Rosetone Tablet
Spironolactone
100mg
CTL Pharmaceuticals Pvt. Ltd.
| Pack size | 100's |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 12.00 NPR |
Available as:
Indications
Rosetone Tablet is used for:
Oedema, Hirsutism, Hypertension, Hepatic cirrhosis w/ ascites and oedema, Hyperaldosteronism, Severe CHF, Hypokalaemia
Adult Dose
Oral
Oedema
Adult: Initially, 100 mg daily, may adjust dose according to response up to 400 mg daily.
Hepatic cirrhosis with ascites and oedema
Adult: Depending on urinary Na/K ratio: If >1: Initially, 100 mg daily; if <1: Initially, 200-400 mg daily.
Diagnosis of primary hyperaldosteronism
Adult: Long test: 400 mg daily for 3-4 wk. Short test: 400 mg daily for 4 days.
Preoperative management of hyperaldosteronism
Adult: 100-400 mg daily. Long-term maintenance in the absence of surgery: Admin the lowest effective dose.
Hypertension
Adult: As monotherapy: Initially, 50-100 mg in 1-2 divided doses, may adjust dose after 2 wk.
Severe congestive heart failure
Adult: As adjunct: Initially, 25 mg once daily to max 50 mg daily. May reduce to 25 mg every other day if 25 mg once daily dose is not tolerated.
Diuretic-induced hypokalaemia
Adult: 25-100 mg daily.
Hirsutism
Women with hirsutism
Adult: 50-200 mg qDay or divided q12hr
Elderly: Initiate w/ the lowest dose then titrate upward if needed.
Child Dose
Oral
Hepatic cirrhosis with ascites and oedema
Child: Initially, 3 mg/kg given in divided doses, may adjust according to response.
Diagnosis of primary hyperaldosteronism
Child: Initially, 3 mg/kg given in divided doses, may adjust according to response.
Preoperative management of hyperaldosteronism
Child: Initially, 3 mg/kg given in divided doses, may adjust according to response.
Severe congestive heart failure
Child: Initially, 3 mg/kg given in divided doses, may adjust according to response.
Renal Dose
Renal impairment
CrCl >50 mL/min/1.73 m²: 12.5-25 mg qDay; use maintenance dose of 25 mg qDay or q12hr after 4 weeks of treatment with potassium <5 mEq/L
CrCl 30-49 mL/min/1.73 m²: 12.5 mg qDay or every other day; use maintenance dose of 12.5-25 mg qDay after 4 weeks of treatment with potassium <5 mEq/L
CrCl <30 mL/min/1.73 m²: Avoid use
Administration
Should be taken with food.
Contra Indications
Anuria, hyperkalaemia, acute or progressive renal insufficiency. Addison's disease.
Precautions
Patient at risk of developing hyperkalaemia and acidosis, w/ DM. Renal and hepatic impairment. Elderly. Pregnancy and lactation. Patient Counselling This drug may cause dizziness and somnolence, if affected do not drive or operate machinery. Monitoring Parameters Monitor serum electrolytes periodically; BP, renal function.
Lactation: Metabolite excreted into breast milk; discontinue breastfeeding or do not use drug
Pregnancy-Lactation
Interactions
Increased risk of hyperkalaemia w/ other K-sparing diuretics or K supplements, ACE inhibitors, angiotensin II receptor antagonists, trilostane, heparin, LMWH. Increased risk of nephrotoxicity w/ ciclosporin, NSAIDs. Increased risk of lithium toxicity. May reduce ulcer-healing properties of carbenoxolone. May increase serum level of digoxin. May reduce vascular response to norepinephrine. Concurrent use w/ colestyramine may cause hyperkalaemic metabolic acidosis. Potentiation of orthostatic hypotension may occur w/ barbiturates or narcotics.
Potentially Fatal: May enhance hyperkalaemic effect w/ eplerenone. Increased risk of lithium toxicity when used concurrently.
Adverse Effects
Side effects of Spironolactone :
Drowsiness, dizziness, headache, lethargy, leg cramps, GI disturbances (e.g. diarrhoea, cramps), ataxia, mental confusion, rashes, pruritus, alopecia, hyponatraemia, electrolyte disturbances, gynaecomastia, hirsutism, menstrual irregularities, breast pain, deepening of the voice, impotence, leucopenia (including agranulocytosis), thrombocytopenia, transient elevation in BUN concentration. Rarely, breast enlargement.
Potentially Fatal: Hyperkalaemia.
Mechanism of Action
Spironolactone acts on the distal renal tubules as a competitive antagonist of aldosterone. It increases the excretion of sodium chloride and water while conserving potassium and hydrogen ions.
Note
Rosetone 100mg Tablet manufactured by CTL Pharmaceuticals Pvt. Ltd.. Its generic name is Spironolactone. Rosetone is availble in Nepal.
Farmaco Nepal drug index information on Rosetone Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.