Inspra com



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Description: Please refer to the SmPC before prescribing Inspra 25mg film-coated tablets or Inspra 50mg film-coated tablets. Presentation: Yellow film-coated tablets containing either 25mg or 50mg

Please refer to the SmPC before prescribing Inspra 25mg film-coated tablets or Inspra 50mg film-coated tablets.

Presentation: Yellow film-coated tablets containing either 25mg or 50mg eplerenone. Indications: Eplerenone is indicated, in addition to standard therapy including beta-blockers, to reduce the risk of cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction (LVEF ≤40 %) and clinical evidence of heart failure after recent myocardial infarction. Eplerenone is also indicated in addition to standard optimal therapy, to reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF ≤30%). Dosage . Treatment should be initiated at 25 mg once daily and titrated to the recommended maintenance dose of 50 mg once daily preferably within 4 weeks, taking into account the serum potassium level. The maximum dose regimen is 50 mg daily. For post-myocardial infarction heart failure patients eplerenone therapy should usually be started within 3-14 days after an acute myocardial infarction. For chronic heart failure NYHA class II patients, treatment should be initiated at a dose of 25 mg once daily and titrated to the target dose of 50 mg once daily preferably within 4 weeks; taking into account the serum potassium level. Patients with a serum potassium of > 5.0 mmol/L should not be started on eplerenone therapy. If serum potassium fluctuates after initiation, dose adjustment may be necessary. Periodic monitoring of serum potassium is recommended, particularly in the elderly, in patients with diabetes and in patients with renal impairment. Patients with moderate renal impairment (CrCl 30-60ml/min) should be started at 25mg every other day and the dose should be adjusted based on the potassium level. Frequent and regular monitoring of serum potassium is recommended in patients with mild-moderate hepatic impairment. Use in children: The safety and efficacy of eplerenone in children and adolescents have not been established. Currently available data are described in section 5.1 and 5.2 of the SPC. Eplerenone has not been studied in paediatric patients with heart failure. Contra-indications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SPC. Patients with serum potassium level > 5.0 mmol/L at initiation. Severe renal insufficiency (eGFR <30 mL per minute per 1.73 m 2 ). Severe hepatic insufficiency (Child Pugh Class C). Patients receiving potassiumsparing diuretics, potassium supplements or strong CYP3A4 inhibitors. The combination of an angiotensin converting enzyme (ACE) inhibitor and an angiotensin receptor blocker (ARB) with eplerenone. Special Precautions: Consistent with the mechanism of action, hyperkalaemia may occur with eplerenone. Serum potassium levels should be monitored in all patients at initiation of treatment and with a change in dosage. Thereafter, periodic monitoring is recommended especially in patients at risk for the development of hyperkalaemia, such as elderly patients, patients with renal insufficiency and patients with diabetes. The risk of hyperkalaemia may increase when eplerenone is used in combination with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin receptor blocker (ARB). The combination of an angiotensin converting enzyme (ACE) inhibitor and an angiotensin receptor blocker (ARB) with eplerenone should not be used. The use of potassium supplements is not recommended. Potassium levels should be monitored regularly in patients with impaired renal function, including diabetic microalbuminuria. Electrolyte levels should be monitored in patients with mild to moderate hepatic impairment. Coadministration with strong CYP3A4 inducers is not recommended. Lithium, cyclosporin and tacrolimus should be avoided during treatment with eplerenone. Inspra tablets contain lactose, therefore lactose intolerance should be considered. Drug Interactions: In addition to the above, care should be taken with the coadministration of eplerenone with trimethoprim, ACE inhibitors or angiotensin receptor blockers (ARB) as this may increase the risk of hyperkalaemia. Coadministration with alpha I blockers, tricyclic antidepressants, neuroleptics, amifostine or baclofen may increase the risk of postural hypotension. Care should be taken when prescribing eplerenone with NSAIDs, as treatment with NSAIDs may lead to acute renal failure by acting directly on glomerular filtration, especially in at-risk patients (elderly and/or dehydrated patients). Co-administration of glucocorticoids or tetracosactide with eplerenone may potentially decrease antihypertensive effects. Care should also be taken when coadministering digoxin, warfarin, CYP3A4 inhibitors (e.g. verapamil, diltiazem, amiodarone) and CYP3A4 inducers. Driving/Use of Machinery: No studies have been performed, but it should be taken into account that dizziness may occur during treatment. Use during pregnancy: Caution should be exercised when prescribing eplerenone to pregnant women. Lactation . It is unknown if eplerenone is excreted in human breast milk. Because of the unknown potential for adverse effects on the breast fed infant, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother. Side-Effects: Common: Hyperkalaemia, infection, dizziness, syncope, myocardial infarction, hypotension, cough, diarrhoea, nausea, constipation, renal impairment, rash, pruritus, muscle spasms, musculoskeletal pain, blood urea increased. Uncommon: Pyelonephritis, pharyngitis, eosinophilia, hypothyroidism, dehydration, hypercholesterolaemia, hypertriglyceridaemia, hyponatraemia, insomnia, headache, hypoaesthesia, atrial fibrillation, left ventricular failure, tachycardia, arterial thrombosis limb, orthostatic hypotension, flatulence, vomiting, hyperhidrosis, back pain, cholecystitis, asthenia, malaise, blood creatinine increased, epidermal growth factor receptor decreased, blood glucose increased, pyelonephritis, Gynaecomastia. Not known: Angioedema. See SmPC for full details. Legal Category . POM. Basic NHS Cost: 25 mg, 28-tablet pack = £42.72. 50 mg, 28-tablet pack = £42.72. PL numbers: 25 mg: PL 00057/0615; 50 mg: PL 00057/0616. Marketing Authorisation Holder: Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom.

Further information on request from: Medical Information at Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey, KT20 7NS, United Kingdom Tel: +44 (0) 1304 616161.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Pfizer Medical Information on 01304 616161






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