Risodren Tablets 500 mg (Mitotane)

Adult dose

Administer 2~6 g of mitotane orally in 3~4 divided doses daily. The dose may be gradually increased to 9~10 g daily. If the patient tolerates higher doses and clinical response is likely to improve, increase the dose within the therapeutic range (mitotane plasma concentration) until adverse reactions occur. If severe adverse reactions occur, reduce the dose until the maximum tolerated dose is reached. The maximum tolerated dose is 2~16 g of this drug daily, usually 9~10 g daily. The maximum dose used in clinical trials was 18~19 g daily. Adjust the dose to achieve the therapeutic range (mitotane plasma concentration: 14~20 mg/L) while ensuring acceptable safety and adequate efficacy. Because severe neurotoxicity has been reported at mitotane plasma concentrations of 20 mg/L or higher, this level must not be exceeded. Mitotane plasma concentrations should generally be measured frequently for 3~5 months until the therapeutic range is reached. Once the maintenance dose is reached, plasma concentrations should be monitored regularly because mitotane accumulates in tissues. (See 5. General Precautions.) If toxicity occurs at mitotane plasma concentrations of 20 mg/L or higher, discontinue treatment and resume it when the plasma concentration reaches the therapeutic range. If unacceptable toxicity occurs within the therapeutic range for mitotane, reduce the dose until the maximum tolerated dose is reached. Dose adjustment does not produce an immediate change in mitotane plasma concentrations. Due to the long half-life of mitotane, plasma concentrations may remain elevated. Therefore, regular monitoring of mitotane plasma concentrations is necessary even after treatment is discontinued.

This medication should be used under the supervision of a qualified physician with experience in chemotherapy. As this medication suppresses adrenal function, treatment should be immediately discontinued if shock, severe trauma, or infection occurs after administration. In these situations, the adrenal gland may not be able to secrete steroids normally, which may require supplemental steroids from outside. If wounds, infections, or other diseases occur, contact a physician immediately. This medication is not to be administered to patients who are allergic to this drug or its components, nursing mothers, or patients taking spironolactone. Patients with impaired liver function should use it with caution, as the drug may accumulate in the body. Gastrointestinal symptoms such as loss of appetite, nausea, vomiting, and diarrhea may frequently occur when taking this medication. Symptoms such as drowsiness, lethargy, dizziness, and depression have also been reported. Transient skin rashes or, rarely, blurred vision, double vision, hematuria, and hypertension may occur. In premenopausal women, cysts may develop in the ovaries, so regular ultrasound examinations are needed. Changes in sex hormone levels may occur, and various side effects such as generalized itching, high fever, liver dysfunction, and neuropsychiatric disorders have been reported. This drug may alter the metabolism of externally administered steroids and could induce adrenal insufficiency, so steroid replacement therapy may be required. It is advisable to use this medication only after the tumor has been surgically removed. Due to the risk of brain damage or neurological side effects, blood concentration should be regularly monitored, and behavioral and neurological status should be assessed. Drowsiness or dizziness may occur, so tasks that require driving or operating machinery should be avoided. This medication may alter blood cell counts, so regular blood tests are necessary. The risk of bleeding necessitates a platelet function test before surgery. Patients with impaired liver function face a risk of hepatic toxicity; therefore, liver function should be periodically tested, and treatment should be discontinued if abnormal findings are noted. Use during pregnancy can pose risks to the fetus; thus, women of childbearing potential should ensure thorough contraception during treatment. Nursing mothers should discontinue breastfeeding as this medication can pass into breast milk and cause adverse reactions in the infant. Safety for children has not been established, and neuropsychiatric damage has been reported. Elderly patients should start at a low dose considering liver, kidney, and heart function decline and comorbidities, frequently monitoring blood concentration. In cases of overdose, CNS disturbances may be severe; administration should be stopped immediately, and treatment according to symptoms should be initiated, with recovery potentially taking a long time. When handling this medication, it should be done safely to avoid skin contact, such as wearing impermeable gloves. Treatment should continue until a stable administration method is established in the hospital, and if clinical effectiveness does not manifest, discontinuation should be considered. This medication interacts with many other drugs, especially affecting liver metabolism; therefore, dose adjustment and monitoring of concomitant medications are necessary. A high-fat diet may increase the absorption of this medication, so care should be taken with meal management.

• Loss of appetite
• nausea
• vomiting
• diarrhea
• drowsiness
• somnolence
• dizziness
• depression
• temporary skin rash
• visual disturbance

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, and it is best to keep it away from direct sunlight and store it at room temperature. This will help maintain the drug's effectiveness.

Appearance

Convex and round white tablets

Package unit

100 tablets/bottle