Isotam Soft Capsule (Isotretinoin)

Adult dose

The therapeutic effect and adverse reactions of this medicine are dose-dependent; therefore, adjust the dose appropriately according to the patient's symptoms and condition. ○ Initial dose Administer isotretinoin at 0.5 mg per kg of body weight daily, while monitoring the response. ○ Maintenance dose Administer this medicine at 0.5～1.0 mg per kg of body weight daily; the dose may be increased up to 2.0 mg for patients with severe acne. For low doses, take once daily; for high doses, divide the dose into 2 administrations daily and take with meals. A cumulative dose of 120 mg per kg of body weight in each course of treatment increases the rate of symptom improvement and reduces the recurrence rate. The duration of treatment may vary depending on the daily dose, but is usually 16～24 weeks. Symptoms may continue to improve even after treatment is discontinued. Therefore, if symptoms recur, repeat the above course of treatment, but restart treatment 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 daily and adjust the dose. ○ Patients with intolerance Continue treatment at a low dose. In this case, the treatment period will be prolonged and the risk of recurrence will increase. In such patients, continue treatment at the maximum tolerated dose to achieve the optimal effect.

This medication carries a very high risk of causing serious birth defects if taken during pregnancy; therefore, women who are pregnant or may become pregnant must not take it under any circumstances. A pregnancy test must be performed before starting treatment and during therapy, and two effective forms of contraception must be used during treatment and for one month after therapy ends. This drug is only to be used for patients with severe acne and must be taken under the strict supervision of a physician. Acute pancreatitis may occur if blood triglyceride levels are very high, so blood lipid levels should be regularly monitored, and treatment should be stopped if abnormalities are found. Common side effects during medication include skin dryness, lip dryness, and eye dryness; using moisturizers or lip balms can help. Since skin irritation may worsen, it is advisable to avoid exposure to ultraviolet rays and not to combine with exfoliants or phototherapy. This medication may affect liver function, blood lipids, and blood glucose levels, so regular blood tests are necessary. It may impact mental health; if symptoms of depression or suicidal thoughts occur, consult a physician immediately. Muscle pain or joint pain may occur, so caution is needed during strenuous physical activity. It may be difficult to wear contact lenses, so if there is discomfort in the eyes, it is better to use glasses. Special precautions are needed when administering this drug to children and the elderly, and it is not recommended for children under 12 years old. Overdosage may result in symptoms such as headache, vomiting, and facial flushing, so dosage must be strictly adhered to. It is advisable to take this medication with sufficient water and food to reduce esophageal irritation. This medication should be stored in a tightly sealed container away from direct sunlight and out of reach of children; do not take medications past their expiration date.

Mucosal dryness, skin dryness, skin damage, itching, nasal dryness, lip dryness, eye dryness, nasal bleeding, pharyngeal mucosal dryness, hoarseness, conjunctivitis, corneal opacity, cheilitis, rash, dermatitis, skin peeling, skin weakening, palm and sole skin peeling, skin infection, increased sensitivity to sunburn, reversible alopecia, fulminant acne, persistent alopecia, hirsutism, paronychia, increased formation of granulation tissue in nail dysplasia, photosensitivity, pyogenic granuloma, hyperpigmentation, sweating, hair abnormalities, pyogenic fungal infection, exacerbated acne, facial dermatitis, urticaria, erythema toxicum, nodular erythema, flushing, disseminated herpes simplex, hypopigmentation, photoallergic reactions, 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, exacerbation of depression, aggressive behavior, emotional instability, behavioral disorder, suicidal ideation, suicide attempt, suicide, psychosis, pseudotumor cerebri, seizure, drowsiness, lethargy, dizziness, insomnia, neuroirritability, sensory abnormalities, weakness, stroke, syncope, blepharitis, ocular irritation, blurred vision, glare, cancer adaptation disorder, color discrimination disorder, cataract, keratitis, difficulty wearing contact lenses, hearing impairment, vision 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, bronchospasm, respiratory infection, voice change, nasal congestion, localized and systemic infections, anemia, increased erythrocyte sedimentation rate, thrombocytopenia, thrombocytosis, neutropenia, agranulocytosis, allergic reactions, decreased erythrocyte count, nonspecific genitourinary symptoms, glomerulonephritis, urethritis, menstrual irregularities, erectile dysfunction, decreased libido, gynecomastia, hypertriglyceridemia, decreased serum HDL, hypercholesterolemia, elevated blood sugar levels, increased blood CPK levels, diabetes, hyperuricemia, increased 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 leukocytes and erythrocytes in urine, headache, vomiting, facial flushing, abdominal pain, dizziness, drowsiness, hypersensitivity, itching, keratitis, dry eye, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

This medication should be stored in a sealed container that blocks light, at a temperature between 1 to 30 degrees Celsius. This storage method helps maintain the drug's efficacy and safety.

Appearance

Brownish-red oval soft capsules containing a thick yellow oily substance

Package unit

30 capsules/PTP, 300 capsules/PTP