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ALDACTONE is a brand name for Spironolactone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ". The concurrent administration of potassium supplements, a diet rich in potassium, or other potassium- sparing diuretics is not recommended as this may induce hyperkalemia. Carcinogenesis and Genotoxicity Tumorigenicity: Spironolactone, in chronic toxicity studies, has been shown to be a tumorigenic in rats. Breast…
Verbatim from this product's HC label. Tap a section to expand.
4 Drug-Drug Interactions) 3. , bananas, prunes, raisins and orange juice). Low-salt or low-sodium diet and daily exercise are recommended. 4. 2. Recommended Dose and Dosage Adjustment 1. Diagnosis and Treatment of Primary Hyperaldosteronism As an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets: Long Test: Administer ALDACTONE at a daily dosage of 400 mg for 3-4 weeks.
Correction of hypokalemia and hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism.
Short Test:
Administer ALDACTONE at a daily dosage of 400 mg x 4 days. If serum potassium increases or urinary potassium decreases during ALDACTONE administration, but reverts when ALDACTONE is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be ALDACTONE (spironolactone tablets USP) Page 6 of 34 considered.
After the diagnosis of primary hyperaldosteronism has been established by more definitive testing procedures, ALDACTONE may be administered in doses of 75 mg to 400 mg daily in preparation for surgery. For those unsuitable for surgery, spironolactone may be employed for long term maintenance therapy at the lowest effective dosage determined for the individual.
2. Edematous Disorders Associated with Congestive Heart Failure, Cirrhosis and the Nephrotic Syndrome When given as sole agent for diuresis, continue administration for at least 5 days. If an adequate response has been achieved within 5 days, continue dosage at the same level (or in selected patients, at a reduced dosage) in either single or divided daily doses.
Some may respond adequately to a dosage of only 75 mg daily. If adequate diuresis is not obtained within 5 days, a second diuretic also should be given for additive effect. Occasionally for severe resistant edema, one may add a potent glucocorticoid to this combined therapy.
Normally, an initial daily dosage of 100 mg (but may range from 25 mg to 200 mg daily) of ALDACTONE administered in either single or divided doses is recommended.
Dosage in Children (<18 years of age):
The initial daily dosage should provide approximately 3 mg/kg of body weight administered in either single or divided doses. This dose should be reduced to 1-2 mg/kg for maintenance therapy or combination use with other diuretics. 1 Pediatrics) 3.
10/2025 Table of Contents Recent Major Label Changes ................................................................................................. 2 Table of Contents .................................................................................................................
2 Part 1: Healthcare Professional Information.......................................................................... 4 1. Indications.....................................................................................................................
1. Pediatrics.................................................................................................................... 2. Geriatrics ....................................................................................................................
5 2. Contraindications .......................................................................................................... 5 3. Serious Warnings and Precautions Box ...........................................................................
5 4. Dosage and Administration ............................................................................................ 2. Recommended Dose and Dosage Adjustment .......................................................... 5. Missed Dose ...............................................................................................................
7 5. Overdose ....................................................................................................................... 7 6. Dosage Forms, Strengths, Composition, and Packaging ..................................................
7 7. Warnings and Precautions ............................................................................................. 8 General ...................................................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Essential Hypertension Usually in combination with other drugs, ALDACTONE is indicated for patients who cannot be treated adequately with other agents or for whom other agents are considered inappropriate. ALDACTONE has mild to moderate antihypertensive activity.
For adults an initial daily dosage of 50 mg/day to 100 mg/day (in either single or divided doses) of ALDACTONE is recommended. ALDACTONE may also be given with diuretics that act more proximally in the renal tubule or with other antihypertensive agents.
Since a stabilized response may not occur before 2 weeks, continue treatment in either single or divided daily doses for that duration of time. Subsequently, adjust dosage in response to patient's needs. Most patients will respond to doses not exceeding 200 mg/day.
4. Hypokalemia ALDACTONE in dosage ranging from 25 mg to 100 mg daily is useful in treating a diuretic induced hypokalemia, when oral potassium supplements or other potassium sparing regimens are inappropriate. See also Table 1 for a summary of dosage recommendations.
Table 1 - ALDACTONE Dosage* In Single or Divided Daily Doses CONDITION TYPE OF TEST INITIAL DOSAGE MAXIMUM DOSAGE Primary Hyperaldosteronism Long Test: 400 mg/day x 3-4 weeks - Short Test: 400 mg/day x 4 days - In Preparation for Surgery: 100-400 mg/day 400 mg/day Edematous Disorders: ALDACTONE (spironolactone tablets USP) Page 7 of 34 * Maintenance dosage should be individually determined, and may be lower than the recommended initial dose.
5. Missed Dose Take the missed dose as soon as you remember it. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take a double dose to make up for a missed one. 5.
Overdose Symptoms:
There have been no reports of fatal overdose in man (except indirectly through hyperkalemia). Nausea and vomiting occur, and (much more rarely) drowsiness, dizziness, mental confusion, diarrhea, or a maculopapular or erythematous rash.
These manifestations disappear promptly on discontinuation of medication. Hyperkalemia may be exacerbated.
Treatment:
No specific antidote. No persistent toxicity has occurred or is expected. Inducing vomiting and evacuating the stomach by lavage could be considered. Spironolactone use should be discontinued and potassium intake (including dietary sources) restricted.
For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764- 7669). 6. Dosage Forms, Strengths, Composition, and Packaging Table 2 – Dosage Forms, Strengths, and Composition Description ALDACTONE 25 mg: In Single or Divided Daily Doses CONDITION TYPE OF TEST INITIAL DOSAGE MAXIMUM DOSAGE Congestive Heart Failure Cirrhosis Nephrotic Syndrome - Urinary: Na+ / K+ ratio >1 Na+ / K+ ratio <1 - 100 mg/day 100 mg/day 200-400 mg/day 100 mg/day 200 mg/day 100 mg/day 400 mg/day 200 mg/day Essential Hypertension - 50-100 mg/day 200 mg/day Hypokalemia - 25-100 mg/day 100 mg/day Route of Administration Dosage Form/ Strength/Composition Non-Medicinal Ingredients oral tablet […]
8 Carcinogenesis and Genotoxicity ........................................................................................... 8 Cardiovascular ........................................................................................................................
8 Driving and Operating Machinery .......................................................................................... 8 Endocrine and Metabolism ....................................................................................................
8 Hepatic/Biliary/Pancreatic ..................................................................................................... 9 Monitoring and Laboratory Tests ............................................ Error! Bookmark not defined.
Neurologic .............................................................................................................................. 9 Reproductive Health...............................................................................................................
1. Special Populations .................................................................................................. 1. Pregnancy.........................................................................................................
2. Breastfeeding ................................................................................................... 3. Pediatrics..........................................................................................................
10 8. Adverse Reactions ....................................................................................................... 1. Adverse Reaction Overview .....................................................................................
5. Post-Market Adverse Reactions............................................................................... 11 9. Drug Interactions .........................................................................................................
4. Drug-Drug Interactions ............................................................................................ 5. Drug-Food Interactions ............................................................................................
6. Drug-Herb Interactions ............................................................................................ 7. Drug-Laboratory Test Interactions........................................................................... 16 10.
Clinical Pharmacology .................................................................................................. 1. Mechanism of Action ...............................................................................................
2. Pharmacodynamics .................................................................................................. 3. Pharmacokinetics .....................................................................................................
17 11. Storage, Stability, and Disposal .................................................................................... 18 Part 2: Scientific Information ..............................................................................................
19 13. Pharmaceutical Information ........................................................................................ 19 14. Clinical Trials ...............................................................................................................
1. Clinical Trials by Indication ...................................................................................... 19 15. Microbiology ...............................................................................................................
24 16. Non-Clinical Toxicology ................................................................................................ 24 Patient Medication Information […]