Each uncoated tablet contains:
Etravirine ………………. 200 mg
Excipients ………………….. q.s.
Indication and Usage:
ETRATEC is a human immunodeficiency virus type 1 (HIV-1) specific , non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated:
In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other antiretroviral agents. In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use ETRATEC in combination with only N[t]RTis.
The safety and efficacy of ETRATEC have not been established in pediatric patients or treatment-naive adult patients .
Dosage and administration:
The recommended oral dose of ETRATEC tablets is 200 mg taken twice daily following a meal. The type of food does not affect the exposure to etravirine
Mechanism of Action:
Etravirine is an NNRTI of human immunodeficiency virus type 1 (HIV-1). Etravirine binds directly to reverse transcriptase (RT) and blocks the RNA-dependent and DNA dependent DNA polymerase activities by causing a disruption of the enzyme’s catalytic site. Etravirine does not inhibit the
human DNA polymerases a, andy
Warning and Precautions:
Severe, potentially life-threatening and fatal skin reactions have been reported. These include cases of Stevens Johnson syndrome , hypersensitivity reaction, toxic epidermal necrolysis and erythema multiforme. Immediately discontinue treatment if severe hypersensitivity , severe rash or rash with systemic symptoms or liver transaminase elevations develop and monitor clinical status, including liver transaminases closely.
ETRATEC should not be co-administered with the following antiretrovirals:
– Ti pra n a vir I riton a vir, fo sam pre n a vir/ riton a vir , atazanavir/ritonavir
-Protease inhibitors administered without ritonavir
Co-administration of ETRATEC with drugs that inhibit or induce CYP3A, CYP2C9, and CYP2C19 may alter the therapeutic effect or adverse reaction profile of etravirine.
Co-administration of ETRATEC with drugs that are substrates of CYP3A, CYP2C9, and CYP2C19 or are transported by P glycoprotein may alter the therapeutic effect or adverse reaction profile of the co-administered drug(s).
Use in Specific Population:
Pregnancy: Pregnancy Category 8- Use during pregnancy only if the potential benefit justifies the potential risk.
Nursing Mothers: Mother should not breastfeed due to both the potential for HIV transmission and the potential for adverse reactions in nursing infants.
The most common adverse drug reactions of moderate to severe intensity(>/= 2%) which occurred at a higher rate than placebo are rash and peripheral neuropathy.
Storage: Store in a cool, dry place and protect from light and moisture.
Keep medicine away from children.
Bottle of 30’s & 60’s Tablets