Piresco Tablet 400 Milligrams (Pirfenidone)

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, up to 600mg per dose 3 times daily (1800mg daily). 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 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 concentrations may increase. Perform liver function tests regularly during treatment with this drug. If liver enzyme levels increase significantly, consider dose adjustment or discontinuation. (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 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 patients with end-stage renal disease receiving dialysis. Elderly patients No dose adjustment is necessary for patients 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 used by patients who are allergic to the active ingredient or excipients. Patients with severely impaired liver or kidney function should also avoid this medication. Patients with certain genetic issues should refrain from using this drug. Careful administration is required for patients with mild liver impairment, decreased kidney function, elderly patients, and those with a history of photosensitivity. This medication may cause photosensitivity; therefore, it is advisable to avoid direct sunlight exposure while taking it, and to wear long clothing, hats, and use sunscreen when outdoors. This medication may affect liver function, so regular liver function tests should be conducted before and during treatment. If there is a significant elevation in liver enzyme levels, it may be necessary to adjust the dosage or discontinue use. Gastrointestinal symptoms such as decreased appetite, nausea, and diarrhea may occur during treatment, so consult a physician if these symptoms become severe. Additionally, monitor changes in leukocyte counts through blood tests and take appropriate actions if abnormalities are noted. This medication may cause drowsiness or dizziness; caution is advised when driving or operating hazardous machinery. Weight loss may occur, and patients should monitor their weight and increase nutritional intake as necessary. Allergic reactions or severe skin reactions may occur; if symptoms such as swelling of the face, lips, or tongue appear, discontinue use immediately and seek medical attention. There is a risk of hyponatremia, and patients should be tested if related symptoms arise. This medication may interact with other drugs, particularly certain antibiotics, antidepressants, grapefruit juice, and when used in combination with smoking. Women who are pregnant or breastfeeding are advised not to take this medication. Children under the age of 18 should not use this medication as its safety and efficacy have not been established. Elderly patients should be closely monitored as their physical functions may be diminished. In case of overdose, immediately inform healthcare professionals and closely monitor vital signs while receiving necessary treatment. This medication should be kept out of reach of children and stored in its original container to maintain quality.

Photosensitivity, loss of appetite, elevated γ-GTP, gastric discomfort, nausea, drowsiness, dizziness, unsteadiness, headache, feeling of heaviness in the head, altered taste, 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, raised bilirubin, indigestion, shortness of breath, cough, productive cough, facial flushing, dry skin, erythematous rash, maculopapular rash, pruritic rash, sunburn, 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, anaphylaxis, skin symptoms, dermatitis, skin pain, palmoplantar erythema and sensory disturbance syndrome, seborrheic dermatitis, skin discoloration, skin disorders, skin tenderness, skin lesions, skin reactions, reduced food intake, pain, loss of taste, seizures, confusion, musculoskeletal discomfort, diplopia, skin abrasion, shingles, COVID-19, acute otitis media, polyps, peripheral edema, angina, unstable angina, aneurysm, vasculitis, dry mouth, memory impairment, hair loss, dysuria, hypersensitivity, hyponatremia

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 degree and 30 degrees Celsius to ensure the drug's effectiveness and prevent deterioration.

Appearance

Oval film-coated tablets of pale yellow to light brown color

Package unit

100 tablets (10 tablets/PTP x 10)