Nimigen Soft Capsule (Isotretinoin)

Adult dose

Because the therapeutic effects and adverse reactions of this medicine are dose-dependent, adjust the dose as appropriate according to the patient's symptoms and condition. ○ Initial dose Administer 0.5 mg/kg body weight per day of isotretinoin while monitoring the response. ○ Maintenance dose Administer 0.5～1.0 mg/kg 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 per day and take with meals. A cumulative dose of 120 mg per kg of body weight during each course of treatment improves the rate of symptom improvement and lowers the relapse rate. The treatment period may vary depending on the daily dose, but usually takes 16～24 weeks, and symptoms may continue to improve even after treatment is discontinued. Therefore, 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 at 10 mg per day of this medicine and adjust the dose. ○ Patients with intolerance: Continue treatment at a low dose. In this case, the treatment period is prolonged and the risk of relapse is increased. In such patients, continue treatment at the maximum tolerated dose to achieve the optimal effect.

This medicine must not be used by women who are pregnant or may become pregnant, as it poses a very high risk of severe fetal malformation. Effective contraception methods must be used before, during, and after treatment with at least two methods. Pregnancy testing should be carried out regularly each month before and during treatment, and per the medical professional's instructions. If the serum triglyceride levels are very high, acute pancreatitis may occur, so these levels should be checked and managed periodically. Healthcare professionals prescribing and dispensing this medication must be thoroughly acquainted with the pregnancy prevention program and provide guidance to the patient. Patients with renal or liver function problems, hypervitaminosis A, significantly elevated blood lipid levels, and those allergic to this medication should not receive it. This medication may cause drying of the skin and mucous membranes, leading to common symptoms such as dry skin, itching, dry lips, dry eyes, etc. Neuropsychiatric adverse effects can also occur, such as skin irritation, hair loss, myalgia, arthralgia, headache, and depression, so it is imperative to consult a healthcare professional immediately if symptoms arise. Due to dry eyes, keratitis or vision disturbances may occur, so it is advisable to consult an ophthalmologist if there is discomfort in the eyes. This medication can interact with other vitamin A preparations, certain antibiotics, and hormonal contraceptives, so any other medications being taken must be disclosed. Nursing mothers should not use this medication as it can be transmitted in breast milk and affect the baby. Caution should be exercised when using in children and adolescents, particularly during growth periods due to the risk of skeletal abnormalities. Elderly patients may have an increased risk of arthralgia, so they should be cautious while taking it. During treatment, regular checks of liver function, blood lipid levels, and blood sugar levels should be performed, and appropriate measures should be taken if abnormalities are found. Symptoms such as headache, vomiting, facial flushing may appear in case of overdose, so it is critical to adhere to the prescribed dosage, and medical facilities should be consulted immediately in case of overdose. This medication should be taken with plenty of water with meals to reduce esophageal irritation. During storage, it should be kept out of the reach of children, protected from direct sunlight, and stored in its original container.

Mucosal dryness, dry skin, skin damage, itching, nasal dryness, lip dryness, eye dryness, nasal bleeding, pharyngeal mucosa dryness, hoarseness, conjunctivitis, reversible corneal opacity, cheilitis, urticaria, dermatitis, skin peeling, skin weakening, peeling of the skin on palms and soles, skin infections, increased sensitivity to sunburn, reversible alopecia, fulminant acne, persistent exfoliation, hirsutism, paronychia, increased granulation tissue formation in nail dystrophy, photosensitivity, pyogenic granuloma, hyperpigmentation, sweating, hair disorders, pyogenic mycosis, acne exacerbation, facial dermatitis, urticaria, papular xanthoma, nodular erythema, flushing, disseminated herpes simplex, hypopigmentation, phot allergic 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, worsening depression, aggressive behavior, violent behavior, emotional instability, behavioral disorders, suicidal ideation, suicide attempts, suicide, psychosis, pseudotumor cerebri, seizures, drowsiness, lethargy, dizziness, insomnia, neuroirritability, sensory disturbances, debility, stroke, fainting, blepharitis, ocular irritation, blurred vision, glare, cancer adaptation disorder, color discrimination 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, gum bleeding, gum inflammation, esophagitis, esophageal ulcer, elevated liver transaminase levels, hepatitis, nasopharyngitis, bronchial spasms, respiratory infections, voice changes, nasal congestion, localized systemic infections, anemia, increased erythrocyte sedimentation rate, thrombocytopenia, thrombocytosis, neutropenia, agranulocytosis, allergic reactions, decreased red blood cell count, nonspecific genitourinary symptoms, glomerulonephritis, urethritis, menstrual abnormalities, erectile dysfunction, decreased libido, gynecomastia, hypertriglyceridemia, decreased serum HDL, hypercholesterolemia, elevated blood glucose levels, increased serum CPK, diabetes mellitus, 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, keratitis, dry eyes, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

This medication is sensitive to light, so it should be stored in a container that blocks light. It is advisable to store it at room temperature between 1 degree and 30 degrees. This helps maintain the efficacy of the medication for a longer period.

Appearance

Yellowish oily substance contained in reddish-brown oval soft capsules

Package unit

Domestic - 50 capsules/PTP, Domestic - 50 capsules/box [10 capsules/PTP×5], Domestic - 60 capsules/box [10 capsules/PTP×6], Domestic - 90 capsules/box [10 capsules/PTP×9], Export - 30 capsules/box [10 capsules/PTP×3]