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ALDACTAZIDE
Overview
What is ALDACTAZIDE?
ALDACTAZIDE oral tablets contain:
spironolactone . . . . . . . . . . . . . . . . . . . . 25 mghydrochlorothiazide . . . . . . . . . . . . . . . . 25 mg
or
spironolactone . . . . . . . . . . . . . . . . . . . . 50 mghydrochlorothiazide . . . . . . . . . . . . . . . . 50 mg
Spironolactone (ALDACTONE), 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.
What does ALDACTAZIDE look like?
What are the available doses of ALDACTAZIDE?
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What should I talk to my health care provider before I take ALDACTAZIDE?
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How should I use ALDACTAZIDE?
Spironolactone, an ingredient of ALDACTAZIDE, has been shown to be a tumorigen in chronic toxicity studies in rats (see section). ALDACTAZIDE should be used only in those conditions described below. Unnecessary use of this drug should be avoided.
Optimal dosage should be established by individual titration of the components (see ).
What interacts with ALDACTAZIDE?
ALDACTAZIDE is 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. ALDACTAZIDE may also be contraindicated in acute or severe hepatic failure.
What are the warnings of ALDACTAZIDE?
Because buspirone hydrochloride tablets have no established antipsychotic activity, it should not be employed in lieu of appropriate antipsychotic treatment.
Potassium supplementation, either in the form of medication or as a diet rich in potassium, should not ordinarily be given in association with ALDACTAZIDE therapy. Excessive potassium intake may cause hyperkalemia in patients receiving ALDACTAZIDE (see ).
Concomitant administration of ALDACTAZIDE with the following drugs or potassium sources may lead to severe hyperkalemia:
ALDACTAZIDE 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 ALDACTAZIDE is given concomitantly with these drugs (see ).
ALDACTAZIDE 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 ).
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.
Acute Myopia and Secondary Angle-Closure Glaucoma
Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
- 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
What are the precautions of ALDACTAZIDE?
General
Serum Electrolyte Abnormalities
Spironolactone can cause hyperkalemia. The risk of hyperkalemia may be increased in patients with renal insufficiency, diabetes mellitus or with concomitant use of drugs that raise serum potassium (see ). Hydrochlorothiazide can cause hypokalemia and hyponatremia. The risk of hypokalemia may be increased in patients with cirrhosis, brisk diuresis, or with concomitant use of drugs that lower serum potassium. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion. Monitor serum electrolytes periodically.
Other Metabolic Disturbances
Gynecomastia
Gynecomastia may develop in association with the use of spironolactone; physicians should be alert to its possible onset. The development of gynecomastia appears to be related to both dosage level and duration of therapy and is normally reversible when ALDACTAZIDE is discontinued. In rare instances, some breast enlargement may persist when ALDACTAZIDE is discontinued.
Somnolence
Somnolence and dizziness have been reported to occur in some patients. Caution is advised when driving or operating machinery until the response to initial treatment has been determined.
Information for patients
Patients who receive ALDACTAZIDE should be advised to avoid potassium supplements and foods containing high levels of potassium including salt substitutes.
Laboratory tests
Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be done at appropriate intervals, particularly in the elderly and those with significant renal or hepatic impairments.
Drug interactions
Drug/Laboratory test interactions
Thiazides should be discontinued before carrying out tests for parathyroid function (see ). Thiazides may also decrease serum PBI levels without evidence of alteration of thyroid function.
Several reports of possible interference with digoxin radioimmunoassays by spironolactone or its metabolites have appeared in the literature. Neither the extent nor the potential clinical significance of its interference (which may be assay specific) has been fully established.
Carcinogenesis, mutagenesis, impairment of fertility
Spironolactone
Hydrochlorothiazide
Pregnancy
Teratogenic effects.
Non-teratogenic effects
Spironolactone or its metabolites may, and hydrochlorothiazide does, cross the placental barrier and appear in cord blood. Therefore, the use of ALDACTAZIDE in pregnant women requires that the anticipated benefit be weighed against possible hazards to the fetus. The hazards include fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.
Nursing mothers
Canrenone, a major (and active) metabolite of spironolactone, appears in human breast milk. Because spironolactone has been found to be tumorigenic in rats, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother. If use of the drug is deemed essential, an alternative method of infant feeding should be instituted.
Thiazides are excreted in human milk in small amounts. Thiazides when given at high doses can cause intense diuresis which can in turn inhibit milk production. The use of ALDACTAZIDE during breast feeding is not recommended. If ALDACTAZIDE is used during breast feeding, doses should be kept as low as possible.
Pediatric use
Safety and effectiveness in pediatric patients have not been established.
What are the side effects of ALDACTAZIDE?
The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity.
Hydrochlorothiazide
Spironolactone
What should I look out for while using ALDACTAZIDE?
ALDACTAZIDE is 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. ALDACTAZIDE may also be contraindicated in acute or severe hepatic failure.
Potassium supplementation, either in the form of medication or as a diet rich in potassium, should not ordinarily be given in association with ALDACTAZIDE therapy. Excessive potassium intake may cause hyperkalemia in patients receiving ALDACTAZIDE (see ).
Concomitant administration of ALDACTAZIDE with the following drugs or potassium sources may lead to severe hyperkalemia:
ALDACTAZIDE 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 ALDACTAZIDE is given concomitantly with these drugs (see ).
ALDACTAZIDE 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 ).
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.
What might happen if I take too much ALDACTAZIDE?
The oral LD of spironolactone is greater than 1000 mg/kg in mice, rats, and rabbits. The oral LD 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 ALDACTAZIDE 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 ALDACTAZIDE contains 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.
How should I store and handle ALDACTAZIDE?
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]; excursions permitted to 15°-30°C (59°-86°F).Dispense accompanying Medication Guide to each patient.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]; excursions permitted to 15°-30°C (59°-86°F).Dispense accompanying Medication Guide to each patient.ALDACTAZIDE tablets containing 25 mg of spironolactone (ALDACTONE) and 25 mg of hydrochlorothiazide are round, tan, film coated, with SEARLE and 1011 debossed on one side and ALDACTAZIDE and 25 on the other side, supplied as:NDC NumberSize0025-1011-31 bottle of 100ALDACTAZIDE tablets containing 50 mg of spironolactone (ALDACTONE) and 50 mg of hydrochlorothiazide are oblong, tan, scored, film coated, with SEARLE and 1021 debossed on the scored side and ALDACTAZIDE and 50 on the other side, supplied as:NDC NumberSize0025-1021-31 bottle of 100ALDACTAZIDE tablets containing 25 mg of spironolactone (ALDACTONE) and 25 mg of hydrochlorothiazide are round, tan, film coated, with SEARLE and 1011 debossed on one side and ALDACTAZIDE and 25 on the other side, supplied as:NDC NumberSize0025-1011-31 bottle of 100ALDACTAZIDE tablets containing 50 mg of spironolactone (ALDACTONE) and 50 mg of hydrochlorothiazide are oblong, tan, scored, film coated, with SEARLE and 1021 debossed on the scored side and ALDACTAZIDE and 50 on the other side, supplied as:NDC NumberSize0025-1021-31 bottle of 100ALDACTAZIDE tablets containing 25 mg of spironolactone (ALDACTONE) and 25 mg of hydrochlorothiazide are round, tan, film coated, with SEARLE and 1011 debossed on one side and ALDACTAZIDE and 25 on the other side, supplied as:NDC NumberSize0025-1011-31 bottle of 100ALDACTAZIDE tablets containing 50 mg of spironolactone (ALDACTONE) and 50 mg of hydrochlorothiazide are oblong, tan, scored, film coated, with SEARLE and 1021 debossed on the scored side and ALDACTAZIDE and 50 on the other side, supplied as:NDC NumberSize0025-1021-31 bottle of 100ALDACTAZIDE tablets containing 25 mg of spironolactone (ALDACTONE) and 25 mg of hydrochlorothiazide are round, tan, film coated, with SEARLE and 1011 debossed on one side and ALDACTAZIDE and 25 on the other side, supplied as:NDC NumberSize0025-1011-31 bottle of 100ALDACTAZIDE tablets containing 50 mg of spironolactone (ALDACTONE) and 50 mg of hydrochlorothiazide are oblong, tan, scored, film coated, with SEARLE and 1021 debossed on the scored side and ALDACTAZIDE and 50 on the other side, supplied as:NDC NumberSize0025-1021-31 bottle of 100ALDACTAZIDE tablets containing 25 mg of spironolactone (ALDACTONE) and 25 mg of hydrochlorothiazide are round, tan, film coated, with SEARLE and 1011 debossed on one side and ALDACTAZIDE and 25 on the other side, supplied as:NDC NumberSize0025-1011-31 bottle of 100ALDACTAZIDE tablets containing 50 mg of spironolactone (ALDACTONE) and 50 mg of hydrochlorothiazide are oblong, tan, scored, film coated, with SEARLE and 1021 debossed on the scored side and ALDACTAZIDE and 50 on the other side, supplied as:NDC NumberSize0025-1021-31 bottle of 100ALDACTAZIDE tablets containing 25 mg of spironolactone (ALDACTONE) and 25 mg of hydrochlorothiazide are round, tan, film coated, with SEARLE and 1011 debossed on one side and ALDACTAZIDE and 25 on the other side, supplied as:NDC NumberSize0025-1011-31 bottle of 100ALDACTAZIDE tablets containing 50 mg of spironolactone (ALDACTONE) and 50 mg of hydrochlorothiazide are oblong, tan, scored, film coated, with SEARLE and 1021 debossed on the scored side and ALDACTAZIDE and 50 on the other side, supplied as:NDC NumberSize0025-1021-31 bottle of 100ALDACTAZIDE tablets containing 25 mg of spironolactone (ALDACTONE) and 25 mg of hydrochlorothiazide are round, tan, film coated, with SEARLE and 1011 debossed on one side and ALDACTAZIDE and 25 on the other side, supplied as:NDC NumberSize0025-1011-31 bottle of 100ALDACTAZIDE tablets containing 50 mg of spironolactone (ALDACTONE) and 50 mg of hydrochlorothiazide are oblong, tan, scored, film coated, with SEARLE and 1021 debossed on the scored side and ALDACTAZIDE and 50 on the other side, supplied as:NDC NumberSize0025-1021-31 bottle of 100ALDACTAZIDE tablets containing 25 mg of spironolactone (ALDACTONE) and 25 mg of hydrochlorothiazide are round, tan, film coated, with SEARLE and 1011 debossed on one side and ALDACTAZIDE and 25 on the other side, supplied as:NDC NumberSize0025-1011-31 bottle of 100ALDACTAZIDE tablets containing 50 mg of spironolactone (ALDACTONE) and 50 mg of hydrochlorothiazide are oblong, tan, scored, film coated, with SEARLE and 1021 debossed on the scored side and ALDACTAZIDE and 50 on the other side, supplied as:NDC NumberSize0025-1021-31 bottle of 100
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
ALDACTAZIDE is a combination of two diuretic agents with different but complementary mechanisms and sites of action, thereby providing additive diuretic and antihypertensive effects. Additionally, the spironolactone component helps to minimize the potassium loss characteristically induced by the thiazide component.
The diuretic effect of spironolactone is mediated through its action as a specific pharmacologic antagonist of aldosterone, primarily by competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. Hydrochlorothiazide promotes the excretion of sodium and water primarily by inhibiting their reabsorption in the cortical diluting segment of the distal renal tubule.
ALDACTAZIDE is effective in significantly lowering the systolic and diastolic blood pressure in many patients with essential hypertension, even when aldosterone secretion is within normal limits.
Both spironolactone and hydrochlorothiazide reduce exchangeable sodium, plasma volume, body weight, and blood pressure. The diuretic and antihypertensive effects of the individual components are potentiated when spironolactone and hydrochlorothiazide are given concurrently.
Non-Clinical Toxicology
ALDACTAZIDE is 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. ALDACTAZIDE may also be contraindicated in acute or severe hepatic failure.Potassium supplementation, either in the form of medication or as a diet rich in potassium, should not ordinarily be given in association with ALDACTAZIDE therapy. Excessive potassium intake may cause hyperkalemia in patients receiving ALDACTAZIDE (see ).
Concomitant administration of ALDACTAZIDE with the following drugs or potassium sources may lead to severe hyperkalemia:
ALDACTAZIDE 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 ALDACTAZIDE is given concomitantly with these drugs (see ).
ALDACTAZIDE 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 ).
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.
ACE inhibitors, Angiotensin II receptor antagonists, aldosterone blockers, potassium supplements, heparin, low molecular weight heparin, and other drugs known to cause hyperkalemia:
Concomitant administration may lead to severe hyperkalemia.
Alcohol, barbiturates, or narcotics:
Corticosteroids, ACTH:
Pressor amines (e.g., norepinephrine):
Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine):
Lithium:
Nonsteroidal anti-inflammatory drugs (NSAIDs):
Cholestyramine:
The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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