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Lamivudine and tenofovir disoproxil oral


Oral formulation containing lamivudine and tenofovir disoproxil.

Drugs List

  • lamivudine 300mg and tenofovir disoproxil 245mg tablets
  • Therapeutic Indications


    Treatment of HIV infected adults

    Treatment of adults infected with HIV-1.


    1 tablet (300mg lamivudine and 245mg tenofovir disoproxil) to be taken once daily, to be taken with food.

    Patients with Renal Impairment

    Creatinine clearance >50ml/minute
    1 tablet once a day.

    Creatinine clearance <50ml/minute
    No dosing recommendations.


    Children under 18 years
    Renal impairment - creatinine clearance below 50ml/minute

    Precautions and Warnings

    Major risk factors for decreased bone mineral content
    Patients over 65 years
    Hepatic cirrhosis
    Hepatitis B
    Hepatitis C
    Severe hepatic impairment

    Therapy cessation not recommended in decompensated liver disease/cirrhosis
    Treatment does not prevent risk of transmission of HIV
    Advise patient dizziness may affect ability to drive or operate machinery
    Before initiating screen all patients for hepatitis B infection
    Treatment should be initiated by doctor experienced in HIV management
    Contains soya or soya derivative
    Monitor renal function prior to initiating treatment
    Autoimmune disorders can occur many months after initiation of treatment
    Blood lipid and glucose levels may increase requiring treatment
    Monitor patient for 4 hours after administration
    Monitor renal function after 2-4 weeks, 3 months and 3-6 monthly thereafter
    Monitor renal function in patients with risk factors for renal impairment
    On discontinuation, may cause recurrence of hepatitis B
    Advise patient to report bone pain, pain in extremities or fractures
    Advise patient to seek medical advice if joint aches or pain occur
    Inflammatory symptoms should be evaluated and treated appropriately
    May cause loss of bone mineral density
    Neonate exposed in utero: Risk of mitochondrial dysfunction
    Risk of developing opportunistic infections
    Discontinue if creatinine clearance falls below 50 ml/minute
    Discontinue if pancreatitis is suspected
    Discontinue if pancreatitis occurs
    Advise patient not to take NSAIDs unless advised by clinician

    Lamivudine and tenofovir disoproxil should be avoided with concurrent or recent use of nephrotoxic medical products e.g. high dose or multiple nonsteroidal anti-inflammatory drugs (NSAIDs). Alternatives to NSAIDs should be considered in patients at risk for renal dysfunction.

    In patients at risk of renal dysfunction, it is recommended that estimated creatinine clearance, serum phosphorus, urine glucose and urine protein be assessed prior to initiation and frequently during treatment.

    Consider interruption of treatment if creatinine clearance decrease to below 50ml/minute or serum phosphate decreases to below 1.0mg/dl (0.32mmol/l).

    Assessment of bone mineral density should be considered for patients who have a history of pathological bone fracture or other risk factors for osteoporosis or bone loss.

    Bone abnormalities may be associated with proximal renal tubulopathy, if bone abnormalities are suspected, appropriate consultation and evaluation should occur.

    Discontinue treatment if signs or symptoms of pancreatitis occur.

    Pregnancy and Lactation


    Use lamivudine and tenofovir disoproxil with caution during pregnancy.

    The manufacturer recommends to avoid the use of lamivudine and tenofovir disoproxil and doravirine during pregnancy as a precautionary measure, and to monitor maternal-foetal outcomes in any patients exposed to doravirine during pregnancy. Encouraging physicians to register patients to the Antiretroviral Pregnancy Registry.

    Animal studies with tenofovir disoproxil do not indicate direct or indirect harmful effects with respects to reproductive toxicity. However, animal studies with lamivudine show an increase in early embryonic deaths, and may inhibit cellular DNA replication.


    Lamivudine and tenofovir disoproxil is contraindicated during breastfeeding.

    The manufacturer does not recommend the use of lamivudine and tenofovir disoproxil during breastfeeding, and that mothers should be instructed to not breastfeed due to the potential HIV-1 transmission and potential adverse reactions in the infant.

    Lamivudine and tenofovir disoproxil are excreted into breast milk. There is limited published information regarding the use of lamivudine and tenofovir disoproxil during breastfeeding.

    Side Effects

    Abdominal cramps
    Abdominal distension
    Abdominal pain
    Acute renal failure
    Autoimmune disorders
    Elevated amylase levels
    Elevation of liver enzymes (transient)
    Exacerbation of hepatitis
    Graves' disease
    Hepatic steatosis
    Increase in creatinine
    Interstitial nephritis
    Lactic acidosis
    Muscle disorders
    Nasal symptoms
    Nephrogenic diabetes insipidus
    Peripheral neuropathy
    Proximal tubulopathy
    Red cell aplasia
    Renal impairment
    Renal tubular necrosis


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: December 2019

    Reference Sources

    Summary of Product Characteristics: Lamivudine/Tenofovir disoproxil 300mg/245mg film coated tablets. Cipla EU Ltd. Revised January 2019.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Lamivudine Last revised: 31 October 2018
    Last accessed: 26 November 2019

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Tenofovir Last revised: 07 February 2019
    Last accessed: 26 November 2019

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.