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Country of origin : Malaysia

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benzydamine

Mouthwash 0.15 % - 100 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Malaysia
GMP approvals
PICS
Manufacturer #540
This global pharmaceutical company boasts an impressive 80 years of experience in developing and delivering a diverse range of products. Their portfolio spans prescription medications, over-the-counter drugs, herbal teas, and penicillin production. They hold over 1643 marketing authorizations for more than 400 products distributed across 50 countries. Key therapy areas include those addressing respiratory health, pain management, and cardiovascular conditions. Their manufacturing facilities are equipped to produce various dosage forms including effervescent & oral liquids, topical preparations, softgels, and oral solids. The company prioritizes quality with GMP certifications, reflecting their commitment to safety and efficacy.

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Benzydamine

Benzydamine relieves the pain and inflammation associated with a sore throat or mouth sores caused by radiation therapy. Odontostomatologists treats patients of gingivitis, stomatitis, glossitis, aphthous ulcers, dental surgery and oral ulceration due to radiation therapy. It is available as the hydrochloride salt and a locally acting nonsteroidal anti- inflammatory drug with local anaesthetic and analgesic properties for pain relief and anti- inflammatory treatment of inflammatory conditions of the mouth and throat. Otorhinolaryngologists prescribed it in the treatment of glandular fever, pharyngitis, tonsillitis, post-tonsillectomy, and radiation or intubation mucositis. Benzydamine is also used alone or as an adjunct to other therapy giving the possibility of increased therapeutic effect with little risk of interaction. Benzydamine is sold under the brand name Tantum Verde Difflam and Septabene to name a few across countries. Focus Pharmaceuticals Limited is the Marketing Authorisation Holder and the manufacturer of this medicine based in the UK.

Dose and forms

Benzydamine is a mouth rinse and or gargle and not to be swallowed. It is diluted with equal amounts of water prior to rinsing or gargling if it causes irritation or burning. For mouth sores, the cream has to stay in the mouth so that the liquid in contact with the sores for at least 30 seconds before spitting it out. For a sore throat, gargling for 30 seconds is recommended.

The cost of Benzydamine

In the United Kingdom, consumers have to pay 7 pounds for 20 Lozenges 3mg and 8 pounds for Sore Throat Rinse of 200ml. The Spray of 30ml costs 7 pounds and the powder is sold for 67 pounds for 1% per 100gram. The formulations of this medicine are not sold widely in the USA.

How does Benzydamine work?

Benzydamine actions effect the local mechanisms of inflammation such as pain, oedema or granuloma specifically. When applied topically, it demonstrates anti-inflammatory activity reducing oedema as well as exudate and granuloma formation. It also has analgesic properties when the source of pain is an inflammatory condition and local anesthetic activity. Benzydamine poorly affects Hyperthermia indicative of systemic functional involvement. Furthermore, Benzydamine is a weak inhibitor of the prostaglandin synthesis. It exerts its effects mostly through inhibition of the synthesis of proinflammatory cytokines including tumour necrosis factor-alpha without significantly affecting other pro-inflammatory or anti- inflammatory cytokines.. The local anesthetic activity of the compound has been related to an interaction with cationic channels.

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