CHLORTHALIDONE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Aphena Pharma Solutions - Tennessee, LLC

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

Chlorthalidone tablets, USP 25 mg are available as follows: Yellow, round, tablets, debossed MP 30 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.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

CHLORTHALIDONE- CHLORTHALIDONE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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 dr