Akinol Soft Capsule (Isotretinoin)

Adult dose

The therapeutic effects 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 0.5 mg/kg of body weight per day of isotretinoin, monitoring 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, take in 2 divided doses daily with meals. A cumulative dose of 120 mg/kg of body weight during each course of treatment improves the rate of symptom resolution and reduces the recurrence rate. The treatment period may vary depending on the daily dose, but is usually 16–24 weeks. Symptoms may continue to improve even after treatment is discontinued. If symptoms recur, repeat the above treatment course, but do not resume treatment until at least an 8-week treatment-free period has elapsed. ○ Patients with renal impairment: Experience with administration is very limited. If this medicine is administered, start at 10 mg per day and adjust the dose. ○ Patients with intolerance: Continue treatment at a low dose. In such cases, the treatment period will be extended and the risk of recurrence will be higher. For these patients, continue treatment at the maximum tolerated dose to achieve optimal effects.

This medication should never be used by women who are pregnant or may become pregnant, as taking this drug during pregnancy carries a very high risk of serious birth defects. Therefore, all women taking this medication must use two or more reliable methods of contraception starting one month before treatment and continuing for one month after treatment ends. Additionally, this medication is not to be administered to patients with impaired liver or kidney function, patients with hypervitaminosis A, or patients with extremely high blood lipid levels. During treatment, the skin and mucous membranes may become very dry, and symptoms such as cracked lips, itching, and skin peeling may occur. The eyes may also become dry and itchy, and rarely, vision changes may occur, so if any abnormal symptoms appear, consult a doctor immediately. Muscle pain, joint pain, headaches, and neurological symptoms such as depression or mood changes may also occur, so caution is advised. Blood tests may show increased triglycerides and cholesterol levels; regular monitoring is necessary, and dietary adjustments or medication changes may be required. This medication must be taken with food and with ample water to prevent esophageal irritation. Also, combining this drug with other vitamin A preparations or certain antibiotics may increase the risk of side effects, so it is essential to inform the doctor of any other medications being taken. Do not donate blood while on this medication, and any leftover medication should be returned to the pharmacist. Lastly, special precautions are necessary for children and elderly patients, especially children under 12 years of age, for whom this medication is not recommended.

Mucosal dryness, skin dryness, skin damage, itching, nasal dryness, lip dryness, eye dryness, nasal bleeding, hoarseness, conjunctivitis, reversible corneal opacification, cheilitis, urticaria, dermatitis, skin peeling, skin weakening, peeling of the skin on palms and soles, skin infection, increased sensitivity to sunburn, reversible alopecia, fulminant acne, persistent alopecia, hirsutism, paronychia, nail dystrophy with increased granulation tissue formation, photosensitivity, pyogenic granuloma, excessive pigmentation, sweating, hair anomalies, pyogenic fungal infection, acne exacerbation, facial dermatitis, urticaria, eruptive xanthomas, nodular erythema, flushing, disseminated herpes simplex, hypopigmentation, photoallergic reaction, contusion, abnormal wound healing, myalgia, arthralgia, abdominal pain, rhabdomyolysis, hyperostosis, arthritis, calcification of ligaments and tendons, decreased bone density, early epiphyseal closure, tendonitis, sacroiliitis, headache, depression, exacerbation of depression, aggressive or violent behavior, emotional instability, behavioral disorders, suicidal ideation, suicide attempts, suicide, psychosis, pseudotumor cerebri, seizures, drowsiness, lethargy, dizziness, insomnia, neuroexcitability, sensory abnormalities, weakness, stroke, syncope, blepharitis, ocular irritation, blurred vision, glare, cancer acumen disorder, color discrimination disorder, cataract, keratitis, corneal opacity, difficulty in wearing contact lenses, hearing impairment, visual 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 infections, voice changes, nasal congestion, local 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, reduced libido, gynecomastia, hypertriglyceridemia, reduced serum HDL, hypercholesterolemia, elevated blood sugar levels, increased serum CPK levels, 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 reaction, 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, hypersensitivity, itching

This medication should be stored in a tightly closed container that blocks light, at a temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain its effectiveness for a longer period.

Appearance

Yellow oily substance in purple oval soft capsules

Package unit

For domestic use) - 100 capsules/box [10 capsules/PTP × 10], for export) - 30 capsules/Alu-Alu, for export) - 100 capsules/Alu-Alu