ALDACTON 50MG Tablets 100s

Aldactone 50mg contains spironolactone, a potassium-sparing diuretic that works by competitively blocking aldosterone receptors in the distal nephron of the kidney. By antagonising aldosterone, spironolactone prevents sodium retention and potassium excretion, leading to a mild diuresis without the risk of hypokalaemia seen with thiazide or loop diuretics.

In Kenya, Aldactone is widely used in the management of heart failure, liver cirrhosis with ascites, resistant hypertension, and primary hyperaldosteronism (Conn's syndrome).

Aldactone is also prescribed by dermatologists and endocrinologists for its anti-androgenic properties in polycystic ovary syndrome (PCOS) and hirsutism.

Approved Indications

•       Oedema associated with congestive heart failure (CHF)

•       Hepatic cirrhosis with ascites and oedema

•       Nephrotic syndrome (as adjunct therapy)

•       Primary hyperaldosteronism (diagnosis and long-term management)

•       Resistant hypertension (as add-on therapy)

•       Polycystic ovary syndrome (PCOS) and hirsutism (off-label)

•       Secondary hyperaldosteronism

General Instructions

Take spironolactone with food to improve absorption and reduce the risk of gastric irritation. Swallow tablets whole with a full glass of water. Take doses at the same time each day.

Dosage, Adults

Heart failure: 25–50 mg once daily (may be titrated to 200 mg/day). Oedema/ascites: 100–400 mg/day in divided doses. Hypertension: 25–100 mg/day. PCOS/hirsutism: 50–200 mg/day.

Elderly Patients

Start at the lower end of the dosing range due to increased risk of hyperkalaemia and renal impairment. Monitor electrolytes closely.

Missed Dose

Take the missed dose as soon as you remember, unless it is almost time for the next dose. Do not double up.

Duration of Treatment

Long-term therapy is often required, especially in heart failure and cirrhosis. Do not stop without consulting your doctor.

Common Side Effects

•       Hyperkalaemia (elevated potassium), monitor electrolytes regularly

•       Gynaecomastia (breast enlargement in men)

•       Menstrual irregularities in women

•       Dizziness and lightheadedness

•       Nausea, vomiting, or stomach cramps

Less Common Side Effects

•       Impotence or decreased libido

•       Headache and drowsiness

•       Skin rash or urticaria

•       Muscle cramps

Serious / Seek Immediate Medical Attention

•       Severe hyperkalaemia (risk of cardiac arrhythmia), seek immediate care if palpitations, weakness or paralysis occur

•       Acute kidney injury (especially if combined with NSAIDs or ACE inhibitors)

•       Agranulocytosis (rare)

•       Monitor serum potassium and renal function at baseline, within 1 week of initiation, and at each dose increase.

•       Avoid potassium supplements, salt substitutes containing KCl, or other potassium-sparing agents unless carefully monitored.

•       Use with extreme caution in diabetic patients, who are at higher risk for hyperkalaemia.

•       Discontinue if creatinine rises significantly or hyperkalaemia occurs.

•       Spironolactone has shown tumorigenic potential in animal studies at high doses; relevance to humans at therapeutic doses is uncertain.

•       Pregnancy: classified Category C; not recommended in the first trimester. Avoid in breastfeeding.

•       In Kenya, patients on co-trimoxazole (a common antibiotic) should be monitored closely, as co-trimoxazole also raises potassium levels.

Always inform your pharmacist and prescriber about all medicines, supplements, and herbal remedies you are currently taking.

ACE inhibitors / ARBs: Increased risk of severe hyperkalaemia, monitor potassium closely

NSAIDs (e.g., ibuprofen, diclofenac): Reduced diuretic effect; increased risk of acute kidney injury

Potassium supplements/salt substitutes: Additive hyperkalaemia risk

Digoxin: Spironolactone may increase digoxin levels; monitor for toxicity

Co-trimoxazole (trimethoprim): Trimethoprim blocks renal potassium excretion; combined use can cause dangerous hyperkalaemia

Lithium: Spironolactone may increase lithium renal clearance and alter levels

Fluconazole: May increase spironolactone plasma concentrations

Store below 25°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children. Do not use beyond the expiry date printed on the pack.

Aldactone is a Prescription Only Medicine (POM) in Kenya, regulated under the Pharmacy and Poisons Act (Cap 244). It must be dispensed on a valid prescription by a registered medical or clinical officer. Pharmily dispenses Aldactone only against a valid prescription uploaded at checkout.

Spironolactone is a renin-angiotensin-aldosterone system (RAAS) modulator frequently co-prescribed with ACE inhibitors or ARBs in heart failure, a combination that demands vigilant potassium and creatinine monitoring, particularly in elderly Kenyan patients who may have baseline renal insufficiency or concurrent use of co-trimoxazole for prophylaxis.

Counsel male patients proactively about gynaecomastia; it is dose-dependent and may take 6–9 months to resolve after discontinuation. In female patients with PCOS, explain that menstrual cycle changes and anti-androgenic effects (reduced hirsutism, acne) are expected and may take 3–6 months to manifest.

When dispensing, confirm the prescriber has documented baseline potassium and eGFR, and flag any concurrent nephrotoxic or potassium-elevating medications. Pharmily's dispensing protocol requires electrolyte review documentation for repeat prescriptions.

Should I take Aldactone with or without food?

A: Take it with food. Food increases absorption of spironolactone by approximately 25% and also reduces the likelihood of stomach discomfort.

Why does Aldactone cause breast enlargement in men?

A: Spironolactone has anti-androgenic properties; it blocks male sex hormone (androgen) receptors. In men, this can cause gynaecomastia (breast tissue growth). This is dose-dependent and is usually reversible when the drug is stopped.

Can I take ibuprofen while on Aldactone?

A: Not without medical advice. NSAIDs like ibuprofen can reduce the effectiveness of spironolactone and increase the risk of kidney injury, particularly if you also take an ACE inhibitor or ARB.

Is Aldactone safe during pregnancy?

A: Aldactone is classified as Pregnancy Category C. Animal studies showed harmful effects at high doses. It is generally avoided in pregnancy, especially the first trimester, as spironolactone can affect hormone development in the fetus. Discuss alternatives with your doctor.

How long does it take for Aldactone to work?

A: For fluid retention and blood pressure, effects begin within 2–3 days. For anti-androgenic effects (e.g., in PCOS or hirsutism), clinical benefit may take 3–6 months of consistent use.