LESTAVOR Film-coated tablet Ref.[50618] Active ingredients: Atorvastatin

Source: Marketing Authorisation Holder  Revision Year: 2020  Publisher: Activo Health (Pty) Ltd. Block B, Arena Office Park, 272 West Avenue, Centurion, 0157

Product name and form

LESTAVOR 20 (film-coated tablets).

LESTAVOR 40 (film-coated tablets).

LESTAVOR 80 (film-coated tablets).

Pharmaceutical Form

LESTAVOR 10: White oval biconvex film-coated tablets, approximately 10,1 × 5,6 mm and 3,7 mm in thickness.

LESTAVOR 20: White oval biconvex film-coated tablets with a non-fuctional breakline on one side, approximately 12,7 × 6,7 mm and 4,6 mm in thickness.

LESTAVOR 40: White oval biconvex film-coated tablets, approximately 19,4 × 7,8 mm and 4,7 mm in thickness.

LESTAVOR 80: White oblong biconvex film-coated tablets with a non-fuctional breakline on one side, approximately 22,8 × 10,9 mm and 5,7 mm in thickness.

Qualitative and quantitative composition

LESTAVOR 10: Each film-coated tablet contains atorvastatin calcium equivalent to 10 mg atorvastatin.

LESTAVOR 20: Each film-coated tablet contains atorvastatin calcium equivalent to 20 mg atorvastatin.

LESTAVOR 40: Each film-coated tablet contains atorvastatin calcium equivalent to 40 mg atorvastatin.

LESTAVOR 80: Each film-coated tablet contains atorvastatin calcium equivalent to 80 mg atorvastatin.

Active Ingredient Description
Atorvastatin

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.

List of Excipients

Activated attapulgite, Microcelac 100 (consisting of lactose monohydrate and microcrystalline cellulose), microcrystalline cellulose, pregelatinised starch, hydroxypropyl cellulose, magnesium stearate, silica colloidal anhydrous, and Opadry White (consisting of hypromellose, lactose monohydrate, polyethylene glycol and titanium dioxide).

Pack sizes and marketing

Packs of 28 (4 blisters of 7 tablets) or 30 (3 blisters of 10 tablets) film-coated tablets packed in Aluminium/Aluminium blister strips in a cardboard carton. Not all pack sizes are necessarily marketed.

Marketing authorization holder

Activo Health (Pty) Ltd. Block B, Arena Office Park, 272 West Avenue, Centurion, 0157

Marketing authorization dates and numbers

LESTAVOR 10: 44/7.5/1058
LESTAVOR 20: 44/7.5/1059
LESTAVOR 40: 44/7.5/1060
LESTAVOR 80: 44/7.5/1061

Drugs

Drug Countries
LESTAVOR South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.