Clindamycin/benzoyl peroxide explained

Verifiedfields:changed
Watchedfields:changed
Verifiedrevid:447548741
Type:combo
Imagel:Benzoyl-peroxide.svg
Imager:Clindamycin phosphate skeletal.svg
Component1:Clindamycin
Class1:Antibiotic
Component2:Benzoyl peroxide
Class2:Antiseptic
Tradename:Benzaclin, others
Dailymedid:Clindamycin phosphate and benzoyl peroxide
Pregnancy Au:A
Pregnancy Au Comment:[1]
Routes Of Administration:Topical
Atc Prefix:D10
Atc Suffix:AE51
Legal Au:S4
Legal Au Comment:[2] [3] [4]
Legal Uk:POM
Legal Uk Comment:[5] [6]
Legal Us:Rx-only
Legal Us Comment:[7] [8] [9] [10]
Legal Status:Rx-only[11]
Cas Number:151864-03-8
Pubchem:57383951
Kegg:D10602

Clindamycin/benzoyl peroxide, sold under the brand name Benzaclin among others, is a topical gel used for the treatment of acne. It is a fixed-dose combination of clindamycin, as the phosphate, an antibiotic; and benzoyl peroxide, an antiseptic.

Common side effects include peeling, itching, and dryness of the skin where the gel was applied.

Clindamycin/benzoyl peroxide was approved for medical use in the United States in December 2000.[12] [13] [14] It is available as a generic medication.[15]

Medical uses

The gel is used on the skin to treat light to medium acne vulgaris in people 12 years and older.[16]

Efficacy

There is an average 52% decrease in inflammatory acne lesions by week 12.[17]

The combination is less effective than benzoyl peroxide/salicylic acid after short-term treatment of two to four weeks, but the two treatments showed similar effectiveness after ten to twelve weeks.

Pregnancy and lactation

Studies on whether or not the use of clindamycin/benzoyl peroxide gels is teratogenic or has adverse effects on nursing infants have not been performed. While oral clindamycin passes into breast milk, no such data are available for clindamycin in gel form. Limited data regarding topical clindamycin and benzoyl peroxide have shown no safety problems.

Contraindications

The gel is not recommended for those who are allergic to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin.[18] Individuals previously diagnosed with regional enteritis, ulcerative colitis, or antibiotic-associated colitis are also recommended not to use it.

Side effects

Common side effects are peeling, itching, redness, dryness, burning, and dermatitis. Benzoyl peroxide bleaches hair, clothes, towels, bedclothing, and the like. Prolonged exposure to natural or artificial sun light (UV rays) is not recommended because the gel may cause photosensitivity. Irritation due to benzoyl peroxide can be reduced by avoiding harsh facial cleansers and wearing sunscreen prior to sun exposure.[19]

Clinical studies have shown systemic absorption of clindamycin through topical application, in some cases leading to diarrhea, bloody diarrhea, and colitis. Reports of anaphylaxis were also seen. However, the sources of these reports were personal accounts without controls and of an unknown population, thus it is difficult to attribute their cause to the clindamycin/benzoyl peroxide gel.

Interactions

No formal interaction studies have been done. Combination with topical products containing alcohol or astringents, as well as skin peelings, may increase the irritant effect of clindamycin/benzoyl peroxide. Topical erythromycin may antagonise the effect of clindamycin, although this has only be demonstrated in in vitro studies. Topical tretinoin and other retinoids may be inactivated by benzoyl peroxide or increase its irritant effect.

Pharmacology

Mechanism of action

Clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic clindamycin, which is synthesized from lincomycin. Like the macrolide antibiotics, it acts as a bacteriostatic agent by interfering with the 50S subunit of the ribosome of Cutibacterium acnes, inhibiting bacterial protein synthesis and preventing bacteria from replicating.[20] C. acnes plays a role in the development of acne.[21]

Benzoyl peroxide also kills C. acnes, but by releasing free radical oxygen species, thus oxidizing bacterial proteins. Also, it dries out the area by reducing sebum production, prevents clogged pores, and is a keratolytic agent. Since benzoyl peroxide is an oxidizer, not an antibiotic, it is not subject to C. acnes resistance unlike clindamycin.[22] [23]

Both ingredients have been shown to reduce the number of acne lesions with statistical significance.

Pharmacokinetics

Clindamycin phosphate is an inactive prodrug. It is quickly activated to clindamycin by hydrolysis. After four weeks of application during a study, 0.043% of the used clindamycin dose were found in the blood. Benzoyl peroxide is only absorbed through the skin after reduction to benzoic acid, which is subsequently metabolized to hippuric acid and eliminated via the kidneys.

Society and culture

Brand names

The combination is sold under various brand names including Acanya, Benzaclin, Duac, and Onexton.

Patent

Dow Pharmaceuticals filed the patent for Onexton, and the United States Patent and Trademark Office issued the patent on 16 October 2012. On 24 November 2014, the US Food and Drug Administration (FDA) approved the new drug application (NDA) No. 050819 for Onexton, with Dow Pharmaceutical as the holder.[24] The patent is set to expire on 5 August 2029.[25]

Lawsuits

On 12 January 2016,[26] Dow Pharmaceutical Sciences and Valeant Pharmaceuticals North America LLC filed a lawsuit against Taro USA and Taro Industries, an Israel-based corporation. The lawsuit was filed for infringement upon their Onexton patent, by Taro attempting to submit an abbreviated new drug application (ANDA) to the Food and Drug Administration (FDA) for its generic 3.75% benzoyl peroxide and 1.2% clindamycin phosphate topical gel. The court concluded that Taro was guilty of attempting to submit an ANDA patent request before the Onexton patent expired. Perrigo settled its patent litigation with Valeant and Dow.[27]

Notes and References

  1. Web site: Prescribing medicines in pregnancy database . Therapeutic Goods Administration (TGA) . 21 June 2022 . 8 July 2024.
  2. http://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=406130&agid=%28PrintDetailsPublic%29&actionid=1
  3. Web site: TGA eBS - Product and Consumer Medicine Information Licence .
  4. Web site: Novadac once daily gel (Nova Pharmaceuticals Australasia Pty Ltd) . Therapeutic Goods Administration (TGA) . 1 July 2024 . 8 July 2024.
  5. Web site: Duac Once Daily 10 mg/g + 30 mg/g Gel - Summary of Product Characteristics (SmPC) . (emc) . 30 April 2021 . 26 August 2022 . 4 February 2022 . https://web.archive.org/web/20220204224416/https://www.medicines.org.uk/emc/product/3238/smpc . live .
  6. Web site: Clindamycin + Benzoyl Peroxide 10mg/g + 50mg/g Gel - Summary of Product Characteristics (SmPC) . (emc) . 14 June 2021 . 26 August 2022 . 22 September 2021 . https://web.archive.org/web/20210922235755/https://www.medicines.org.uk/emc/product/12604 . live .
  7. Web site: Benzaclin- clindamycin phosphate and benzoyl peroxide gel . DailyMed . 16 February 2017 . 26 August 2022 . 19 January 2022 . https://web.archive.org/web/20220119063340/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4c6b2aca-d940-42af-a068-418f015d277a . live .
  8. Web site: Acanya- clindamycin phosphate and benzoyl peroxide gel . DailyMed . 30 September 2020 . 26 August 2022 . 24 March 2021 . https://web.archive.org/web/20210324112404/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3dcd2c96-72b1-4a9f-b65c-08198d63b7df . live .
  9. Web site: Onexton- clindamycin phosphate and benzoyl peroxide gel . DailyMed . 6 April 2020 . 26 August 2022 . 26 August 2022 . https://web.archive.org/web/20220826063956/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=697e760a-c206-4565-8f4e-a8085e215827 . live .
  10. Web site: Duac (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5%for topical use Initial U.S. Approval: 2000 . DailyMed . 15 April 2015 . 26 August 2022 . 26 August 2022 . https://web.archive.org/web/20220826063956/https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=510482 . live .
  11. Regulatory Update -- Stiefel, a GSK company announces a new, alternate, fixed-dose combination of Duac (clindamycin 1% and benzoyl peroxide 3%) gains positive recommendation for approval in Europe . GlaxoSmithKline . PR Newswire . 4 March 2013 . 26 August 2022 . 4 December 2020 . https://web.archive.org/web/20201204175824/https://www.prnewswire.co.uk/news-releases/regulatory-update----stiefel-a-gsk-company-announces-a-new-alternate-fixed-dose-combination-of-duac-clindamycin-1-and-benzoyl-peroxide-3-gains-positive-recommendation-for-approval-in-europe-194957091.html . live .
  12. Web site: Drug Approval Package: Benzaclin (Clindamycin 1% and Benzoyl Peroxide 5%) NDA #50-756 . U.S. Food and Drug Administration (FDA) . 24 December 1999 . 26 August 2022 . 2 April 2021 . https://web.archive.org/web/20210402020145/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-756_Benzaclin.cfm . live .
  13. Web site: Drug Approval Package: Duac (clindamycin, benzyoyl) NDA #050741 . U.S. Food and Drug Administration (FDA) . 27 April 2003 . 26 August 2022 . 11 April 2021 . https://web.archive.org/web/20210411055347/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050741_duac.cfm . live .
  14. Web site: Drug Approval Package: Acanya (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) Gel NDA #050819 . U.S. Food and Drug Administration (FDA) . 29 October 2009 . 26 August 2022 . 14 May 2021 . https://web.archive.org/web/20210514093358/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050819_acanya_toc.cfm . live .
  15. Perrigo Receives FDA Approval and Commences Launch of Clindamycin Phosphate and Benzoyl Peroxide 1.2% / 5% Gel . Perrigo Company . PR Newswire . 27 June 2012 . 26 August 2022 . 26 August 2022 . https://web.archive.org/web/20220826065730/https://www.prnewswire.com/news-releases/perrigo-receives-fda-approval-and-commences-launch-of-clindamycin-phosphate-and-benzoyl-peroxide-12--5-gel-160504545.html . live .
  16. Book: Austria-Codex. Haberfeld H . Österreichischer Apothekerverlag. Indoxyl 10 mg/g + 50 mg/g Gel. Vienna. 2016. de.
  17. Onexton gel for acne . The Medical Letter on Drugs and Therapeutics . 57 . 1476 . 124–5 . August 2015 . 26305525 .
  18. News: Onexton (Valeant Pharmaceuticals North America LLC): FDA Package Insert. MedLibrary.org. 2016-11-19. 26 August 2022. https://web.archive.org/web/20220826063957/https://medlibrary.org/lib/rx/meds/onexton-2/. live.
  19. Book: Koda-Kimble MA, Alldredge BK . Applied Therapeutics: The Clinical Use of Drugs. 2013. Wolters Kluwer Health/Lippincott Williams & Wilkins. Baltimore. 978-1609137137. 949. 10th.
  20. Web site: Lincosamides, Oxazolidinones, and Streptogramins . November 2005 . 2007-12-01 . . . 2 December 2007 . https://web.archive.org/web/20071202164507/http://www.merck.com/mmpe/print/sec14/ch170/ch170g.html . live .
  21. Kim J . Review of the innate immune response in acne vulgaris: activation of Toll-like receptor 2 in acne triggers inflammatory cytokine responses . Dermatology . 211 . 3 . 193–8 . 2005 . 16205063 . 10.1159/000087011 . 21459334 .
  22. Seidler EM, Kimball AB . Meta-analysis comparing efficacy of benzoyl peroxide, clindamycin, benzoyl peroxide with salicylic acid, and combination benzoyl peroxide/clindamycin in acne . Journal of the American Academy of Dermatology . 63 . 1 . 52–62 . July 2010 . 20488582 . 10.1016/j.jaad.2009.07.052 .
  23. Simonart T . Newer approaches to the treatment of acne vulgaris . American Journal of Clinical Dermatology . 13 . 6 . 357–64 . December 2012 . 22920095 . 10.2165/11632500-000000000-00000 . 12200694 .
  24. Dow Pharmaceutical Sciences, Inc. and Valeant Pharmaceuticals North America LLC v. Taro Pharmaceuticals U.S.A., INC. and Taro Pharmaceutical Industries LTD. United States District Court District of New Jersey. 01 Dec. 2016. Print.
  25. Book: Approved Drug Products With Therapeutic Equivalence Evaluations . 36th . U.S. Food and Drug Administration . 19 November 2016 .
  26. Web site: Chuderewicz . Melissa A. . vanc . Case 2:16-cv-00217-SRC-CLW . 15 April 2018 . 16 April 2018 . https://web.archive.org/web/20180416013219/https://insight.rpxcorp.com/litigation_documents/11809288 . live .
  27. Perrigo Announces Patent Litigation Settlement for the Generic Version of Onexton Gel . Perrigo Company . PR Newswire . 26 October 2017 . 26 August 2022 . 26 October 2017 . https://web.archive.org/web/20171026165233/https://www.prnewswire.com/news-releases/perrigo-announces-patent-litigation-settlement-for-the-generic-version-of-onexton-gel-300543948.html . live .

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