HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

HYDROCHLOROTHIAZIDE

Composition:

HYDROCHLOROTHIAZIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets 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 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 du

Product summary:

Hydrochlorothiazide Tablets, USP are available as light orange, circular, flat, beveled, uncoated tablets, with score line having "U" and "128" debossed across the score line on one side and plain on other side containing 25 mg of hydrochlorothiazide, USP. Bottle of 15 - 68788-9965-1 Bottle of 30 - 68788-9965-3 Bottle of 60 - 68788-9965-6 Bottle of 90 - 68788-9965-9 Bottle of 100 - 68788-9965-0 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) [see USP Controlled Room Temperature]. Please address medical inquiries to Unichem's toll free # 1-866-562-4616. Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: East Brunswick, NJ 08816 07-R-04/2020 13012736 Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE TABLET
PREFERRED PHARMACEUTICALS, INC.
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HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
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, 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 or 50 mg
hydrochlorothiazide, USP. In addition, each tablet contains the
following inactive
ingredients: corn starch, FD&C Yellow #6, dibasic calcium phosphate,
pregelatinized
starch, colloidal silicon dioxide, lactose monohydrate 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