Tretinoin Soft Capsules (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 isotretinoin at 0.5 mg/kg of body weight per day, while monitoring the response. ○ Maintenance dose Administer 0.5～1.0 mg/kg of this medicine per day; the dose may be increased to 2.0 mg for patients with severe acne. At low doses, take once daily; at high doses, take in 2 divided doses daily with meals. A cumulative dose of 120 mg/kg of body weight during each treatment course improves the rate of symptom resolution and lowers 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, the above treatment course may be repeated, but treatment should be resumed only after a drug-free interval of at least 8 weeks. ○ Patients with renal impairment : Experience with administration is very limited. If this medicine is administered, start at 10 mg per day and adjust the dose. ○ Patients who are intolerant : Continue treatment at a low dose. In this case, treatment will be prolonged and the risk of relapse will increase. In such patients, continue treatment at the highest dose they can tolerate to achieve optimal efficacy.

This medication must not be used by women who are pregnant or may become pregnant, as it can cause serious birth defects. Before starting treatment, two pregnancy tests must be conducted, and monthly pregnancy tests should be repeated during treatment. Also, two effective methods of contraception must be used throughout the treatment period and for one month after treatment. This medication should not be used by patients with liver or kidney function issues, patients with vitamin A overdose, patients with very high blood lipid levels, and patients allergic to this medication or its components. During treatment, regular blood lipid levels and liver function tests must be conducted, and patients with diabetes or a family history should frequently check their blood sugar levels. This medication can cause dryness of the skin and mucous membranes, so it is important to use moisturizers and protect the lips. Moreover, exposure to ultraviolet light and irritating skin treatments should be avoided during treatment. It may also affect mental health, so if symptoms of depression or emotional changes occur, a doctor should be consulted immediately. Muscle or joint pain may occur, so caution should be exercised with vigorous physical activity, and night vision may deteriorate, requiring careful attention when driving or operating machinery. This medication must be taken with sufficient water during meals, and special caution is needed when given to children or the elderly. Additionally, this medication is contraindicated in breastfeeding women, and blood donation should not occur during and for a certain period after treatment. Patients taking this medication should not share their medication with others, and male patients must use condoms during sexual intercourse with women who may become pregnant for 30 days following overdose. Finally, this medication should be stored in a tightly sealed container away from direct sunlight and kept out of reach of children, stored in its original container.

Mucosal dryness, skin dryness, skin damage, itching, nasal dryness, lip dryness, eye dryness, nasal bleeding, pharyngeal mucosal dryness, hoarseness, conjunctivitis, corneal opacity, cheilitis, eczema, dermatitis, skin peeling, skin weakening, peeling of the palms and soles, skin infection, increased sensitivity to sunburn, reversible alopecia, eruptive acne, persistent hair loss, hirsutism, paronychia, increase in fibrous tissue formation in abnormal nail growth, photosensitivity, pyogenic granuloma, hyperpigmentation, sweating, hair abnormalities, pyogenic fungal infection, worsening of acne, facial dermatitis, urticaria, eczematous xanthomas, 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 closure of growth plates, 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, neurogenic irritability, sensory disturbances, weakness, stroke, syncope, blepharitis, ocular irritation, blurred vision, photophobia, cancer adaptation disorder, color discrimination disorder, cataract, keratitis, corneal opacity, difficulty 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 ulcers, 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 erythrocyte counts, nonspecific genitourinary symptoms, glomerulonephritis, urethritis, menstrual irregularities, erectile dysfunction, decreased libido, gynecomastia, hypertriglyceridemia, decreased serum HDL, hypercholesterolemia, elevated blood glucose levels, increased blood CPK levels, diabetes, hyperuricemia, elevated ALP, AST, ALT, GGTP, and LDH, vasculitis, palpitations, tachycardia, thromboembolic disease, stroke, transient chest pain, fatigue, systemic hypersensitivity reaction, anaphylactic reaction, lymphadenopathy, edema, weight loss, hematuria, proteinuria, increased fibroblast formation, delayed recovery, lymphadenitis, 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 and should be stored in a light-resistant, tightly sealed container. It is also recommended to store the medication at room temperature between 1°C and 30°C. Proper storage will help maintain the medication's efficacy over time.

Appearance

(for domestic use) yellowish oily substance inside a light brownish ellipsoidal soft capsule (for export) deep yellow oily content inside a light brown oval-shaped soft capsule

Package unit

100 capsules (10 capsules/PTP*10)