HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

HYDROCHLOROTHIAZIDE

Composition:

HYDROCHLOROTHIAZIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrochlorothiazide tablets USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets USP have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets USP are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. Use in pregnancy: Routine use of diuretics during normal pregnancy 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 toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indica

Product summary:

Hydrochlorothiazide Tablets USP 25 mg are available as peach color, round, flat face, beveled edge, bisected tablets, debossed "EP" above bisect and "131" below bisect on one side and plain on the other side containing 25 mg of hydrochlorothioazide USP, packaged in bottles of 100 NDC 68071-1736-1 Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 Rev.01 05/16

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE TABLET
NUCARE PHARMACEUTICALS, INC.
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HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
005025-05-16
DESCRIPTION
Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the
3,4-dihydro derivative of
chlorothiazide. It is chemically designated as
6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine -7-
sulfonamide 1,1-dioxide and has the following structural formula:
Hydrochlorothiazide USP is a white, or practically white, crystalline
powder which is slightly soluble
in water, but freely soluble in sodium hydroxide solution, in
n-butylamine, and in dimethylformamide;
sparingly soluble in methanol, insoluble in ether, in chloroform, and
in dilute mineral acids. Each tablet
for oral administration contains 25 mg and 50 mg hydrochlorothiazide.
In addition, each tablet contains
the following inactive ingredients: FD&C yellow #6, Microcrystalline
cellulose, lactose anhydrous,
Sodium starch glycolate, Stearic acid and Magnesium stearate.
CLINICAL PHARMACOLOGY
The mechanism of the antihypertensive effect of thiazides is unknown.
Hydrochlorothiazide does not
usually affect normal blood pressure. Hydrochlorothiazide affects the
distal renal tubular mechanism of
electrolyte reabsorption. At maximal therapeutic dosage all thiazides
are approximately equal in their
diuretic efficacy.
Hydrochlorothiazide increases excretion of sodium and chloride in
approximately equivalent amounts.
Natriuresis may be accompanied by some loss of potassium and
bicarbonate.
After oral use diuresis begins within 2 hours, peaks in about 4 hours
and lasts about 6 to12 hours.
PHARMACOKINETICS AND METABOLISM:
Hydrochlorothiazide is not metabolized but is eliminated rapidly by
the kidney. When plasma levels
have been followed for at least 24 hours, the plasma half-life has
been observed to vary between 5.6
and 14.8 hours. At least 61 % of the oral dose is eliminated unchanged
within 24 hours.
Hydrochlorothiazide crosses the placental but not the blood-brain
barrier and is excreted in breast milk.
INDICATIO