Uniphenidone 200 mg (Pirfenidone)

Adult dose

Adults: The initial dose is 1 tablet (equivalent to 200mg of pirfenidone) orally 3 times daily after meals. Depending on the patient's response and tolerability, the dose may be increased by 1 tablet (200mg) per dose at 2-week intervals, up to 3 tablets per dose (600mg per dose, 1800mg per day) 3 times daily. If gastrointestinal adverse reactions occur during treatment with this medicine, 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 or B); however, this medicine should be administered with caution because its blood concentration may increase. Perform liver function tests regularly during treatment with this medicine and consider dose adjustment or discontinuation if liver enzyme levels increase significantly. (See section 4. General precautions under Precautions for use.) This medicine should 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 medicine should 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 in patients who are allergic to the active ingredients or additives. Patients with severely impaired liver or kidney function should avoid this medication. Consult a doctor when taking with certain drugs as it may exacerbate side effects. Patients with compromised liver function, the elderly, or those with a history of photosensitivity should use this medication with caution. This medication may increase sensitivity to sunlight; therefore, it is important to take precautions against UV exposure when going outdoors. Notify a doctor immediately if any unusual symptoms such as skin rash or itching occur. Regular liver function tests should be conducted, and if liver enzyme levels rise significantly, the medication should be discontinued or adjusted. If gastrointestinal symptoms such as loss of appetite, nausea, or diarrhea occur, consult a doctor to adjust the dosage. Regular blood tests should be conducted, and if abnormalities like leukopenia occur, appropriate treatment is necessary. Drowsiness or dizziness may occur, so avoid driving or operating dangerous machinery. Weight loss may occur, so observe weight changes closely and increase nutritional intake if necessary. In case of serious allergic reactions or angioedema, discontinue the medication immediately and seek emergency treatment. Symptoms of hyponatremia may occur, so regular testing should be conducted, and if symptoms appear, notify a doctor immediately. Rarely, life-threatening skin reactions may occur; therefore, discontinue use immediately if any unusual symptoms are observed. This medication may interact with certain drugs, so inform your doctor if you are taking other medications. Smoking may decrease the effectiveness of this medication, so it is advisable to refrain from smoking during the treatment period. It is safer for women who are pregnant or may become pregnant to avoid this medication. Breastfeeding women are also recommended to avoid taking this medication while nursing. This medication is not established for safety and efficacy in pediatric patients under 18 years of age. The elderly may have decreased bodily functions, so they should use this medication more cautiously. In cases of overdose, patient's condition should be closely monitored and treated as necessary. Store out of reach of children, and keep in the original container to prevent misuse and deterioration of quality.

Photosensitivity, loss of appetite, elevated γ-GTP, stomach discomfort, nausea, drowsiness, dizziness, unsteadiness, headache, feeling of heaviness in the head, altered taste sensation, anxiety, insomnia, depression, diarrhea, chest burning, abdominal bloating, vomiting, constipation, gastroesophageal reflux disease, stomatitis, abdominal discomfort, abdominal pain, papulosis, dry lips, 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, dyspnea, cough, productive cough, facial flushing, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions accompanied by systemic symptoms and eosinophilia, myalgia, arthralgia, weakness, chest pain, decreased appetite, upper respiratory infection, urinary tract infection, drug-induced liver damage, angioedema, anaphylaxis, hyponatremia, pneumonia, sputum diseases, hemoptysis, common cold, pneumothorax, runny nose, worsening of disease, systemic weakness, urticaria, facial edema, pleural effusion, sputum discoloration, rhinitis, pharyngitis, increased sputum, pulmonary edema, purulent sputum, postnasal drip, pleuritic pain, aspiration pneumonia, back pain, chills, discomfort in the chest, flu-like syndrome, death, flank pain, limb swelling, increased C-reactive protein, dry mouth, epigastric pain unrelated to food, colitis, increased bowel movements, dry lips, cheilitis, gingivitis, hyperlipidemia, hypokalemia, thirst, hypernatremia, hyperkalemia, hyperglycemia, serum lipid abnormalities, pigmentation disorders, exfoliative dermatitis, vitiligo, hair loss, sensory abnormalities, cerebral hypoxia, trigeminal neuralgia, neuropathy, syncope, dysuria, polyuria, pulmonary hypertension, aortic aneurysm, peripheral cyanosis, cyanosis, clubbing, multiple fractures, joint dislocation, cataract, ocular abnormalities, anemia, sleep disorders, pain from medical device use, 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 abrasion, shingles, COVID-19, acute otitis media, polyps, peripheral edema, angina, unstable angina, vasculitis, dry mouth, memory disturbances, hypersensitivity

This medication should be stored in a tightly closed container to avoid exposure to air and moisture. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Yellowish to yellow-brown oblong film-coated tablet

Package unit

100 tablets/PTP [(10 tablets/PTP × 10)]