HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DIRECT RX

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. 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 indicated in pregnancy

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. Bottles of 100 : NDC 29300-128-01 Bottles of 500 : NDC 29300-128-05 Bottles of 1000 : NDC 29300-128-10 Bottles of 5000 : NDC 29300-128-50 Hydrochlorothiazide Tablets USP are available as light orange, circular, flat, beveled, uncoated tablets, with score line having "U" and "129" debossed across the score line on one side and plain on other side containing 50 mg of hydrochlorothiazide USP. Bottles of 100 : NDC 29300-129-01 Bottles of 500 : NDC 29300-129-05 Bottles of 1000 : NDC 29300-129-10 Bottles of 5000 : NDC 29300-129-50 PHARMACIST: Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required) Store at 20° - 25° C (68°-77° F) [See USP Controlled Room Temperature]. Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: Rochelle Park, NJ 07662. 13004203 R-02-11/2011

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE TABLET
DIRECT RX
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HYDROCHLOROTHIAZIDE
DESCRIPTION SECTION
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-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 SECTION
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 & USAGE SECTION
Hydrochlorothiazide tablets are indicated as adjunctive therapy in
edema associated with congestiv