Each film coated tablet contains:
Emtricitabine………………………. 200 mg
Tenofovir Disoproxil Fumarate ……….. 300 mg
(To Provide Tenofovir Disoproxil …….. 245 mg)
Colour: Approved coloured use.
Indications and Usage:
TUTEC is a combination of Emitricitabine and Tenofovir Disoproxil Fumarate, both nucleoside analog HIV-1 reverse transcriptase inhibitors.
TUTEC is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.
TUTEC is indicated in combination with safer sex practices for pre exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.
Dosage and Administration:
Treatment of HIV-1 infection
-Recommended dose in adults and pediatric patients (12 years of age and older and weighing greater than or equal to 35 kg): One tablet once daily taken orally with or without food.
-Recommended dose in renally impaired HIV-1 infected adult patients: Creatinine clearance 3(}-49 mUmin: 1 tablet every 48 hours. CrCI below 30 mUm in or hemodialysis: Do not use TUTEC.
Recommended dose in HIV-1 uninfected adults: One tablet once daily taken orally with or without food.) Recommended dose in renally impaired HIV-uninfected individuals: Do not use TUTEC in HIV-uninfected individuals if CrCI is below 60 mUmin.lf a decrease in CrCI is observed in uninfected individuals while using TUTEC for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use.
Dosage forms and Strengths:
Each Film- coated tablets contains: 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate.
Do not use TUTEC for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status. TUTEC should be used in HIV-. infected patients only in combination with other antiretroviral agents.
Warnings and Precautions:
New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Assess creatinine clearance (CrCI) before initiating treatment with TUTEC. Monitor CrCI and serum phosphorus in patients at risk. Avoid administering TUTEC with concurrent or recent use of nephrotoxic drugs.
Coadministration with Other Products: Do not use with drugs containing emtricitabine or tenofovir disoproxil fumarate including drugs containing lamivudine/zidovudine/abacavir sulphate.Do not administer in combination with adefovir dipivoxil.
Decreases in bone mineral density (BMD): Consider assessment of BMD in patients with a history of pathologic fracture or other risk factors for osteoporosis or bone loss.
Redistribution/accumulation of body fat: Observed in patients receiving antiretroviral therapy.
Immune reconstitution syndrome: May necessitate further evaluation and treatment.
Triple nucleoside-only regimens: Early virologic failure has been reported in HIV-infected patients. Monitor carefully and consider treatment modification.
Comprehensive management to reduce the risk of acquiring HIV-1:
Use as part of a comprehensive prevention strategy including other prevention measures; strictly adhere to dosing schedule.
Management to reduce the risk of acquiring HIV-1 drug resistance: Prior to initiating TUTEC for PrEP- if clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least one month and reconfirm negative HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection. While using TUTEC for PrEP- HIV-1 screening tests should be repeated at least every 3 months.
In HIV 1 infected patients, the most common adverse reactions
(incidence greater than or equal to 10%) are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. In HIV-1 uninfected individuals adverse reactions that was reported were headache, abdominal pain and weight decreased.
Didanosine: Tenofovir disoproxil fumarate increases didanosine concentrations. Use with caution and monitor for evidence of didanosine toxicity (e.g., pancreatitis , neuropathy) when coadministered. Consider dose reductions or discontinuations of didanosine if warranted.
Atazanavir: Coadministration decreases atazanavir concentrations and inCreases tenofovir concentrations. Use atazanavir with TUTEC only with ritonavir; monitor for evidence of tenofovir toxicity. Lopinavir/ritonavir: Coadministration increases tenofovir concentrations. “-\onitorfor evidence of tenofovir toxicity.
Use in Specific Populations:
Nursing mothers: Women infected with HIV-1 should be instructed not to breastfeed.
Pediatrics: Safety and efficacy not established in patients-less than 12 years of age or weighing less than 35 kg.
Store in a cool dry place and protect from light and moisture. Keep Medicine away from children.
30’s tablets bottle pack.