ifabutin serum concentrations and risk of adverse events including uveitis (see section 4.4). Recommendations regarding use of ritonavir dosed as a pharmacokinetic enhancer with rifabutin are noted in section 4.5
Antipsychotics/ Neuroleptics
Clozapine, pimozide
Increased plasma concentrations of clozapine and pimozide. Thereby, increasing the risk of serious haematologic abnormalities, or other serious adverse effects from these agents.
Ergot Derivatives
Dihydroergotamine, ergonovine, ergotamine, methylergonovine
Increased plasma concentrations of ergot derivatives leading to acute ergot toxicity, including vasospasm and ischaemia.
GI motility agent
Cisapride
Increased plasma concentrations of cisapride. Thereby, increasing the risk of serious arrhythmias from this agent.
HMG Co-A Reductase Inhibitor
Lovastatin, simvastatin
Increased plasma concentrations of lovastatin and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (see section 4.5).
PDE5 inhibitor
Sildenafil
Contraindicated when used for the treatment of pulmonary arterial hypertension (PAH) only. Increased plasma concentrations of sildenafil. Thereby, increasing the potential for sildenafil-associated adverse events (which include hypotension and syncope). See section 4.4 and section 4.5 for coadministration of sildenafil in patients with erectile dysfunction.
Sedatives/hypnotics
Clorazepate, diazepam, estazolam, flurazepam, oral midazolam and triazolam
Increased plasma concentrations of clorazepate, diazepam, estazolam, flurazepam, oral midazolam and triazolam. Thereby, increasing the risk of extreme sedation and respiratory depression from these agents. (For caution on parenterally administered midazolam, see section 4.5).
Ritonavir medicinal product level decreased
Herbal Preparation
St. John's Wort
Herbal preparations containing St John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of ritonavir (see section 4.5).
4.4 Special warnings and precautions for use
Ritonavir is not a cure for HIV-1 infection or AIDS. Patients receiving ritonavir or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV-1 infection.
Patients should be advised that current antiretroviral therapy has not been proven to prevent the risk of transmission of HIV to others through blood or sexual contact. Appropriate precautions should continue to be used.
When ritonavir is used as a pharmacokinetic enhancer with other PIs, full details on the warnings and precautions relevant to that particular PI should be considered, therefore the Summary of Product Characteristics for the particular PI must be consulted.
Ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer
Patients with chronic diarrhoea or malabsorption: Extra monitoring is recommended when diarrhoea occurs. The relatively high frequency of diarrhoea during treatment with ritonavir may compromise the absorption and efficacy (due to decreased compliance) of ritonavir or other concurrent medicinal products. Serious persistent vomiting and/or diarrhoea associated with ritonavir use might also compromise renal function. It is advis |
