Besanoyd Soft Capsules 10 mg (Tretinoin)

Adult dose

Administer a total of 45 mg/㎡ (body surface area) orally divided into two equal doses per day. Treatment should continue for 30 to 90 days until complete remission is achieved. For patients with renal or hepatic failure, the dosage should be reduced to 25 mg/㎡.

Child dose

Administer a total of 45 mg/㎡ (body surface area) orally divided into two equal doses per day. Treatment should continue for 30 to 90 days until complete remission is achieved.

This medication should not be used in patients with hypersensitivity to the components or other retinoids. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication. Careful monitoring should be conducted, as various symptoms related to vitamin A excess might appear during treatment with this medication. When used in patients with acute promyelocytic leukemia, a severe side effect known as differentiation syndrome may occur, hence administration should be conducted under strict medical supervision. Various adverse reactions such as skin rash, itching, hair loss, nausea, vomiting, difficulty breathing, dizziness, and headaches can occur, and immediate consultation with healthcare professionals is required if symptoms arise. This medication should only be used under the management of a specialist experienced in treating blood and tumor diseases, and attention is needed due to the risk of thromboembolism during the first month after treatment begins. Regular monitoring of blood calcium levels is necessary during treatment, and it is advisable to refrain from driving or operating machinery in the presence of dizziness or severe headaches. Mental health issues such as depression or anxiety can arise, so patients with a history of these conditions should be monitored closely and receive appropriate treatment if necessary. As this medication may interact with other drugs, care must be taken not to take it in conjunction with drugs affecting liver function, certain antibiotics, antifungals, vitamin A preparations, etc. This medication is recommended to be taken during meals or immediately after meals to enhance absorption. Exceeding the recommended dosage can cause vitamin A excess, so prescribed dosages should be strictly adhered to, and appropriate treatment should be sought in case of overdose.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue throughout the body, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

• Rash
• pruritus
• facial edema
• difficulty breathing
• symptoms of vitamin A excess
• erythema
• itching
• increased sweating
• soft tissue inflammation
• hair loss

This medication is sensitive to light and should be stored in a dark place. Store it in a sealed container to prevent air from entering. It is also recommended to keep it at a normal room temperature, avoiding places that are too hot or too cold.

Appearance

Upper surface of a yellowish liquid: opaque yellow, lower surface: opaque reddish-brown oval soft capsule

Package unit

100 capsules