Inspra (Eplerenone) Drug Information: Overdosage and Contraindications

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May 27, 2012

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Stroke »

What is a stroke?

Brain cell function requires a constant delivery of oxygen and glucose from the bloodstream. A stroke, or cerebrovascular accident (CVA), occurs when blood supply to part of the brain is disrupted, causing brain cells to die. Blood flow can be compromised by a variety of mechanisms.

Blockage of an artery

Narrowing of the small arteries within the brain can cause a lacunar stroke, (lacune means "empty space"). Blockage of a single arteriole can affect a tiny area of brain causing that tissue to die (infarct).
Hardening of the arteries (atherosclerosis) leading to the brain. There are four major blood vessels that supply the brain with blood. The anterior circulation of the brain that controls most motor activity, sensation, thought, speech, and emotion is supplied by the carotid arteries. The posterior circulation, which supplies the brainstem and the cer...

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OVERDOSE

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.

CONTRAINDICATIONS

For All Patients

INSPRA (eplerenone) is contraindicated in all patients with:

serum potassium > 5.5 mEq/L at initiation,
creatinine clearance ≤ 30 mL/min, or
concomitant administration of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir). [See DRUG INTERACTIONS, CLINICAL PHARMACOLOGY]

For Patients Treated for Hypertension

INSPRA (eplerenone) 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]