Active ingredients: Atorvastatin
Lipitor 10 mg film-coated tablets.
White, round, 5.6 mm, film-coated tablets debossed ‘10’ on one side and ‘ATV’ on the other.
Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate).
Excipient(s) with known effect: Each Lipitor 10 mg film-coated tablet contains 27.25 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase. Atorvastatin lowers plasma cholesterol and lipoprotein serum concentrations by inhibiting HMG-CoA reductase and subsequently cholesterol biosynthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.
Film coating containing:
Titanium dioxide (E171)
Simethicone emulsion containing:
Stearate emulsifiers (polyethylene glycol sorbitan tristearate, polyethoxylate stearate, glycerides)
Thickeners (methylcellulose, xanthan gum)
The blisters consist of a forming film made of polyamide/aluminium foil/polyvinyl chloride and a backing made of aluminium foil/vinyl heat-seal coating.
The bottle is made of HDPE, containing desiccant, with squeeze-and-turn child-resistant closure.
Blister packs containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98 and 100 film-coated tablets.
Hospital packs containing 50, 84, 100, 200 (10 × 20) or 500 film-coated tablets.
HDPE bottle containing 90 film-coated tablets.
Not all pack sizes may be marketed.
Pfizer Ireland Pharmaceuticals, Operations Support Group, Ringaskiddy, Co Cork, Ireland
Date of first authorisation: 8 September 1997
Date of latest renewal: 03 March 2013