Dosing and uses of Aldactazide, (spironolactone-hydrochlorothiazide)
Adult dosage forms and strengths
spironolactone/hydrochlorothiazide
tablet
- 25mg/25mg
- 50mg/50mg
Edema, Ascites, Congestive Heart Failure
1-8 tablets/day PO (spironolactone 25 mg/hydrochlorothiazide 25 mg)
1-4 tablets/day PO (spironolactone 50 mg/hydrochlorothiazide 50 mg)
Hypertension, Hypokalemia (Diuretic Induced)
2-4 tablets/day PO (spironolactone 25 mg/hydrochlorothiazide 25 mg)
1-2 tablets/day PO (spironolactone 50 mg/hydrochlorothiazide 50 mg)
Geriatric dosing
Avoid spironolactone doses >25 mg/day in heart failure, or patients with CrCl< 30 mL/min; heart failure and risk of hyperkalemia is higher in older adults taking doses > 25 mg/day, or taking concomitant angiotensin-converting enzyme inhibitor, angiotensin-receptor blocker, NSAID, or potassium supplement
Renal Impairment
CrCL <30 mL/min: Hydrochlorothiazide efficacy decreased
Not for administration in hyperkalemia, anuria, acute renal insufficiency, or significant impairment of renal excretory function
Hepatic Impairment
Acute or severe hepatic failure: Contraindicated
Pediatric dosage forms and strengths
Safety and efficacy not established
Aldactazide, (spironolactone-hydrochlorothiazide) adverse (side) effects
Frequency not defined
Spironolactone
- Drowsiness
- Lethargy
- Headache
- Stevens-Johnson Syndrome
- Rash
- Urticaria
- Gynecomastia
- Impotence
- Menstrual disorders
- Abdominal cramping
- Diarrhea
- Gastritis
- Nausea/vomiting
- Drug rash with eosinophilia and systemic symptoms (DRESS)
- Toxic epidermal necrolysis
Hydrochlorothiazide
- Anorexia
- Epigastric distress
- Hypotension
- Orthostatic hypotension
- Photosensitivity
- Anaphylaxis
- Anemia
- Confusion
- Erythema multiforme
- Stevens-Johnson syndrome
- Exfoliative dermatitis including toxic epidermal necrolysis
- Hypomagnesemia
- Dizziness
- Headache
- Hyperuricemia
Warnings
Contraindications
Hypersensitivity to spironolactone, hydrochlorothiazide, or sulfonamides
Acute renal failure
Acute/severe hepatic failure
Anuria
Hyperkalemia
Addison’s disease or other conditions associated with hyperkalemia
Coadministration with eplerenone
Cautions
Somnolence and dizziness reported
Caution with hepatic impairment
Spironolactone
- May cause hyperkalemia; risk may be increased in patients with renal insufficiency, diabetes mellitus, or if coadministered with other drugs/diet that raise serum potassium levels
- Gynecomastia reported
Hydrochlorothiazide
- May cause hypokalemia and hyponatremia; risk of hypokalemia may be increased in patients with cirrhosis, brisk diuresis, or if coadministered with other drugs that lower serum potassium
- May cause hypomagnesemia, which can then result in hypokalemia which appears difficult to treat despite potassium repletion
- May alter glucose tolerance and increase risk for hyperglycemia
- May increase serum levels of calcium and uric acid by decreasing urinary excretion; may also increase cholesterol and triglycerides
- Thiazides diuretics 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 transient myopia and acute angle-closure glaucoma has been reported, particularly with history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)
Pregnancy and lactation
Pregnancy category: C
Lactation: discontinue drug or do not nurse
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
