CHLORTHALIDONE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Rising Pharmaceuticals, Inc.

INN (Международно Name):

CHLORTHALIDONE

Композиция:

CHLORTHALIDONE 25 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 pregna

Каталог на резюме:

Chlorthalidone Tablets, USP are available containing 25 mg or 50 mg of Chlorthalidone, USP. The 25 mg tablets are green colored, biconvex, round shaped tablets debossed with ‘010’ on one side, and plain on the other side. They are available as follows: NDC 64980-303-01 Bottles of 100 tablets NDC 64980-303-10 Bottles of 1000 tablets The 50 mg tablets are green colored, capsule shaped tablets debossed with ‘011’ on one side, and a break-line on the other side. They are available as follows: NDC 64980-304-01 Bottles of 100 tablets Store at 20ºC to 25º C (68º to 77º 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.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

CHLORTHALIDONE - CHLORTHALIDONE TABLET
RISING PHARMACEUTICALS, INC.
----------
CHLORTHALIDONE TABLETS USP, 25 MG AND 50 MG
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 CIN 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: Calcium Stearate,
Colloidal Silicon Dioxide,
D&C Yellow #10, FD&C Blue #1, Microcrystalline Cellulose,
Pregelatinized Starch (Maize),
and Sodium Starch Glycolate.
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 i