Viramune Dosage
Generic name: nevirapine
Dosage form: tablet, extended release
See also:
This dosage information does not include all the information needed to use Viramune safely and effectively. See full prescribing information for Viramune.
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2.1 Adults
Patients not currently taking immediate-release VIRAMUNE
Patients must initiate therapy with one 200 mg tablet of immediate-release VIRAMUNE daily for the first 14 days in combination with other antiretroviral agents (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 400 mg tablet of VIRAMUNE XR once daily. Patients must swallow VIRAMUNE XR tablets whole. They must not be chewed, crushed, or divided. For concomitantly administered therapy, the manufacturer's recommended dosage and monitoring should be followed. VIRAMUNE XR can be taken with or without food.
Switching Patients from immediate-release VIRAMUNE to VIRAMUNE XR
Patients already on a regimen of immediate-release VIRAMUNE twice daily in combination with other antiretroviral agents can be switched to VIRAMUNE XR 400 mg once daily in combination with other antiretroviral agents without the 14-day lead-in period of immediate-release VIRAMUNE.
Patients must never take more than one form of nevirapine at the same time.
2.2 Monitoring of Patients
Intensive clinical and laboratory monitoring, including liver enzyme tests, is essential at baseline and during the first 18 weeks of treatment with nevirapine. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, would include monitoring of liver enzyme tests prior to beginning the 14-day lead-in period with immediate-release VIRAMUNE, prior to initiation of VIRAMUNE XR, and at two weeks after initiation of VIRAMUNE XR therapy. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout VIRAMUNE XR treatment [see Warnings and Precautions (5)]. In some cases, hepatic injury has progressed despite discontinuation of treatment.
Patients already on a regimen of immediate-release VIRAMUNE twice daily who switch to VIRAMUNE XR once daily should continue with their ongoing clinical and laboratory monitoring.
2.3 Dosage Adjustment
Patients with Rash
Discontinue nevirapine if a patient experiences severe rash or any rash accompanied by constitutional findings [see Boxed Warning, Warnings and Precautions (5.2), and Patient Counseling Information (17.1)]. Do not initiate therapy with VIRAMUNE XR if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of immediate-release VIRAMUNE (200 mg once daily) until the rash has resolved [see Warnings and Precautions (5.2) and Patient Counseling Information (17.1)]. The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought.
Patients with Hepatic Events
If a clinical (symptomatic) hepatic event occurs, permanently discontinue nevirapine. Do not restart nevirapine after recovery [see Warnings and Precautions (5.1)].
Patients with Dose Interruption
For patients who interrupt VIRAMUNE XR dosing for more than 7 days restart the recommended lead-in dosing with immediate-release VIRAMUNE, using one 200 mg tablet daily for the first 14 days.
Patients with Renal Impairment
Patients with CrCL greater than or equal to 20 mL/min and not requiring dialysis do not require an adjustment in dosing. An additional 200 mg dose of immediate-release VIRAMUNE following each dialysis treatment is indicated in patients requiring dialysis. Nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known [see Clinical Pharmacology (12.3)]. VIRAMUNE XR has not been studied in patients with renal dysfunction.
