CHLORTHALIDONE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

REMEDYREPACK 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. 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

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, unscored tablets, debossed with 'L1' on one side of the tablet and plain on the other side, free of physical defects. They are available as follows: NDC: 70518-3718-00 PACKAGING: 30 in 1 BLISTER PACK Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP. Keep this and all medication out of the reach of children. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

CHLORTHALIDONE- CHLORTHALIDONE TABLET
REMEDYREPACK INC.
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CHLORTHALIDONE TABLETS, USP
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: 338.76
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,
microcrystalline
cellulose, pregelatinized starch (maize), sodium starch glycolate Type
A, stearic acid.
FDA approved dissolution test specifications differ from USP.
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
14
11
2
4
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
appro