Oficutan Soft Capsules (Isotretinoin)

Adult dose

Because the therapeutic effects and adverse reactions of this medicine are dose-dependent, adjust the dose appropriately according to the patient's symptoms and condition. ○ Initial dose Administer isotretinoin at 0.5 mg/kg body weight per day while monitoring the response. ○ Maintenance dose Administer this medicine at 0.5～1.0 mg/kg body weight per day; the dose may be increased to 2.0 mg for patients with severe acne. For low doses, take once daily; for high doses, divide into 2 doses per day and take with meals. A cumulative dose of 120 mg/kg body weight per course of treatment improves the rate of symptom resolution and reduces the relapse rate. The treatment duration may vary depending on the daily dose, but is usually 16～24 weeks. Symptoms may continue to improve even after treatment is discontinued. If symptoms recur, repeat the above course of treatment, but resume treatment only after a drug-free period of at least 8 weeks. ○ Patients with renal impairment Experience with administration is very limited. If this medicine is administered, start with 10 mg per day and adjust the dose. ○ Patients with intolerance Continue treatment at a low dose. In such cases, the treatment duration is longer and the risk of relapse is higher. For these patients, continue treatment at the maximum tolerated dose to achieve optimal efficacy.

This medication should not be taken by women who are pregnant or may become pregnant, as it poses a very high risk of causing serious birth defects in the fetus. During treatment with this medication, two or more effective methods of contraception must be used, and regular pregnancy tests should be conducted before, during, and after treatment. If serum triglyceride levels are very high, serious complications such as acute pancreatitis may occur, so serum lipid levels should be checked regularly, and appropriate action should be taken if abnormalities are detected. Common side effects include skin dryness, chapped lips, dry and itchy eyes, and other symptoms such as increased skin sensitivity, hair loss, muscle pain, joint pain, and headaches. Psychiatric symptoms, such as depression or mood changes, may manifest, especially in patients with a history of psychiatric conditions or depression, and immediate consultation with healthcare professionals is required if symptoms worsen. There is increased sensitivity to ultraviolet light during treatment with this medication, so it is advisable to avoid direct sunlight and to use sunscreen. Regular tests, such as liver function tests, blood tests, and blood glucose tests, should be conducted to monitor the physical condition, and if abnormalities are found, a healthcare provider should be consulted. This medication should not be used by pregnant or breastfeeding women, patients with kidney or liver issues, patients with hypervitaminosis A, or individuals with certain allergies (e.g., soy oil, peanuts, etc.). This medication can interact with other drugs, so if you are currently taking other medications, it is crucial to inform your healthcare provider, especially to avoid concurrent use with vitamin A preparations, certain antibiotics, antiepileptics, hormonal contraceptives, etc. This medication should be taken with a sufficient amount of water and during meals, and special caution is required for children and the elderly. Do not donate blood during treatment with this medication, and it is recommended for men to use condoms during sexual intercourse with women of childbearing potential if overdosing occurs. Store the medication away from direct sunlight and keep it out of reach of children, and do not use expired medications.

Mucosal dryness, skin dryness, skin damage, itching, nasal dryness, lip dryness, eye dryness, nasal bleeding, hoarseness, conjunctivitis, corneal opacity, cheilitis, papules, dermatitis, skin peeling, skin weakening, peeling of the palms and soles, skin infection, increased sensitivity to sunburn, reversible hair loss, acne fulminans, persistent hair loss, hirsutism, paronychia, nail dystrophy with increased granulation tissue formation, photosensitivity, pyogenic granuloma, hyperpigmentation, sweating, hair abnormalities, pyogenic fungal infection, acne exacerbation, facial dermatitis, urticaria, erythema multiforme, nodular erythema, flushing, disseminated herpes simplex, hypopigmentation, photoallergic reaction, contusion, abnormal wound healing, myalgia, arthralgia, abdominal pain, rhabdomyolysis, hyperostosis, arthritis, calcification of ligaments and tendons, decreased bone density, early epiphyseal closure, tendinitis, sacroiliitis, headache, depression, exacerbation of depression, aggressive or violent behavior, emotional instability, behavioral disorder, suicidal thoughts, suicide attempts, suicide, psychosis, pseudotumor cerebri, seizures, drowsiness, lethargy, dizziness, insomnia, nervousness, sensory abnormalities, weakness, stroke, fainting, blepharitis, ocular irritation, blurred vision, photophobia, cancer adaptation disorder, color discrimination disorder, cataract, keratitis, difficulty wearing contact lenses, hearing impairment, visual impairment, optic neuritis, tinnitus, nonspecific gastrointestinal symptoms, nausea, hemorrhagic diarrhea, enteritis, inflammatory bowel disease, pancreatitis, gum bleeding and inflammation, esophagitis, esophageal ulcer, elevated liver transaminases, hepatitis, nasopharyngitis, bronchospasm, respiratory infection, voice changes, nasal congestion, localized and systemic infections, anemia, increased erythrocyte sedimentation rate, thrombocytopenia, thrombocytosis, neutropenia, agranulocytosis, allergic reactions, decreased erythrocyte measurements, nonspecific genitourinary symptoms, glomerulonephritis, urethritis, menstrual irregularities, erectile dysfunction, decreased libido, gynecomastia, hypertriglyceridemia, decreased serum HDL, hypercholesterolemia, elevated blood sugar levels, increased serum CPK levels, diabetes, hyperuricemia, elevated ALP, AST, ALT, GGTP, LDH, vasculitis, palpitations, tachycardia, vascular thromboembolic disease, stroke, transient chest pain, fatigue, generalized hypersensitivity reaction, anaphylactic reaction, lymphadenopathy, edema, weight loss, hematuria, proteinuria, increased granulation tissue formation, delayed recovery, lymphadenopathy, increased prolactin, detection of leukocytes and erythrocytes in urine, headache, vomiting, facial flushing, drowsiness, hypersensitivity, itching, keratitis, dry eyes, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

This medication is sensitive to light, so it should be stored in a container that does not allow light to enter. Additionally, it is important to keep it at room temperature between 1 degrees and 30 degrees Celsius to maintain its efficacy.

Appearance

Brownish red oval soft capsules containing a dark yellow oily content

Package unit

100 capsules/box [(10 capsules/PTP × 10)]