CHLORTHALIDONE- chlorthalidone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLORTHALIDONE (UNII: Q0MQD1073Q) (CHLORTHALIDONE - UNII:Q0MQD1073Q)

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

CHLORTHALIDONE

Composition:

CHLORTHALIDONE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Chlorthalidone is indicated in pre

Product summary:

Chlorthalidone tablets, USP 25 mg are available as follows: Yellow, round, tablets, debossed MP 30 Bottles of 20 NDC 68788-6852-2 Bottles of 30 NDC 68788-6852-3 Bottles of 60 NDC 68788-6852-6 Bottles of 90 NDC 68788-6852-9 Bottles of 100 NDC 68788-6852-1 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORTHALIDONE- CHLORTHALIDONE TABLET
PREFERRED PHARMACEUTICALS INC.
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CHLORTHALIDONE TABLETS USP 25MG AND 50MG
DESCRIPTION
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:
Molecular Formula: C14H11ClN2O4S Molecular Weight: 338.76
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, croscarmellose
sodium, povidone, lactose, magnesium stearate, microcrystalline
cellulose, and sodium lauryl sulfate. In
addition, the 25 mg yellow tablets contain FD&C Yellow #6 Lake and D&C
Yellow #10 Lake. The 50
mg green tablets contain FD&C Blue #1 Lake and D&C Yellow #10 Lake.
CLINICAL PHARMACOLOGY
Chlorthalidone is an oral diuretic with prolonged action (48–72
hours) and low toxicity. The major
portion of the drug is excreted unchanged by the kidneys. The diuretic
effect of the drug occurs in
approximately 2.6 hours and continues for up to 72 hours. The mean
half-life following a 50 to 200 mg
dose is 40 hours. In the first order of absorption, the elimination
half-life is 53 hours following a 50
mg dose, and 60 hours following a 100 mg dose. Approximately 75
percent of the drug is bound to
plasma proteins, 58 percent of the drug being bound to albumin. This
is caused by an increased affinity
of the drug to erythrocyte carbonic anhydrase. Nonrenal routes of
elimination have yet to be clarified.
Data are not available regarding percentage of dose as unchanged drug
and metabolites, concentration
of the drug in body fluids, degree of uptake by a particular organ or
in the fetus, or passage across the
blood-brain barrier.
The drug produc