CHLORTHALIDONE tablet CHLORTHALIDONE- chlorthalidone tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Appco Pharma 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.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

Resumo do produto:

Chlorthalidone Tablets, USP are available containing 25 mg or 50 mg of Chlorthalidone, USP. The 25 mg tablets are white to off-white, round, tablet debossed with “AC 145” on one side and plain on other side. They are available as follows: NDC 55801-145-01 bottles of 100 tablets NDC 55801-145-02 bottles of 1000 tablets The 50 mg tablets are white to off-white, round, scored tablet debossed “AC” and “146” on one side separated by horizontal and plain on other side. They are available as follows: NDC 55801-146-01 bottles of 100 tablets NDC 55801-146-02 bottles of 1000 tablets 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.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

CHLORTHALIDONE- CHLORTHALIDONE TABLET
CHLORTHALIDONE - CHLORTHALIDONE TABLET
APPCO PHARMA LLC
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CHLORTHALIDONE TABLETS, USP- CHLORTHALIDONE TABLET
APPCO PHARMA LLC
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:
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, Magnesium
Stearate, Microcrystalline
Cellulose, Pregelatinized Starch, Sodium Starch Glycolate Type-A,
Talc.
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 produces copious diuresis with greatly increased excretion of
sodium and chloride. At
maximal therapeutic dosage, chlorthalidone is approximately equal in
its diuretic effect to comparable