CHLORTHALIDONE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Preferred Pharmaceuticals Inc.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 pregnancy w

Podsumowanie produktu:

Chlorthalidone Tablets, USP are available containing 25 mg or 50 mg of chlorthalidone, USP. The 25 mg tablets are  white to off-white, round flat beveled edge, uncoated tablets debossed  with 'C' on one side and '25' on other side. They are available as follows: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

CHLORTHALIDONE- CHLORTHALIDONE TABLET
PREFERRED PHARMACEUTICALS INC.
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CHLORTHALIDONE TABLETS, USP
25 MG AND 50 MG
RX ONLY
DESCRIPTION
Chlorthalidone 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: 338.77
Chlorthalidone, USP is practically insoluble in water, in ether, and
in chloroform; soluble in
methanol; slightly soluble in ethanol.
Chlorthalidone tablets, USP are available containing either 25 mg or
50 mg of
chlorthalidone, USP and the following inactive ingredients: colloidal
silicon dioxide,
microcrystalline cellulose, pregelatinized starch (corn), sodium
starch glycolate Type A
(potato), magnesium stearate.
CLINICAL PHARMACOLOGY
Chlorthalidone is an oral diuretic with prolonged action (48 hours to
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 mg 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
14
11
2
4
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
approxim