lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Oral solution
CAUTIONARY AND ADVISORY LABELS 21
EXCIPIENTS:May contain Alcohol, propylene glycol
▶Kaletra(AbbVie Ltd)
Ritonavir 20 mg per 1 ml, Lopinavir 80 mg per 1 mlKaletra
80 mg/ 20 mg/ 1 ml oral solution| 120 mlP£ 122. 96 |
300 mlP£ 307. 39
Tablet
CAUTIONARY AND ADVISORY LABELS 25
▶Kaletra(AbbVie Ltd)
Ritonavir 25 mg, Lopinavir 100 mgKaletra 100 mg/ 25 mg tablets|
60 tabletP£ 76. 85
Ritonavir 50 mg, Lopinavir 200 mgKaletra 200 mg/ 50 mg tablets|
120 tabletP£ 285. 41eiiiiF 423Ritonavir
lINDICATIONS AND DOSE
HIV infection in combination with other antiretroviral
drugs (high-dose ritonavir)
▶BY MOUTH
▶Child 2–17 years:Initially 250 mg/m^2 twice daily,
increased in steps of 50 mg/m^2 every 2 – 3 days;
increased to 350 mg/m2
twice daily (max. per dose
600 mg twice daily), tolerability of this regimen is poor
Low-dose ritonavir to increase the effect of atazanavir
▶BY MOUTH
▶Child 6–17 years (body-weight 15–19 kg): 80 – 100 mg once
daily
▶Child 6–17 years (body-weight 20 kg and above): 100 mg
once daily
Low-dose ritonavir to increase the effect of darunavir
▶BY MOUTH
▶Child 3–17 years (body-weight 15–29 kg): 50 mg twice daily
▶Child 3–17 years (body-weight 30–39 kg): 60 mg twice
daily
▶Child 3–17 years (body-weight 40 kg and above): 100 mg
twice daily
▶Child 12–17 years (body-weight 40 kg and above): 100 mg
once daily for use in patients taking darunavir once
daily
Low-dose ritonavir to increase the effect of fosamprenavir
▶BY MOUTH
▶Child 6–17 years (body-weight 25–32 kg): 3 mg/kg twice
daily
▶Child 6–17 years (body-weight 33 kg and above): 100 mg
twice daily
Low-dose ritonavir to increase the effect of tipranavir
▶BY MOUTH
▶Child 2–11 years: 150 mg/m^2 twice daily (max. per dose
200 mg)
▶Child 12–17 years: 200 mg twice dailylCAUTIONSCardiac conduction disorders.pancreatitis.
structural heart disease
lINTERACTIONS→Appendix 1 : HIV-protease inhibitors
lSIDE-EFFECTS
▶Common or very commonBack pain.concentration
impaired.confusion.cough.dehydration.feeling hot.
flushing.gastrointestinal discomfort.gastrointestinal
haemorrhage.gout.hypotension.menorrhagia.
myopathy.oedema.oral paraesthesia.oropharyngeal
pain.paraesthesia.peripheral coldness.pharyngitis.
renal impairment.skin reactions.syncope.
thrombocytopenia.urinary frequency increased.vision
blurred
▶UncommonMyocardial infarction▶Rare or very rareHyperglycaemia.toxic epidermal
necrolysis
SIDE-EFFECTS, FURTHER INFORMATIONSigns and
symptoms suggestive of pancreatitis (including raised
serum lipase) should be evaluated—discontinue if
pancreatitis diagnosed.
lPREGNANCY
Dose adjustmentsOnly use low-dose booster to increase
the effect of other protease inhibitors.
lHEPATIC IMPAIRMENTAvoid in decompensated liver
disease; in severe impairment without decompensation,
use‘booster’doses with caution (avoid treatment doses).
lDIRECTIONS FOR ADMINISTRATIONBitter taste of oral
solution can be masked by mixing with chocolate milk; do
not mix with water, measuring cup must be dry.
lPATIENT AND CARER ADVICEPatients or carers should be
given advice on how to administer ritonavir oral solution.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Tablet
CAUTIONARY AND ADVISORY LABELS21, 25
▶Norvir(AbbVie Ltd)
Ritonavir 100 mgNorvir 100 mg tablets| 30 tabletP£ 19. 44eiiiiF 423Tipranavir
lINDICATIONS AND DOSE
HIV infection resistant to other protease inhibitors, in
combination with other antiretroviral drugs in patients
previously treated with antiretrovirals–with low-dose
ritonavir
▶BY MOUTH USING CAPSULES
▶Child 12–17 years: 500 mg twice daily
▶BY MOUTH USING ORAL SOLUTION
▶Child 2–11 years: 375 mg/m^2 twice daily (max. per dose
500 mg)
DOSE EQUIVALENCE AND CONVERSION
▶The bioavailability of tipranavir oral solution is higher
than that of the capsules; the oral solution is not
interchangeable with the capsules on a milligram-for-
milligram basis.lCAUTIONSPatients at risk of increased bleeding from
trauma, surgery or other pathological conditions
lINTERACTIONS→Appendix 1 : HIV-protease inhibitors
lSIDE-EFFECTS
▶Common or very commonHyperlipidaemia
▶UncommonExanthema.hepatic disorders.
hyperamylasaemia.hyperglycaemia.influenza like illness
.renal failure.thrombocytopenia
▶Rare or very rareDehydration.hyperbilirubinaemia.
intracranial haemorrhage
▶Frequency not knownBleeding tendency
SIDE-EFFECTS, FURTHER INFORMATIONPotentially life-
threatening hepatotoxicity reported. Discontinue if signs
or symptoms of hepatitis develop or if liver-function
abnormality develops (consult product literature).
lPREGNANCYManufacturer advises use only if potential
benefit outweighs risk—toxicity inanimalstudies.
lHEPATIC IMPAIRMENTManufacturer advises caution in
mild impairment; avoid in moderate or severe
impairment—no information available.
lMONITORING REQUIREMENTSMonitor liver function
before treatment then every 2 weeks for 1 month, then
every 3 months.
lPRESCRIBING AND DISPENSING INFORMATIONFlavours of
oral liquid formulations may include toffee and mint.426 Viral infection BNFC 2018 – 2019
Infection5