Prezcobix Tablets

Adult dose

Swallow this medicine whole; do not chew or crush it. Patients who start treatment with this medicine should not change the dose or stop taking it without consulting a specialist. For patients who are antiretroviral treatment-naive, or who have received antiretroviral treatment and have no resistance* to darunavir, administer 1 tablet of this medicine once daily with food. *Darunavir resistance-associated mutations (DRV-RAMs) : V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V Genotypic testing is recommended for patients who have previously received antiretroviral treatment. However, if genotypic testing is not available, patients with no prior protease inhibitor (PI) treatment may take this medicine once daily, while patients with prior protease inhibitor (PI) treatment should use other antiretroviral agents, including darunavir as a single agent, instead of this medicine. The type of food does not affect exposure to this medicine. Do not initiate treatment with this medicine in patients with creatinine clearance below 70 mL/min when it is administered with medicines requiring dose adjustment according to creatinine clearance, including emtricitabine, lamivudine, and tenofovir disoproxil fumarate. Assess creatinine clearance before initiating this medicine. When this medicine is used concomitantly with tenofovir disoproxil fumarate, assess creatinine clearance, urine glucose, and urine protein at baseline. Do not administer this medicine to patients with severe hepatic impairment. Do not initiate this medicine during pregnancy. Patients who become pregnant while taking this medicine should switch to another treatment. If less than 12 hours have passed since the missed dose, take the missed dose as soon as possible. If 12 hours or more have passed since the missed dose, do not take the missed dose; resume the regular dosing schedule. Take with food, and do not take a double dose.

Child dose

The safety and efficacy of this drug in pediatric patients have not been established.

This medication should not be used in conjunction with certain other drugs. In particular, for patients with liver function issues, there is a risk of liver damage, so liver function tests should be performed before use, and liver status should be monitored periodically during treatment. This medication is not administered to patients with hypersensitivity or those prohibited from combining with certain drugs, as well as to patients with severe liver impairment. For patients with mild to moderate liver impairment, it should be used cautiously, and if abnormal symptoms appear during medication use, consult a doctor immediately. During the use of this medication, various side effects may occur, such as diarrhea, rash, and headache, and treatment may be discontinued in cases of severe side effects. This medication has many drug interactions; therefore, if taking other medications, a consultation with a doctor or pharmacist is essential, and it should not be combined with certain drugs. Use during pregnancy is not recommended, and if breastfeeding, it should be avoided as it may affect the baby through breast milk. Safety has not been fully established for children, the elderly, or patients with kidney disorders, so caution is required. In cases of overdose, there is no specific antidote, so appropriate treatment must be sought immediately from a medical institution, and it should be stored out of reach of children in its original container.

Hepatitis, acute hepatitis, cytolytic hepatitis, abnormal liver function, fatigue, loss of appetite, nausea, jaundice, dark urine, liver tenderness, hepatomegaly, diarrhea, rash, drug hypersensitivity reaction, abdominal pain, dyspepsia, bloating, nausea, vomiting, fatigue, immune reconstitution syndrome, diabetes mellitus, myalgia, headache, abnormal dreams, pruritus, angioedema, Stevens-Johnson syndrome, urticaria, bone necrosis, decreased appetite, asthenia, acute pancreatitis, gynecomastia, abdominal distension, fat redistribution, rhabdomyolysis, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis, crystalline kidney disease, increased bleeding, hyperglycemia, hypercholesterolemia, hypertriglyceridemia, nausea, increased pancreatic enzymes, rash, gynecomastia, abdominal distension, osteonecrosis, dizziness, severe skin reactions, severe rash, fever, generalized malaise, myalgia, arthralgia, vesicle, oral mucosal lesions, conjunctivitis, hepatitis, eosinophilia, spontaneous cutaneous hematoma, hemorrhagic arthropathy, diabetes, hyperglycemia, ketoacidosis, weight gain, increased blood lipid and glucose levels, immune reconstitution syndrome, autoimmune disease, myositis, rhabdomyolysis, arthralgia, joint stiffness, dizziness

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best kept at room temperature between 1 degree and 30 degrees Celsius.

Appearance

Pink oval film-coated tablets

Package unit

30 tablets/bottle