"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
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. Eplerenone 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
INSPRA is contraindicated in all patients with:
- serum potassium > 5.5 mEq/L at initiation,
- creatinine clearance ≤ 30 mL/min, or
- concomitant administration of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir) [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY].
For Patients Treated for Hypertension
INSPRA is contraindicated for the treatment of hypertension in patients with:
- type 2 diabetes with microalbuminuria,
- serum creatinine > 2.0 mg/dL in males or > 1.8 mg/dL in females,
- creatinine clearance < 50 mL/min, or
- concomitant administration of potassium supplements or potassium-sparing diuretics (e.g., amiloride, spironolactone, or triamterene) [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].
Last reviewed on RxList: 5/16/2016
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