Tutec
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Tutec
Contents
Emtricitabine 200 mg, tenofovir disoproxil fumarate 300 mg
Indications / Uses
TUTEC is a combination of Emtricitabine 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 / Direction for Use
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 30-49 mL/min: 1 tablet every 48 hours. CrCl below 30 mL/min or hemodialysis: Do not use TUTEC.
Pre-exposure Prophylaxis: 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 CrCl is below 60 mL/min. If a decrease in CrCl is observed in uninfected individuals while using TUTEC for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use.
Contraindications
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.
Special Precautions
New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Assess creatinine clearance (CrCl) before initiating treatment with TUTEC. Monitor CrCl and serum phosphorus in patients at risk. Avoid administering TUTEC with concurrent or recent use of nephrotoxic drugs.
Co-administration 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.
Pediatrics: Safety and efficacy not established in patients- less than 12 years of age or weighing less than 35 kg.
Use In Pregnancy & Lactation
Nursing mothers: Women infected with HIV-1 should be instructed not to breastfeed.
Adverse Reactions
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.
Interactions
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. Monitor for evidence of tenofovir toxicity.
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 film-coated tablet contains 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate, (which is equivalent to 245 mg of tenofovir disoproxil), as active ingredients.
TUTEC tablets are fixed dose combination tablets containing emtricitabine and tenofovir disoproxil fumarate. Emtricitabine, a synthetic nucleoside analog of cytidine. Tenofovir disoproxil fumarate (tenofovir DF) is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both emtricitabine and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase.
Emtricitabine: The chemical name of emtricitabine is 5-fluoro-1-(2R,5S)-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl] cytosine. Emtricitabine is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position.
It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.24.
Emtricitabine is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25°C. The partition coefficient (log p) for emtricitabine is -0.43 and the pKa is 2.65.
Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir disoproxil fumarate is 9-[(R)-2[[bis[[(isopropoxycarbonyl)oxy]-methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52.
Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25°C. The partition coefficient (log p) for tenofovir disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of tenofovir disoproxil fumarate except where otherwise noted.
TUTEC tablets are for oral administration.
ATC Classification
J05AR03 – tenofovir disoproxil and emtricitabine ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation / Packing
FC tab 30’s.
Manufacturer
Distributor