Edurant

Edurant

rilpivirine

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Rilpivirine HCl
Indications/Uses
HIV-1 infection in combination w/ other antiretroviral agents in treatment-naive adults.
Dosage/Direction for Use
Administration
Should be taken with food: Take w/ meals for optimal absorption.
Contraindications
Special Precautions
Virologic failure; development of resistance; prolongation of QTc interval of ECG; Torsade de pointes. Fat redistribution; severe immune deficiency. Cytomegalovirus retinitis; generalised &/or focal mycobacterial infections; Pneumocystis jiroveci pneumonia. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive or operate machinery. Pregnancy & lactation. Childn <18 yr. Elderly >65 yr.
Adverse Reactions
Decreased WBC count, Hb, platelet count. Increased fasted total cholesterol, LDL-cholesterol, triglycerides, pancreatic amylase, lipase transaminases & bilirubin. Decreased appetite. Insomnia, abnormal dreams, depression, sleep disorders, depressed mood. Headache, dizziness; somnolence. Nausea, abdominal pain & discomfort, vomiting, dry mouth. Rash; fatigue.
Drug Interactions
Decreased plasma conc w/ CYP3A inducers. Increased plasma conc w/ CYP3A inhibitors. Reduced therapeutic effect w/ drugs that increase gastric pH. Increased exposure to other drugs transported by P-gp. Inhibited active renal tubular creatinine secretion therefore increased exposure to metformin.
MIMS Class
ATC Classification
J05AG05 - rilpivirine ; Belongs to the class of non-nucleoside reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Presentation/Packing
Form
Edurant FC tab 25 mg
Packing/Price
30's
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