Etratec
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Manufacturer
Distributor
Contents
Etravirine 200 mg
Indications / Uses
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]RTls.
The safety and efficacy of ETRATEC have not been established in pediatric patients or treatment-naïve adult patients.
Dosage / Direction for Use
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.
Contraindications
None.
Special 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.
Use In Pregnancy & Lactation
Pregnancy: Pregnancy Category B – 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.
Adverse Reactions
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.
Click to View ADR Monitoring Form
Interactions
ETRATEC should not be co-administered with the following antiretrovirals: tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/ritonavir; protease inhibitors administered without ritonavir; NNRTls.
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).
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Storage
Store in a cool, dry place and protect from light and moisture.
Description
Each uncoated tablet contains Etravirine 200 mg.
ETRATEC (etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1).
The chemical name for etravirine is 4-[[6-amino-5-bromo-2-[(4-cyanophenyl)amino]-4-pyrimidinyl]oxy]-3,5-dimethylbenzonitrile. Its molecular formula is C20H15BrN6O and its molecular weight is 435.28.
Etravirine is a white to slightly yellowish brown powder. Etravirine is practically insoluble in water over a wide pH range. It is very slightly soluble in propylene glycol and slightly soluble in ethanol. Etravirine is soluble in polyethylene glycol (PEG) 400 and freely soluble in some organic solvents (e.g., N,N-dimethylformamide and tetrahydrofuran).
Mechanism of Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Etravirine is an NNRTI of human immunodeficiency virus type1 (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 α, β and γ.
ATC Classification
J05AG04 – etravirine ; Belongs to the class of non-nucleoside reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Presentation / Packing
Tab 200 mg x 30’s, 60’s.