LOPINAVIR/RITONAVIR = LPV/r oral

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    Prescription under medical supervision

     

    Therapeutic action

    • Antiretrovirals, HIV protease inhibitors

    Indications

    • HIV infection, in combination with other antiretroviral drugs

    Forms and strengths

    • 40 mg lopinavir/10 mg ritonavir capsule and sachet of oral pellets
    • 100 mg lopinavir/25 mg ritonavir and 200 mg lopinavir/50 mg ritonavir film coated tablets
    • 80 mg lopinavir/20 mg ritonavir per ml oral solution, containing 42% alcohol (v/v), with a graduated syringe for oral administration

    Dosage

    • Child from 14 days to 6 months: 16/4 mg/kg 2 times daily
    • Child over 6 months:
      • 7 to < 15 kg: 12/3 mg/kg 2 times daily
      • 15 to 35 kg: 10/2.5 mg/kg 2 times daily
    • Child ≥ 35 kg and adult: 400/100 mg 2 times daily

     

    Weight

    80/20 mg/ml
    oral sol.

    40/10 mg capsule
    or sachet of oral pellets

    100/25 mg tablet

    200/50 mg tablet

    3 to < 6 kg

    1 ml x 2

    6 to < 10 kg

    1.5 ml x 2

    3 capsules or sachets x 2

    10 to < 14 kg

    2 ml x 2

    4 capsules or sachets x 2

    2 tab morning
    and 1 tab evening

    14 to < 20 kg

    2.5 ml x 2

    5 capsules or sachets x 2

    2 tab x 2

    20 to < 25 kg

    3 ml x 2

    6 capsules or sachets x 2

    2 tab x 2

    25 to < 35 kg

    3 tab x 2

    ≥ 35 kg

    4 tab x 2

    2 tab x 2

     

    Duration

    • The duration of treatment depends on the efficacy and tolerance of lopinavir and ritonavir.

    Contra-indications, adverse effects, precautions

    • Do not administer to patients with severe hepatic impairment or hypokalaemia.
    • Do not administer oral solution to patients with renal or hepatic impairment and capsules to children under 3 months.
    • Administer with caution and monitor use in patients with haemophilia (increased bleeding).
    • May cause:
      • gastrointestinal disturbances (mainly diarrhoea), skin rash, fatigue, headache, insomnia, paraesthesia, muscle pain, hypertriglyceridaemia, hypercholesterolemia, hyperglycaemia, conduction disorders, lipodystrophy;
      • hepatic and pancreatic disorders; in this event, stop treatment immediately.
    • Administer with caution and monitor combination with:
      • drugs that prolong the QT interval (amiodarone, co-artemether, mefloquine, quinine, haloperidol, etc.);
      • metronidazole when using LPV/r oral solution that contains alcohol (risk of antabuse reaction).
    • LPV/r reduces the efficacy of oral contraceptives: use a non-hormonal contraception or injectable medroxyprogesterone or an oral contraceptive containing 50 micrograms ethinylestradiol per tablet.
    • Avoid combination with rifampicin; preferably use rifabutin. If only rifampicin is available, adjust LPV/r dosage.
    • Pregnancy: oral solution is CONTRA-INDICATED; no contra-indication for tablets and capsules

    Remarks

    • Tablets may be taken with meals or on an empty stomach. The oral solution must be taken with meals.
    • The tablets must not be cut, crushed or chewed.
    • Capsules or sachets must be opened then oral pellets must be poured into a small amount of breast milk or soft foods and administered to the child immediately. Pellets must not be stirred, crushed, dissolved/dispersed in food, or chewed.

    Storage

    • Tablets, capsules and sachets of oral pellets:
     
     
    - Below 25 °C 
    • Oral solution: between 2 °C and 8 °C. If refrigeration is not available, oral solution kept below 25 °C may be stored for 6 weeks maximum.