The FDA approved changes to the Viramune (nevirapine) Extended-Release (XR) tablet label to include the 100-mg tablet and dosing information for children ages six to 18 years. Previously, only 200-mg immediate release (IR) tablets or 400-mg extended release (XR) tablets were available.
The Dosage and Administration section was updated to include the following:
- Viramune XR tablets must be swallowed whole and must not be chewed, crushed, or divided.
- Children should be assessed for their ability to swallow tablets before prescribing Viramune XR tablets.
- Viramune XR can be taken with or without food.
No recommendations were made regarding substitution of four Viramune XR 100-mg tablets for one Viramune XR 400-mg tablet.
Dosing information in the Pediatric Patients section states that pediatric patients may be dosed using Viramune XR 400-mg or 100-mg tablets, still twice daily (adults get a once-daily dose with either IR or XR tablets). They must also follow the same special directions that adults do for taking Viramune: a lead-in dose of one 200-mg IR tablet a day for two weeks before starting their full dose (critical for preventing rash, which can be dangerous). The total daily dose should not exceed 400-mg for any patient.