Finple 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/day of isotretinoin while monitoring the response. ○ Maintenance dose Administer 0.5～1.0 mg/kg/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 meals. A cumulative dose of 120 mg/kg over each course of treatment increases the rate of symptom improvement and reduces the relapse rate. The duration of treatment may vary according to 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 resume treatment only after a washout period of at least 8 weeks. ○ Patients with renal failure: Experience with administration is very limited. If this medicine is administered, start at 10 mg/day and adjust the dose. ○ Patients with intolerance: Continue treatment at a low dose. In such cases, the treatment period is extended and the risk of relapse is increased. For these patients, continue treatment at the maximum tolerated dose to achieve the best possible effect.

This medication should never be given to women who are pregnant or may become pregnant. This is due to the very high risk of serious congenital disabilities for the fetus. Women of childbearing potential must practice strict contraception before, during, and after treatment, and undergo regular pregnancy tests. If pregnancy is confirmed during treatment, consult a physician immediately. This medication should not be used by patients with poor liver or kidney function, vitamin A toxicity, high blood lipid levels, or allergies to soybean oil, soy, or peanuts. Caution is advised when administering to patients with metabolic abnormalities such as hyperlipidemia, diabetes, or pancreatitis. During treatment, various skin and eye-related side effects may arise, including dry skin, dry lips, itching, keratitis, so it is recommended to use moisturizers and lip protectants. Additionally, symptoms related to the central nervous system such as myalgia, arthralgia, headache, and depression may appear, so if such symptoms occur, consult healthcare professionals immediately. Regular monitoring of liver function, blood lipids, and blood glucose is necessary, and if abnormalities are found, dosage adjustments or discontinuation of the medication may be required. During treatment, it is safe to avoid exposure to UV light and not to use in conjunction with keratolytic or peeling acne treatments. This medication should be taken with plenty of water to reduce esophageal irritation. Moreover, for a period after treatment, blood donation should be prohibited, and any leftover medication should be returned to a pharmacist. Special precautions are required for children and the elderly, and it is not recommended for children under 12 years of age. In case of overdose, symptoms of vitamin A excess such as headache, vomiting, and facial flushing may appear, requiring immediate visit to a medical institution. Finally, it is essential to follow the doctor's instructions strictly and comply thoroughly with pregnancy prevention programs during the course of this medication.

Mucosal dryness, skin dryness, skin damage, itching, nasal dryness, lip dryness, eye dryness, nasal bleeding, oropharyngeal mucosal dryness, hoarseness, conjunctivitis, reversible corneal opacity, cheilitis, vesicular lesions, dermatitis, skin peeling, skin atrophy, peeling of the skin on palms and soles, skin infection, increased sensitivity to sunburn, reversible alopecia, acute acne, persistent alopecia, hirsutism, paronychia, dysplastic nail growth with increased granulation tissue formation, photosensitivity, purulent granuloma, hyperpigmentation, sweating, hair abnormalities, fungal skin infection, exacerbation of acne, facial dermatitis, urticaria, eruptive xanthomas, erythema nodosum, flushing, disseminated herpes simplex, hypopigmentation, photoallergic reaction, bruising, abnormal wound healing, myalgia, joint pain, abdominal pain, rhabdomyolysis, hyperostosis, arthritis, calcification of ligaments and tendons, decreased bone density, premature 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, fatigue, dizziness, insomnia, nervousness, sensory abnormalities, weakness, stroke, syncope, blepharitis, eye irritation, blurred vision, photophobia, cancer adaptation disorder, color discrimination disorder, cataract, keratitis, corneal opacity, difficulty wearing contact lenses, hearing impairment, visual impairment, optic neuritis, tinnitus, nonspecific gastrointestinal symptoms, nausea, hemorrhagic diarrhea, enteritis, inflammatory bowel disease, pancreatitis, bleeding and inflammation of the gums, esophagitis, esophageal ulcer, increased liver transaminase levels, hepatitis, nasopharyngitis, bronchospasm, respiratory infection, voice changes, 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 glucose 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, lymphadenitis, increased prolactin, presence of leukocytes and erythrocytes in urine, headache, vomiting, facial flushing, abdominal pain, dizziness, drowsiness, hypersensitivity, itching, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

This medication is sensitive to light and should be stored in a container that does not allow light in. Additionally, it is important to store it at room temperature between 1 to 30 degrees Celsius to maintain potency.

Appearance

[Domestic] Yellowish opaque substance in a reddish-brown oval soft capsule [Export] Yellow viscous content in a reddish-brown soft capsule

Package unit

[Domestic] - 100 capsules/box [(10 capsules/PTP×10)], [Export] - 30 capsules/PTP