Clindamycin/benzoyl peroxide

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Clindamycin/benzoyl peroxide
Benzoyl-peroxide.svg Clindamycin phosphate skeletal.svg
Combination of
Clindamycin Antibiotic
Benzoyl peroxide Antiseptic
Clinical data
Trade names Benzaclin, others
AHFS/Drugs.com Multum Consumer Information
MedlinePlus a603021
License data
Pregnancy
category
Routes of
administration 		Topical
ATC code
Legal status
Legal status
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CAS Number
PubChem CID
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Clindamycin/benzoyl peroxide, sold under the brand name Benzaclin among others, is a topical gel used for the treatment of acne. [7] It is a fixed-dose combination of clindamycin, as the phosphate, an antibiotic; and benzoyl peroxide, an antiseptic. [7]

Contents

Common side effects include peeling, itching, and dryness of the skin where the gel was applied. [7]

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. [18]

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. [16] [7]

Contraindications

The gel is not recommended for those who are allergic to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. [16] [19] Individuals previously diagnosed with regional enteritis, ulcerative colitis, or antibiotic-associated colitis are also recommended not to use it. [9]

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. [16] [19] Irritation due to benzoyl peroxide can be reduced by avoiding harsh facial cleansers and wearing sunscreen prior to sun exposure. [20]

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. [19]

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. [16] [19]

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. [16] [21] C. acnes plays a role in the development of acne. [22]

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. [16] Since benzoyl peroxide is an oxidizer, not an antibiotic, it is not subject to C. acnes resistance unlike clindamycin. [18] [23]

Both ingredients have been shown to reduce the number of acne lesions with statistical significance. [18]

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. [16]

Society and culture

Brand names

The combination is sold under various brand names including Acanya, [8] Benzaclin, [7] Duac, [10] and Onexton. [9]

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. [24] Perrigo settled its patent litigation with Valeant and Dow. [27]

Related Research Articles

<span class="mw-page-title-main">Acne</span> Skin condition characterized by pimples

Acne also known as acne vulgaris, is a long-term skin condition that occurs when dead skin cells and oil from the skin clog hair follicles. Typical features of the condition include blackheads or whiteheads, pimples, oily skin, and possible scarring. It primarily affects skin with a relatively high number of oil glands, including the face, upper part of the chest, and back. The resulting appearance can lead to lack of confidence, anxiety, reduced self-esteem, and, in extreme cases, depression or thoughts of suicide.

<span class="mw-page-title-main">Clindamycin</span> Antibiotic

Clindamycin is a lincosamide antibiotic medication used for the treatment of a number of bacterial infections, including osteomyelitis (bone) or joint infections, pelvic inflammatory disease, strep throat, pneumonia, acute otitis media, and endocarditis. It can also be used to treat acne, and some cases of methicillin-resistant Staphylococcus aureus (MRSA). In combination with quinine, it can be used to treat malaria. It is available by mouth, by injection into a vein, and as a cream or a gel to be applied to the skin or in the vagina.

<span class="mw-page-title-main">Tretinoin</span> Medication

Tretinoin, also known as all-trans retinoic acid (ATRA), is a medication used for the treatment of acne and acute promyelocytic leukemia. For acne, it is applied to the skin as a cream, gel or ointment. For acute promyelocytic leukemia, it is effective only when the RARA-PML fusion mutation is present and is taken by mouth for up to three months. Topical tretinoin is also the most extensively investigated retinoid therapy for photoaging.

<span class="mw-page-title-main">Benzoyl peroxide</span> Chemical compound with uses in industry and acne treatment

Benzoyl peroxide is a chemical compound (specifically, an organic peroxide) with structural formula (C6H5−C(=O)O−)2, often abbreviated as (BzO)2. In terms of its structure, the molecule can be described as two benzoyl (C6H5−C(=O)−, Bz) groups connected by a peroxide (−O−O−). It is a white granular solid with a faint odour of benzaldehyde, poorly soluble in water but soluble in acetone, ethanol, and many other organic solvents. Benzoyl peroxide is an oxidizer, which is principally used in the production of polymers.

<span class="mw-page-title-main">Adapalene</span> Third-generation topical retinoid

Adapalene is a third-generation topical retinoid primarily used in the treatment of mild-moderate acne, and is also used off-label to treat keratosis pilaris as well as other skin conditions. Studies have found adapalene is as effective as other retinoids, while causing less irritation. It also has several advantages over other retinoids. The adapalene molecule is more stable compared to tretinoin and tazarotene, which leads to less concern for photodegradation. It is also chemically more stable compared to the other two retinoids, allowing it to be used in combination with benzoyl peroxide. Due to its effects on keratinocyte proliferation and differentiation, adapalene is superior to tretinoin for the treatment of comedonal acne and is often used as a first-line agent. The Swiss company Galderma sells adapalene under the brand name Differin.

<span class="mw-page-title-main">Tazarotene</span> Topical retinoid medication

Tazarotene, sold under the brand name Tazorac, among others, is a third-generation prescription topical retinoid. It is primarily used for the treatment of plaque psoriasis and acne. Tazarotene is also used as a therapeutic for photoaged and photodamaged skin. It is a member of the acetylenic class of retinoids.

Bausch Health Companies Inc. is an American-Canadian multinational specialty pharmaceutical company based in Laval, Quebec, Canada. It develops, manufactures and markets pharmaceutical products and branded generic drugs, primarily for skin diseases, gastrointestinal disorders, eye health and neurology. Bausch Health owns Bausch & Lomb, a supplier of eye health products. Bausch Health's business model is primarily focused on acquiring small pharmaceutical companies and then sharply increasing the prices of the drugs these companies sell.

<span class="mw-page-title-main">Proactiv</span> Acne focused skincare products

Proactiv is an American brand of skin-care products developed by two American dermatologists, Katie Rodan and Kathy A. Fields, and launched in 1995 by Guthy-Renker, a California-based direct marketing company, that was endorsed by famous celebrities The range includes moisturizers, body washes and treatment products, but the brand is known for its three-step anti-acne Solutions 3-step routine consisting of a BPO cleanser, glycolic toner and treatment lotion. Proactiv+, a reformulation of the three-step kit, was introduced in 2013, and in 2017, ProactivMD launches powered by Adapalene.

<span class="mw-page-title-main">Lincosamides</span> Group of antibiotics

Lincosamides are a class of antibiotics, which include lincomycin, clindamycin, and pirlimycin.

Erythromycin/benzoyl peroxide, sold under the brand name Benzamycin, is a topical gel containing of 5% benzoyl peroxide and 3% erythromycin primarily used to treat acne. Erythromycin/benzoyl peroxide is a prescription medication.

<span class="mw-page-title-main">Amcinonide</span> Chemical compound

Amcinonide is a topical glucocorticoid used to treat itching, redness and swelling associated with several dermatologic conditions such as atopic dermatitis and allergic contact dermatitis. Amcinonide can also be classified as a multi-functional small molecule corticosteroid, which has been approved by the FDA and is currently marketed as an ointment, lotion, or cream. It acts as both a transcription factor for responses to glucocorticoids and modulator for other transcription factors while also regulating phospholipase A2 activity.

<span class="mw-page-title-main">Azilsartan</span> Chemical compound

Azilsartan, sold under the brand name Edarbi among others, is used for the treatment of hypertension. It is used as the prodrug azilsartan medoxomil, is an angiotensin II receptor antagonist, and was developed by Takeda.

Clindamycin/tretinoin is a topical gel used in the treatment of acne. The two active ingredients are the antibiotic clindamycin phosphate (1.2%) and tretinoin (0.025%), a retinoid. The two active ingredients perform different functions, the clindamycin is active against gram-positive bacteria, including streptococci and penicillin-resistant staphylococci. The Tretinoin element acts to reduce the amount of oil released by oil glands in skin, as well as encouraging skin cell replenishment. The topical treatment is stored in 2, 30, and 60 gram tubes and should be stored at 25°C (77°F), with the tube tightly shut away from light. Side effects may include peeling, redness, dryness, itching and photosensitivity. Also, topical clindamycin may rarely cause diarrhea or colitis. Sun exposure while using this preparation can cause skin irritation.

<span class="mw-page-title-main">Pimple</span> Type of comedo

A pimple or zit is a kind of comedo that results from excess sebum and dead skin cells getting trapped in the pores of the skin. In its aggravated state, it may evolve into a pustule or papule. Pimples can be treated by acne medications, antibiotics, and anti-inflammatories prescribed by a physician, or various over the counter remedies purchased at a pharmacy.

<span class="mw-page-title-main">Tedizolid</span> Oxazolidinone-class antibiotic

Tedizolid, sold under the brand name Sivextro is an oxazolidinone-class antibiotic. Tedizolid phosphate is a phosphate ester prodrug of the active compound tedizolid. It was developed by Cubist Pharmaceuticals, following acquisition of Trius Therapeutics, and is marketed for the treatment of acute bacterial skin and skin structure infections.

<span class="mw-page-title-main">Adapalene/benzoyl peroxide</span> Pharmaceutical combination

Adapalene/benzoyl peroxide, sold under the brand name Epiduo among others, is a fixed-dose combination medication for the treatment of severe acne vulgaris. It consists of a combination of adapalene and benzoyl peroxide in a topical gel formulation.

<span class="mw-page-title-main">Efinaconazole</span> Chemical compound

Efinaconazole, sold under the brand name Jublia among others, is a triazole antifungal medication. It is approved for use in the United States, Canada, and Japan as a 10% topical solution for the treatment of onychomycosis. Efinaconazole acts as a 14α-demethylase inhibitor.

<span class="mw-page-title-main">Trifarotene</span> Chemical compound

Trifarotene, sold under the brand name Aklief, is a medication for the topical treatment of acne vulgaris. It is a retinoid; specifically, a fourth-generation selective retinoic acid receptor (RAR)-γ agonist.

Tretinoin/benzoyl peroxide, sold under the brand name Twyneo, is a fixed-dose combination medication used for the treatment of acne. It contains tretinoin, a vitamin A derivative, and benzoyl peroxide, an oxidizing agent.

Clindamycin/adapalene/benzoyl peroxide, sold under the brand name Cabtreo, is a fixed-dose combination medication used for the treatment of acne. It contains clindamycin, as the phosphate, a lincosamide antibacterial; adapalene, a synthetic retinoid; and benzoyl peroxide, an oxidizing agent. It is applied to the skin.

References

  1. ↑ "Prescribing medicines in pregnancy database". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 8 July 2024.
  2. ↑ http://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=406130&agid=%28PrintDetailsPublic%29&actionid=1 [ bare URL ]
  3. ↑ "TGA eBS - Product and Consumer Medicine Information Licence".
  4. ↑ "Novadac once daily gel (Nova Pharmaceuticals Australasia Pty Ltd)". Therapeutic Goods Administration (TGA). 1 July 2024. Retrieved 8 July 2024.
  5. ↑ "Duac Once Daily 10 mg/g + 30 mg/g Gel - Summary of Product Characteristics (SmPC)". (emc). 30 April 2021. Archived from the original on 4 February 2022. Retrieved 26 August 2022.
  6. ↑ "Clindamycin + Benzoyl Peroxide 10mg/g + 50mg/g Gel - Summary of Product Characteristics (SmPC)". (emc). 14 June 2021. Archived from the original on 22 September 2021. Retrieved 26 August 2022.
  7. 1 2 3 4 5 6 "Benzaclin- clindamycin phosphate and benzoyl peroxide gel". DailyMed. 16 February 2017. Archived from the original on 19 January 2022. Retrieved 26 August 2022.
  8. 1 2 "Acanya- clindamycin phosphate and benzoyl peroxide gel". DailyMed. 30 September 2020. Archived from the original on 24 March 2021. Retrieved 26 August 2022.
  9. 1 2 3 "Onexton- clindamycin phosphate and benzoyl peroxide gel". DailyMed. 6 April 2020. Archived from the original on 26 August 2022. Retrieved 26 August 2022.
  10. 1 2 "Duac (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5%for topical use Initial U.S. Approval: 2000". DailyMed. 15 April 2015. Archived from the original on 26 August 2022. Retrieved 26 August 2022.
  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" (Press release). GlaxoSmithKline. 4 March 2013. Archived from the original on 4 December 2020. Retrieved 26 August 2022– via PR Newswire.
  12. ↑ "Drug Approval Package: Benzaclin (Clindamycin 1% and Benzoyl Peroxide 5%) NDA #50-756". U.S. Food and Drug Administration (FDA). 24 December 1999. Archived from the original on 2 April 2021. Retrieved 26 August 2022.
  13. ↑ "Drug Approval Package: Duac (clindamycin, benzyoyl) NDA #050741". U.S. Food and Drug Administration (FDA). 27 April 2003. Archived from the original on 11 April 2021. Retrieved 26 August 2022.
  14. ↑ "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. Archived from the original on 14 May 2021. Retrieved 26 August 2022.
  15. ↑ "Perrigo Receives FDA Approval and Commences Launch of Clindamycin Phosphate and Benzoyl Peroxide 1.2% / 5% Gel" (Press release). Perrigo Company. 27 June 2012. Archived from the original on 26 August 2022. Retrieved 26 August 2022– via PR Newswire.
  16. 1 2 3 4 5 6 7 8 Haberfeld H, ed. (2016). Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag. Indoxyl 10 mg/g + 50 mg/g Gel.
  17. ↑ "Onexton gel for acne". The Medical Letter on Drugs and Therapeutics. 57 (1476): 124–5. August 2015. PMID   26305525.
  18. 1 2 3 Seidler EM, Kimball AB (July 2010). "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. doi:10.1016/j.jaad.2009.07.052. PMID   20488582.
  19. 1 2 3 4 "Onexton (Valeant Pharmaceuticals North America LLC): FDA Package Insert". MedLibrary.org. Archived from the original on 26 August 2022. Retrieved 19 November 2016.
  20. ↑ Koda-Kimble MA, Alldredge BK, eds. (2013). Applied Therapeutics: The Clinical Use of Drugs (10th ed.). Baltimore: Wolters Kluwer Health/Lippincott Williams & Wilkins. p. 949. ISBN   978-1609137137.
  21. ↑ "Lincosamides, Oxazolidinones, and Streptogramins". Merck Manual of Diagnosis and Therapy . Merck & Co. November 2005. Archived from the original on 2 December 2007. Retrieved 1 December 2007.
  22. ↑ Kim J (2005). "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. doi:10.1159/000087011. PMID   16205063. S2CID   21459334.
  23. ↑ Simonart T (December 2012). "Newer approaches to the treatment of acne vulgaris". American Journal of Clinical Dermatology. 13 (6): 357–64. doi:10.2165/11632500-000000000-00000. PMID   22920095. S2CID   12200694.
  24. 1 2 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. ↑ Approved Drug Products With Therapeutic Equivalence Evaluations (36th ed.). U.S. Food and Drug Administration. 19 November 2016.
  26. ↑ Chuderewicz MA. "Case 2:16-cv-00217-SRC-CLW". Archived from the original on 16 April 2018. Retrieved 15 April 2018.
  27. ↑ "Perrigo Announces Patent Litigation Settlement for the Generic Version of Onexton Gel" (Press release). Perrigo Company. 26 October 2017. Archived from the original on 26 October 2017. Retrieved 26 August 2022– via PR Newswire.
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