Roaccutane Soft Capsules (Isotretinoin)

Adult dose

The therapeutic effect and adverse reactions of this drug 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 body weight per day of this drug; the dose may be increased to 2.0 mg in 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 of body weight during each course of treatment improves the rate of symptom improvement and reduces the relapse rate. The duration of treatment may vary according to 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 treatment should be resumed only after a drug-free period of at least 8 weeks. ○ Patients with renal failure: Experience with administration is very limited. If this drug is administered, start at 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. In such patients, continue treatment at the maximum dose that can be tolerated to achieve optimal efficacy.

This medicine can cause severe fetal malformations if taken during pregnancy; therefore, women who are pregnant or may become pregnant must not take it under any circumstances. Regular pregnancy tests must be conducted before and during treatment, and at least two pregnancy tests are required before starting treatment. Additionally, during treatment and for one month after it ends, two or more reliable contraceptive methods must be used. If pregnancy is confirmed, consult a doctor immediately to decide whether to discontinue treatment or continue the pregnancy. There is a risk of acute pancreatitis if blood triglyceride levels are very high, so blood lipid levels should be checked regularly, and treatment should be adjusted if abnormalities are found. This medicine can cause side effects related to vitamin A overdose, with common symptoms including dry skin, chapped lips, and dry eyes. Rarely, severe skin reactions, neurological abnormalities, and liver function abnormalities may occur, and any unusual symptoms should be reported to a doctor immediately. While taking this medicine, do not use other vitamin A preparations or certain antibiotics, and be cautious as the effectiveness of hormonal contraceptives may be reduced. Avoid vigorous physical activities during treatment, and be careful when driving or operating machinery as night vision impairment or visual disturbances may occur. This medicine should be taken with plenty of water and food to reduce esophageal irritation. Store it out of reach of children, away from direct sunlight, and keep it sealed in its original container.

Mucosal dryness, skin dryness, skin damage, itching, nasal dryness, lip dryness, eye dryness, nosebleeds, pharyngeal mucosal dryness, hoarseness, conjunctivitis, corneal opacification, cheilitis, rash, dermatitis, skin peeling, skin weakening, palm and sole skin peeling, skin infection, increased sensitivity to sunburn, reversible alopecia, explosive acne, persistent hair loss, hirsutism, paronychia, increased formation of granulation tissue in nail dystrophy, photosensitivity, pyogenic granuloma, hyperpigmentation, sweating, hair abnormalities, pyogenic fungal infection, worsening of acne, facial dermatitis, urticaria, erythema multiforme, nodular erythema, flushing, disseminated herpes simplex, hypopigmentation, photoallergic reaction, bruising, abnormal wound healing, myalgia, arthralgia, abdominal pain, rhabdomyolysis, hyperostosis, arthritis, calcification of ligaments and tendons, decreased bone density, premature epiphyseal closure, tendinitis, sacroiliitis, headache, depression, exacerbation of depression, aggressive or violent behavior, emotional instability, behavioral disorders, suicidal thoughts, suicide attempts, suicide, psychosis, pseudotumor cerebri, seizures, drowsiness, lethargy, dizziness, insomnia, neural hyperexcitability, sensory abnormalities, weakness, stroke, syncope, blepharitis, ocular irritation, blurred vision, photophobia, cancer adaptation disorder, color vision 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, bleeding and inflammation of the gums, esophagitis, esophageal ulcer, elevated liver transaminases, hepatitis, nasopharyngitis, bronchial spasm, respiratory infection, voice changes, congestion, localized and systemic infections, anemia, increased erythrocyte sedimentation rate, thrombocytopenia, thrombocytosis, neutropenia, agranulocytosis, allergic reactions, decreased erythrocyte count, nonspecific urogenital symptoms, glomerulonephritis, urethritis, menstrual irregularities, erectile dysfunction, decreased libido, gynecomastia, hypertriglyceridemia, decreased serum HDL, hypercholesterolemia, elevated blood glucose levels, increased serum CPK, diabetes, hyperuricemia, elevated ALP, elevated AST, elevated ALT, elevated GGTP, elevated LDH, vasculitis, palpitations, tachycardia, vascular thrombotic disease, stroke, transient chest pain, fatigue, systemic hypersensitivity response, 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, irritability, itching

This medicine is sensitive to light and should be stored in a container that does not allow light in. It is also important to store the medicine at room temperature, which should not be too high or too low, specifically between 1 and 30 degrees Celsius.

Appearance

Brown oval soft capsules containing a thick yellow oily substance

Package unit

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