Spironolactone 25mg Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Spironolactone 25mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Spironolactone 25mg
For excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
Pale yellow biconvex tablets with MP28 engraved on one side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
1. Cirrhosis with ascites and oedema
2. Malignant ascites
3. Nephrotic syndrome
4. Diagnosis and treatment of primary hyperaldosteronism
5. Congestive cardiac failure
6. The treatment of hypertension associated with primary
hyperaldosteronism
4.2. Posology and Method of Administration
Adults:
Congestive heart failure: Usual dose - 100mg/day.
In difficult or severe cases the dosage may be gradually increased up to 400mg/day. When oedema is controlled, the usual maintenance level is 75-200mg/day.
Cirrhosis: If urinary Na' / K' ratio is greater than 1.0, 100mg per day. If the ratio is less than 1.0. 200-400mg/day. Maintenance dosage should be individually determined.
Nephrotic syndrome: Usual dose - 100-200mg/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.
Long tests: Spironolactone is administered at a daily dose of 400mg for three to four weeks. Correction of hypokalaemia and of hypertension provides presumption evidence for the diagnosis of primary hyperaldosteronism.
Short tests: Spironolactone is administered at a daily dosage of 400mg for four 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 in doses of 100mg to 400mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, Spironolactone may be employed for longterm maintenance therapy at the lowest effective dosage determined for the individual patient.
Children:
Initial daily dosage should provide 3mg of spironolactone per kilogram bodyweight, given in divided doses. Dosage should be adjusted on the basis of response and tolerance. If necessary a suspension may be prepared by crushing Spironolactone tablets. A suitable suspending vehicle is methylcellulose 20% v/v, purified water to 100%. Such suspension is stable for one month when refrigerated.
Elderly:
Dosage in the elderly should be adjusted on the basis of response and tolerance and may be found to be less than the recommended adult dose.
Route of administration: Oral
4.3. Contra-indications
Spironolactone is contraindicated in patients with anuria, acute renal insufficiency, rapidly progressing impairment of renal function, hyperkalaemia and in patients who are hypersensitive to spironolactone.
Carcinogenicity: Spironolactone has been shown to produce tumours in rats when administered at high doses over a long period of time. The significance of those findings with respect to clinical use is not certain. However the longterm use of spironolactone in young patients requires careful consideration of the benefits and the potential hazards involved.
Precautions: Potentiation of the effect of other anti-hypertensive drugs occurs and their dosage should first be reduced by at least 50% when Spironolactone 100mg or Spironolactone 25mg is added to the treatment regime and then adjusted as necessary.
4.5. Interactions with other Medicaments and other forms of Interaction
Spironolactone should not be administered concurrently with other potassium-conserving diuretics as hyperkalaemia may be induced. For the same reason the use of potassium supplements in association with spironolactone therapy is also not recommended except in cases of initial potassium depletion. If potassium supplementation is considered essential, serum electrolytes should be monitored.
4.6. Pregnancy and Lactation
Spironolactone or its metabolites may cross the placental barrier. The use of Spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and foetus.
Nursing Mothers: Canrenone, a metabolite of spironolactone, appears in breast milk. If use of Spironolactone is considered essential, an alternative method of infant feeding should be instituted.
4.7. Effects on Ability to Drive and Use Machines
Not applicable
4.8
Undesirable Effects
Patients receiving spironolactone therapy should be carefully evaluated for possible disturbances of fluid and electrolyte balance.
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 if necessary active measures taken to reduce the serum potassium to normal. Reversible increase in blood urea has been reported in association with spironolactone therapy, particularly in the presence of impaired renal function.
Dilutional hyponatraemia may be induced, especially when spironolactone is administered in combination with other diuretics.
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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme [www.mhra.gov.uk/yellowcard].
4.9. Overdose
Acute overdosage may be manifested by drowsiness, mental confusion, nausea, vomiting, dizziness or diarrhoea. Hyponatraemia or hyperkalaemia may be induced but these effects are unlikely to be associated with acute overdosage. Symptoms of hyperkalaemia may manifest as paraesthesia, weakness, flaccid paralysis or muscle spasm and may be difficult to distinguish clinically from hyperkalaemia. Electrocardiographic changes are the earliest specific signs of potassium disturbances.
No specific antidote has been identified. Improvement may be expected after withdrawal of the drug. General supportive measures including replacement of fluids and electrolytes may be indicated. For hyperkalaemia, reduce potassium intake, administer potassium excreting diuretics, intravenous glucose with regular insulin or oral ion-exchange resins.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Spironolactone is a steroid, which acts on the distal portion of the renal tubule as a competitive inhibitor of aldosterone thereby increasing sodium and water excretion and reducing potassium excretion. It acts as a diuretic.
Spironolactone has a slow onset of action requiring two or three days for maximum effect.
5.2. Pharmacokinetic Properties
Spironolactone is incompletely but fairly rapidly absorbed from the gastrointestinal tract, the extent of absorption depending on particle size and formulation. Canrenone, which is an active metabolite, has biphasic plasma half-life of about 4 and 17 hours. Spironolactone is excreted in the urine and in the faeces, in the form of metabolites. It is extensively bound to plasma proteins. Spironolactone or its metabolites may cross the placental barrier, and canrenone is excreted in breast milk.
5.3. Preclinical Safety Data
No relevant information additional to that contained elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maize starch
Calcium sulphate dihydrate
Crospovidone
Povidone
Starch, pregelatinised Quinoline yellow lake E104
Peppermint flavour (17% peppermint oil and 83% starch) Magnesium stearate
6.2. Incompatibilities
Not applicable
6.3. Shelf Life
36 months
6.4. Special Precautions for Storage
Containers: Do not store above 25°C. Keep the container tightly closed. Blister packs: Do not store above 25°C. Store in the original package.
High density polystyrene tablet containers with polythene caps and/or polypropylene tablet containers with polypropylene or polythene caps and polyurethane or polythene inserts.
Blister packs. 250 micron green rigid PVC pharmaceutical grade. 20 micron hard-tempered aluminium foil coated on the dull side with 6-7 gsm heat seal lacquer and printed on the bright side.
Pack sizes: 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets Not all pack sizes may be marketed
6.6. Instruction for Use/Handling
Not applicable
7 MARKETING AUTHORISATION HOLDER
Metwest Pharmaceuticals Limited
15 Runnelfield
Harrow on the Hill
Middlesex
HA1 3NY
United Kingdom
8. Marketing Authorisation Number
PL 17521/0028
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
13/03/2009 20/02/2015