Generic Medicine Info
Should be taken with food.
Hyperkalaemia, Addison's disease, anuria, acute renal insufficiency, diabetic nephropathy. Severe renal impairment. Children with moderate to severe renal impairment. Lactation. Concomitant use with eplerenone or other K-sparing diuretics, and K supplements (except in cases of initial K depletion).
Special Precautions
Patient with diabetes mellitus, porphyria, menstrual abnormalities or breast enlargement; cirrhosis, predisposition to respiratory or metabolic acidosis, salt-depletion. Patient with heart failure: eGFR must be >30 mL/min/1.73 m2 or creatinine must be ≤2.5 mg/dL (men) or ≤2 mg/dL (women) with no recent worsening, and K <5 mEq/L with no history of severe hyperkalaemia. Discontinue use prior to adrenal vein catheterisation. Susp is not therapeutically equivalent to tab; patient requiring >100 mg/dose should use tab. Avoid unnecessary use. Renal and hepatic impairment. Children and elderly. Pregnancy . Patient Counselling This drug may cause dizziness, drowsiness or somnolence, if affected, do not drive or operate machinery. Do not switch between dosage forms unless instructed by your doctor. Monitoring Parameters Monitor blood pressure, uric acid, blood glucose, renal function, volume status, and BUN periodically; serum electrolytes, including K (within 1 week of treatment initiation or dose titration, and regularly thereafter) and Na. Closely monitor serum K and renal function 3 days after initiating therapy, at 1 week after initiation, at least monthly for the 1st 3 months of treatment, and every 3 months thereafter for patient with heart failure.
Adverse Reactions
Significant: Fluid-electrolyte imbalance (e.g. hypomagnesaemia, hyponatraemia, hypocalcaemia, hyperglycaemia), hyperchloraemic metabolic acidosis (reversible), asymptomatic hyperuricaemia, gout, gynaecomastia (reversible), symptomatic dehydration, hypotension, and worsened renal function; increased BUN (reversible). Blood and lymphatic system disorders: Rarely, agranulocytosis, leucopenia, thrombocytopenia. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, gastritis, gastrointestinal ulcer or haemorrhage. General disorders and administration site conditions: Malaise, ataxia, fever. Hepatobiliary disorders: Hepatotoxicity. Immune system disorders: Rarely, hypersensitivity. Metabolism and nutrition disorders: Hypovolaemia. Musculoskeletal and connective tissue disorders: Muscle spasms. Nervous system disorders: Dizziness, headache, drowsiness. Psychiatric disorders: Confusional state. Renal and urinary disorders: Acute kidney injury. Reproductive system and breast disorders: Breast pain, benign breast neoplasm (male), decreased libido, irregular menses, erectile dysfunction, postmenopausal bleeding. Skin and subcutaneous tissue disorders: Pruritus, rash, urticaria, toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, hypertrichosis.
Potentially Fatal: Hyperkalaemia.
Drug Interactions
Reduced renal clearance of lithium thereby increased risk of lithium toxicity. Diuretic, natriuretic, and antihypertensive effects may be reduced by NSAIDs (e.g. aspirin, indometacin, mefenamic acid). May increase the serum levels of digoxin. May cause hyperkalaemic metabolic acidosis with colestyramine. May potentiate the hypotensive effects of antihypertensives. Effectiveness may be decreased by carbenoxolone. May reduce the vascular response to norepinephrine. May increase the risk of hyponatraemia with chlorpropamide.
CIMS Class
ATC Classification
C03DA01 - spironolactone ; Belongs to the class of aldosterone antagonists. Used as potassium-sparing diuretics.
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