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 125 mg gastro-resistant hard capsule
Videx 200 mg gastro-resistant hard capsule.
Videx 250 mg gastro-resistant hard capsule.
Videx 400 mg gastro-resistant hard capsule.
| Pharmaceutical Form |
|---|
|
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. |
Each gastro-resistant capsule, hard contains 125 mg, 200 mg, 250 mg or 400 mg of didanosine.
For a full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Didanosine belongs to a class of medicines called nucleoside analogues or nucleoside reversetranscriptase inhibitors (NRTIs). Intracellularly, didanosine is converted by cellular enzymes to the active metabolite, dideoxyadenosine 5'-triphosphate. Dideoxyadenosine 5'-triphosphate inhibits the activity of HIV-1 reverse transcriptase both by competing with the natural substrate, deoxyadenosine 5'-triphosphate, and by its incorporation into viral DNA causing termination of viral DNA chain elongation. |
| List of Excipients |
|---|
|
Sodium carmellose Capsule shell: Gelatin 125 mg: Potassium hydroxide 200 mg: FD&C Blue #2 Aluminium Lake (E132) 250 mg: FD&C Blue #2 Aluminium Lake (E132) 400 mg: Ammonium hydroxide |
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.
Bristol-Myers Squibb Pharmaceuticals Limited
Uxbridge Business Park
Sanderson Road
Uxbridge
Middlesex
UB8 1DH
Videx EC 125 mg gastro-resistant hard capsule: PL 11184/0083
Videx EC 200 mg gastro-resistant hard capsule: PL 11184/0084
Videx EC 250 mg gastro-resistant hard capsule: PL 11184/0085
Videx EC 400 mg gastro-resistant hard capsule: PL 11184/0086
10/06/2009
| Drug | Countries | |
|---|---|---|
| VIDEX | Estonia, Mexico, United States, South Africa |
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