Lesibem Soft Capsule (Isotretinoin)

Adult dose

As 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 per kg of body weight daily while monitoring the response. ○ Maintenance dose Administer 0.5～1.0 mg of this medicine per kg of body weight daily. 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 daily and take with meals. A cumulative dose of 120 mg per kg of body weight during each course of treatment improves the rate of symptom resolution and reduces the recurrence rate. The duration of treatment may vary depending on the daily dose, but is usually 16～24 weeks. Symptoms may continue to improve even after treatment is discontinued. Therefore, if symptoms recur, repeat the treatment course described above, but resume treatment only after a drug-free period of at least 8 weeks. ○ Patients with renal failure: Experience with use is very limited. If this medicine is administered, start at 10 mg daily and adjust the dose. ○ Patients with intolerance: Continue treatment at a low dose. In this case, the treatment period will be longer and the risk of recurrence will be increased. In such patients, continue treatment at the maximum tolerated dose to achieve the best possible effect.

This medication has a very high potential to cause birth defects, so women who are pregnant or may become pregnant must not take it under any circumstances. If pregnancy occurs during treatment, it can have serious effects on the fetus, so two or more reliable contraceptive methods must be used from before starting treatment until one month after completing treatment. Additionally, two pregnancy tests must be conducted before starting treatment to confirm pregnancy, and monthly pregnancy tests must be repeated during treatment. This medication is not administered to patients with liver and kidney dysfunction, hypervitaminosis A, or very high blood lipid levels. During administration, symptoms such as dry skin, itching, chapped lips, and dry eyes may frequently occur, so it is advisable to use moisturizers and lip protectants. Muscle pain, joint pain, headaches, and depressive symptoms may also occur, so if symptoms worsen, consult a physician immediately. Blood tests to monitor liver function, blood lipid levels, and blood sugar should be conducted periodically, and adjustments in dosage or discontinuation of therapy may be necessary if abnormalities are detected. Taking this medication along with other vitamin A preparations or certain antibiotics may increase the risk of side effects, so inform your physician. It is important to take the medication with a sufficient amount of water during meals to reduce esophageal irritation. During the use of this medication, blood donation should be avoided, and male patients should use condoms to prevent pregnancy for 30 days after excessive dosage. Special caution is needed for children and the elderly, and it is especially recommended not to use it in children under 12 years of age. Keep the medication in a sealed container away from direct sunlight and out of reach of children, and do not take expired medication.

Mucosal dryness, skin dryness, skin damage, itching, nasal dryness, lip dryness, dry eyes, nasal bleeding, pharyngeal mucosa dryness, hoarseness, conjunctivitis, corneal opacity, cheilitis, rash, dermatitis, skin peeling, skin thinning, palm and sole skin peeling, skin infections, increased sensitivity to sunburn, reversible hair loss, fulminant acne, persistent hair loss, hirsutism, paronychia, increased granuloma formation in nail dystrophy, phototoxicity, purulent granuloma, hyperpigmentation, sweating, hair abnormalities, purulent fungal infection, acne exacerbation, facial dermatitis, hives, eruptive xanthomas, nodular erythema, flushing, disseminated herpes simplex, hypopigmentation, phot allergic reactions, contusions, 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, aggravated depression, aggressive or violent behavior, emotional instability, behavioral disorders, suicidal thoughts, suicide attempts, suicide, psychosis, pseudotumor cerebri, seizures, drowsiness, lethargy, dizziness, insomnia, neuroexcitability, sensory abnormalities, weakness, stroke, syncope, blepharitis, eye irritation, blurred vision, glare, cancer adaptation disorder, color discrimination disorder, cataract, keratitis, difficulties wearing contact lenses, hearing impairment, vision impairment, optic neuritis, tinnitus, nonspecific gastrointestinal symptoms, nausea, hemorrhagic diarrhea, enteritis, inflammatory bowel disease, pancreatitis, bleeding and inflammation of the gums, esophagitis, esophageal ulcer, elevated liver transaminase levels, hepatitis, nasopharyngitis, bronchospasm, respiratory infections, voice changes, nasal congestion, localized and systemic infections, anemia, increased erythrocyte sedimentation rate, thrombocytopenia, thrombocytosis, neutropenia, agranulocytosis, allergic reactions, decreased red blood cell counts, nonspecific genitourinary symptoms, glomerulonephritis, urethritis, menstrual irregularities, erectile dysfunction, decreased libido, gynecomastia, hypertriglyceridemia, decreased serum HDL, hypercholesterolemia, elevated blood glucose levels, increased serum CPK levels, diabetes, hyperuricemia, elevated ALP, AST, ALT, GGTP, LDH, vasculitis, palpitations, tachycardia, vascular thromboembolic disease, stroke, transient chest pain, fatigue, systemic hypersensitivity reactions, anaphylactic reactions, lymphadenopathy, edema, weight loss, hematuria, proteinuria, increased granuloma 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 should be stored in a light-protected sealed container at room temperature between 1 degree and 30 degrees Celsius. Keeping it stored this way will maintain the effectiveness of the medication and prevent deterioration.

Appearance

Yellowish viscous substance contained in a maroon oval soft capsule

Package unit

100 capsules/box [10 capsules/PTP x 10]