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Tenvir-EM Tablet belongs to a group of medicines called antiretrovirals. It is used to treat HIV (human immunodeficiency virus), the virus that can cause AIDS (acquired immunodeficiency syndrome). It helps to control HIV infection so your immune system can work better.
Tenvir-EM Tablet is not a cure for HIV/AIDS and only helps to decrease the amount of HIV in your body. This helps to lower your risk of getting HIV-related complications and improves your lifespan. It may also be used to prevent HIV infection in some people at high risk. It may be prescribed alone or in combination with other HIV medicines. Your doctor will recommend the best medicines for you and will decide the doses that you need. Follow carefully the instructions for all the medicines that you are given. This medicine is best taken with food. Taking these medicines regularly at the right time greatly increases their effectiveness and reduces the chances of HIV becoming resistant to them. It is important not to miss doses and to keep taking them until your doctor tells you it is safe to stop.
Common side effects of this medicine include nausea, diarrhea, headache, trouble sleeping, rash, and dizziness. These are usually not serious but inform your doctor if they bother you or do not go away. It can also increase the risk of bone loss (osteoporosis) if you take it for a long time. Exercise regularly and take calcium and vitamin D supplements as suggested by your doctor. Some people put on weight while taking medicines to treat HIV/AIDS.
Before taking it, let your doctor know if you have any liver or kidney disease or bone problems. While using it, you may need regular blood tests to check your blood counts, liver function, and kidney function. Since this medicine may cause dizziness or sleepiness, do not drive if you experience these symptoms. Pregnant or breastfeeding women should consult their doctor before using this medicine. Do not have unprotected sex or share personal items like razors or toothbrushes, if you are HIV positive. Talk to your doctor about safe ways like condoms to prevent HIV transmission during sex.
USES OF TENVIR-EM TABLET
SIDE EFFECTS OF TENVIR-EM TABLET
Insomnia (difficulty in sleeping)
HOW TO USE TENVIR-EM TABLET
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Tenvir-EM Tablet is to be taken with food.
HOW TENVIR-EM TABLET WORKS
Tenvir-EM Tablet is a combination of two anti-HIV medicines: Emtricitabine and Tenofovir disoproxil fumarate. They prevent HIV (virus) from multiplying, thereby reducing the amount of virus in your body. They also increase the CD4 cell (white blood cells that protect against infection) count in your blood.
CONSULT YOUR DOCTOR
It is not known whether it is safe to consume alcohol with Tenvir-EM Tablet. Please consult your doctor.
SAFE IF PRESCRIBED
Tenvir-EM Tablet is generally considered safe to use during pregnancy. Animal studies have shown low or no adverse effects to the developing baby; however, there are limited human studies.
SAFE IF PRESCRIBED
Tenvir-EM Tablet is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby.
Tenvir-EM Tablet may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur.
Tenvir-EM Tablet should be used with caution in patients with kidney disease. Dose adjustment of Tenvir-EM Tablet may be needed. Please consult your doctor.
SAFE IF PRESCRIBED
Tenvir-EM Tablet is probably safe to use in patients with liver disease. Limited data available suggests that dose adjustment of Tenvir-EM Tablet may not be needed in these patients. Please consult your doctor.
Black Box Warnings
Post treatment acute exacerbation of hepatitis b, and risk of drug resistance with use of tenofovir df/emtricitabine for pre-exposure prophylaxis (PrEP) in undiagnosed early HIV-1 infection
Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected patients who have discontinued tenofovir DF/emtricitabine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in HBV-infected patients who discontinue tenofovir DF/emtricitabine. If appropriate, initiation of anti-hepatitis B therapy may be warranted (see warnings and precautions).
Tenofovir disoproxil fumarate/emtricitabine used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of tenofovir disoproxil fumarate/emtricitabine for a PrEP indication following undetected acute HIV-1 infection. Do not initiate tenofovir disoproxil fumarate/emtricitabine for a PrEP if signs or symptoms of acute hiv-1 infection are present unless negative infection status is confirmed (see warnings and precautions).
Each tablet contains
Emtricitabine ………………………..200 mg
Tenofovir disoproxil fumarate……..300 mg
Equivalent to tenofovir disoproxi….245 mg
Oral, fixed-dose tablet
Emtricitabine, a synthetic nucleoside analog of cytidine, is phosphorylated by cellular enzymes to form emtricitabine 5′-triphosphate. Emtricitabine 5′-triphosphate inhibits the activity of the HIV-1 reverse transcriptase (RT) by competing with the natural substrate deoxycytidine 5′-triphosphate and by being incorporated into nascent viral DNA which results in chain termination. Emtricitabine 5′-triphosphate is a weak inhibitor of mammalian DNA polymerase alpha, beta, epsilon and mitochondrial DNA polymerase gamma.
Tenofovir disoproxil fumarate (Tenofovir DF)
Tenofovir disoproxil fumarate is an acyclic nucleoside phosphonate diester analog of adenosine monophosphate. Tenofovir disoproxil fumarate requires initial diester hydrolysis for conversion to tenofovir and subsequent phosphorylations by cellular enzymes to form tenofovir diphosphate. Tenofovir diphosphate inhibits the activity of HIV-1 RT by competing with the natural substrate deoxyadenosine 5′-triphosphate and, after incorporation into DNA, by DNA chain termination. Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerases alpha, beta, and mitochondrial DNA polymerase gamma.
One Tenofovir DF/Emtricitabine tablet was bioequivalent to one emtricitabine capsule (200 mg) plus one Tenofovir DF tablet (300 mg) following single-dose administration to fasting healthy subjects (N=39).
The pharmacokinetic properties of emtricitabine are summarized in Table 1. Following oral administration of emtricitabine, emtricitabine is rapidly absorbed with peak plasma concentrations occurring at 1–2 hours post-dose. Less than 4 % of emtricitabine binds to human plasma proteins in vitro and the binding is independent of concentration over the range of 0.02-200 μg/mL. Following administration of radiolabelled emtricitabine, approximately 86% is recovered in the urine and 13% is recovered as metabolites. The metabolites of emtricitabine include 3′-sulfoxide diastereomers and their glucuronic acid conjugate. Emtricitabine is eliminated by a combination of glomerular filtration and active tubular secretion. Following a single oral dose of emtricitabine, the plasma emtricitabine half-life is approximately 10 hours.
Tenofovir Disoproxil Fumarate
The pharmacokinetic properties of tenofovir disoproxil fumarate are summarized in Table 1. Following oral administration of Tenofovir DF, maximum tenofovir serum concentrations are achieved in 1.0 ± 0.4 hour. Less than 0.7 % of tenofovir binds to human plasma proteins in vitro and the binding is independent of concentration over the range of 0.01–25 μg/mL. Approximately 70–80% of the intravenous dose of tenofovir is recovered as unchanged drug in the urine. Tenofovir is eliminated by a combination of glomerular filtration and active tubular secretion. Following a single oral dose of Tenofovir DF, the terminal elimination half-life of tenofovir is approximately 17 hours.
Table 1: Single dose pharmacokinetic parameters for emtricitabine and tenofovir in adultsa