Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: Bristol-Myers Squibb Pharmaceuticals Limited Uxbridge Business Park Sanderson Road Uxbridge Middlesex UB8 1DH
Videx is indicated in combination with other antiretroviral drugs for the treatment of HIV-1 infected patients.
Oral use.
Because didanosine absorption is reduced in the presence of food, Videx gastro-resistant capsules should be administered on an empty stomach (at least 2 hours before or 2 hours after a meal) (see section 5.2).
Videx gastro-resistant capsules may be administered on a once-daily (QD) or a twice-daily (BID) regimen (see section 5.1).
Adults: The recommended daily dose is dependent on patient weight:
The following table defines the administration schedule for all strengths of the gastro-resistant capsules:
| Patient Weight | Total Daily Dose | Corresponding Regimen |
| ≥ 60 kg | 400 mg | 1 capsule of 400 mg (once-daily) or 1 capsule of 200 mg (twice-daily) |
| < 60 kg | 250 mg | 1 capsule of 250 mg (once-daily) or 1 capsule of 125 mg (twice-daily) |
Children older than 6 years: The use of Videx gastro-resistant capsules has not been specifically studied in children. The recommended daily dose (based on body surface area) is 240 mg/m² (180 mg/m² in combination with zidovudine).
Children younger than 6 years: The gastro-resistant capsules should not be opened as there is a potential for inadvertent aspiration. Therefore, this medicine is contraindicated in this age group. Other more appropriate Videx formulations are available.
Renal impairment: The following dose adjustments are recommended:
| Creatinine Clearance(ml/min) | Patient Weight | |
| ≥ 60 kgTotal Daily Dose | < 60 kgTotal Daily Dose | |
| ≥ 60 | 400 mg | 250 mg |
| 30 – 59 | 200 mg | 150 mg |
| 10 – 29 | 150 mg* | 100 mg* |
| < 10 | 100 mg* | 75 mg* |
* These strengths of Videx gastro-resistant capsules are not available. An alternative Videx formulation should 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.
Hepatic impairment: No dose adjustment is required in patients with hepatic impairment (see section 5.2).
To optimise absorption, the gastro-resistant capsule should be taken intact with at least 100 ml of water. Patients should be instructed not to open the capsule to facilitate administration, since this could reduce absorption (see section 5.2).
There is no known antidote for didanosine overdosage. Experience in early studies, in which didanosine was initially administered at doses ten times the recommended doses, indicates that the anticipated complications of overdosage could include pancreatitis, peripheral neuropathy, hyperuricemia and hepatic dysfunction.
Didanosine is not dialysable by peritoneal dialysis, although there is some clearance by haemodialysis. (The fractional removal of didanosine during an average haemodialysis session of 3 to 4 hours was approximately 20-35% of the dose present in the body at the start of dialysis.)
2 years.
Do not store above 25°C.
Polyvinyl Chloride/Polyethylene/ACLAR/Aluminium foil blisters with 10 hard capsules per blister card and 3 cards (30 capsules) per carton or with 10 hard capsules per blister card and 6 cards (60 capsules) per carton.
Any unused product or waste material should be disposed of in accordance with local requirements.
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