Is There a Lactose-Free Lipid Regulating Medicine?
Q&A 234.3
Is there a lactose-free lipid regulating medicine?
Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals
Before using this Q&A, read the disclaimer at www.ukmi.nhs.uk/activities/medicinesQAs/default.asp
Date prepared: 31st July 2013
Background
For general information about lactose intolerance and medicines see Medicines Q&A 131 “What factors need to be considered when prescribing for lactose intolerant adults?”
Answer
The following table lists which lipid regulating medicines do not contain lactose, i.e. are defined as lactose-free.
Statins
Atorvastatin 10mg, 20mg, 40mg, 80mg film coated tablets / N/A / Actavis, Wockhardt / 1-7
Atorvastatin 5mg, 10mg, 20mg, 40mg chewable tablets / Lipitor / Pfizer / 8-9
Atorvastatin 80mg tablets / N/A / Sandoz / 10, 11
Fluvastatin 20mg and 40mg capsules / N/A
N/A
Lescol
N/A
N/A / Actavis
Mylan
Novartis
Sandoz
Zentiva / 5, 12-13
14
15-16
11,17,18
19-21
Fluvastatin 80mg prolonged release tablets / Luvinsta XL
Dorisin XL
Pinmactil
Lescol XL
Stefluvin XL / Actavis
Aspire Pharma
Mylan
Novartis
Zentiva / 5, 22
23
14
16,24
21, 25
Simvastatin 20mg/5ml & 40mg/5ml suspension / N/A / Rosemont / 26-28
Fibrates
Bezafibrate 200mg tablets / Bezalip / Actavis / 5, 29
Bezafibrate 400 mg modified release tablets / Fibrazate XL / Sandoz / 11, 30
Gemfibrozil 300mg capsules & 600mg tablets / Lopid / Pfizer / 9, 31
Fenofibrate 267mg Capsules / N/A / Zentiva / 21, 32
Nicotinic acid groups
Acipimox 250mg capsules / Olbetam / Pfizer / 9, 33
Bile acid sequestrants
Colesevelam 625 mg tablets / Cholestagel / Sanofi / 34-35
Anhydrous colestyramine 4g sachets / Questran,
Questran Light / Bristol-Myers Squibb / 36-38
Colestipol 5g granules for oral suspension / Colestid,
Colestid Orange / Pharmacia / 9, 39-40
Omega 3 fatty acid compounds
Omega-3-acid ethyl esters 1g capsules / Omacor / Abbott Healthcare / 41-42
Omega-3-acid ethyl esters 1g capsules / Prestylon / Teva / 43-44
Limitations
Lactose-free complementary medicine, generic or ‘specials’ products may also be available and have not been considered. Individual Summary of Product Characteristics should be checked before prescribing as formulations may change. It has been assumed that all information concerning lactose in manufacturers’ Summaries of Product Characteristics is complete and correct.
References
1. Summary of Product Characteristics. Atorvastatin 10mg Film-coated Tablets, Actavis UK Ltd. Date last updated 10.01.13. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
2. Summary of Product Characteristics. Atorvastatin 20mg Film-coated Tablets, Actavis UK Ltd. Date last updated 14.01.13. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
3. Summary of Product Characteristics. Atorvastatin 40mg Film-coated Tablets, Actavis UK Ltd. Date last updated 14.01.13. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
4. Summary of Product Characteristics. Atorvastatin 80mg Film-coated Tablets, Actavis UK Ltd. Date last updated 19.04.13. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
5. Personal Communication. Actavis UK Ltd. Contacted 02.08.13.
6. Summary of Product Characteristics. Atorvastatin 10mg, 20mg, 40mg & 80mg Film-Coated Tablets, Wockhardt UK Ltd. Date last updated 23.10.12. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
7. Personal Communication. Wockhardt UK Ltd. Contacted 02.08.13.
8. Summary of Product Characteristics. Lipitor 5mg, 10mg, 20mg, 40mg chewable tablets, Pfizer Limited. Date last updated 29.06.12. Accessed 02.08.13 via http://www.medicines.org.uk/emc/
9. Personal Communication. Pfizer. Contacted 02.08.13.
10. Summary of Product Characteristics. Lipitor Atorvastatin 80 mg Film-coated Tablets, Sandoz Limited. Date last updated 13.08.12. Accessed 02.08.13 via http://www.medicines.org.uk/emc/
11. Personal Communication. Sandoz. Contacted 02.08.13.
12. Summary of Product Characteristics. Fluvastatin 20mg Capsules, Actavis UK Ltd. Date last updated 27.11.12. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
13. Summary of Product Characteristics. Fluvastatin 40mg Capsules, Actavis UK Ltd. Date last updated 14.12.12. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
14. Personal Communication. Mylan. Contacted 02.08.13.
15. Summary of Product Characteristics. Lescol (fluvastatin* sodium) 20 mg and 40 mg capsules, Novartis Pharmaceuticals UK Ltd. Date last updated 04.04.13. Accessed 31.07.13 via http://www.medicines.org.uk/emc
16. Personal Communication. Novartis Pharmaceuticals UK Limited. Contacted 02.08.13.
17. Summary of Product Characteristics Fluvastatin 20 mg Capsules, Sandoz Limited. Date last updated 10.04.13. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
18. Summary of Product Characteristics. Fluvastatin 40 mg Capsules, Sandoz Limited. Date last updated 10.04.13. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
19. Summary of Product Characteristics. Fluvastatin 20mg - Capsules, Zentiva. Date last updated 18.07.2012. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
20. Summary of Product Characteristics. Fluvastatin 40mg - Capsules, Zentiva. Date last updated 10.10.12. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
21. Personal Communication. Zentiva. Contacted 02.08.13.
22. Summary of Product Characteristics. Luvinsta XL 80 mg Prolonged-Release Tablets, Actavis UK Ltd. Date last updated 27.11.12. Accessed 31.07.13 via http://www.medicines.org.uk/emc
23. Personal Communication. Aspire Pharma Limited. Contacted 02.08.13.
24. Summary of Product Characteristics. Lescol XL 80 mg Prolonged Release Tablets, Novartis Pharmaceuticals UK Ltd. Date last updated 09.01.13. Accessed 31.07.13 via http://www.medicines.org.uk/emc
25. Summary of Product Characteristics. Stefluvin XL 80mg Prolonged Release Tablets, Zentiva. Date last updated 13.07.12. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
26. Summary of Product Characteristics. Simvastatin 20mg/5ml Oral Suspension, Rosemont Pharmaceuticals Limited. Date last updated 17.09.12. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
27. Summary of Product Characteristics. Simvastatin 40mg/5ml Oral Suspension, Rosemont Pharmaceuticals Limited. Date last updated 17.09.12. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
28. Personal Communication. Rosemont Pharmaceuticals Ltd. Contacted 02.08.13.
29. Summary of Product Characteristics. Bezalip 200mg tablets, Actavis UK Ltd. Date last updated 30.05.12. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
30. Summary of Product Characteristics. Fibrazate XL 400 mg Modified Release Tablets, Sandoz Limited. Date last updated 05.02.13. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
31. Summary of Product Characteristics. Lopid 300mg hard capsules & 600mg Film-coated Tablets, Pfizer Limited. Date last updated 24.05.11. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
32. Summary of Product Characteristics. Fenofibrate 267mg Capsules, Zentiva. Date last updated 05.09.12. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
33. Summary of Product Characteristics. Olbetam Capsules 250, Pfizer Limited. Date last updated 03.06.13. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
34. Personal Communication. Sanofi. Contacted 02.08.13.
35. Summary of Product Characteristics. Cholestagel 625 mg film-coated tablets, Sanofi. Date last updated 19.10.12. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
36. Personal Communication. Bristol-Myers Squibb Pharmaceuticals Ltd. Contacted 02.08.13.
37. Summary of Product Characteristics. Questran Powder for Oral Suspension 4g, Bristol-Myers Squibb Holdings Limited. Date last updated 09.08.12. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
38. Summary of Product Characteristics. Questran Light, Bristol-Myers Squibb Holdings Limited. Date last updated 09.08.12. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
39. Summary of Product Characteristics. COLESTID granules for oral suspension, Pharmacia Limited. Date last updated 04.04.08. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
40. Summary of Product Characteristics. COLESTID Orange 5g, Pharmacia Limited. Date last updated 27.03.13. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
41. Personal Communication. Abbott Healthcare Products Ltd. Contacted 02.08.13.
42. Summary of Product Characteristics. Omacor, Abbott Healthcare Products Limited. Date last updated 13.03.08. Accessed 31.07.13 via http://www.medicines.org.uk/emc/
43. Personal Communication. Teva UK Ltd. Contacted 02.08.13.
44. Summary of Product Characteristics. Prestylon 1g soft capsules, Teva UK Ltd. Date last updated 14.01.13. Accessed 02.08.13 via http://www.tevauk.com/mediafile/id/6079.pdf
Quality Assurance
Prepared by
Mark Cheeseman, East Anglia Medicines Information Service
Date Prepared
31st July 2013
Checked by
Katie Smith, East Anglia Medicines Information Service
Date of check
6th September 2013
Search strategy
· In-house database/resources: British National Formulary [http://www.bnf.org/bnf/] July 2013 (all preparations listed in section 2.12 (lipid regulating drugs)).
· Electronic Medicines Compendium [http://www.medicines.org.uk/emc/]: search terms: atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin, cholestagel, colestyramine, colestid, ezetrol, bezafibrate, ciprofibrate, fenofibrate, gemfibrozil, acipimox, nicotinic acid, omacor, prestylon
· Manufacturers contacted: Actavis, Wockhardt, Sandoz, Pfizer, Sanofi, Novartis, Rosemont, Bristol-Myers Squibb, Abbott Healthcare Products Ltd, Teva, Aspire Pharma, Mylan on 02.08.13. All responses received in writing.
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Available through NICE Evidence Search at www.evidence.nhs.uk