CHLORTHALIDONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ingenus Pharmaceuticals NJ, LLC

INN (International Name):

CHLORTHALIDONE

Composition:

CHLORTHALIDONE 25 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORTHALIDONE- CHLORTHALIDONE TABLET
INGENUS PHARMACEUTICALS NJ, LLC
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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 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: 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 equa