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CLORPRES (CLONIDINE HYDROCHLORIDE, CHLORTHALIDONE) TABLETS: PRESCRIBING INFORMATION

DESCRIPTION

Clorpres is a combination of clonidine hydrochloride (a centrally acting antihypertensive agent) and chlorthalidone (a diuretic). Clorpres is available as tablets for oral administration in three dosage strengths: 0.1 mg/15 mg, 0.2 mg/15 mg and 0.3 mg/15 mg of clonidine hydrochloride / chlorthalidone, respectively.

The inactive ingredients are colloidal silicon dioxide, ammonium chloride, croscarmellose sodium (Type A), microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate, D&C yellow #10.

Clonidine Hydrochloride

Clonidine Hydrochloride, USP is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-[(2,6-dichlorophenyl)imino]imidazoline monohydrochloride. The molecular formula is C9H9Cl2N3xHCl, and molecular weight 266.56.

Clonidine hydrochloride is an odorless, bitter, white crystalline substance soluble in water and alcohol.

Chlorthalidone

Chlorthalidone, USP is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double ring system is incorporated in its structure. It is 2-chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl) benzenesulfonamide with the molecular formula is C14H11ClN2O4S, and molecular weight 338.76.

Chlorthalidone is practically insoluble in water, in ether and in chloroform; soluble in methanol; slightly soluble in alcohol.


CLINICAL PHARMACOLOGY

Clorpres clinical pharmacology


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 hypertens ion. Hypertens ion requires therapy titrated to the individual patient. If the fixed combination repres ents the dos age s o determined, its us e may be more convenient in patient management. The treatment of hypertens ion is not s tatic, but mus t be reevaluated as conditions in each patient warrant.


CONTRAINDICATIONS

Anuria

Clorpres is contraindicated in patients with known hypersensitivity to chlorthalidone or other sulfonamide-derived drugs.


WARNINGS

Clorpres warnings


GENERAL PRECAUTIONS

Clorpres general precautions


PRECAUTIONS FOR CLONIDINE

Clorpres precautions for clonidine


PRECAUTIONS FOR CHLORTHALIDONE

Clorpres precautions for chlorthalidone


USE IN SPECIFIC POPULATIONS

Clorpres use in specific populations


ADVERSE REACTIONS

Clorpres is generally well tolerated. Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100.

In addition to the reactions listed above, certain less frequent adverse experiences, which are shown below, have also been reported in patients receiving the component drugs of Clorpres but in many cases patients were receiving concomitant medication and a causal relationship has not been established:


ADVERSE REACTIONS OF CLONIDINE HYDROCHLORIDE

Clorpres adverse reactions of clonidine


ADVERSE REACTIONS OF CHLORTHALIDONE

Clorpres adverse reactions of chlorthalidone


OVERDOSAGE

Clorpres overdosage


DOSAGE AND ADMINISTRATION

Clorpres dosage and administration


HOW SUPPLIED

Clorpres how supplied

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