CHLORTHALIDONE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

American Health Packaging

Designación común internacional (DCI):

CHLORTHALIDONE

Composición:

CHLORTHALIDONE 25 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 pregnan

Resumen del producto:

Chlorthalidone tablets, USP 25 mg are available as follows: Yellow, round, tablets, debossed MP 30 Unit dose packages of 30 (5 x 6) NDC 60687-317-25 Unit dose packages of 100 (10 x 10) NDC 60687-317-01 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] Protect from light. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

CHLORTHALIDONE- CHLORTHALIDONE TABLET
AMERICAN HEALTH PACKAGING
----------
CHLORTHALIDONE TABLETS USP
8431725/0220
RX ONLY
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: C
H
ClN
O
S            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-br