Viramune

Viramune Manufacturers

• State Of Florida Doh Central Pharmacy
  

  ×

  Viramune | State Of Florida Doh Central Pharmacy

  

  ---

  2.1   Adults

  The recommended dose for VIRAMUNE is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents. The lead-in period has been observed to decrease the incidence of rash. For concomitantly administered antiretroviral therapy, the manufacturer’s recommended dosage and monitoring should be followed.

  2.2   Pediatric Patients

  The recommended oral dose for pediatric patients 15 days and older is 150 mg/m2 once daily for 14 days followed by 150 mg/m2 twice daily thereafter. The total daily dose should not exceed 400 mg for any patient.
  

  Table 1 Calculation of the Volume of VIRAMUNE Oral Suspension (50 mg/5 mL) Required for Pediatric Dosing Based on Body Surface and a Dose of 150 mg/m2 BSA range (m2) Volume (mL) 0.06 – 0.12 1.25 0.12 – 0.25 2.5 0.25 – 0.42 5 0.42 – 0.58 7.5 0.58 – 0.75 10 0.75 – 0.92 12.5 0.92 – 1.08 15 1.08 – 1.25 17.5 1.25+ 20

  VIRAMUNE suspension should be shaken gently prior to administration. It is important to administer the entire measured dose of suspension by using an oral dosing syringe or dosing cup. An oral dosing syringe is recommended, particularly for volumes of 5 mL or less. If a dosing cup is used, it should be thoroughly rinsed with water and the rinse should also be administered to the patient.

  2.3   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 VIRAMUNE. 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 at baseline, prior to dose escalation, and at two weeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout VIRAMUNE treatment [see Warnings and Precautions (5)]. In some cases, hepatic injury has progressed despite discontinuation of treatment.

  2.4   Dosage Adjustment

  Patients with Rash

  VIRAMUNE should be discontinued 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)]. A patient experiencing mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (150 mg/m2/day in pediatric patients) should not have their VIRAMUNE dose increased 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, VIRAMUNE should be permanently discontinued. Do not restart VIRAMUNE after recovery [see Warnings and Precautions (5.1)].

  Patients with Dose Interruption

  Patients who interrupt VIRAMUNE dosing for more than 7 days should restart the recommended dosing, using one 200 mg tablet daily (150 mg/m2/day in pediatric patients) for the first 14 days (lead-in) followed by one 200 mg tablet twice daily (150 mg/m2 twice daily for pediatric patients).

  Patients on Dialysis

  An additional 200 mg dose of 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)]. Patients with CrCL ≥20 mL/min do not require an adjustment in VIRAMUNE dosing.

  Close
  No Recall

  More Info
• Physicians Total Care, Inc.
  

  ×

  Viramune | Physicians Total Care, Inc.

  

  ---

  2.1 General Dosing Considerations 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 can be made regarding substitution of four VIRAMUNE XR 100 mg tablets for one VIRAMUNE XR 400 mg tablet. 2.2  Adult Patients 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.

  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.

  2.3  Pediatric Patients

  Pediatric patients may be dosed using VIRAMUNE XR 400 mg or 100 mg tablets. VIRAMUNE XR is dosed based on a patient’s body surface area (BSA) calculated using the Mosteller formula. All pediatric patients must initiate therapy with immediate-release VIRAMUNE (as 150 mg/m2 of VIRAMUNE Oral Suspension or as VIRAMUNE tablets), at a dose not to exceed 200 mg per day, administered once daily for the first 14 days. This lead-in period should be used because it has been demonstrated to reduce the frequency of rash. This lead-in period is not required if the patient is already on a regimen of twice daily immediate-release formulation in combination with other antiretroviral agents.

  The recommended oral doses of VIRAMUNE XR for pediatric patients 6 to less than 18 years of age based upon their BSA are described in the table below. The total daily dose should not exceed 400 mg for any patient.

  Table 1 Recommended VIRAMUNE XR Dosing for Pediatric Patients 6 to less than 18 years of age by BSA after the Lead-in Period with Immediate-Release VIRAMUNE BSA range (m2) VIRAMUNE XR tablets dose (mg) 0.58 - 0.83 200 mg once daily (2 x 100 mg) 0.84 - 1.16 300 mg once daily (3 x 100 mg) Greater than or equal to 1.17 400 mg once daily (1 x 400 mg)

  Mosteller Formula: BSA (m2) =

  2.4  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.

  2.5  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 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 per min and not requiring dialysis do not require an adjustment in dosing. The pharmacokinetics of nevirapine have not been evaluated in patients with CrCL less than 20 mL per min. 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.

  Close
  No Recall

  More Info
• Boehringer Ingelheim Pharmaceuticals Inc.
  

  ×

  Viramune | Boehringer Ingelheim Pharmaceuticals Inc.

  

  ---

  2.1   Adult Patients

  The recommended dose for VIRAMUNE is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents. The lead-in period has been observed to decrease the incidence of rash. For concomitantly administered antiretroviral therapy, the manufacturer's recommended dosage and monitoring should be followed.

  2.2   Pediatric Patients

  The recommended oral dose for pediatric patients 15 days and older is 150 mg/m2 once daily for 14 days followed by 150 mg/m2 twice daily thereafter. The total daily dose should not exceed 400 mg for any patient.
  

  Table 1 Calculation of the Volume of VIRAMUNE Oral Suspension (50 mg per 5 mL) Required for Pediatric Dosing Based on Body Surface and a Dose of 150 mg/m2 BSA range (m2) Volume (mL) 0.06 – 0.12 1.25 0.12 – 0.25 2.5 0.25 – 0.42 5 0.42 – 0.58 7.5 0.58 – 0.75 10 0.75 – 0.92 12.5 0.92 – 1.08 15 1.08 – 1.25 17.5 1.25+ 20

  VIRAMUNE suspension should be shaken gently prior to administration. It is important to administer the entire measured dose of suspension by using an oral dosing syringe or dosing cup. An oral dosing syringe is recommended, particularly for volumes of 5 mL or less. If a dosing cup is used, it should be thoroughly rinsed with water and the rinse should also be administered to the patient.

  2.3   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 VIRAMUNE. 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 at baseline, prior to dose escalation, and at two weeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout VIRAMUNE treatment [see Warnings and Precautions (5)]. In some cases, hepatic injury has progressed despite discontinuation of treatment.

  2.4   Dosage Adjustment

  Patients with Rash

  Discontinue VIRAMUNE if a patient experiences severe rash or any rash accompanied by constitutional findings [see Boxed Warning and Warnings and Precautions (5.2)]. Do not increase VIRAMUNE dose if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (150 mg/m2/day in pediatric patients) until the rash has resolved [see Warnings and Precautions (5.2)]. 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 VIRAMUNE. Do not restart VIRAMUNE after recovery [see Warnings and Precautions (5.1)].

  Patients with Dose Interruption

  For patients who interrupt VIRAMUNE dosing for more than 7 days, restart the recommended dosing, using one 200 mg tablet daily (150 mg/m2/day in pediatric patients) for the first 14 days (lead-in) followed by one 200 mg tablet twice daily (150 mg/m2 twice daily for pediatric patients).

  Patients with Renal Impairment

  Patients with CrCL greater than or equal to 20 mL per min do not require an adjustment in VIRAMUNE dosing. The pharmacokinetics of nevirapine have not been evaluated in patients with CrCL less than 20 mL per min. An additional 200 mg dose of 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)].

  Close
  No Recall

  More Info
• Boehringer Ingelheim Pharmaceuticals, Inc.
  

  ×

  Viramune | Boehringer Ingelheim Pharmaceuticals, Inc.

  

  ---

  2.1  General Dosing Considerations 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 can be made regarding substitution of four VIRAMUNE XR 100 mg tablets for one VIRAMUNE XR 400 mg tablet. 2.2  Adult Patients 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.

  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.

  2.3  Pediatric Patients

  Pediatric patients may be dosed using VIRAMUNE XR 400 mg or 100 mg tablets. VIRAMUNE XR is dosed based on a patient’s body surface area (BSA) calculated using the Mosteller formula. All pediatric patients must initiate therapy with immediate-release VIRAMUNE (as 150 mg/m2 of VIRAMUNE Oral Suspension or as VIRAMUNE tablets), at a dose not to exceed 200 mg per day, administered once daily for the first 14 days. This lead-in period should be used because it has been demonstrated to reduce the frequency of rash. This lead-in period is not required if the patient is already on a regimen of twice daily immediate-release formulation in combination with other antiretroviral agents.

  The recommended oral doses of VIRAMUNE XR for pediatric patients 6 to less than 18 years of age based upon their BSA are described in the table below. The total daily dose should not exceed 400 mg for any patient.

  Table 1 Recommended VIRAMUNE XR Dosing for Pediatric Patients 6 to less than 18 years of age by BSA after the Lead-in Period with Immediate-Release VIRAMUNE BSA range (m2) VIRAMUNE XR tablets dose (mg) 0.58 - 0.83 200 mg once daily (2 x 100 mg) 0.84 - 1.16 300 mg once daily (3 x 100 mg) Greater than or equal to 1.17 400 mg once daily (1 x 400 mg)

  2.4  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.

  2.5  Dosage Adjustment Patients with Rash

  Discontinue nevirapine if a patient experiences severe rash or any rash accompanied by constitutional findings [see Boxed Warning and Warnings and Precautions (5.2)]. 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 until the rash has resolved [see Warnings and Precautions (5.2)]. 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 per min and not requiring dialysis do not require an adjustment in dosing. The pharmacokinetics of nevirapine have not been evaluated in patients with CrCL less than 20 mL per min. 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.

  Close
  No Recall

  More Info