Tretin Soft Capsule 10 mg (Isotretinoin)

Adult dose

The therapeutic effects and adverse reactions of this medicine are dose-dependent; therefore, adjust the dose as appropriate according to the patient's symptoms and condition. ○ Initial dose Administer 0.5 mg/kg of body weight per day of isotretinoin while monitoring the response. ○ Maintenance dose Administer 0.5～1.0 mg/kg of body weight per day of this medicine; the dose may be increased to 2.0 mg for patients with severe acne. Take the low dose once daily; divide the high dose into 2 doses per day and take with meals. A cumulative dose of 120 mg/kg of body weight during each course of treatment improves the rate of symptom resolution and reduces the relapse rate. The duration of treatment may vary depending on the daily dose, but usually takes 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 washout 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 who are intolerant: Continue treatment at a low dose. In these patients, the duration of treatment will be longer and the risk of relapse will be higher. In such patients, continue treatment at the maximum tolerable dose to achieve optimal effects.

This medication can cause serious fetal deformities if used during pregnancy; therefore, women who are pregnant or may become pregnant must not take it under any circumstances. While taking this medication, it is essential to use at least two effective methods of contraception, and regular pregnancy tests should be conducted before starting treatment, during treatment, and after stopping treatment. Severe adverse effects such as acute pancreatitis can occur if triglyceride levels in the blood are very high. Therefore, blood lipid levels should be regularly monitored and managed both before and during the course of this medication. Dry skin, dry lips, and dry eyes are common symptoms, and in severe cases, keratitis or conjunctivitis may occur, so careful observation of eye and skin conditions is necessary. Various physical and mental side effects such as muscle pain, joint pain, headaches, and depression can occur; if any adverse symptoms persist or worsen, consult a doctor immediately. This medication may also affect liver function and blood sugar levels, so regular tests for liver function and blood sugar are required, particularly for diabetic patients or those with a family history. While taking this medication, avoid exposure to ultraviolet rays and do not combine it with strong acne treatments or phototherapy to reduce skin irritation. Follow the doctor's instructions strictly as per the pregnancy prevention program, never share the medication with others, and return any leftover medication to the pharmacist after treatment. When taking this medication, it should be taken with plenty of water during meals to reduce esophageal irritation, and special precautions are needed for children or the elderly. Finally, this medication should be stored in a cool, dry place away from direct sunlight and kept out of the reach of children.

Mucosal dryness, skin dryness, skin damage, itching, nasal dryness, lip dryness, eye dryness, nasal bleeding, hoarseness, conjunctivitis, corneal opacification, cheilitis, dermatitis, eczema, skin peeling, skin weakness, palm and sole skin peeling, skin infection, increased sensitivity to sunburn, reversible alopecia, explosive acne, persistent alopecia, hirsutism, paronychia, increased formation of granulation tissue in nail dysplasia, photosensitivity, pyogenic granuloma, hyperpigmentation, sweating, hair abnormalities, pyogenic mycosis, exacerbation of acne, facial dermatitis, urticaria, yellowish rash, nodular erythema, flushing, disseminated herpes simplex, hypopigmentation, phot allergic 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, worsening of depression, aggressive or violent behavior, emotional instability, behavioral disorders, suicidal thoughts, suicide attempts, suicide, psychosis, pseudotumor cerebri, seizures, drowsiness, lethargy, dizziness, insomnia, nervousness, sensory abnormalities, weakness, stroke, fainting, blepharitis, eye irritation, blurred vision, glare, 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 transaminase levels, hepatitis, nasopharyngitis, bronchial spasm, respiratory infection, voice change, nasal congestion, localized or systemic infection, anemia, increased erythrocyte sedimentation rate, thrombocytopenia, thrombocytosis, neutropenia, agranulocytosis, allergic reactions, decreased red blood cell count, 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, increased ALP, AST, ALT, GGTP, LDH, vasculitis, palpitations, tachycardia, vascular thromboembolic disease, stroke, transient chest pain, fatigue, systemic hypersensitivity reaction, anaphylactic reaction, lymphadenopathy, edema, weight loss, hematuria, proteinuria, increased granulation tissue formation, delayed recovery, lymphadenitis, increased prolactin, detection of leukocytes and erythrocytes in urine, headache, vomiting, facial flushing, drowsiness, hypersensitivity, itching

This medication is sensitive to light and should be stored in a light-blocking container. For optimal preservation of its effects, keep it at room temperature between 1°C and 30°C.

Appearance

Yellowish oily substance contained in reddish-brown oval soft capsules

Package unit

100 capsules (10 capsules/PTP*10)