Fibro 600 mg Tablet (Pirfenidone)

Adult dose

Adults: The initial dose of this drug is 200 mg of pirfenidone orally 3 times a day after meals. Depending on the patient's response and tolerability, the dose may be increased by 200 mg per dose at 2-week intervals, up to 600 mg per dose 3 times a day (1800 mg per day). If gastrointestinal adverse reactions occur during treatment with this drug, closely monitor the patient's response and consider reducing the dose or discontinuing treatment. Patients with hepatic impairment No dose adjustment is necessary for patients with mild to moderate hepatic impairment (e.g., Child-Pugh A, B); however, this drug should be administered with caution because its plasma concentration may increase. Perform liver function tests regularly during treatment with this drug. If liver enzyme levels increase significantly, consider dose adjustment or discontinuation of treatment (see 4. General Precautions under Precautions for Use). This drug must not be administered to patients with severe hepatic impairment. Patients with renal impairment No dose adjustment is necessary for patients with mild to moderate renal impairment. This drug must not be administered to patients with severe renal impairment (creatinine clearance<30mL/min) or end-stage renal disease requiring dialysis. Elderly patients No dose adjustment is necessary for elderly patients aged 65 years or older.

Child dose

The safety and efficacy have not been established in pediatric and adolescent patients 18 years of age or younger.

This medication should not be used by patients who are allergic to the active ingredient or any excipients. Patients with very poor liver function or severely impaired kidney function should not take this medication. Additionally, it should not be taken with certain medications, so consultation with a physician is required. Patients with a genetic lactose intolerance should also avoid this medication. Patients with mild liver dysfunction, reduced kidney function, elderly patients, and those with allergies to specific dyes should use this medication with caution. During treatment with this medication, light sensitivity may increase, so it is advisable to avoid direct sunlight and to wear long clothing or hats and use sunscreen when going outside. If any abnormal reactions occur, such as skin rashes or itching, the physician should be informed immediately, and liver function tests should be conducted regularly. If liver enzyme levels rise significantly, the dose may need to be reduced or the medication stopped. Gastrointestinal symptoms such as reduced appetite, nausea, diarrhea, etc., may occur, and if the symptoms are severe, medical advice should be sought. Regular blood tests should be performed to monitor changes in white blood cell counts, and if dizziness or drowsiness occurs, it is advisable to avoid driving or operating dangerous machinery. Weight loss may occur during treatment, so weight changes should be monitored, and nutritional intake should be increased if necessary. Rarely, severe allergic reactions or angioedema can occur, so immediate treatment should be sought if symptoms such as swelling of the face, lips, or tongue occur. Symptoms of hyponatremia may also appear, so monitoring for symptoms such as nausea, headache, and dizziness is necessary, along with regular check-ups. Serious skin reactions that may threaten life can occur, so if there are any abnormal skin symptoms, medication should be discontinued immediately. This medication interacts with specific liver metabolic enzymes, so it should not be taken with certain medications or grapefruit juice, and smoking may diminish its effects, so cessation is encouraged. Pregnant or nursing women are advised to avoid this medication, and it is not used in children under 18 years of age as its safety has not been established. Elderly patients may have reduced bodily functions, so they should take this medication cautiously under a doctor's direction. In case of overdose, the patient's condition should be observed closely, and appropriate treatment should be administered. This medication should be stored out of reach of children, kept in its original container, and handled carefully to maintain quality.

Phototoxicity, loss of appetite, elevated γ-GTP, gastric discomfort, nausea, drowsiness, dizziness, unsteadiness, headache, feeling of heaviness in the head, taste disturbances, anxiety, insomnia, depression, diarrhea, heartburn, abdominal bloating, vomiting, constipation, gastroesophageal reflux disease, stomatitis, abdominal discomfort, abdominal pain, papular dermatitis, lip numbness, rash, itching, erythema, eczema, lichen planus, palpitations, leukocytosis, eosinophilia, thrombocytopenia, leukopenia, agranulocytosis, neutropenia, musculoskeletal pain, fatigue, weight loss, fever, flushing, elevated liver enzymes (AST, ALT), increased alkaline phosphatase, elevated LDH, increased bilirubin, dyspepsia, shortness of breath, cough, productive cough, facial flushing, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions with systemic symptoms and eosinophilia, myalgia, arthralgia, weakness, chest pain, decreased appetite, upper respiratory tract infection, urinary tract infection, drug-induced liver injury, angioedema, anaphylaxis, hyponatremia, pneumonia, pneumothorax, hemoptysis, exacerbated shortness of breath, pleural effusion, aspiration pneumonia, lung cancer, myocardial infarction, colitis, gastrointestinal bleeding, influenza-like syndrome, death, limb weakness, eye abnormalities, aortic aneurysm, pancytopenia, hemiparesis, subarachnoid hemorrhage, urticaria, facial edema, rhinitis, sore throat, pulmonary edema, purulent sputum, postnasal drip, pleuritic pain, hemoptysis, back pain, chills, chest discomfort, flank pain, limb edema, elevated C-reactive protein, dry mouth, pain in the epigastrium unrelated to food, increased bowel movements, dry lips, cheilitis, gingivitis, hyperlipidemia, hypokalemia, thirst, hypernatremia, hyperkalemia, hyperglycemia, serum lipid abnormalities, pigmentary disorders, exfoliative dermatitis, alopecia, sensory disturbances, brain hypoxia, trigeminal neuralgia, neuropathy, syncope, dysuria, frequent urination, pulmonary hypertension, peripheral cyanosis, cyanosis, clubbing, multiple fractures, joint dislocation, cataracts, sleep disturbances, pain from medical device usage, pulmonary embolism, skin symptoms, dermatitis, skin pain, palmoplantar erythema syndrome, seborrheic dermatitis, skin discoloration, skin disorders, skin tenderness, skin lesions, skin reactions, decreased appetite, pain, loss of taste, seizures, confusion, musculoskeletal discomfort, double vision, skin abrasions, herpes zoster, COVID-19, acute otitis media, polyps, peripheral edema, angina, unstable angina, vasculitis, dry mouth, memory disturbances, hypersensitivity

This medication should be stored in a sealed container to avoid exposure to air or moisture and kept at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the efficacy of the medication for a long time.

Appearance

Pale yellow oval film-coated tablet

Package unit

90 tablets (6 tablets/PTPX15)