tein bound it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis.
Hepatic impairment: Ritonavir is principally metabolised and eliminated by the liver. Pharmacokinetic data indicate that no dose adjustment is necessary in patients with mild to moderate hepatic impairment (see section 5.2). Ritonavir should not be given to patients with severe hepatic impairment (see section 4.3).
Elderly: Pharmacokinetic data indicated that no dose adjustment is necessary for elderly patients (see section 5.2).
The bitter taste of Norvir solution may be lessened if mixed with chocolate milk.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
When ritonavir is used as a pharmacokinetic enhancer of other PIs, consult the Summary of Product Characteristics of the co-administered protease inhibitor for contraindications.
Ritonavir should not be given as a pharmacokinetic enhancer or as an antiretroviral agent to patients with decompensated liver disease.
In vitro and in vivo studies have demonstrated that ritonavir is a potent inhibitor of CYP3A- and CYP2D6- mediated biotransformations. The following medicines are contraindicated when used with ritonavir and unless otherwise noted, the contraindication is based on the potential for ritonavir to inhibit metabolism of the co-administered medicinal product, resulting in increased exposure to the co-administered medicinal product and risk of clinically significant adverse effects.
The enzyme-modulating effect of ritonavir may be dose dependent. For some products, contraindications may be more relevant when ritonavir is used as an antiretroviral agent than when ritonavir is used as a pharmacokinetic enhancer (eg rifabutin and voriconazole):
Medicinal Product Class
Medicinal Products within Class
Rationale
Concomitant medicinal product levels increased or decreased
α1-Adrenoreceptor Antagonist
Alfuzosin
Increased plasma concentrations of alfuzosin which may lead to severe hypotension (see section 4.5).
Analgesics
Pethidine, piroxicam, propoxyphne
Increased plasma concentrations of norpethidine, piroxicam and propoxyphene. Thereby, increasing the risk of serious respiratory depression or haematologic abnormalities, or other serious adverse effects from these agents.
Antiarrthymics
Amiodarone, bepridil, encainide, flecanide, propafenone, quinidine
Increased plasma concentrations of amiodarone, bepridil, encainide, flecanide, propafenone, quinidine. Thereby, increasing the risk of arrhythmias or other serious adverse reactions from these agents.
Antibiotic
Fusidic Acid
Increased plasma concentrations of fusidic acid and ritonavir.
Antifungal
Voriconazole
Concomitant use of ritonavir (400 mg twice daily and more) and voriconazole is contraindicated due to a reduction in voriconazole plasma concentrations and possible loss of effect (see section 4.5)
Antihistamines
Astemizole, terfenadine
Increased plasma concentrations of astemizole and terfenadine. Thereby, increasing the risk of serious arrhythmias from these agents.
Antimycobacterial
Rifabutin
Concomitant use of ritonavir dosed as an antiretroviral agent (600 mg twice daily) and rifabutin due to an increase of r |
