Viramune xr should be used with extreme caution in children younger than 15 days old, safety and effectiveness in these children have not been confirmed.
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Patients with severe hepatic impairmentChild-Pugh Cor pre-treatment ASAT or ALAT5 ULN until baseline ASAT/ALAT are stabilised 5 ULN during nevirapine therapy and had recurrence of liver function abnormalities upon readministration of nevirapinesee section 4.4
The Committee noted that most of the experience with Viramune was in combination with nucleoside reverse-transcriptase inhibitorsNRTIsa type of antiviral medicineand that there was insufficient evidence on the use of combination treatment including a protease inhibitoranother type of antiviral medicineafter Viramune treatmentThe Committee recommended that Viramune be given marketing authorisation.
No clinical data availableDue to the metabolic pathway of raltegravir no interaction is expected.
In clinical studiesViramune has been associated with an increase in HDLcholesterol and an overall improvement in the total to HDL-cholesterol ratioHoweverin the absence of specific studiesthe clinical impact of these findings is not knownIn additionViramune has not been shown to cause glucose disturbances.
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the 14-day lead-in period with viramune 200 mg daily dosing must be strictly followed, it has been demonstrated to reduce the frequency of rash see dosage and administration and warnings and precautions .
