Abbreviated Prescribing Information: Urospir™ 25 mg/5 ml and 50mg/5ml Oral Solution Consult Summary of Product Characteristics before prescribing. Presentation: A clear colourless to pale yellow non aqueous liquid. Each 5 ml contains 25 mg spironolactone for Urospir™ 25 mg/5 ml oral solution and each 5 ml contains 50 mg spironolactone for Urospir™ 50 mg/5 ml Oral Solution. Therapeutic Indications: Urospir is indicated for Congestive cardiac failure, Hepatic cirrhosis with ascites and oedema, Malignant ascites, Nephrotic syndrome and Diagnosis and treatment of primary aldosteronism. Posology and Method of Administration: Note – Urospir Oral Solution is only suitable for administration of single doses up to 100 mg and up to 200 mg/day in two equally divided doses. Urospir is not bioequivalent to the innovator tablet. Switching between spironolactone tablets or other spironolactone products and this formulation should be avoided if possible. If a switch is necessary, caution and increased clinical supervision are required. For management of oedema an initial daily dose of 100 mg of spironolactone administered in either single or divided doses is recommended but may range from 25 mg to 200 mg daily. For management of severe heart failure standard therapy should be initiated at a dose of spironolactone 25 mg once daily if serum potassium is ≤5.0 mEq/L and serum creatinine is ≤2.5 mg/dL. Patients who tolerate 25 mg once daily may have their dose increased to 50 mg once daily as clinically indicated. For management of Hepatic cirrhosis with ascites and oedema If urinary Na+/K+ ratio is greater than 1.0, 100 mg per day. If the ratio is less than 1.0, 200 mg to 400 mg per day. For management of malignant ascites Initial dose usually 100 mg to 200 mg per day. In severe cases the dosage may be gradually increased up to 400 mg per day. For management of Nephrotic syndrome Usual dose 100 mg to 200 mg per day. For management of diagnosis and treatment of primary aldosteronism spironolactone may be administered at doses of 100 mg to 400 mg daily in preparation for surgery. For elderly It is recommended that treatment is started with the lowest dose and titrated upwards as required to achieve maximum benefit. Spironolactone is intended for oral administration. Paediatric population: Initial daily dosage should provide 1-3 mg of spironolactone per kilogram (kg) body weight given in divided doses. Dosage should be adjusted on the basis of response and tolerance. Contra-indications: Spironolactone is contraindicated in acute renal insufficiency, significant renal compromise, anuria, Addison’s disease, hyperkalaemia, hypersensitivity to spironolactone or to any of the excipients listed, concomitant use of eplerenone or other potassium sparing diuretics. Spironolactone is contraindicated in paediatric patients with moderate to severe renal impairment. Spironolactone should not be administered concurrently with other potassium conserving diuretics and potassium supplements should not be given routinely with spironolactone as hyperkalaemia may be induced. Special Warnings and Precautions for use: Fluid and electrolyte balance to be monitored regularly particularly in the elderly patients with significant renal and hepatic impairment. Hyperkalaemia may occur in patients with impaired renal function or excessive potassium intake and can cause cardiac irregularities which may be fatal. Should hyperkalaemia develop spironolactone should be discontinued and active measures to be taken to reduce the serum potassium to normal. Reversible hyperchloraemic metabolic acidosis, usually in association with hyperkalaemia has been reported to occur in some patients with decompensated hepatic cirrhosis, even in the presence of normal renal function. Concomitant use of spironolactone with other potassium-sparing diuretics, angiotensin converting enzyme (ACE) inhibitors, nonsteroidal anti-inflammatory drugs, angiotensin II antagonists, aldosterone blockers, heparin, low molecular weight heparin or other drugs or conditions known to cause hyperkalaemia. Reversible increases in blood urea have been reported in association with spironolactone therapy, particularly in the presence of impaired renal function. It is crucial to monitor and manage serum potassium in patients with severe heart failure receiving spironolactone. Oral potassium supplements should be avoided. Potassium-sparing diuretics should be used with caution in hypertensive paediatric patients with mild renal insufficiency due to the risk of hyperkalaemia. Any warning from the MC, CHM CSM or MHRA: See below*. Black Triangle notice (if relevant): Not applicable. Legal Category: POM.A list of common and serious adverse reactions (include a statement to consult the SmPC for full details of other adverse reactions): Common (Hyperkalaemia, Confusional state, Dizziness, Nausea, Pruritus, Rash, Muscle spasms, Acute kidney injury, Gynaecomastia, Breast pain (male), Malaise). Pack Size and NHS Price: 150ml – 25mg/5ml – £123.93, 150ml – 50mg/5ml – £247.85. Marketing Authorisation Number: PL 00427/0250, PL 00427/0251.Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [Jul-2024].
*Urospir is not bioequivalent to the innovator tablet. Switching between spironolactone tablets or other spironolactone products and this formulation should be avoided if possible. If a switch is necessary, caution and increased clinical supervision are required.