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Indications and usage:
Inspra (Eplerenone) is an aldosterone antagonist indicated for:
Dosage and administration:
HFrEF Post-MI: Initiate treatment with 25 mg once daily. Titrate to maximum of 50 mg once daily within 4 weeks, as tolerated. Dose adjustments may be required based on potassium levels.
Hypertension: Eplerenone 50 mg once daily, alone or combined with other antihypertensive agents. For inadequate response, increase to 50 mg twice daily. Higher dosages are not recommended.
For all patients: measure serum potassium before starting Inspra and periodically thereafter.
Dosage forms and strengths:
Inspra (Eplerenone) tablets: 25 mg and 50 mg.
No cases of human overdosage with eplerenone have been reported. Lethality was not observed in mice, rats, or dogs after single oral doses that provided Cmax exposures at least 25 times higher than in humans receiving eplerenone 100 mg/day. Dogs showed emesis, salivation, and tremors at a Cmax 41 times the human therapeutic Cmax, progressing to sedation and convulsions at higher exposures.
The most likely manifestation of human overdosage would be anticipated to be hypotension or hyperkalemia. Eplerenone cannot be removed by hemodialysis. Inspra has been shown to bind extensively to charcoal. If symptomatic hypotension should occur, supportive treatment should be instituted. If hyperkalemia develops, standard treatment should be initiated.
For all patients:
For the treatment of hypertension:
Warnings and precautions:
Hyperkalemia: patients with decreased renal function, diabetes, proteinuria or patients who are taking ACEs and ARBs, NSAIDs or moderate CYP3A inhibitors are at increased risk. Monitor serum potassium levels and adjust dose as needed.
Side effects, adverse reactions:
HFrEF Post-MI: most common adverse reactions ( > 2% and more frequent than with placebo): hyperkalemia and increased creatinine.
Hypertension: in clinical studies, adverse reactions with Eplerenone (Inspra) were uncommon.
To report suspected adverse reactions, contact Pfizer Inc. or your local FDA.
CYP3A Inhibitors: in post-MI HFrEF patients do not exceed 25 mg once daily when used with moderate CYP3A inhibitors (e.g., verapamil, saquinavir, erythromycin, fluconazole). In patients with hypertension initiate at 25 mg once daily. For inadequate blood pressure response, dosing may be increased to a maximum of 25 mg twice daily.
Patient counseling information:
Advise patients receiving Inspra (Eplerenone) tablets:
Where to buy eplerenone online:
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Here is a list of popular medications containing eplerenone as a main active pharmaceutical ingredient; their trade names, forms, doses, companies - manufacturers, distributors, suppliers, researchers and developers:
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