See Supplemental Patient Information
- Restrict potassium supplementation during therapy with spironolactone, as excessive potassium intake can cause hyperkalemia. Do not administer with other potassium sparing diuretics
- Coadministration with ACE inhibitors or indomethacin, even in the presence of a diuretic can cause severe hyperkalemia. Exercise extreme caution when hydrochlorothiazide/spironolactone is given concomitantly with these drugs
- Minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Use with extreme caution in patients with impaired hepatic function
- Avoid concomitant lithium use
- Therapy may precipitate azotemia in patients with renal disease. Therefore use with caution in severe renal disease. Cumulative effects of the drug may develop in patients with impaired renal function
- Use with caution in patients with or without a history of allergy or bronchial asthma to avoid sensitivity reactions
- Therapy may cause exacerbation or activation of systemic lupus erythematosus
- Thiazides can add to or potentiate the action of other antihypertensive drugs
- Therapy can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms manifested as decreased visual acuity or ocular pain occurs within hours to weeks of drug initiation. Treatment includes discontinuation of drug and prompt medical or surgical treatments, if the intraocular pressure remains uncontrolled. Patient with history of sulfonamide or penicillin allergy are at higher risk
- Monitor all the patients for evidence of fluid or electrolyte imbalance, e.g., hypomagnesemia, hyponatremia, hypochloremic alkalosis, and hypokalemia or hyperkalemia. Evaluate serum and urine electrolyte
- Warning signs or symptoms of fluid and electrolyte imbalance, include dryness of the mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting
- Hyperkalameia can cause cardiac irregularities, which can be fatal. Monitor serum potassium levels frequently, if hyperkalemia is suspected obtain an ECG, discontinue the therapy and administer calcium chloride solution, sodium bicarbonate solution, or the oral or parenteral glucose with a rapid-acting insulin preparation and also sodium polystyrene sulfonate can be orally or rectally administered. Persistent hyperkalemia may require dialysis
- Profound diuresis can cause hypokalemia, particularly when used concomitantly with loop diuretics, glucocorticoids, or ACTH, or severe cirrhosis or after prolonged therapy. Cardiac arrhythmias and exaggerate effect of digitalis therapy has been reported due to hypokalemia
- Chloride replacement can be given in the treatment of metabolic alkalosis
- Reversible hyperchloremic metabolic acidosis, usually in association with hyperkalemia, has been reported in some patients with decompensated hepatic cirrhosis
- Transient elevation of BUN has been reported with hydrochlorothiazide/spironolactone therapy. BUN level returns to normal after discontinuation of therapy. Progressive elevation of BUN suggests the presence of preexisting renal impairment
- Therapy may cause increases in cholesterol and triglyceride levels
- Hydrochlorothiazide/spironolactone when administered in combination with other diuretics can cause dilutional hyponatremia manifested by dryness of the mouth, thirst, lethargy, and drowsiness and confirmed by a low serum sodium level. Appropriate therapy includes water restriction and sodium administration in life-threatening hyponatremia
- Thiazides treatment can cause hyperuricemia or precipitation of acute gout. It also increase the urinary excretion of magnesium resulting in to hypomagnesemia
- Carefully adjust dosage of insulin or oral hypoglycemic agents when administering hydrochlorothiazide in diabetic patients
- Suspend therapy before carrying out tests for parathyroid function because marked hypercalcemia may be evidence of hidden hyperparathyroidism. Pathologic changes in the parathyroid gland with hypercalcemia and hypophosphatemia have been reported in patients on prolonged thiazide therapy
- Prolong use of spironolactone can cause dose dependent gynecomastia. Discontinuation of therapy reverse this condition
- Somnolence and dizziness have been reported to occur in few patients, hence caution is advised while driving or operating machinery
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Electrolyte abnormalities
- Volume depletion
- Arrhythmias
- Diabetes mellitus
- Co-administration of ACE inhibitors
- Co-administration of indomethacin
- SLE
- History of gout
- Hyponatremia
Supplemental Patient Information
- Advise patients to avoid potassium supplements and foods containing high levels of potassium including salt substitutes
Pregnancy Category:C
Breastfeeding: Hydrochlorothiazide doses of 50 mg daily or less are acceptable during lactation. Intense diuresis with large doses may decrease breastmilk production. Spironolactone appears acceptable to use during breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 23 May 2011). Hydrochlorothiazide maternal medication usually compatible with breastfeeding, no observable change was seen in the nursing infant while the mother was ingesting the compound. Spironolactone is compatible and considered safe with breastfeeding based upon data from AAP Policy Guidelines This information is based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776/T6 last accessed 23 May 2011). As per manufacturer's data canrenone, a major metabolite of spironolactone is excreted in human milk. Because spironolactone has been found to be tumorigenic in rats, taking into account the importance of the drug to the mother, a decision should be made whether to discontinue the drug. Institute an alternative method of infant feeding, if use of the drug is deemed essential.
US Trade Name(s)
US Availability
hydrochlorothiazide/spironolactone (generic)
Aldactazide (hydrochlorothiazide/spironolactone)
- TABS: 25 mg/25 mg
- TABS: 50 mg/50 mg
Canadian Trade Name(s)
- Aldactazide
- APO-Spirozide
- NOVO-Spirozine
Canadian Availability
Aldactazide (hydrochlorothiazide/spironolactone)
- TABS: 25 mg/25 mg
- TABS: 50 mg/50 mg
APO-Spirozide (hydrochlorothiazide/spironolactone)
NOVO-Spirozine (hydrochlorothiazide/spironolactone)
- TABS: 25 mg/25 mg
- TABS: 50 mg/50 mg
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Aldactazide 25-25 MG TABS [Bottle] (PFIZER U.S.)
30 mg = $41.99
90 mg = $103.97 - Aldactazide 50-50 MG TABS [Bottle] (PFIZER U.S.)
30 mg = $67.99
90 mg = $187.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
