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UROSPIR is a brand name for Spironolactone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: • Congestive cardiac failure • Hepatic cirrhosis with ascites and oedema • Malignant ascites • Nephrotic syndrome • Diagnosis and treatment of primary aldosteronism. Children should only be treated under guidance of a paediatric specialist. There is limited paediatric data available (see sections 5.1 and 5.2).
Verbatim from this product's MHRA label. Tap a section to expand.
NOTE
Urospir 25 mg/5 ml Oral Solution is only suitable for administration of single doses up to 100 mg (20 ml) and up to 200 mg/day in two equally divided doses (20 ml twice a day). When doses more than 200 mg/day are required, other suitable spironolactone formulations should be used.
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.
2. Posology Adults Congestive cardiac failure with oedema For management of oedema an initial daily dose of 100 mg (20 ml) of spironolactone administered in either single or divided doses is recommended, but may range from 25 mg (5 ml) to 200 mg daily (20 ml twice a day).
Maintenance dose should be individually determined. 5 mg/dL. Patients who tolerate 25 mg once daily may have their dose increased to 50 mg (10 ml) once daily as clinically indicated. Patients who do not tolerate 25 mg once daily may have their dose reduced to 25 mg every other day.
4 for advice on monitoring serum potassium and serum creatinine. 0, 100 mg (20 ml)/day. 0, 200 mg/day (20 ml twice a day) to 400 mg/day (use a suitable spironolactone formulation; see NOTE above).. Maintenance dosage should be individually determined.
Malignant ascites Initial dose usually 100 mg (20 ml)/day to 200 mg/day (20 ml twice a day). In severe cases the dosage may be gradually increased up to 400 mg/day (use a suitable spironolactone formulation; see NOTE above). When oedema is controlled, maintenance dosage should be individually determined.
Nephrotic syndrome Usual dose 100 mg (20 ml)/day to 200 mg/day (20 ml twice a day). Spironolactone has not been shown to be anti-inflammatory, nor to affect the basic pathological process. Its use is only advised if glucocorticoids by themselves are insufficiently effective.
Diagnosis and treatment of primary aldosteronism Spironolactone may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets. As the tests require daily doses higher than 200 mg, other suitable spironolactone formulations should be used; see NOTE above Long test: Spironolactone is administered at a daily dosage of 400 mg for 3 to 4 weeks.
Gynaecomastia may develop in association with the use of spironolactone. Development appears to be related to both dosage level and duration of therapy and is normally reversible when the drug is discontinued. In rare instances some breast enlargement may persist.
The following adverse events have been reported in association with spironolactone therapy: Adverse effects have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100; <1/10); uncommon (≥1/1,000; <1/100); rare (≥1/10,000; <1/1,000); very rare (<1/10,000); frequency not known (cannot be estimated from the available data).
System Organ Class Very Commo n ≥ 1/10 Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000 Very Rare < 1/10,000 Frequency Not Known (cannot be estimated from the available data) Neoplasms benign, malignant and unspecified (including cysts and polyps) Benign breast neoplasm (male) Blood and lymphatic system disorders Agranulocytosi s, Leukopenia, Thrombocytop enia Metabolism and nutrition disorders Hyperkal aemia Electrolyte imbalance Psychiatric disorders Confusion al state Libido disorder Nervous system disorders Dizziness Gastrointestinal disorders Nausea Gastrointestina l disorder Hepatobiliary disorders Hepatic function abnormal Skin and subcutaneous tissue disorders Pruritus, Rash Urticaria Toxic epidermal necrolysis (TEN), Stevens- Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS), Alopecia, Hypertrichosis, Pemphigoid Musculoskeletal and connective tissue disorders Muscle spasms Renal and urinary disorders Acute kidney injury Reproductive system and breast disorders Gynaecom astia, Breast pain (male)a Menstrual disorder, Breast pain (female)b General disorders and administration site conditions Malaise Abbreviations: CDS = Core Data Sheet; F = female; LLT = lower level term; M = male; PT = preferred term; WHO-ART = World Health Organization Adverse Drug Reaction Terminology.
Fluid and electrolyte balance Fluid and electrolyte status should be regularly monitored particularly in the elderly, in those 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.
3). 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, angiotensinconverting 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, potassium supplements, a diet rich in potassium or salt substitutes containing potassium, may lead to severe hyperkalaemia.
Urea Reversible increases in blood urea have been reported in association with spironolactone, therapy, particularly in the presence of impaired renal function. Hyperkalaemia in Patients with Severe Heart Failure Hyperkalaemia may be fatal.
It is critical to monitor and manage serum potassium in patients with severe heart failure receiving spironolactone. Avoid using other potassium-sparing diuretics. 5 mEq/L. The recommended monitoring for potassium and creatinine is 1 week after initiation or increase in dose of spironolactone, monthly for the first 3 months, then quarterly for a year, and then every 6 months.
2). Paediatric population Potassium-sparing diuretics should be used with caution in hypertensive paediatric patients with mild renal insufficiency because of the risk of hyperkalaemia. 3).
1 • 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Correction of hypokalaemia and hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism.
Short test:
Spironolactone is administered at a daily dosage of 400 mg for 4 days. If serum potassium increases during spironolactone administration but drops when spironolactone is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered.
After the diagnosis of hyperaldosteronism has been established by more definitive testing procedures, spironolactone may be administered at doses of 100 mg (20 ml) to 400 mg daily (see NOTE above) in preparation for surgery. For patients who are considered unsuitable for surgery, spironolactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.
Elderly It is recommended that treatment is started with the lowest dose and titrated upwards as required to achieve maximum benefit. Care should be taken with severe hepatic and renal impairment which may alter drug metabolism and excretion.
6 ml/kg) given in divided doses. 4). Due to the level of medium chain triglycerides in Spironolactone Oral Solution, it is recommended that doses of 3mg/kg be administered using the 50 mg/5ml Oral Solution. Children should only be treated under guidance of a paediatric specialist.
2). Method of administration For oral administration. Administration of spironolactone with a meal is recommended. 6. This product is incompatible with polystyrene or PVC and therefore, other devices may react with the product. 5 mg 3 ml 15 mg
aThe term Breast pain is mapped from CDS and the frequency is derived from WHO-ART term Breast pain (M); however, Breast pain male is the LLT. bBreast pain is the PT from CDS, and the frequency is derived from WHO-ART term Breast pain (F).
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.