Piresco Tablet 600 Milligrams (Pirfenidone)

Adult dose

Adults: The initial dose of this drug is 200 mg of pirfenidone per dose, taken orally 3 times daily 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 daily (1800 mg/day). If gastrointestinal adverse reactions occur during treatment, closely monitor the patient's response and consider reducing the dose or discontinuing treatment. Patients with hepatic impairment No dosage adjustment is necessary in patients with mild to moderate hepatic impairment (e.g., Child-Pugh A or B); however, this drug should be administered with caution because its blood concentration may increase. Perform liver function tests regularly during treatment, and consider dosage adjustment or discontinuation if liver enzyme levels increase significantly (see Precautions for Use, 4. General Precautions). This drug should not be administered to patients with severe hepatic impairment. Patients with renal impairment No dosage adjustment is necessary in patients with mild to moderate renal impairment. This drug should not be administered to patients with severe renal impairment (creatinine clearance <30mL/min) or end-stage renal disease requiring dialysis. Older adults No dosage adjustment is necessary in adults aged 65 years or older.

Child dose

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

This medication should not be taken by individuals who are allergic to the active ingredient or additives. Patients with severe liver dysfunction or end-stage liver disease, those with severe kidney dysfunction, or patients with end-stage renal disease requiring dialysis should not use this medication. In particular, it should not be taken with the drug fluvoxamine, and those with a genetic lactase deficiency should also avoid this medication. Patients with slightly impaired liver function, weak kidney function, the elderly, and those with a history of photosensitivity should use this medication with caution. During use, sensitivity to sunlight may increase, so it is important to avoid direct sunlight and wear long clothing or hats, and use sunscreen. If any abnormal symptoms such as skin rash or itching occur, consult a doctor immediately. Liver function test results may worsen, so regular liver function tests should be performed before and during use, and if liver enzyme levels rise significantly, the medication should be discontinued or the dosage reduced. Gastrointestinal symptoms such as loss of appetite, nausea, and diarrhea may occur, so if symptoms are severe, consult a doctor. Blood tests should also be performed regularly to check for blood abnormalities such as leukopenia, and if symptoms like dizziness or drowsiness occur, avoid driving or operating dangerous machinery. Weight loss may occur, so monitor weight changes carefully and increase nutritional intake if necessary. Rarely, severe allergic reactions or angioedema, serious skin reactions may occur, so if these symptoms occur, stop taking the medication immediately and seek medical attention. Smoking may reduce the efficacy of this medication, so it is advisable to quit smoking during treatment. Grapefruit juice should also be avoided, and there may be interactions with other medications, so if you are taking other drugs, be sure to inform your doctor or pharmacist. The use of this medication is not recommended for pregnant or breastfeeding women, and it should not be used in children under 18 years of age as safety and efficacy have not been established. In case of overdose, seek medical treatment immediately.

Photosensitivity, loss of appetite, increased γ-GTP, gastric discomfort, nausea, drowsiness, dizziness, unsteadiness, headache, sensation of heaviness in the head, taste disorder, anxiety, insomnia, depression, diarrhea, chest burning, abdominal bloating, vomiting, constipation, gastroesophageal reflux disease, stomatitis, abdominal discomfort, abdominal pain, papulosis, lip paresthesia, rash, itching, erythema, eczema, lichen planus, palpitations, leukocytosis, eosinophilia, thrombocytopenia, leukopenia, agranulocytosis, neutropenia, musculoskeletal pain, fatigue, weight loss, fever, flushing, elevated liver enzymes (γ-GTP, AST, ALT), increased alkaline phosphatase, elevated LDH, increased bilirubin, dyspepsia, respiratory distress, cough, productive cough, facial flushing, dry skin, erythematous rash, maculopapular rash, pruritic rash, sunburn, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with systemic symptoms and eosinophilia, myalgia, arthralgia, weakness, chest pain, decreased appetite, upper respiratory tract infection, urinary tract infection, drug-induced hepatic injury, anaphylaxis, skin symptoms, dermatitis, skin pain, palmoplantar erythematous sensory dysesthesia syndrome, seborrheic dermatitis, skin discoloration, skin disorders, skin tenderness, skin lesions, skin reactions, decreased food intake, pain, loss of taste, seizures, altered mental status, musculoskeletal discomfort, diplopia, skin abrasion, herpes zoster, COVID-19, acute otitis media, polyps, peripheral edema, angina pectoris, unstable angina, aneurysm, vasculitis, dry mouth, memory impairment, alopecia, dysuria, hypersensitivity, hyponatremia

This medication should be stored in a tightly closed container to prevent air or moisture from entering, and it is best stored at room temperature between 1 degree to 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication and prevents degradation.

Appearance

Pale yellow to light brown oval film-coated tablets

Package unit

100 tablets (10 tablets/PTP x 10)