Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Chlorthalidone Tablets, USP are available containing 25 mg or 50 mg of Chlorthalidone, USP. The 25 mg tablets are white to off white, round shaped, flat faced, uncoated tablet with ‘ ET30 ’ debossed on one side and plain on other side. They are available as follows: NDC 62135-505-30 Bottles of 30 NDC 62135-505-90 Bottles of 90 The 50 mg tablets are white to off white, round shaped, flat faced, uncoated tablet with break line and ‘ ET31 ’ debossed on one side and plain on other side. They are available as follows: NDC 62135-506-30 Bottles of 30 NDC 62135-506-90 Bottles of 90 Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Chlorthalidone Tablets, USP-NDC 62135-505-30 -25mg -30 Tablets Bottle-Label. Chlorthalidone Tablets, USP-NDC 62135-505-90 -25mg-90 Tablets Bottle-Label. Chlorthalidone Tablets, USP-NDC 62135-506-30- 50mg -30 Tablets Bottle-Label. Chlorthalidone Tablets, USP-NDC 62135-506-90- 50mg -90 Tablets Bottle-Label. Chlorthalidone Tablets, USP-NDC 62135-505-30-25mg-30 Tablets Bottle-Label. Chlorthalidone Tablets, USP-NDC 62135-505-90-25mg-90 Tablets Bottle-Label. Chlorthalidone Tablets, USP-NDC 62135-506-30-50mg-30 Tablets Bottle-Label. Chlorthalidone Tablets, USP-NDC 62135-506-90-50mg-90 Tablets Bottle-Label.
- HOW SUPPLIED Chlorthalidone Tablets, USP are available containing 25 mg or 50 mg of Chlorthalidone, USP. The 25 mg tablets are white to off white, round shaped, flat faced, uncoated tablet with ‘ ET30 ’ debossed on one side and plain on other side. They are available as follows: NDC 62135-505-30 Bottles of 30 NDC 62135-505-90 Bottles of 90 The 50 mg tablets are white to off white, round shaped, flat faced, uncoated tablet with break line and ‘ ET31 ’ debossed on one side and plain on other side. They are available as follows: NDC 62135-506-30 Bottles of 30 NDC 62135-506-90 Bottles of 90 Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Chlorthalidone Tablets, USP-NDC 62135-505-30 -25mg -30 Tablets Bottle-Label. Chlorthalidone Tablets, USP-NDC 62135-505-90 -25mg-90 Tablets Bottle-Label. Chlorthalidone Tablets, USP-NDC 62135-506-30- 50mg -30 Tablets Bottle-Label. Chlorthalidone Tablets, USP-NDC 62135-506-90- 50mg -90 Tablets Bottle-Label. Chlorthalidone Tablets, USP-NDC 62135-505-30-25mg-30 Tablets Bottle-Label. Chlorthalidone Tablets, USP-NDC 62135-505-90-25mg-90 Tablets Bottle-Label. Chlorthalidone Tablets, USP-NDC 62135-506-30-50mg-30 Tablets Bottle-Label. Chlorthalidone Tablets, USP-NDC 62135-506-90-50mg-90 Tablets Bottle-Label.
Overview
Chlorthalidone is an oral antihypertensive/diuretic. It 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 following structural formula: Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch (corn), sodium starch glycolate, stearic acid. chemical structure
Indications & 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.
Dosage & Administration
Therapy should be initiated with the lowest possible dose, then titrated according to individual patient response. A single dose given in the morning with food is recommended; divided daily doses are unnecessary.
Warnings & 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. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported with thiazide diuretics, which are structurally related to chlorthalidone. However, systemic lupus erythematosus has not been reported following chlorthalidone administration.
Contraindications
Anuria. Known hypersensitivity to chlorthalidone or other sulfonamide-derived drugs.
Adverse Reactions
The following adverse reactions have been observed, but there is not enough systematic collection of data to support an estimate of their frequency. Gastrointestinal System Reactions: anorexia, gastric irritation, nausea, vomiting, cramping, diarrhea, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis. Central Nervous System Reactions: dizziness, vertigo, paresthesias, headache, xanthopsia. Hematologic Reactions: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia. Dermatologic-Hypersensitivity Reactions: purpura, photosensitivity, rash, urticaria, necrotizing angiitis (vasculitis, cutaneous vasculitis), Lyell’s syndrome (toxic epidermal necrolysis). Cardiovascular Reactions: orthostatic hypotension may occur and may be aggravated by alcohol, barbiturates, or narcotics. Other Adverse Reactions: hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness, impotence. Whenever adverse reactions are moderate or severe, chlorthalidone dosage should be reduced or therapy withdrawn.
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