 15 mg chlorthalidone, USP

The 0.1 mg/15 mg product is a yellow, round, scored tablet debossed with M1. They are available as follows:

NDC 62794-001-01
bottles of 100 tablets

The 0.2 mg/15 mg product is a yellow, round, scored tablet debossed with M27. They are available as follows:

NDC 62794-027-01
bottles of 100 tablets

The 0.3 mg/15 mg product is a yellow, round, scored tablet debossed with M72. They are available as follows:

NDC 62794-072-01
bottles of 100 tablets

Dispense in tight, light-resistant container as defined in the USP using a child-resistant closure.

Keep this and all medication out of the reach of children.

Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]

Avoid excessive humidity.

BERTEK
PHARMACEUTICALS INC.
Morgantown,WV 26505

REVISED FEBRUARY 2008
BKCLCH:R4

Page last updated: 2009-05-28

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