Videx 125 mg gastro-resistant hard capsules
Videx 200 mg gastro-resistant hard capsules
Videx 250 mg gastro-resistant hard capsules
Videx 400 mg gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 125 mg, 200 mg, 250 mg, 400 mg of didanosine.
For the full list of excipients, see section 6.1.
Gastro-resistant capsule, hard
125 mg:Gastro-resistant capsules are opaque white and embossed in tan with "6671" on one half, and "BMS 125 mg" on the other half.
200 mg: Gastro-resistant capsules are opaque white and embossed in green with "6672" on one half, and "BMS 200 mg" on the other half.
250 mg: Gastro-resistant capsules are opaque white and embossed in blue with "6673" on one half, and "BMS 250 mg" on the other half.
400 mg: Gastro-resistant capsules are opaque white and embossed in red with "6674" on one half, and "BMS 400 mg" on the other half.
Videx is indicated in combination with other antiretroviral drugs for the treatment of HIV-1 infected patients only when other antiretrovirals cannot be used.
Because didanosine absorption is reduced in the presence of food, Videx gastro-resistant capsules must be administered on an empty stomach (at least 2 hours before or 2 hours after a meal) (see section 5.2).
Posology
Videx gastro-resistant capsules are administered on a once daily or a twice daily regimen (see section 5.1).
The recommended total daily dose is based on patient body weight (kg):
• for patients weighing at least 60 kg: 400 mg per day
• for patients weighing less than 60 kg: 250 mg per day
The following table defines the administration schedule for all strengths of the gastro-resistant capsules:
|
Patient Weight
|
Total Daily Dose
|
Corresponding Regimen
|
|
at least 60 kg
|
400 mg
|
1 capsule of 400 mg (once daily)
or
1 capsule of 200 mg (twice daily)
|
|
less than 60 kg
|
250 mg
|
1 capsule of 250 mg (once daily)
or
1 capsule of 125 mg (twice daily)
|
Special populations
Elderly population: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. In addition, renal function should be monitored and dosage adjustments should be made accordingly (see below).
Renal impairment: The following dose adjustments are recommended:
|
Creatinine Clearance
(ml/min) / Patient Weight
|
Total Daily Dose
|
|
at least 60 kg
(dose, mg)
|
less than 60 kg
(dose, mg)
|
|
at least 60
30 – 59
10 – 29
less than 10
|
400 mg
200 mg
150 mg*
100 mg*
|
250 mg
150 mg*
100 mg*
75 mg*
|
* These strengths of Videx gastro-resistant capsules are not available. An alternative Videx formulation is to be used.
The dose should preferably be administered after dialysis (see section 4.4). However, it is not necessary to administer a supplemental dose of Videx following haemodialysis.
Paediatric patients: Since urinary excretion is also a major route of elimination of didanosine in paediatric patients, the clearance of didanosine may be altered in paediatric patients with renal impairment. Although there are insufficient data to recommend a specific dosage adjustment of Videx in this patient population, a reduction in the dose and/or an increase in the interval between doses must be considered.
Hepatic impairment: No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Paediatric population
Paediatric patients older than 6 years: The use of Videx gastro-resistant capsules has not been specifically studied in paediatric patients. The recommended daily dose (based on body surface area) is 240 mg/m2.
Paediatric patients yo
