ZeroQutan Soft Capsule (Isotretinoin)

Adult dose

Because 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 isotretinoin at 0.5 mg/kg of body weight per day, while monitoring the response. ○ Maintenance dose Administer this medicine at 0.5～1.0 mg/kg of body weight per day; 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 with meals. A cumulative dose of 120 mg/kg of body weight per course of treatment increases the rate of symptom improvement and decreases the relapse rate. The duration of treatment may vary according to the daily dose, but usually takes 16～24 weeks. Symptoms may continue to improve even after treatment is stopped. Therefore, if symptoms recur, repeat the above course of treatment, but resume 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 per day and adjust the dose. ○ Patients with intolerance: Continue treatment at a low dose. In this case, the treatment period will be extended and the risk of relapse will increase. In such patients, continue treatment at the maximum tolerated dose to achieve optimal effect.

This medication must not be used by women who are pregnant or may become pregnant because it poses a very high risk of causing serious birth defects. While taking this medication, at least two reliable methods of contraception must be used, and regular pregnancy tests should be conducted before, during, and after treatment. Pregnancy tests should be performed monthly before and during treatment, and for a period following the discontinuation of treatment. This medication may pose risks for patients with hypertriglyceridemia, so serum triglyceride levels should be monitored and controlled regularly. If triglyceride levels become too high or symptoms of pancreatitis occur, the medication should be stopped immediately. This medication can cause significant dryness of the skin and mucous membranes, resulting in symptoms such as dry skin, chapped lips, and dry eyes. Therefore, using moisturizers and lip protectants is recommended. Additionally, as the skin may become sensitive and sunburn more easily, it is necessary to avoid direct sunlight and use sunscreen. This medication can also affect mental health, leading to symptoms of depression or mood changes; immediate consultation with healthcare professionals is necessary if any psychological changes occur. It may affect the eyes and vision, so if symptoms like eye pain or blurred vision occur, an ophthalmologist should be consulted immediately. This medication can affect liver function and blood lipid levels, thus regular blood tests and liver function tests are required. Especially, this medication should not be used by children under 12 years old, pregnant women, nursing mothers, or people with weakened kidney or liver function. While taking the medication, it is important not to combine it with other vitamin A drugs or specific antibiotics, and not to take other medications without consulting a doctor or pharmacist. This medication should be taken with a sufficient amount of water during meals, and habits should be maintained to minimize exposure to direct sunlight and skin irritation after taking it. Finally, this medication must never be shared with others, and any remaining medication should be returned to a pharmacist for safe disposal.

Mucous membrane dryness, skin dryness, skin damage, itching, nasal dryness, lip dryness, eye dryness, nasal bleeding, pharyngeal mucosa 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, acute acne, persistent hair loss, hirsutism, paronychia, increase in the formation of granulation tissue in nail growth abnormalities, photosensitivity, pyogenic granuloma, hyperpigmentation, sweating, hair abnormalities, pyogenic fungal infection, acne exacerbation, facial dermatitis, urticaria, rash-like xanthomas, nodular erythema, flushing, disseminated herpes simplex, hypopigmentation, photoallergic reaction, contusions, 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 or violent behavior, emotional instability, behavioral disorders, suicidal thoughts, suicide attempts, suicide, psychosis, pseudotumor cerebri, seizures, drowsiness, lethargy, dizziness, insomnia, hyperexcitability, sensory disturbances, weakness, stroke, fainting, blepharitis, eye irritation, blurred vision, photophobia, cancer-related fatigue, color discrimination disorders, cataracts, keratitis, difficulty wearing contact lenses, hearing impairment, visual impairment, optic neuritis, tinnitus, nonspecific gastrointestinal symptoms, nausea, hemorrhagic diarrhea, enteritis, inflammatory bowel disease, pancreatitis, gum bleeding, gum inflammation, esophagitis, esophageal ulcer, increased liver transaminase levels, hepatitis, nasopharyngitis, bronchospasm, respiratory infections, voice changes, nasal congestion, localized and systemic infections, anemia, increased erythrocyte sedimentation rate, thrombocytopenia, thrombocytosis, neutropenia, agranulocytosis, allergic reactions, decreased red blood cell count, nonspecific urogenital symptoms, glomerulonephritis, urethritis, menstrual abnormalities, erectile dysfunction, decreased libido, sexual dysfunction, gynecomastia, hypertriglyceridemia, decreased serum HDL, hypercholesterolemia, increased blood glucose levels, elevated serum CPK levels, diabetes, hyperuricemia, increased ALP, increased AST, increased ALT, increased GGTP, increased 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 white blood cells and red blood cells in urine, headache, vomiting, facial flushing, abdominal pain, dizziness, drowsiness, hypersensitivity, itching, keratitis, dry eyes, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

This medication should be stored in a tightly sealed container that does not allow light, preferably at a temperature between 1 and 30 degrees Celsius. By storing it this way, the effectiveness of the medication can be maintained for a longer time.

Appearance

A reddish-brown oval soft capsule containing a dark yellow emulsion.

Package unit

100 capsules (10 capsules/PTP*10)