Edurant Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Rilpivirine HCl

Indications/Uses

HIV-1 infection in combination w/ other antiretroviral agents in treatment-naive adults w/ viral load ≤100,000 HIV-1 RNA copies/mL.

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Dosage/Direction for Use

Adult 1 tab once daily.

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Overdosage

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Administration

Should be taken with food: Take w/ meals for optimal absorption.

Contraindications

Hypersensitivity. Co-administration w/ anticonvulsants carbamazepine, oxcarbazepine, phenobarb, phenytoin; antimycobacterials, rifampicin, rifapentine; PPIs, omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole; glucocorticoid systemic dexamethasone (except single dose treatment); St John's wort.

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Special Precautions

Virologic failure & development of resistance; fat redistribution; immune reconstitution inflammatory syndrome. Pregnancy & lactation. Childn <18 yr. Elderly >65 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Decreased WBC count, Hb, platelet count. Increased fasted total cholesterol, LDL-C, 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. Grade 3 & 4: Increased rransaminases, depression, abdominal pain, dizziness, rash.

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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.

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Storage

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Description

View Edurant description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Antivirals

ATC Classification

J05AG05 - rilpivirine ; Belongs to the class of non-nucleoside reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.

Regulatory Classification

Presentation/Packing

Form

Edurant FC tab 25 mg

Packing/Price

30's

Edurant

rilpivirine

Manufacturer:

Janssen

Distributor:

Zuellig Pharma