Isotrein Soft Capsule (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 of isotretinoin per kg of body weight per day, monitoring the response. ○ Maintenance dose Administer 0.5～1.0 mg of this medicine per kg of body weight 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, take in 2 divided doses daily with food. A cumulative dose of 120 mg per kg of body weight during each course of treatment increases the rate of symptom improvement 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 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 the optimal effect.

This medication should not be used by women who are pregnant or may become pregnant. It can cause serious congenital malformations in the fetus, so it is essential to conduct pregnancy tests before and during treatment and to use two or more effective contraceptive methods concurrently. This medication should not be administered to patients with poor liver and kidney function, those with hypervitaminosis A, patients with very high levels of blood lipids, and those with specific allergy histories. During treatment, symptoms such as dry skin, chapped lips, and dry eyes may occur, so it is advisable to use moisturizers and lip protectants. Additionally, the skin may become more sensitive to sunlight, so caution regarding UV protection is necessary. This medication can increase blood triglyceride levels, posing a risk for acute pancreatitis, so lipid levels should be regularly monitored through blood tests. If symptoms of pancreatitis arise, the medication should be discontinued immediately. It can also affect mental health, and if symptoms of depression or psychiatric disturbances occur, treatment should be stopped promptly and a specialist should be consulted. This medication may exacerbate side effects when used in combination with other vitamin A formulations or certain antibiotics, so patients should inform their physician or pharmacist of any other medications they are taking. During the treatment period, regular blood tests should be conducted to check liver function, lipid levels, and blood sugar, and if abnormalities are observed, dosage adjustment or treatment discontinuation should be considered. This medication should be used with caution in specific patient populations such as children, the elderly, and diabetic patients, and it is essential to follow regular examinations as directed by a physician before and during treatment. When taking medication, it should always be consumed with a sufficient amount of water with meals to reduce esophageal irritation, and it should be stored in a tightly closed container that protects from light and out of reach of children.

Mucosal dryness, skin dryness, skin damage, itching, nasal dryness, lip dryness, eye dryness, epistaxis, hoarseness, conjunctivitis, reversible corneal opacity, cheilitis, rash, dermatitis, skin peeling, skin weakening, peeling of the skin on palms and soles, skin infection, increased sensitivity to sunlight, reversible hair loss, fulminant acne, persistent alopecia, hirsutism, paronychia, increased formation of granulation tissue in nail dysplasia, photosensitivity, pyogenic granuloma, hyperpigmentation, sweating, hair abnormalities, pyogenic fungal infection, acne exacerbation, facial dermatitis, urticaria, erythema multiforme, 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, premature epiphyseal closure, tendinitis, sacroiliitis, headache, depression, exacerbation of depression, aggressive or violent behavior, emotional instability, behavioral disorder, suicidal thoughts, suicide attempts, suicide, psychosis, pseudotumor cerebri, seizures, drowsiness, lethargy, dizziness, insomnia, neurotoxicity, sensory disturbances, weakness, stroke, syncope, blepharitis, eye irritation, blurred vision, glare, cancer adaptation disorder, color discrimination disorder, cataract, keratitis, corneal opacity, difficulty wearing contact lenses, hearing impairment, visual impairment, optic neuritis, tinnitus, non-specific 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 infection, voice changes, congestion, localized or systemic infection, anemia, increased erythrocyte sedimentation rate, thrombocytopenia, thrombocytosis, neutropenia, agranulocytosis, allergic reactions, decreased red blood cell counts, non-specific 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 thrombotic 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 white blood cells and red blood cells in urine, headache, vomiting, flushing, abdominal pain, dizziness, drowsiness, hyperreactivity, itching, keratitis, dry eyes, polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis

This medication should be stored in a tightly closed container that blocks light and kept at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the effectiveness of the medication and prevent degradation.

Appearance

(Domestic use) A yellow, oily substance in a reddish-brown oval soft capsule. (Export use) A reddish-brown soft capsule containing a yellow oily substance.

Package unit

Domestic use - 30 capsules/box [(10 capsules/PTP x 3)], Export use - 30 capsules/box [(10 capsules/PTP x 3)]