Renon 10 mg (Tablet)

Indications

• reduce risk of sustained eGFR decline
• reduce risk of end-stage kidney disease
• reduce risk of cardiovascular death
• reduce risk of nonfatal myocardial infarction
• reduce risk of hospitalization for heart failure
• for adult patients with chronic kidney disease (CKD)
• associated with type 2 diabetes (T2D)

Pharmacology

• nonsteroidal
• selective antagonist of the mineralocorticoid receptor (MR)
• blocks MR mediated sodium reabsorption
• blocks MR overactivation in epithelial and nonepithelial tissues
• high potency and selectivity for the MR
• no relevant affinity for androgen, progesterone, estrogen and glucocorticoid receptors
• mean systolic blood pressure decrease
• mean diastolic blood pressure decrease
• absorption after oral administration
• metabolism resulting in absolute bioavailability of 44%
• Cmax achieved between 0.5 and 1.25 hours after dosing
• exposure increased proportionally over a dose range
• steady state achieved after 2 days of dosing
• terminal half-life about 2 to 3 hours
• systemic blood clearance about 25 L/h
• metabolized primarily by CYP3A4 and to a lesser extent by CYP2C8
• about 80% excreted in urine

Dosage & Administration

• recommended starting dosage of 10 mg or 20 mg orally once daily
• may be taken with or without food
• dosage adjustment based on serum potassium levels
• recommended dosages based on eGFR levels

Interaction

• interaction with strong CYP3A4 inhibitors
• interaction with moderate and weak CYP3A4 inhibitors
• interaction with strong and moderate CYP3A4 inducers

Contraindications

• concomitant use with strong CYP3A4 inhibitors
• patients with adrenal insufficiency

Side Effects

• hyperkalemia
• hypotension
• hyponatremia

Pregnancy & Lactation

• no available data on use in pregnancy
• developmental toxicity in animal studies
• unknown background risk of major birth defects and miscarriage
• no data on presence in human milk

Precautions & Warnings

• risk of developing hyperkalemia
• need for serum potassium and eGFR monitoring
• avoid initiation if serum potassium is above a certain level
• more frequent monitoring for high-risk patients

Use in Special Populations

• safety and efficacy not established in patients below 18 years of age
• no overall differences in safety or efficacy in geriatric patients
• no dose adjustment required in geriatric patients
• avoid use in patients with severe hepatic impairment
• no dosage adjustment in mild or moderate hepatic impairment

Overdose Effects

• manifestation of overdose is hyperkalemia
• standard treatment for hyperkalemia

Therapeutic Class

• Mineralocorticoid Receptor Antagonists

Storage Conditions

• keep below 30°C temperature
• away from light and moisture
• keep out of the reach of children

Related Brands

• Fincor 20 mg (Tablet) - aci-limited
• Fincor 10 mg (Tablet) - aci-limited