CHLORTHALIDONE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

NuCare Pharmaceuticals,Inc.

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. 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 pregnancy when edema is due to

Resumo do produto:

Chlorthalidone Tablets, USP are available containing 25 mg or 50 mg of Chlorthalidone, USP. The 25 mg Tablets are Light yellow colour, round, unscored tablet, debossed with N on one side and plain on other side. NDC 68071-4636-3 BOTTLES OF 30 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 and continuous threads closure for 100’s and 1000’s count respectively. Biochemical studies in animals have suggested reasons for the prolonged effect of chlorthalidone. Absorption from the gastrointestinal tract is slow due to its low solubility. After passage to the liver, some of the drug enters the general circulation, while some is excreted in the bile, to be reabsorbed later. In the general circulation, it is distributed widely to the tissues, but is taken up in highest concentrations by the kidneys, where amounts have been found 72 hours after ingestion, long after it has disappeared from other tissues. The drug is excreted unchanged in the urine. Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA Toll free number: 1-877-977-0687 Manufactured by: Umedica Laboratories Pvt. Ltd. Plot No.221, PB No.73, GIDC, II nd Phase, Vapi, Gujarat 396195, India (IND) Revised May 2018, V-00

Status de autorização:

Abbreviated New Drug Application

Características técnicas

CHLORTHALIDONE- CHLORTHALIDONE TABLET
NUCARE PHARMACEUTICALS,INC.
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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: microcrystalline
cellulose, partially
pregelatinized maize starch, sodium starch glycolate, colloidal
silicon dioxide, magnesium
stearate, ingredients of pigment blend yellow like iron oxide yellow,
lactose monohydrate,
Ferrosoferric Oxide for 25 mg and ingredients of lake blend green like
D & C Yellow #10
aluminum lake, FD & C blue #1/ Brilliant Blue FCF Aluminum Lake for 50
mg.
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 greatl