HYDROCHLOROTHIAZIDE - hydrochlorothiazide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Citron Pharma LLC

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

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 57237-198-01             Bottles of 1,000               NDC 57237-198-99 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 57237-199-01             Bottles of 1,000              NDC 57237-199-99 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: Citron Pharma LLC Suite -1101 2 Tower Center Blvd East Brunswick NJ 08816  Code No.: DRUGS/AP/19/1993 Made in India  Issued: 02/2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE TABLET
CITRON PHARMA LLC
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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
congestive h