Eletec
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Eletec
Manufacturer
Distributor
Contents
Efavirenz 600 mg, Tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg
Indications / Uses
Used alone as a complete regimen or in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection in adults.
Dosage / Direction for Use
Recommended Dose: 1 tab once daily taken orally on the empty stomach, preferably at bedtime.
Renal Impairment: Should not administered in patients with creatinine clearance (CrCl) <50 mL/min.
Contraindications
Hypersensitivity to efavirenz, tenofovir disoproxil fumarate, lamivudine or to any of the excipients of Eletec.
Eletec should not be administered concurrently with astemizole, bepridil, cisapride, midazolam, pimozide, triazolam or ergot derivatives because competition for CYP3A4 by efavirenz could result in the inhibition of the metabolism of these drugs and create the potential for serious and/or life-threatening adverse reactions (eg, cardiac arrhythmias, prolonged sedation or respiratory depression).
Eletec must be administered with herbal preparations containing St. John’s wort (Hypericum perforatum) used for anxiety and depression or voriconazole (antifungal agent).
Special Precautions
Serious Psychiatric Symptoms: Immediate medical evaluation is recommended.
Nervous System Symptoms (NSS): Nervous system symptoms are frequent usually begins 1-2 days after initiating therapy and resolve in 2-4 weeks. Dosing at bedtime may improve tolerability.
Rash: Discontinue if severe rash develops.
Convulsions: Use caution in patients with a history of seizures.
Redistribution/Accumulation of Body Fat: Observed in patients receiving antiretroviral therapy.
Products with Same or Similar Active Ingredients: Do not use with drugs containing efavirernz, tenofovir disoproxil fumarate, lamivudine or with drugs containing emtricitabine.
Efavirenz: Co-administration of efavirenz, lamivudine or with drugs containing emtricitabine can alter the concentrations of other drugs and other drugs may alter the concentration of efavirenz.
The potential for drug-drug interactions must be consider before and during therapy.
Didanosine: Tenofovir disoproxil fumarate increases didanosine concentrations. Use with caution and monitor for evidence of didanosine toxicity when co-administered.
Consider dose reductions or discontinuation of didanosine if warranted.
Atazanavir: Co-administration of Eletec and atazanavir/ritonavir is not recommended.
Lopinavir/Ritonavir: C-atazanavir administration increases tenofovir concentrations. Monitor for evidence of tenofovir toxicity.
Hepatitis B or C Co-Infection or Therapy with Medications Associated with Liver Toxicity: Monitor liver enzymes. Caution must be observed in patients with hepatic impairment.
Use In Pregnancy & Lactation
Use in pregnancy: Eletec should not be used during the 1st trimester of pregnancy.
Women of Childbearing Potential: Women receiving Eletec should avoid pregnancy.
Use in lactation: Women infected with HIV should be instructed not to breastfeed.
Use in children: Safety and efficacy not established in patients <18 years.
Adverse Reactions
Most common adverse reactions (≥10%) which occurred are diarrhea, nausea, fatigue, headache, dizziness, depression, insomia, abnormal dreams and rash.
Description
Each film-coated tablet contains efavirenz 600 mg, tenofovir disoproxil fumarate 300 mg (equivalent to tenofovir disoproxil 245 mg) and lamivudine 300 mg.
Eletec, a combination of 2 nucleoside analog human immunodeficiency virus (HIV)-1 reverse transcriptase inhibitors and non-nucleoside HIV-1 reverse transcriptase inhibitor is indicated for use alone as a complete regimen or in combination with other antiretroviral agent for the treatment of HIV-1 infection in adults.
ATC Classification
J05AR11 – lamivudine, tenofovir disoproxil and efavirenz ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
POM
Presentation / Packing
FC Tab x 30’s.