Train Soft Capsule (Isotretinoin)

Adult dose

The therapeutic effects and adverse reactions of this drug are dose-dependent; therefore, 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 0.5～1.0 mg/kg body weight of this drug 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 daily and take with meals. A cumulative dose of 120 mg/kg body weight per course of treatment improves the rate of symptom improvement and reduces the relapse rate. The duration of treatment may vary depending on the daily dose, but is usually 16～24 weeks. Symptoms may continue to improve after treatment is discontinued. If symptoms recur, repeat the treatment course described above, 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 drug is administered, start with 10 mg per day 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 relapse will be higher. For these patients, continue treatment at the maximum tolerated dose to achieve optimal efficacy.

This medication should never be used by women who are pregnant or may become pregnant. It can cause serious malformations in the fetus, so effective contraception must be carried out before and after pregnancy. Regular pregnancy tests should be conducted before and during treatment, following the doctor's instructions. If triglyceride levels in the blood are very high, there is a risk of acute pancreatitis, so lipid levels should be checked periodically. During treatment, skin and mucous membranes may become dry, so moisturizers should be used frequently. Increased sensitivity to sunlight can occur, so it is advisable to avoid UV exposure and external irritants. As this may affect mental health, consult a doctor immediately if symptoms of depression appear. Muscle pain or joint pain can occur, so avoid excessive physical activity and inform healthcare professionals if symptoms are severe. Contact lenses may become difficult to wear, so wearing glasses if necessary is advisable. This medication should not be used during pregnancy or breastfeeding, and nursing mothers should not take this medication. Children and adolescents require special precautions, and it is not recommended for children under 12 years of age. The elderly may have a higher risk of side effects such as joint pain, so caution is needed. This drug must be taken with sufficient water during meals to reduce esophageal irritation. Taking this drug with other vitamin A preparations or certain antibiotics may increase the risk of side effects, so inform healthcare professionals. This medication should never be shared with others, and any unused medicine after treatment should be returned to the pharmacist. It should be stored away from direct sunlight and kept out of reach of children.

Mucosal dryness, skin dryness, skin damage, itching, nasal dryness, chapped lips, dry eyes, nasal bleeding, pharyngeal mucosal dryness, hoarseness, conjunctivitis, reversible corneal opacification, cheilitis, dermatitis, skin peeling, skin weakening, palm and sole skin peeling, skin infection, increased sensitivity to sunburn, reversible alopecia, fulminant acne, persistent alopecia, hypertrichosis, paronychia, nail growth abnormalities with increased granulation tissue formation, photosensitivity, pyogenic granuloma, hyperpigmentation, sweating, hair abnormalities, pyogenic fungal infection, worsening acne, facial dermatitis, urticaria, eruptive xanthoma, nodular erythema, erythema, disseminated herpes simplex, hypopigmentation, photoallergic reaction, contusions, abnormal wound healing, myalgia, arthralgia, abdominal pain, rhabdomyolysis, hyperostosis, arthritis, calcification of ligaments and tendons, reduced bone density, premature 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, fatigue, dizziness, insomnia, neuro-irritability, sensory abnormalities, weakness, stroke, fainting, blepharitis, ocular irritation, blurred vision, glare, cancer cachexia, color discrimination disorder, cataract, keratitis, corneal opacification, 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 infections, voice changes, congestion, localized and systemic infections, anemia, increased erythrocyte sedimentation rate, thrombocytopenia, thrombocytosis, neutropenia, agranulocytosis, allergic reactions, reduced erythrocyte count, nonspecific genitourinary symptoms, glomerulonephritis, urethritis, menstrual irregularities, erectile dysfunction, decreased libido, gynecomastia, hypertriglyceridemia, reduced serum HDL, hypercholesterolemia, increased blood glucose levels, elevated serum CPK levels, diabetes, hyperuricemia, elevated ALP, elevated AST, elevated ALT, elevated GGTP, elevated LDH, vasculitis, palpitations, tachycardia, vascular thromboembolic disease, stroke, transient chest pain, fatigue, systemic hypersensitivity reactions, anaphylactic reactions, 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, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

This medication is sensitive to light, so it should be stored in an opaque, airtight container. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius to prolong the effectiveness of the drug.

Appearance

For domestic use: oval soft capsules of dark brown color containing a deep yellow oily substance. For export: oval soft capsules of purple color containing a yellow oily substance.

Package unit

For domestic use: 100 capsules (10 capsules/PTP X 10) For export: 30 capsules (10 capsules/PTP X 3)