Pirespa 200 mg (Pirfenidone)

Adult dose

Adults: The initial dose is 1 tablet (200mg of pirfenidone) 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 daily) 3 times daily. If gastrointestinal adverse reactions occur during administration of this drug, closely monitor the patient's response and consider dose reduction or discontinuation. Patients with hepatic impairment No dose adjustment is required in patients with mild to moderate hepatic impairment (e.g., Child-Pugh A, B); however, administer with caution because plasma concentrations of this drug may increase. Perform liver function tests regularly during administration of this drug. If liver enzyme levels increase significantly, consider dose adjustment or discontinuation (see 4. General Precautions under Precautions for Use). Do not administer this drug to patients with severe hepatic impairment. Patients with renal impairment No dose adjustment is required in patients with mild to moderate renal impairment. Do not administer this drug to patients with severe renal impairment (creatinine clearance <30mL/min) or end-stage renal disease who are on dialysis. Older adults No dose adjustment is required in older adults aged 65 years or older.

Child dose

The safety and efficacy have not been established in children and adolescents 18 years of age or younger.

This medication should not be used in patients with allergies to the active ingredient or excipients. Patients with severe liver or kidney damage, and those with certain genetic metabolic disorders should not take this medication. Additionally, it may pose risks when taken with certain other medications, so consultation with healthcare professionals is necessary. Patients with impaired liver function, reduced kidney function, the elderly, and those with a history of photosensitivity should use this medication cautiously. This drug can cause various side effects such as photosensitivity, loss of appetite, elevated liver enzymes, gastrointestinal disturbances, skin rashes, etc., so if any symptoms appear during treatment, the patient should consult a doctor immediately. In particular, regular liver function tests should be conducted, and if liver enzyme levels rise, dosage adjustment or discontinuation may be required. Blood tests should be performed to check white blood cell counts, and if any abnormalities are detected, appropriate measures should be taken. If drowsiness or dizziness occurs during treatment, driving or operating hazardous machinery should be avoided. Patients should carefully monitor weight changes and adjust nutritional intake if necessary during treatment. In case of severe allergic reactions or angioedema, discontinue use immediately and seek medical assistance. If symptoms of hyponatremia are suspected, blood tests should be performed to check the condition. If serious skin reactions occur, the medication should be discontinued immediately, and treatment should be sought, and patients who have previously experienced such reactions should not use this medication. This medication may interact with drugs that inhibit or induce specific enzymes, so patients must discuss any simultaneous medications with healthcare professionals. Smoking may reduce the efficacy of this medication, so it is advisable to refrain from smoking during treatment. Grapefruit juice intake should be limited as it can increase the blood concentration of this medication. Women who are pregnant or may become pregnant are advised to avoid taking this medication, and nursing mothers should also refrain from using it. The safety and efficacy in pediatric patients under the age of 18 have not been established; therefore, it is not used in this population. Elderly patients may need careful monitoring due to the possibility of reduced bodily function during treatment. In the case of overdose, inform healthcare professionals immediately to receive appropriate treatment, and closely monitor the patient's condition. This medication should be stored out of reach of children and should be kept in its original container to maintain quality. During treatment, patients should avoid direct sunlight exposure and take precautions against photosensitivity, such as using sunscreen.

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, papular dermatitis, 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, dyspepsia, dyspnea, cough, productive cough, facial flushing, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with systemic symptoms and eosinophilia, myalgia, arthralgia, weakness, chest pain, decreased appetite, upper respiratory infection, urinary tract infection, drug-induced liver injury, increased bilirubin accompanied by ALT and AST elevation, angioedema, anaphylaxis, pneumonia, sputum disease, hemoptysis, cold, pneumothorax, runny nose, systemic weakness, urticaria, facial edema, pleural effusion, sputum discoloration, rhinitis, sore throat, increased sputum, pulmonary edema, purulent sputum, post-nasal drip, pleuritic pain, aspiration pneumonia, back pain, chills, discomfort in the chest, influenza-like symptoms, death, flank pain, limb edema, dry mouth, epigastric pain unrelated to food, colitis, gastrointestinal bleeding, chapped lips, cheilitis, gingivitis, hyperlipidemia, hypokalemia, thirst, hypernatremia, hyperkalemia, hyperglycemia, serum lipid abnormalities, pigmentation abnormalities, exfoliative dermatitis, alopecia, sensory disturbances, hemiparesis, cerebral hypoxia, trigeminal neuralgia, neuropathy, syncope, dysuria, increased urination, pulmonary hypertension, aortic aneurysm, peripheral cyanosis, cyanosis, clubbing, multiple fractures, limb weakness, joint dislocation, brain metastasis, cataracts, ocular abnormalities, myocardial infarction, anemia, sleep disorders, pain due to medical device use, pulmonary embolism, skin symptoms, dermatitis, skin pain, palmoplantar erythema sensory syndrome, seborrheic dermatitis, skin discoloration, skin disorders, skin sensitivity, skin lesions, skin reactions, decreased appetite, pain, loss of taste, seizures, confusion, musculoskeletal discomfort, diplopia, skin abrasions, shingles, COVID-19, acute otitis media, polyps, peripheral edema, angina, unstable angina, vasculitis, dry mouth, memory impairment, hypersensitivity, hyponatremia

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

Appearance

Oval film-coated tablet, light yellow to light brown in color

Package unit

100 tablets (10 tablets x 10)/PTP