Inspra Special Precautions

Hyperkalemia: Eplerenone is associated with an increased risk of hyperkalemia. This risk can be minimized by patient selection, avoidance of certain concomitant treatments, and monitoring. Eplerenone should generally not be administered to patients who are receiving potassium supplements (see Contraindications). Potassium levels should be monitored regularly in patients with impaired renal function, including diabetic microalbuminuria (see as follows). Dose reduction of eplerenone has been shown to decrease serum potassium levels (see Dosage & Administration).
The risk of hyperkalemia may increase when eplerenone is used in combination with an Angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin receptor blocker (ARB).
Impaired Hepatic Function: Due to increased systemic exposure to eplerenone in patients with mild-to-moderate hepatic impairment, frequent and regular monitoring of serum potassium is recommended in these patients, especially when elderly. The use of eplerenone in patients with severe hepatic impairment (Child-Pugh Class C) has not been evaluated and is therefore contraindicated (see Dosage & Administration and Contraindications).
Impaired Renal Function: See Hyperkalemia as previously mentioned and Contraindications.
CYP 3A4 Inducers: Co-administration of eplerenone with potent CYP 3A4 inducers is not recommended (see Interactions).
Information for Patients: Patients receiving eplerenone should be informed not to use potassium supplements, salt substitutes containing potassium, or contraindicated medications without consulting the prescribing healthcare professional.
Effects on Ability to Drive and Use Machines: Dizziness and syncope have been reported to occur in some patients. Caution is advised when driving or operating machinery until the response to initial treatment has been determined.
Use in the Elderly: Due to age-related decline in renal function, the risk of hyperkalemia is increased in elderly patients. Periodic monitoring of serum potassium is recommended.