Medically reviewed by Drugs.com. Last updated on Apr 27, 2023.
Applies to the following strengths: 1 mg; 5 mg; 10 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Cushing's Syndrome
Initial dose: 2 mg orally twice a day
Titration: Initially by 1 to 2 mg twice a day, no more frequently than every 2 weeks
- Further titration (after reaching 10 mg orally twice a day): By 5 mg twice a day every 2 weeks
- The dose should be titrated based on rate of cortisol changes, individual tolerability, and individual improvement in signs/symptoms of Cushing's disease.
- If a patient tolerates 10 mg twice a day and continues to have elevated 24-hour urine free cortisol (UFC) level above the upper limit of normal (ULN), the dosage can be titrated further by 5 mg twice a day every 2 weeks.
- Cortisol levels should be monitored from at least two 24-hour UFC collections every 1 to 2 weeks until adequate clinical response is maintained.
- The maintenance dosage is individualized and determined by titration based on cortisol levels and patient's signs/symptoms; the maintenance dosage varied between 2 and 7 mg twice a day in clinical trials.
- Once maintenance dosage achieved, cortisol levels should be monitored at least every 1 to 2 months or as indicated.
Use: For the treatment of patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative
Renal Dose Adjustments
Renal dysfunction: No adjustment recommended
- UFC levels should be interpreted with caution in patients with moderate to severe renal dysfunction, due to reduced UFC excretion.
Liver Dose Adjustments
Mild liver dysfunction (Child-Pugh A): No adjustment recommended
Moderate liver dysfunction (Child-Pugh B): The recommended starting dose is 1 mg orally twice a day.
Severe liver dysfunction (Child-Pugh C): The recommended starting dose is 1 mg orally once a day in the evening.
- More frequent monitoring of adrenal function may be needed in patients with liver dysfunction during dose titration.
Dosage Interruptions and Modifications:
- This drug should be decreased or temporarily discontinued if UFC levels fall below target range, there is a rapid decrease in cortisol levels, and/or patients report symptoms of hypercortisolism; if needed, glucocorticoid replacement therapy should be started.
- This drug should be stopped and exogenous glucocorticoid replacement therapy should be administered if serum/plasma cortisol levels are below target range and patients have symptoms of adrenal insufficiency.
- If treatment is interrupted, this drug should be restarted at a lower dose when cortisol levels are within target ranges and patient symptoms have resolved.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
- Correct hypokalemia and hypomagnesemia before starting this drug.
- Obtain baseline ECG; repeat ECG within 1 week after starting therapy and as clinically indicated thereafter.
- Administer with or without food.
- Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
- Protect from moisture.
- Cardiovascular: ECG (before starting therapy); for effect on QTc interval (during therapy), for worsening hypertension
- Endocrine: Cortisol levels (every 1 to 2 weeks until adequate clinical response maintained, then every 1 to 2 months or as indicated); 24-hour UFC and serum/plasma cortisol (periodically during therapy)
- General: Patient's signs/symptoms (periodically during therapy); for edema
- Metabolic: For hypokalemia and hypomagnesemia (during therapy)
- Read the US FDA-approved patient labeling (Patient Information).
- Laboratory monitoring is important; adhere to return visit schedule.
- Report symptoms of hypercortisolism to health care provider.
- Contact health care provider at once if signs/symptoms of QT prolongation occur.
- Report the occurrence of low potassium levels, worsening hypertension, edema, hirsutism, hypertrichosis, and acne (in females) to health care provider.
- If a dose is missed, take the next dose at the regularly scheduled time.
- Do not breastfeed during therapy and for at least 1 week after the last dose.
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