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Videx EC 125mg, 200mg, 250mg and 400mg Gastro-resistant Capsules (2012)

Active ingredients: Didanosine

Product Name and Form

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.

Qualitative and Quantitative Composition

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.

Chemical substance
Description
Didanosine

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
Diethyl phthalate
30% methacrylic acid copolymer dispersion (EUDRAGIT L30D-55)
Sodium starch glycolate (Type A)
Talc

Capsule shell:

Gelatin
Sodium laurilsulfate
Titanium dioxide (E171)
Capsule shell imprints (edible ink):
Shellac
Propylene glycol

125 mg:

Potassium hydroxide
Titanium dioxide (E171)
Yellow and red iron oxide (E172)

200 mg:

FD&C Blue #2 Aluminium Lake (E132)
Titanium dioxide (E171)
Yellow iron oxide (E172)

250 mg:

FD&C Blue #2 Aluminium Lake (E132)

400 mg:

Ammonium hydroxide
Simethicone
Red iron oxide (E172)

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

Bristol-Myers Squibb Pharmaceuticals Limited
Uxbridge Business Park
Sanderson Road
Uxbridge
Middlesex
UB8 1DH

10/06/2009

Marketing authorization number:

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