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Antifungals & Antivirals

Trenstad


Pack size:

Box of 3 blisters x 10 film-coated tablets.


Composition:

Each film-coated tablet contains emtricitabine 200 mg

and tenofovir disoproxil fumarate 300 mg


Shelf-life: 

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.


 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Trenstad is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adult aged 18 years and over.
  • Administered orally, once daily, orally with food. If patients have difficulty in swallowing, can be disintegrated one tablet in approximately 100 ml of water, orange juice or grape juice and taken immediately.
     
  • Adults:
    The recommended dose is one tablet, once daily.
    If a patient misses a dose of Trenstad within 12 hours, please should take one dose with food as soon as possible and resume their normal dosing schedule. If a patient misses a dose of Trenstad by more than 12 hours and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule.
    If the patient vomits within 1 hour of taking Trenstad, another tablet should be taken. If the patient vomits more than 1 hour after taking Trenstad, they do not need to take another dose.
  • Renal impairment:
    In patients with renal impairment Trenstad should only be used if the potential benefits of treatment are considered to outweigh the potential risks. Patients with renal impairment may require close monitoring of renal function.
    Moderate renal impairment (creatinine clearance 30 - 49 ml/min): Administration of Trenstad every 48 hours is recommended.
    Severe renal impairment (creatinine clearance < 30 ml/min) and haemodialysis patients: Trenstad is not recommended for severe renal impairment and haemodialysis patients.
  • Older people:
    No data are available on which to make a dose recommendation for patients over the age of 65 years. However, no adjustment in the recommended daily dose for adults should be required unless there is evidence of renal insufficiency.
  • Hepatic impairment:
    The pharmacokinetics of Trenstad and emtricitabine have not been studied in patients with hepatic impairment. The pharmacokinetics of tenofovir have been studied in patients with hepatic impairment and no dose adjustment is required for tenofovir in these patients. Based on minimal hepatic metabolism and the renal route of elimination for emtricitabine, it is unlikely that a dose adjustment would be required for Trenstad in patients with hepatic impairment. If Trenstad is discontinued in patients co-infected with HIV and HBV, these patients should be closely monitored for evidence of exacerbation of hepatitis.
  • Paediatric population:
    The safety and efficacy of Trenstad in children under the age of 18 years have not been established.
     

Or as presceribed by physicians.

 

  • Known hypersensitivity to emtricitabine, tenofovir disoproxil fumarate or to any ingredient of the drug.
  • Trenstad must not be administered to children or adolescents under the age of 18 years.
  • Trenstad is a fixed-dose combination of tenofovir and emtricitabine. Trenstad should not be administered concurrently with other medicinal products containing any of the same active components: tenofovir, emtricitabine, or with medicinal products containing lamivudine or with adefovir.

     

Emtricitabine

  • Very common
    Headache, diarrhoea, nausea, elevated creatine kinase.
  • Common:
    Neutropenia, allergic reaction, hyperglycaemia, hypertriglyceridaemia, insomnia, abnormal dreams, dizziness, elevated amylase including elevated pancreatic amylase, elevated serum lipase, vomiting, abdominal pain, dyspepsia, elevated serum aspartate aminotransferase (AST) and/or elevated serum alanine aminotransferase (ALT), hyperbilirubinaemia, vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discolouration, pain, asthenia.
  • Uncommon:
    Anaemia, angioedema.

Tenofovir disoproxil fumarate

  • Very common:
    Hypophosphataemia, dizziness, diarrhoea, vomiting, nausea, rash, asthenia.
  • Common
    Headache, abdominal pain, abdominal distension, flatulence, increased transaminases.
  • Uncommon:
    Hypokalaemia, pancreatitis, rhabdomyolysis, muscular weakness, increased creatinine, proteinuria.
  • Rare: 
    Lactic acidosis, hepatic steatosis, hepatitis, angioedema, osteomalacia (manifested as bone pain and infrequently contributing to fractures), myopathy, renal failure (acute and chronic), acute tubular necrosis, proximal renal tubulopathy including Fanconi syndrome, nephritis (including acute interstitial nephritis), nephrogenic diabetes insipidus.

 

  • Adipogenic effects: Redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (“buffalo hump”), peripheral wasting, facial wasting, breast enlargement, and general Cushingoid appearance, has been reported with antiretroviral therapy.
  • Opportunistic infections: Patients receiving Trenstad or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
  • Transmission of HIV: Patients must be advised that antiretroviral therapies, including Trenstad, have not been proven to prevent the risk of transmission of HIV to others through sexual contact or contamination with blood. Appropriate precautions must continue to be used.
  • Patients with HIV-1 harbouring mutations: Trenstad should be avoided in antiretroviral-experienced patients with HIV-1 harbouring the K65R mutation.
  • Liver disease: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice. If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
  • Immune reactivation syndrome: In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms. Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis jirovecii pneumonia. Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
  • Lactic acidosis/severe hepatomegaly with steatosis: Treatment with Trenstad should be suspended in any patient or uninfected individual 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).
  • HBV infection: In some patients infected with HBV and treated with Trenstad, the exacerbations of hepatitis B were associated with liver decompensation and liver failure.
  • Renal impairment: Emtricitabine and tenofovir are principally eliminated by the kidney. Renal impairment, including cases of acute renal failure and Fanconi syndrome has been reported with the use of Trenstad.
  • Coadministration with other products: Do not coadminister Trenstad with other drugs containing lamivudine, including Combivir (lamivudine/zidovudine), Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), or Trizivir (abacavir sulfate/lamivudine/zidovudine).
  • Bone effects of tenofovir: Bone toxicity including a reduction in bone mineral density have been observed in tenofovir DF studies in three animal species. Clinically relevant bone abnormalities have not been seen in long term clinical studies (> 3 years). However, bone abnormalities (infrequently contributing to fractures) may be associated with proximal renal tubulopathy. If bone abnormalities are suspected during therapy then appropriate consultation should be obtained.
  • Pregnancy: There are reports on pregnant women indicate no malformations or foetal/neonatal toxicity associated with emtricitabine and tenofovir disoproxil fumarate. Animal studies on emtricitabine and tenofovir disoproxil fumarate do not indicate reproductive toxicity. Therefore the use of Trenstad may be considered during pregnancy, if necessary.
  • No studies on the effects on the ability to drive or use machines have been performed. However, patients should be informed that dizziness has been reported during treatment with both emtricitabine and tenofovir disoproxil fumarate.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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