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Antifungals & Antivirals

Trenstad

Packaging:

Blister of 10 tablets. Box of 3 blisters.

Bottle of 60 tablets. Box of 1 bottle.

Composition:

Each film- coated tablet contains:

Emtricitabine                                       200 mg

Tenofovir disoproxil fumarate            300 mg

Excipients q.s                                      1 tablet

Shelf – Life:  

24 months from the date of manufacturing.

  • Indications
  • Contraindications
  • Adverse reactions
  • Dosage and administration

Trenstad is indicated in antiretroviral combination therapy for the treatment of HIV-1 and chronic hepatitis B infected adults aged 18 years and over.

  • Known hypersensitivity to emtricitabine, tenofovir disoproxil fumarate or any ingredient in the formulation.

Pregnancy and Lactation:
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.

Lactation

  • Emtricitabine and tenofovir have been shown to be excreted in human milk. There is insufficient information on the effects of emtricitabine and tenofovir in newborns/infants. Therefore should not be used during breast-feeding. As a general rule, it is recommended that HIV infected women do not breast-feed their infants in order to avoid transmission of HIV to the infant.

Emtricitabine

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

Tenofovir disoproxil fumarate

  • Very common: Hypophosphataemia, dizziness, diarrhoea, nausea, vomiting, rash, asthenia.
  • Common: Headache, abdominal pain, abdominal distension, flatulence, increased transaminases.
  • Uncommon: Hypokalaemia, pancreatitis, rhabdomyolysis, muscular weakness, increased creatinine, proteinuria.
  • Rare: Lactic acidosis, 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.

Trenstad is administered orally, once daily with food. If patients have difficulty in swallowing, can disintegrate one tablet in approximately 100 ml of water, orange juice or grape juice and take it immediately.

Adults

  • The recommended dose is one tablet, once daily.
  • If a patient misses a dose of Trenstad within 12 hours, 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 the 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.

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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