Anti-infective Agents : Antiviral Agents
OEDUR1 “Edurant FC tablet” 25mg/tab.
適應症：適用於與其他抗反轉錄病毒藥物併用，藉以治療先前未曾使用過抗病毒藥物治療之愛滋病毒(HIV-1)感染且病毒量HIV-1 RNA≦100,000 copies/mL之患者。
Dosing:
Adult:
patients ≥35 kg: Oral: 25 mg once daily.
Pediatric:
Infants and Children <12 years or <35kg: not recommended for use; no dosing recommendations available.
children ≥12 years and adolescents ≥35 kg: refer to adult dosing.
Dose adjustment:
For concomitant therapy with rifabutin: increase to 50 mg once daily in patients on concomitant rifabutin. Decrease to 25 mg once daily when rifabutin is stopped.
Renal Impairment:
Mild or moderate renal impairment: No dosage adjustment necessary.
Severe or end-stage renal impairment (ESRD): Use with caution; no dosage adjustment necessary (HHS [adult] 2015).
Hemodialysis/peritoneal dialysis: Due to extensive protein binding, significant removal by hemodialysis or peritoneal dialysis is unlikely.
Hepatic Impairment:
Mild to moderate impairment: no dosage adjustment necessary.
Severe impairment: there are no dosage adjustments provided in the manufacturer’s labeling.
Contraindication: coadministration with anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin), antimycobacterials (rifampin, rifapentine), proton pump inhibitors (esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole), systemic dexamethasone (more than a single dose), or St John’s wort.
Precaution: depressive disorders, fat redistribution, hepatotoxicity, hypersensitivity, immune reconstitution syndrome.
Adverse effect:
Depression, headache, drowsiness, decreased plasma cortisol, increased serum cholesterol, increased LDL cholesterol, nausea, increased serum ALT, increased serum AST, dizziness, insomnia, abnormal dreams, fatigue, skin rash, increased serum triglycerides, abdominal pain, vomiting, increased serum bilirubin, increased serum creatinine.