Viramune

Viramune Dosage/Direction for Use

nevirapine

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Full Prescribing Info
Dosage/Direction for Use
Viramune: Adults: The recommended dose for VIRAMUNE is one 200 mg tablet daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 200 mg tablet twice daily, in combination with at least two additional antiretroviral agents. VIRAMUNE can be taken with or without food. For concomitantly administered therapy, the manufacturers recommended dosage and monitoring should be followed.
Paediatric Patients: The total daily dose should not exceed 400 mg for any patient. VIRAMUNE may be dosed in paediatric patients either by body surface area (BSA) or by body weight as follows: By BSA using the Mosteller formula the recommended oral dose for paediatric patients of all ages is 150 mg/m2 once daily for two weeks followed by 150 mg/m2 twice daily thereafter.
Calculation of the volume of VIRAMUNE oral suspension (50 mg/5 ml) required for paediatric dosing on a body surface basis of 150 mg/m2. (See Table 5 and Equation.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

By weight the recommended oral dose for paediatric patients up to 8 years of age is 4 mg/kg once daily for two weeks followed by 7 mg/kg twice daily thereafter. For patients 8 years and older the recommended dose is 4 mg/kg once daily for two weeks followed by 4 mg/kg twice daily thereafter.
Calculation of the volume of VIRAMUNE oral suspension (50 mg/5 ml) required for paediatric dosing after the two weeks lead-in period. (See Table 6.)

Click on icon to see table/diagram/image

In a subset of pediatric patients (n=17) less than 3 months of age, the plasma nevirapine concentrations observed were within the range observed in adults and the remainder of the pediatric population, but were more variable between patients, particularly in the second month of age.
General:
Viramune XR: Extended-release tablets are not suitable for the 14 day lead-in period for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used.
Adults: Patients should initiate therapy with one 200 mg tablet of VIRAMUNE immediate-release once daily for the first 14 days (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 extended-release once daily.
The VIRAMUNE XR extended-release tablets should not be broken or chewed. VIRAMUNE XR extended-release tablets can be taken with or without food. VIRAMUNE immediate-release tablets and VIRAMUNE XR extended-release tablets should be combined with at least two additional antiretroviral agents. For concomitantly administered therapy, the manufacturers recommended dosage should be followed.
Adult patients currently on a VIRAMUNE immediate-release twice daily regimen
Patients already on a regimen of VIRAMUNE immediate-release 200 mg twice daily in combination with other antiretroviral agents can be switched to VIRAMUNE XR extended-release 400 mg once daily in combination with other antiretroviral agents without a 14-day lead-in period of VIRAMUNE immediate-release.
Patients must never take more than one form of nevirapine at the same time.
Paediatric Patients Three Years and Older: The safety and efficacy of VIRAMUNE XR extended-release tablets in children aged less than 3 years has not been established.
The total daily dose at any time during treatment should not exceed 400 mg for any patient. VIRAMUNE XR extended-release tablets may be dosed based on a patient's weight or body surface area (BSA).
Lead-In dosing with VIRAMUNE Immediate-Release Tablets or Oral Suspension (First 14 Days): All paediatric patients should initiate therapy with 150 mg/m2 (calculated using the Mosteller formula) or 4 mg/kg body weight administered once daily for the first 14 days. This lead-in period should be used because it has been found to lessen the frequency of rash. The lead-in period is not required if the patient is already on chronic VIRAMUNE oral suspension or VIRAMUNE immediate- release 200 mg tablets twice daily treatment.
Maintenance Dosing with VIRAMUNE XR Extended-Release Tablets (After the Lead-In): The recommended oral doses for paediatric patients based upon their BSA is described in the table below.
Recommended Paediatric Dosing by BSA after the Lead-in Period: (See Table 7 above and Equation.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

The recommended oral doses for paediatric patients based upon their weight are described in the table below. The recommended weight-based paediatric dose is dependent upon the patient's age, with different recommended doses for children from 3 to <8 years of age and children 8 years or older. (See Table 8.)

Click on icon to see table/diagram/image

All paediatric patients should have their weight or BSA checked frequently to assess if dose adjustments are necessary.
The VIRAMUNE XR extended-release tablets should not be broken or chewed. VIRAMUNE XR extended-release tablets can be taken with or without food. VIRAMUNE immediate-release tablets and VIRAMUNE XR extended-release tablets should be combined with at least two additional antiretroviral agents. For concomitantly administered therapy, the manufacturer's recommended dosage should be followed.
Alternatively, VIRAMUNE immediate-release oral suspension is available for all age groups for twice daily administration.
General: Patients should be advised of the need to take VIRAMUNE every day as prescribed. If a dose is missed the patient should not double the next dose but should take the next dose as soon as possible.
Clinical chemistry tests, including liver function tests, should be performed prior to initiating VIRAMUNE therapy and at appropriate intervals during therapy (see Precautions).
Patients experiencing rash during the 14 day lead-in period of 200 mg daily should not have their dose increased until the rash has resolved (see Precautions). The 200 mg once daily dosing regimen should not be continued beyond 28 days at which point an alternative antiretroviral regimen should be sought.
Patients who interrupt VIRAMUNE dosing for more than 7 days should restart the recommended dosing regimen using the two week lead-in period.
Viramune XR: Patients already on a regimen of VIRAMUNE immediate-release twice daily who switch to VIRAMUNE XR extended-release once daily should continue with their ongoing clinical and laboratory monitoring.
There are no data on the interchangeability of 100 mg VIRAMUNE XR extended-release tablets compared to 400 mg extended-release tablets. Therefore no dosage recommendation can be given for the use of 100 mg VIRAMUNE XR extended-release tablets as a substitute for the 400 mg dose form.
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