Pirfenidone 400 mg Tablet

Adult dose

Adults: As the initial dose, administer 200mg of pirfenidone orally 3 times daily after meals. Depending on the patient's response and tolerability, the dose may be increased by 200mg per dose at 2-week intervals to 600mg per dose 3 times daily (1800mg per day). If gastrointestinal adverse reactions occur during treatment with this drug, closely monitor the patient's response and consider dose reduction or discontinuation. 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 blood concentration may increase. Perform liver function tests regularly during treatment with this drug, and consider dose adjustment or discontinuation if liver enzyme levels increase significantly. (See 4. General Precautions under Precautions for Use.) This drug 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 drug should not be administered to patients with severe renal impairment (creatinine clearance<30mL/min) or patients with end-stage renal disease on 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 with allergies to the active ingredients or excipients. It is also contraindicated in patients with severe liver dysfunction, end-stage liver disease, severe kidney dysfunction, or patients with end-stage kidney disease requiring dialysis. This drug should not be used in conjunction with the specific medication fluvoxamine and should also be avoided in patients with hereditary lactose intolerance. Caution is required when administering to patients with mild liver impairment, diminished kidney function, the elderly, and those with allergies or sensitivities to certain pigment components. During the use of this medication, photosensitivity may occur, leading to skin reactions such as rashes or itching; therefore, it is advisable to avoid direct sunlight and wear long clothing, hats, and sunscreen when going outside. Regular liver function tests are necessary, and if liver enzyme levels rise significantly, discontinuation or dosage adjustment should be considered. Gastrointestinal symptoms may include decreased appetite, nausea, diarrhea, etc., and if symptoms become severe, consulting a physician is necessary. Regular blood tests should be conducted to check for leukopenia or agranulocytosis, and if abnormalities are found, appropriate measures must be taken. This drug may cause drowsiness, dizziness, or fatigue; caution should be taken when driving or operating heavy machinery. Weight loss can occur frequently, so weight changes should be monitored and nutritional intake increased if necessary. Angioedema or severe allergic reactions may occur, so if swelling of the face, lips, or tongue, or breathing difficulties arise, treatment should be stopped immediately, and medical attention sought. Hyponatremia may occur, so if symptoms such as nausea, headache, or dizziness appear, a doctor should be consulted. Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported; if skin abnormalities occur, the drug should be discontinued immediately. This drug may interact with medications that inhibit or induce certain enzymes, so it is essential to consult a doctor or pharmacist regarding concomitant medications. Smoking can reduce the effectiveness of this medication, so it is advisable to quit smoking during the treatment period. Grapefruit juice may interfere with the metabolism of this drug, so intake should be limited. It is recommended that women who are pregnant or of childbearing potential avoid using this drug, and it should be avoided during breastfeeding as well. Safety and efficacy have not been established in children under 18 years of age. Elderly patients may have diminished body functions, so caution should be exercised when administering this medication. In cases of overdose, the patient's condition should be closely monitored, and necessary treatment should be administered. This medication should be kept out of the reach of children and stored in its original container to prevent degradation.

Photosensitivity, loss of appetite, increased γ-GTP, gastrointestinal discomfort, nausea, drowsiness, dizziness, unsteadiness, headache, heaviness in the head, taste disturbance, anxiety, insomnia, depression, diarrhea, heartburn, abdominal bloating, vomiting, constipation, gastroesophageal reflux disease, stomatitis, abdominal discomfort, abdominal pain, papulitis, chapped 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, indigestion, shortness of breath, cough, productive cough, facial flushing, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction accompanied by 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, headache, coma, gastroesophageal reflux disease, epigastric pain, gastritis, intestinal gas retention, dry skin, erythematous rash, maculopapular rash, pruritic rash, sunburn, shingles, COVID-19, acute otitis media, pneumonia, sputum disease, hemoptysis, cold, nasal discharge, systemic weakness, urticaria, facial swelling, pleural effusion, sputum discoloration, rhinitis, sore throat, increased sputum, pulmonary edema, purulent sputum, postnasal drip, pleuritic pain, aspiration pneumonia, back pain, chills, chest discomfort, flu-like symptoms, flank pain, limb edema, elevated C-reactive protein, dry mouth, non-food-related epigastric pain, increased bowel movements, chapped lips, cheilitis, gingivitis, hyperlipidemia, hypokalemia, thirst, hypernatremia, hyperkalemia, hyperglycemia, serum lipid abnormalities, pigmentation abnormalities, exfoliative dermatitis, alopecia, sensory disturbances, brain hypoxia, trigeminal neuralgia, neuropathy, syncope, dysuria, frequent urination, pulmonary hypertension, peripheral cyanosis, cyanosis, clubbing, multiple fractures, limb weakness, joint dislocation, cataract, ocular abnormalities, anemia, sleep disorders, pain associated with medical device usage, pulmonary embolism, skin symptoms, dermatitis, skin pain, palmoplantar erythematous sensory syndrome, seborrheic dermatitis, skin discoloration, skin disorder, skin tenderness, skin lesions, skin reactions, reduced appetite, pain, taste loss, seizures, confusion, musculoskeletal discomfort, diplopia, skin abrasions, memory disturbances

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, ideally at room temperature between 1 and 30 degrees Celsius. By storing it this way, the effectiveness of the medication can be maintained and degradation prevented.

Appearance

Pale yellow oval film-coated tablets

Package unit

90 tablets (6 tablets/PTPX15)