Composition:

Benzydamine hydrochloride BP 0.15 %w/v with Brilliant Blue and Tartarazine Yellow color in Aqueous base

Understanding Benzydamine hydrochloride:

Benzydamine hydrochloride is an anti-inflammatory, analgesic with anaesthetic action that can provide instant relief from a variety of painful inflammatory conditions of the oropharyngeal region when used as a rinse/ gargle.

Benzydamine shows some properties that are common with other nonsteroidal antiinflammatory drugs (NSAIDs) but also displays properties which are different from other NSAIDs.

Ref: Segre G, Hammarström S. Aspects of the mechanisms of action of benzydamine.

Int J Tissue React. 1985;7(3):187-93. PMID: 4044146.

Link: https://pubmed.ncbi.nlm.nih.gov/4044146/

Benzydamine inhibits prostaglandin and thromboxane biosynthesis at high concentrations,
which can be reached by topical application of the drug.

Ref: Segre G, Hammarström S. Aspects of the mechanisms of action of benzydamine.

Int J Tissue React. 1985;7(3):187-93. PMID: 4044146.

Link: https://pubmed.ncbi.nlm.nih.gov/4044146/

Benzydamine mouthwash is considered the gold standard among anti-inflammatory agents in the management of oral mucositis in cancer patients.

Ref: Benzydamine Oro-mucosal Solution in Oral Mucositis. ClinicalTrials.gov

(NCT05055726), NIH U.S. National Library of Medicine, Sept 2021

Link:https://clinicaltrials.gov/ct2/show/NCT05055726

International guidelines and recommendations for Oral Mucositis (OM): Benzydamine is recommended

International guidelines in the management of oral mucositis were published in 2004 and then updated in 2007 and 2014. The Multinational Association of Supportive Care in Cancer and International SocietyOral Oncology (MASCC/ISOO) clinical practice guidelines (2014)recommend that benzydamine mouthwash be used to prevent OM in patients with cancer (level I evidence) – this is in agreement with the meta-analyses conducted in 2020.

Ref: Lalla RV, Bowen J, Barasch A, Elting L, Epstein J, Keefe DM, McGuire DB, Migliorati C, Nicolatou- Galitis O, Peterson DE, Raber-Durlacher JE, Sonis ST, Elad S; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy.

Cancer. 2014 May 15;120(10):1453-61. doi: 10.1002/cncr.28592. Epub 2014 Feb 25.

Erratum in: Cancer. 2015 Apr 15;121(8):1339. PMID: 24615748; PMCID: PMC4164022.

Bayesian network analysis (2020)

Chamomile, honey, curcumin and benzydamine mouthwashes may be the most advantageous in terms of the prevention of intolerable Oral Mucositis.

Ref: Zhang X, Sun D, Qin N, Liu M, Zhang J, Li X. Comparative prevention potential of 10 mouthwashes on intolerable oral mucositis in cancer patients: A Bayesian network analysis. Oral Oncol. 2020 Aug;107:104751. doi: 10.1016/j.oraloncology.2020.104751.

Epub 2020 May 7. PMID: 32388411.

Link: https://www.sciencedirect.com/science/article/abs/pii/S1368837520301871

Network Meta-analysis (2020)

A total of 28 RCTs involving 1861 patients were included. The results of network meta- analysis showed that chlorhexidine, benzydamine, honey, and curcumin were more effective than placebo (P < 0.05).

Ref: Yu YT, Deng JL, Jin XR, Zhang ZZ, Zhang XH, Zhou X. Effects of 9 oral care solutions on the prevention of oral mucositis: a network meta-analysis of randomized controlledtrials. Medicine (Baltimore). 2020 Apr;99(16):e19661. doi: 10.1097/MD.0000000000019661.
PMID: 32311938; PMCID: PMC7220734.

Link: https://journals.lww.com/md journal/Fulltext/2020/04170/Effects_of_9_oral_care_solutions_on_the_prevention.22.aspx

Benzydamine mouthwash is the only anti-inflammatory agent with evidence in the prevention of Oral Mucositis to date.

Ref: Ariyawardana A, Cheng KKF, Kandwal A, Tilly V, Al-Azri AR, Galiti D, Chiang K, Vaddi A, Ranna V, Nicolatou- Galitis O, Lalla RV, Bossi P, Elad S; Mucositis Study Group of the

Multinational Association of Supportive Care in Cancer/International Society for Oral Oncology (MASCC/ISOO). Systematic review of anti-inflammatory agents for the management of oral mucositis in cancer patients and clinical practice guidelines.

Support Care Cancer. 2019 Oct;27(10):3985-3995. doi: 10.1007/s00520-019-04888-w.

Epub 2019 Jul 8. PMID: 31286230.

Clinical indications:

1. Burning mouth due to various types of desquamative gingivitis: Lichen planus, pemphigoid types, pemphigus, and more
2. Burning mouth due to oral submucous fibrosis
3. Various red & white lesions affecting the oral mucosa.
4. Generalized oropharyngeal ulcers due to nutritional deficiency or infections.
5. Oral mucositis during and after cancer therapy.
6. Multiple oral mucosal injuries due to orthodontic appliances, oral surgery appliances
7. Painful sore throat, painful dysphagia.

Coolora rinse / gargle provides instant relief from painful inflammatory conditions of the oro-pharyngeal region and helps patients get back on track with their essential life activities, such as eating, drinking, speaking, swallowing, etc.

Dosage & Administration:

Adults and Elderly:

Rinse or gargle with 15 ml (approximately 1 tablespoonful) every 11⁄2 to 3 hours as required for pain relief. The solution should be expelled from the mouth after use. Professional advice recommended. CHILDREN: Not suitable for children aged 12 years or under.

Presentation:

PET bottles of 100ml with 15ml measuring cap.