HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aurobindo Pharma Limited

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. 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 indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy ). Dependent edema in pregnan­cy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unneces­sary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, in­creased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate. Anuria. Hypersensitivity to this product or to other sulfonamide-derived drugs.

Product summary:

Hydrochlorothiazide Tablets USP, 25 mg are light pink colored, round shaped, flat faced beveled edge uncoated tablets, debossed with ‘D’ and ‘27’ on one side separated by scoring and plain on the other side.             Bottles of 100                  NDC 65862-133-01             Bottles of 1,000                NDC 65862-133-99 Hydrochlorothiazide Tablets USP, 50 mg are light pink colored, round shaped, flat faced beveled edge uncoated tablets, debossed with ‘D’ and ‘28’ on one side separated by scoring and plain on the other side.             Bottles of 100                 NDC 65862-134-01             Bottles of 1,000               NDC 65862-134-99 PHARMACIST:  Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 10/2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE TABLET
AUROBINDO PHARMA LIMITED
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HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
DESCRIPTION
Hydrochlorothiazide is a diuretic and antihypertensive. It is the
3,4-dihydro derivative of
chlorothiazide. It is chemically designated as
6-chloro-3,4-dihydro-2_H_-1,2,4-
benzothiadiazine-7-sulfonamide 1,1-dioxide and it 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. Each tablet for
oral administration contains 25 mg or 50 mg hydrochlorothiazide USP.
In addition, each
tablet contains the following inactive ingredients: dibasic calcium
phosphate, lactose
monohydrate, pregelatinized starch, FD&C yellow No.6 lake, corn
starch, colloidal silicon
dioxide, 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
to 12 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 percent 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.
INDICATIONS AND USAGE
Hydrochlorothiazide tablets, USP are indicated as adjunctive therapy
in edema
associated with conge