Product Information Viread (tenofovir disoproxil fumarate) 300 mg Tablets NAME OF THE MEDICINE VIREAD 300 mg tablets The active substance in VIREAD is tenofovir disoproxil fumarate Tenofovir disoproxil fumarate is a salt of a prodrug of tenofovir. Tenofovir disoproxil fumarate is designated chemically as fumarate (1:1). Chemical structure: Molecular formula: C23H34O14N5P Molecular mass: 635.52 CAS number: 202138-50-9 DESCRIPTION Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25°C. The partition coefficient (log P) for tenofovir disoproxil is 1.25 and the pKa is 3.75. The active pharmaceutical product is a single enantiomer that does not undergo racemisation either or in vitro in vivo. VIREAD tablets contain the following ingredients as excipients: microcrystalline cellulose Core: (E460), pregelatinised maize starch, croscarmellose sodium, lactose and magnesium stearate (E572). Opadry II Y-30-10671-A-(ARTG3968). Coating: Each VIREAD tablet is light blue and almond-shaped. Each tablet is debossed on one side with the markings and and on the other side with the marking The tablets are “” “4331” “300”. supplied in bottles with screw cap closures. PHARMACOLOGY Pharmacokinetics
Product Information Viread (tenofovir disoproxil fumarate) 300 mg Tablets NAME OF THE MEDICINE VIREAD 300 mg tablets The active substance in VIREAD is tenofovir disoproxil fumarate Tenofovir disoproxil fumarate is a salt of a prodrug of tenofovir. Tenofovir disoproxil fumarate is designated chemically as fumarate (1:1). Chemical structure: Molecular formula: C23H34O14N5P Molecular mass: 635.52 CAS number: 202138-50-9 DESCRIPTION Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25°C. The partition coefficient (log P) for tenofovir disoproxil is 1.25 and the pKa is 3.75. The active pharmaceutical product is a single enantiomer that does not undergo racemisation either in vitro or in vivo. VIREAD tablets contain the following ingredients as excipients: Core: microcrystalline cellulose (E460), pregelatinised maize starch, croscarmellose sodium, lactose and magnesium stearate (E572). Coating: Opadry II Y-30-10671-A-(ARTG3968). Each VIREAD tablet is light blue and almond-shaped. Each tablet is debossed on one side with the markings “” and “4331” and on the other side with the marking “300”. The tablets are supplied in bottles with screw cap closures. PHARMACOLOGY Pharmacokinetics
auspar-tenofovir-disoproxil-fumarate-131014-pi.docx