DESCRIPTION
id: b8e79616-b217-404d-adf4-669f6700839f
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
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:
C7H8ClN3O4S2 M.W. 297.74
Hydrochlorothiazide 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 12.5 mg, 25 mg and 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium starch glycolate.Tablets of 12.5 mg and 25 mg strengths also contain FD&C yellow #6.
CLINICAL PHARMACOLOGY
id: f2ac0123-8af9-468e-83de-1f9063481b1c
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
id: adeec9fb-165e-4eb5-9a18-de0d6890891f
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
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.
CONTRAINDICATIONS
id: 9d7ea60e-bdfa-4f9f-bf56-024ba1fe32f5
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Anuria.
Hypersensitivity to this product or to other sulfonamide-derived drugs.
WARNINGS
id: 4424a565-36f3-4ceb-80d5-00be0a7daf33
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
id: e6325152-1c62-4cb8-9078-c2c29919613a
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
id: 5149b8e1-8461-4ca1-ac5b-3176348875ba
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
id: f10ff3cc-f0b0-41ba-89c3-471c3b4d5394
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: ed888761-7009-4690-80a4-4a10a7c0a78f
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Hydrochlorothiazide tablets, USP 12.5 mg and 25 mg are available as light orange colored, round, flat face, beveled edge, uncoated tablets. Hydrochlorothiazide tablets, USP 50 mg are available as white to off-white colored round, flat face, beveled edge uncoated tablets.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
id: e209bf4d-ba7b-4b6f-8999-dae88989103c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 23155-137-01
HYDROCHLOROTHIAZIDE TABLETS, USP
12.5 mg
100 Tablets
(Light Orange)
Rx only
Heritage
NDC 23155-047-01
HYDROCHLOROTHIAZIDE TABLETS, USP
25 mg
1000 Tablets
(Light Orange)
Rx only
Heritage
NDC 23155-046-01
HYDROCHLOROTHIAZIDE TABLETS, USP
50 mg
1000 Tablets
(White to Off-white)
Rx only
Heritage
