Chlorthalidone

Indications

INDICATIONS AND USAGE Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Usage in Pregnancy The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Therapy should be initiated with the lowest possible dose. This dose should be titrated according to individual patient response to gain maximal therapeutic benefit while maintaining lowest dosage possible. A single dose given in the morning with food is recommended; divided daily doses are unnecessary. Hypertension Initiation: Therapy, in most patients, should be initiated with a single daily dose of 25 mg. If the response is insufficient after a suitable trial, the dosage may be increased to a single daily dose of 50 mg.

Contraindications

CONTRAINDICATIONS Anuria. Known hypersensitivity to chlorthalidone or other sulfonamide-derived drugs.

Warnings and precautions

WARNINGS Chlorthalidone should be used with caution in severe renal disease. In patients with renal disease, chlorthalidone or related drugs may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function. Chlorthalidone should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Sensitivity reactions may occur in patients with a history of allergy or bronchial asthma.

Storage and supply

HOW SUPPLIED Chlorthalidone Tablets, USP are available containing 25 mg of Chlorthalidone, USP. The 25 mg Tablets are Light yellow colour, round, unscored tablet, debossed with "N" on one side and plain on other side. 25 mg Tablets are supplied as follows: Bottles of 30 tablets ... NDC # 71205-592-30 Bottles of 60 tablets ...

Source: Chlorthalidone (Chlorthalidone) — US FDA prescribing information, 2022-05-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.