DESCRIPTION
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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
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:
C7H8CIN3O4S2 M.W. 297.74
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: corn starch, FD&C yellow #6, dibasic calcium phosphate, lactose monohydrate and magnesium stearate.
CLINICAL PHARMACOLOGY
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displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
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.
INDICATIONS AND USAGE
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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Hydrochlorothiazide USP is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
Hydrochlorothiazide USP has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide USP is 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.
CONTRAINDICATIONS
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displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Anuria.
Hypersensitivity to this product or to other sulfonamide-derived drugs.
WARNINGS
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displayName: WARNINGS SECTION
FDA Article Code: 34071-1
Use with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.
Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Thiazides may add to or potentiate the action of other antihypertensive drugs.
Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma.
The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.
Lithium generally should not be given with diuretics (see PRECAUTIONS, Drug Interactions).
ADVERSE REACTIONS
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displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity.
OVERDOSAGE
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displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.
In the event of overdosage, symptomatic and supportive measures should be employed. Emesis should be induced or gastric lavage performed. Correct dehydration, electrolyte imbalance, hepatic coma and hypotension by established procedures. If required, give oxygen or artificial respiration for respiratory impairment. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established.
The oral LD50 of hydrochlorothiazide is greater than 10 g/kg in the mouse and rat.
DOSAGE AND ADMINISTRATION
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displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.
HOW SUPPLIED
id: 9c986eef-1744-4567-bad5-8ea6a2aab486
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Hydrochlorothiazide Tablets USP, 25 mg are available as round, light orange, bisected tablets, debossed with “” and “2083”, containing 25 mg hydrochlorothiazide USP, packaged in bottles of 100 and 1000 tablets, and unit-dose boxes of 100 tablets.
Hydrochlorothiazide Tablets USP, 50 mg are available as round, light orange, bisected tablets, debossed with “” and “2089”, containing 50 mg of hydrochlorothiazide USP, packaged in bottles of 100, 1000 and 5000 tablets, and unit-dose boxes of 100 tablets.
PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Rev. D 6/2009
Manufactured In Ireland By:
IVAX PHARMACEUTICALS IRELAND
Waterford, Ireland
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Repackaged by:
Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA
Original–03/2010–NJW
Hydrochlorothiazide Tablets USP
PRINCIPAL DISPLAY PANEL
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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
PRINCIPAL DISPLAY PANEL
id: 6eaf8957-0e6f-4c6a-a4d1-70e726c582f4
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
