Truvada 300mg. 200mg Tablet

TRUVADA is indicated in combination with other antiretroviral agents (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults.

TRUVADA is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) in proven HIV-1 uninfected adults to reduce the risk of sexually acquired HIV-1 in adults at high risk, provided maximum treatment compliance can be monitored.

The dose of TRUVADA is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food.

The dose of TRUVADA in HIV-1 uninfected adults is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food. Significantly increased medicine exposures occurred when emtricitabine or tenofovir disoproxil fumarate were administered to patients with moderate to severe renal impairment (see CONTRAINDICATIONS).

• TRUVADA is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of TRUVADA.
• Pregnancy and lactation.
• Creatinine CL < 60 ml/min when used for PrEP.
• Creatinine CL < 50 ml/min when used for treatment of HIV-1.
• TRUVADA should not be co-administered with other tenofovir-containing products, or with other emtricitabine-containing products. TRUVADA should not be administered with lamivudine-containing products due to similarities between emtricitabine and lamivudine.
• TRUVADA should not be used for Pre-Exposure Prophylaxis (PrEP) in individuals with unknown or positive HIV-1 status.
• TRUVADA should not be used for PrEP in individuals not fully committed to full treatment compliance.

There are no study results demonstrating the effect of TRUVADA on clinical progression of HIV-1.

It is not recommended that TRUVADA be used as a component of a triple nucleoside regime.

Individuals should be warned that full compliance with treatment is essential to the efficacy in preventing HIV-1 transmission and should be fully informed about the use of other preventative measures including barrier contraception (condoms). Individuals not fully committed or trusted to be treatment-compliant should not use TRUVADA for HIV-1 transmission prophylaxis.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues such as TRUVADA alone or in combination with other antiretrovirals. This is caused by mitochondrial dysfunction. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administering nucleoside analogues such as TRUVADA to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with TRUVADA should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations). Clinical features are non-specific, and include nausea, vomiting, abdominal pain, dyspnoea, fatigue and weight loss.

TRUVADA is a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate. TRUVADA should not be co-administered with other medicines containing emtricitabine or tenofovir (see CONTRAINDICATIONS). Due to similarities between emtricitabine and lamivudine, TRUVADA should not be co-administered with other medicines containing lamivudine, including lamivudine and zidovudine co-formulation, lamivudine for HIV, lamivudine for HBV, abacavir sulfate and lamivudine co-formulation or abacavir sulfate, lamivudine and zidovudine co-formulation (see CONTRAINDICATIONS).

Co-administration of didanosine buffered tablet formulation with TRUVADA should be under fasted conditions (see INTERACTIONS). Co-administration of TRUVADA and didanosine should be undertaken with caution and patients receiving this combination should be monitored closely for didanosine-associated adverse events. Didanosine should be discontinued in patients who develop didanosine-associated adverse events (see SIDE EFFECTS).

The safety of TRUVADA in pregnancy and lactation has not been established (see CONTRAINDICATIONS). A reliable method of contraception should be used to avoid pregnancy while taking TRUVADA.

There are no adequate and well-controlled studies in pregnant women. TRUVADA should not be used in pregnancy (see CONTRAINDICATIONS).

Nursing Mothers: HIV-infected mothers should not breastfeed their infants, to avoid risking postnatal transmission of HIV. Studies in rats have demonstrated that tenofovir is secreted in milk. It is not known whether tenofovir is excreted in human milk. It is not known whether emtricitabine is excreted in human milk. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving TRUVADA.

Frequencies are defined as follows: very common u2265 10 %; common u2265 1 % and < 10 %; uncommon u2265 0,1 % and < 1 %; rare u2265 0,01 % and < 0,1 %; very rare < 0,01 %.

Common: Neutropenia, allergic reaction, including angioedema, hypertriglyceridemia, hyperglycaemia, insomnia, abnormal dreams, dizziness, headache, dyspnoea, diarrhoea, nausea, vomiting, flatulence, dyspepsia, abdominal pain, amylase elevation, lipase elevation, hyperbilirubinemia, increased liver enzymes (including increased AST, increased ALT and/or gamma GT), rash event (rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash), skin discoloration, creatine kinase elevation, pain, asthenia.

The following side effects have been reported but frequencies are unknown: Anaemia, hypophosphataemia, lactic acidosis, hypokalaemia, pancreatitis, hepatitis, hepatic steatosis, myopathy, osteomalacia (both associated with proximal renal tubulopathy), rhabdomyolysis, muscular weakness, increased creatinine, renal insufficiency, renal failure, acute renal failure, Fanconi syndrome, proximal tubulopathy, nephrogenic diabetes insipidus, proteinuria, acute tubular necrosis, polyuria, interstitial nephritis (including acute cases).

If overdose occurs the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.

Emtricitabine: Haemodialysis treatment removes approximately 30 % of the emtricitabine dose over a 3-hour dialysis period starting within 1,5 hours of emtricitabine dosing (blood flow rate of 400 ml/min and a dialysate flow rate of 600 ml/min). It is not known whether emtricitabine can be removed by peritoneal dialysis.

Tenofovir disoproxil fumarate: Tenofovir is poorly removed by haemodialysis. Following a single 300 mg dose of tenofovir DF, a four-hour haemodialysis session removed only approximately 10 % of the administered tenofovir dose.