Country: United States
Language: English
Source: NLM (National Library of Medicine)
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Excellium Pharmaceutical Inc.
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE 25 mg
ORAL
PRESCRIPTION DRUG
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
Hydrochlorothiazide Tablets USP are available as round, peach, bisected tablets, debossed EP 131, containing 25 mg of hydrochlorothiazide USP, packaged in bottles of 100, 1000 and 5000 tablets. Hydrochlorothiazide Tablets USP are available as round, peach, bisected tablets, debossed EP 130, containing 50 mg of hydrochlorothiazide USP, packaged in bottles of 100 and 1000 tablets. Dispense in a well-closed container as defined in the USP. Use child-resistant closure. Store at controlled room temperature 20-25°C (68-77°F). [See USP Controlled Room Temperature]
Abbreviated New Drug Application
HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE TABLET EXCELLIUM PHARMACEUTICAL INC. ---------- 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-2H-1,2,4-benzothiadiazine- 7- sulfonamide 1,1-dioxide and has the following structural formula: Hydrochlorothiazide 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, 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 reabsorbtion. 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 halflife 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 Hydrochlo Read the complete document