Isotino Soft Capsule 10 Milligrams (Isotretinoin)

Adult dose

Since the therapeutic effects and adverse reactions of this medicine are dose-dependent, adjust the dose appropriately according to the patient's symptoms and condition. ○ Initial dose Administer 0.5 mg/kg of body weight per day of isotretinoin, observing the response. ○ Maintenance dose Administer 0.5–1.0 mg/kg of body weight per day of this medicine; 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 food. A cumulative dose of 120 mg/kg of body weight during each course of treatment improves the rate of symptom resolution and reduces the relapse rate. The treatment period 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 drug-free 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 of this medicine and adjust the dose. ○ Patients with intolerance: Continue treatment at a low dose. In these patients, the treatment period will be longer and the risk of relapse will be higher. To achieve optimal efficacy in such patients, continue treatment at the maximum dose they can tolerate.

This medicine can cause serious birth defects if taken during pregnancy, so women who are pregnant or may become pregnant should not take it under any circumstances. If pregnancy is confirmed during treatment, consult a doctor immediately, and regular pregnancy tests must be conducted before and during treatment. This medicine should not be administered to patients with liver and kidney function issues, those with hypervitaminosis A, or individuals with very high serum lipid levels. Regular monitoring of serum triglyceride levels is necessary during treatment to prevent severe side effects such as acute pancreatitis. Symptoms such as dry skin, itching, dry lips, and dry eyes may occur frequently, so it is advisable to use moisturizers and lip protectants. Mental symptoms such as muscle aches, joint pain, headaches, and depression can also occur, so consult a doctor immediately if any unusual symptoms appear. This medicine should not be used in conjunction with other vitamin A preparations or certain antibiotics, and caution is necessary as it may interact with contraceptives. Women who are breastfeeding should not take this medicine as it can be transmitted through breast milk and affect the baby. Special attention is needed for children and the elderly, and it is particularly not recommended for children under 12 years old. It is advisable to take this medicine with sufficient water and food to reduce esophageal irritation. During treatment, avoid exposure to ultraviolet light, and avoid treatments that can irritate the skin, such as chemical peels, laser treatments, and waxing. Liver function and serum lipid and glucose levels should be checked periodically during treatment and adjusted as necessary if any abnormalities are found. After taking this medicine, men should use condoms for 30 days to avoid sexual relations with women who could become pregnant. This medicine must be taken according to a doctor's prescription and instructions, and should not be shared with others or stopped arbitrarily.

Mucosal dryness, skin dryness, skin damage, itching, nasal dryness, lip dryness, eye dryness, nosebleeds, hoarseness, conjunctivitis, corneal opacity, cheilitis, dermatitis, skin peeling, skin fragility, peeling of the palms and soles, skin infections, increased sensitivity to sunburn, reversible alopecia, fulminant acne, persistent hair loss, hirsutism, paronychia, nail dysplasia with increased granulation tissue, photosensitivity, pustular granuloma, hyperpigmentation, sweating, hair abnormalities, pustular fungal infection, worsening acne, facial dermatitis, rash, eruptive xanthomas, nodular erythema, flushing, disseminated herpes simplex, hypopigmentation, photoallergic reactions, bruising, 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, worsening depression, aggressive or violent behavior, emotional instability, behavioral disorders, suicidal thoughts, suicide attempts, suicide, psychosis, pseudotumor cerebri, seizures, drowsiness, lethargy, dizziness, insomnia, nervous hyperexcitability, sensory disturbances, weakness, stroke, fainting, blepharitis, ocular irritation, blurred vision, glare, cancer adaptation disorder, color differentiation 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 ulcer, elevated liver transaminase levels, hepatitis, nasopharyngitis, bronchospasm, respiratory infections, voice changes, congestion, localized and systemic infections, anemia, increased erythrocyte sedimentation rate, thrombocytopenia, thrombocytosis, neutropenia, agranulocytosis, allergic reactions, decreased erythrocyte levels, nonspecific genitourinary symptoms, glomerulonephritis, urethritis, menstrual irregularities, erectile dysfunction, decreased libido, gynecomastia, hypertriglyceridemia, decreased serum HDL, hypercholesterolemia, elevated blood sugar levels, increased 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, lymphadenitis, increased prolactin, detection of leukocytes and erythrocytes in urine, keratitis, dry eyes, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

This medicine should be stored in a tightly closed container that can block light, and should ideally be kept at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the effectiveness and safety of the medication.

Appearance

Red-brown oval soft capsules containing a thick yellow oily substance.

Package unit

100 capsules (10 capsules/PTPX10)