Usual Adult Dose for Chronic Kidney Disease

Initial dose:

• For estimated glomerular filtration rate (eGFR) at least 60 mL/min/1.73 m2: 20 mg orally once a day
• For eGFR 25 to less than 60 mL/min/1.73 m2: 10 mg orally once a day

Target dose: 20 mg orally once a day

Comments:

• Initiation of therapy is not recommended if serum potassium is greater than 5 mEq/L; if serum potassium levels are greater than 4.8 to 5 mEq/L, initiation of therapy may be considered with additional serum potassium monitoring within the first 4 weeks based on clinical judgment and serum potassium levels.
• Initiation of therapy is not recommended in patients with eGFR less than 25 mL/min/1.73 m2.

Use: To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in patients with chronic kidney disease associated with type 2 diabetes

Renal Dose Adjustments

Initial dose:

• For eGFR at least 60 mL/min/1.73 m2: 20 mg orally once a day
• For eGFR 25 to less than 60 mL/min/1.73 m2: 10 mg orally once a day
• For eGFR less than 25 mL/min/1.73 m2: Not recommended.

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Not recommended.

Comments:

• In patients with moderate liver dysfunction, additional serum potassium monitoring should be considered.

Dose Adjustments

Serum potassium should be measured 4 weeks after initiating treatment and dose should be adjusted; serum potassium should be monitored 4 weeks after dose adjustment and throughout therapy, and dose should be adjusted as needed.

Dose Adjustment Based on Current Serum Potassium Level and Current Dose:
Dose: 10 mg orally once a day

• Serum potassium 4.8 mEq/L or less: Dose should be increased to 20 mg orally once a day.
• If eGFR has decreased by more than 30% compared to prior measurement: Dose should be maintained at 10 mg orally once a day.
• Serum potassium greater than 4.8 to 5.5 mEq/L: Dose should be maintained at 10 mg orally once a day.
• Serum potassium greater than 5.5 mEq/L: This drug should be withheld.
• If serum potassium 5 mEq/L or less: Restarting at 10 mg orally once a day should be considered.

Dose: 20 mg orally once a day

• Serum potassium 5.5 mEq/L or less: Dose should be maintained at 20 mg orally once a day.
• Serum potassium greater than 5.5 mEq/L: This drug should be withheld.
• If serum potassium 5 mEq/L or less: This drug should be restarted at 10 mg orally once a day.

Precautions

CONTRAINDICATIONS:

• Concomitant treatment with strong CYP450 3A4 inhibitors
• Adrenal insufficiency

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:

• This drug is highly bound to plasma proteins; efficient removal via hemodialysis is unlikely.

Other Comments

Administration advice:

• Measure serum potassium levels and eGFR before treatment initiation.
• If serum potassium is greater than 5 mEq/L, do not initiate therapy.
• For patients unable to swallow whole tablets, the tablet may be crushed and mixed with water or soft foods (e.g., applesauce) immediately before use and administered orally.

Storage requirements:

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).

Monitoring:

• General: Serum potassium (prior to and 4 weeks after initiation, 4 weeks after dose adjustment, and throughout therapy)
• Renal: Estimated GFR (prior to and during therapy, as appropriate)

Patient advice:

• If a dose is missed, take it as soon as you remember but only on the same day, otherwise skip the missed dose and take the next dose as scheduled.
• Periodic monitoring of serum potassium levels is necessary; consult physician before using potassium supplements or salt substitutes containing potassium.
• Avoid grapefruit and grapefruit juice while taking this drug.
• Do not breastfeed during therapy and for 1 day after treatment.