WARNING
id: 50f70e1f-4dab-4c62-adeb-c57622ef4c2c
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1
Spironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, has been shown to be a tumorigen in chronic toxicity studies in rats (see
Precautions
). Spironolactone and hydrochlorothiazide tablets should be used only in those conditions described under
Indications and Usage. Unnecessary use of this drug should be avoided.
Fixed-dose combination drugs are not indicated for initial therapy of edema or hypertension. Edema or hypertension requires therapy titrated to the individual patient. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management. The treatment of hypertension and edema is not static but must be reevaluated as conditions in each patient warrant.
DESCRIPTION
id: ea6c4af7-2a2b-40d1-a6e4-13b8866d45e8
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Spironolactone and hydrochlorothiazide oral tablets contain:
spironolactone . . . . . . . . . . . . . . . . . . . . 25 mg
hydrochlorothiazide . . . . . . . . . . . . . . . . 25 mg
Spironolactone, an aldosterone antagonist, is 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate and has the following structural formula:
Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform.
Hydrochlorothiazide, a diuretic and antihypertensive, is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula:
Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution.
Inactive ingredients include calcium sulfate, corn starch, flavor, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.
INDICATIONS AND USAGE
id: 05e1225b-a948-47ba-8d9c-11ce907b3d56
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Spironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, has been shown to be a tumorigen in chronic toxicity studies in rats (see
Precautions
section). Spironolactone and hydrochlorothiazide tablets should be used only in those conditions described below. Unnecessary use of this drug should be avoided.
CONTRAINDICATIONS
id: 06e43a9a-8323-4a47-a567-e7e9d3012e3e
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Spironolactone and hydrochlorothiazide tablets are contraindicated in patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, hypercalcemia, hyperkalemia, Addison’s disease, and in patients who are allergic to thiazide diuretics or to other sulfonamide-derived drugs. Spironolactone and hydrochlorothiazide tablets may also be contraindicated in acute or severe hepatic failure.
WARNINGS
id: ccc30b49-9ffb-4ce5-9667-699a7898e669
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
Potassium supplementation, either in the form of medication or as a diet rich in potassium, should not ordinarily be given in association with spironolactone and hydrochlorothiazide tablets therapy. Excessive potassium intake may cause hyperkalemia in patients receiving spironolactone and hydrochlorothiazide tablets (see
Precautions: General
).
Concomitant administration of spironolactone and hydrochlorothiazide tablets with the following drugs or potassium sources may lead to severe hyperkalemia:
- other potassium-sparing diuretics
- ACE inhibitors
- angiotensin II receptor antagonists
- aldosterone blockers
- non-steroidal anti-inflammatory drugs (NSAIDs), e.g., indomethacin
- heparin and low molecular weight heparin
- other drugs or conditions known to cause hyperkalemia
- potassium supplements
- diet rich in potassium
- salt substitutes containing potassium
Spironolactone and hydrochlorothiazide tablets should not be administered concurrently with other potassium-sparing diuretics. Spironolactone, when used with ACE inhibitors or indomethacin, even in the presence of a diuretic, has been associated with severe hyperkalemia. Extreme caution should be exercised when spironolactone and hydrochlorothiazide tablets are given concomitantly with these drugs (see
Precautions: Drug interactions
).
Spironolactone and hydrochlorothiazide tablets should be used with caution in patients with impaired hepatic function because minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Lithium generally should not be given with diuretics (see
Precautions: Drug interactions
).
Thiazides should be used 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 may add to or potentiate the action of other antihypertensive drugs.
Sensitivity reactions to thiazides may occur in patients with or without a history of allergy or bronchial asthma.
Sulfonamide derivatives, including thiazides, have been reported to exacerbate or activate systemic lupus erythematosus.
ADVERSE REACTIONS
id: 6b8c41f4-f6bd-4eec-9ff0-3f2173de8d77
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity.
OVERDOSAGE
id: be3e039e-7bde-427a-bc6d-758326eb8678
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
The oral LD50 of spironolactone is greater than 1000 mg/kg in mice, rats, and rabbits. The oral LD50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.
Acute overdosage of spironolactone may be manifested by drowsiness, mental confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness, or diarrhea. Rarely, instances of hyponatremia, hyperkalemia (less commonly seen with spironolactone and hydrochlorothiazide tablets because the hydrochlorothiazide component tends to produce hypokalemia), or hepatic coma may occur in patients with severe liver disease, but these are unlikely due to acute overdosage.
However, because spironolactone and hydrochlorothiazide tablets contain both spironolactone and hydrochlorothiazide, the toxic effects may be intensified, and signs of thiazide overdosage may be present. These include electrolyte imbalance such as hypokalemia and/or hyponatremia. The potassium-sparing action of spironolactone may predominate and hyperkalemia may occur, especially in patients with impaired renal function. BUN determinations have been reported to rise transiently with hydrochlorothiazide. There may be CNS depression with lethargy or even coma.
DOSAGE AND ADMINISTRATION
id: fb1b5d37-290e-40fb-ba41-65c5b7069044
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Optimal dosage should be established by individual titration of the components (see
boxed Warning
).
HOW SUPPLIED
id: 76eb5a52-1120-4a4d-91bb-845bcae5005b
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Spironolactone and hydrochlorothiazide tablets containing 25 mg of spironolactone and 25 mg of hydrochlorothiazide are round, tan, film coated, with G debossed on one side and 5014 on the other side, supplied as:
NDC Number Size
59762-5014-1 bottle of 100
PRINCIPAL DISPLAY PANEL – 25 mg/25 mg Tablet Bottle Label
id: 00ad2da4-43fb-4cfa-ab6e-61cc7e57e536
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 59762-5014-1
100 Tablets
GREENSTONE® BRAND
spironolactone and
hydrochlorothiazide
tablets
25 mg/25 mg
Rx only
