Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Bm_squib
VIDEX Tablets 25 mg VIDEX Tablets 50 mg VIDEX Tablets 100 mg VIDEX Tablets 150 mg VIDEX Paediatric Powder 2g SCHEDULING STATUS: S4 PP ZIMBABWE ONLY 2000/7.13/3866 2000/7.13/3867 2000/7.13/3868 2000/7.13/3869 2000/7.13/3870 PROPRIETARY NAME (and dosage form): VIDEX Tablets 25 mg VIDEX Tablets 50 mg VIDEX Tablets 100 mg VIDEX Tablets 150 mg VIDEX Paediatric Powder 2g COMPOSITION: Tablets containing Didanosine (25, 50, 100 and 150 mg). Paediatric powder containing 2g didanosine PHARMACOLOGICAL CLASSIFICATION: A20.2.8 Antiviral agents PHARMACOLOGICAL ACTION: VIDEX (2',3'-dideoxyinosine or ddI) is an inhibitor of the in vitro replication of the Human Immunodeficiency Virus (HIV) [(also known as HTLV III, LAV)] in human primary cell cultures and in established cell lines. After VIDEX enters the cell, it is enzymatically converted to dideoxyadenosine-triphosphate (ddATP), its active metabolite. In viral nucleic acid replication, incorporation of this 2',3'-dideoxynucleoside prevents chain extension and thereby inhibits viral replication. In addition, ddATP inhibits HIV-reverse transcriptase by competing with dATP for binding to the enzyme's active site, preventing proviral DNA synthesis. The relationship between in vitro susceptibility of HIV to didanosine and clinical response to therapy has not been established. Likewise, in vitro sensitivity results vary greatly and methods to establish virologic responses have not been proven. PHARMACOKINETICS: Adults: Didanosine is rapidly degraded at an acidic pH. Therefore, all oral formulations must contain or be administered with buffering agents designed to increase gastric pH. The presence of food significantly reduces the bioavailability of didanosine. Therefore, VIDEX should be administered at least 30 minutes before a meal or 2 hours after eating. Alt Read the complete document