TENSOPLERON 50MG 20TAB; eplerenone, cardiovascular agents .
ACTIVE-INGREDIENT OF TENSOPLERON 50MG 20TAB
Each film-coated Tensopleron 50 mg tablet contains 50 mg eplerenone.
INDICATION OF TENSOPLERON 50MG 20TAB
1- Congestive heart failure post-myocardial infarction: Tensopleron is indicated, in addition to standard therapy including beta-blockers, to reduce the risk of cardiovascular mortality & morbidity in stable patients with left venreicular dysfunction (LVEF ≤ 40%) and clinical evidence of heart failure after recent myocardial infarction. 2- Hypertension: Tensopleron is indicated for the treatment of hypertension. Tensopleron may be used alone or in combination with other antihypertensive agents.
DOSAGE OF TENSOPLERON 50MG 20TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
Following withholding Tensopleron due to serum potassium 6.0 mmol/L, Tensopleron can be re-started at a dose of 25 mg every other day when potassium levels have fallen below 5.0 mmol/L. In Hypertension: The recommended starting dose of Tensopleron is 50 mg administered once daily. The full therapeutic effect of Tensopleron is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of Tensopleron should be increased to 50 mg twice daily. Higher dosages of Tensopleron are not recommended because they have no greater effect on blood pressure than 100 mg and are associated with an increased risk of hyperkalemia. Children and adolescents: There are no date to recoomend the use of Tensopleron in the paediatric population, and therefore, use in this age group is not recommended. Elderly: No initial dose adjustment is required in the elderly. Due to an age-related decline in renal function, the risk of hyperkalaemia is increased in elderly patients. This risk may be further increased when co-morbidity associated with increased systemic exposure is also present, in particular mild-to-moderate hepatic impairment. Periodic monitoring of serum potassium is recommended. Renal impairment: No initial dose adjustment is required in patients with mild renal impairment. Periodic monitoring of serum potassium is recommended. Tensopleron is not dialysable. Hepatic impairment: No initial dosage adjustment is necessary for patients with mild-to-moderate hepatic impairment. Due to an increased systemic exposure to Tensopleron in patients with mild-to-moderate hepatic impairment, frequent and regular monitoring of serum potassium is recommended in these patients, especially in elderly. Concomitant treatment: In case of concomitant treatment with mild to moderate CYP3A4 inhibitors, e.g. amiodarone, diltiazem and verapamil, a starting dose of 25 mg OD may be initiated. Dosing should not exceed 25 mg OD. Tensopleron may be administered with or without food.
OVER-DOSAGE OF TENSOPLERON 50MG 20TAB
No cases of human overdosage with eplerenone have been reported. The most likely manifestation of human overdosage would be anticiptated to be hypotension or hyperkalaemia. Eplerenone cannot be removed by haemodialysis. Eplerenone has been shown to bind extensively to charcoal. If symptomatic hypotension should occur, supportive treatment should be initiated. If hyperkalaemia develops, standard treatment should be initiated.
CONTRA-INDICATION OF TENSOPLERON 50MG 20TAB
Hypersensitivity to eplerenone or any of the excipients. Patients with serum potassium level > 5.0 mmol/L at initiation. Patients with moderate to severe renal insufficiency (creatinine clearance STORAGE OF TENSOPLERON 50MG 20TAB
Store at a temperature not exceeding 30 °C, in a dry place.
PACK OF TENSOPLERON 50MG 20TAB
Carton boxes of 1, 2 or 3 (Al/Opaque PVC-PE-PVDC) blisters each of 10 film-coated tablets and insert leaflet.
TENSOPLERON 50MG 20TAB MANUFACTURED BY
GLOBAL NAPI PHARMACEUTICALS 6th of October City – Egypt For: Global Pharmaceutical Industries.