MedPath

Benzydamine

Generic Name
Benzydamine
Brand Names
Pharixia, Tantum
Drug Type
Small Molecule
Chemical Formula
C19H23N3O
CAS Number
642-72-8
Unique Ingredient Identifier
4O21U048EF
Background

Benzydamine (also known as Tantum Verde or Difflam), available as the hydrochloride salt, is a locally-acting nonsteroidal anti-inflammatory drug (NSAID) with local anaesthetic and analgesic properties. It is used topically for pain relief and anti-inflammatory treatment of the mouth, throat, or muscoskeletal system.

Although the indazole analogue benzydamine is a non-steroidal anti-inflammatory drug (NSAID), it has various physicochemical properties and pharmacologic activities that are different from those of traditional aspirin-like NSAIDs but facilitate benzydamine's mechanism of action as an effective locally-acting NSAID with local anaesthetic and analgesic properties. Moreover, unlike aspirin-like NSAIDs which are acids or metabolised to acids, benzydamine is in fact a weak base.

Indication

Available predominantly as a liquid mouthwash, oromucosal spray, or topical cream, benzydamine is most frequently employed as a locally acting analgesic and anti-inflammatory treatment for the relief of painful inflammatory conditions.

When formulated as a mouthwash or spray, benzydamine may be used to treat traumatic conditions like pharyngitis following tonsillectomy or the use of a naso-gastric tube, inflammatory conditions like pharyngitis, aphthous ulcers and oral ulceration due to radiation therapy, dentistry operations and procedures, or more general conditions like sore throat, sore tongue, sore gums, mouth ulcers, or discomfort caused by dentures.

When used as a topical cream, benzydamine may be employed to relieve symptoms associated with painful inflammatory conditions of the muscolo-skeletal system including acute inflammatory disorders such as myalgia and bursitis or traumatic conditions like sprains, strains, bruises, sore muscles, stiff joints, or even the after-effects of fractures.

Associated Conditions
Acute Sore Throat, Gingivitis, Inflammation of Mouth, Laryngitis, Mouth irritation, Mucositis of the oro-pharyngeal, Pain, Pain, Orofacial, Pharyngitis, Sore gums, Throat irritation, Traumatic Injuries caused by Dental Prosthesis, Gum irritation
Associated Therapies
Oral Hygiene, Tooth Extractions, Oral antisepsis

Tolerability and Pharmacokinetic Study of Econazole Nitrate Plus Benzydamine HCl Vaginal Pessary

First Posted Date
2016-03-28
Last Posted Date
2017-02-07
Lead Sponsor
Aziende Chimiche Riunite Angelini Francesco S.p.A
Target Recruit Count
49
Registration Number
NCT02720783
Locations
🇨🇭

CROSS Research S.A., Phase I Unit, Arzo, Switzerland

Tolerability and Pharmacokinetic Study of Econazole Nitrate and Benzydamine HCl Intravaginal Cream

First Posted Date
2016-03-21
Last Posted Date
2018-01-17
Lead Sponsor
Aziende Chimiche Riunite Angelini Francesco S.p.A
Target Recruit Count
48
Registration Number
NCT02713893
Locations
🇨🇭

CROSS Research S.A., Phase I Unit, Arzo, Switzerland

The Influence of Tantum Verde® on Recovery Following Tonsillectomy

Not Applicable
Completed
Conditions
Tonsillectomy
Adenoidectomy
Interventions
Other: Placebo mouthwash
First Posted Date
2014-07-15
Last Posted Date
2018-10-02
Lead Sponsor
Western Galilee Hospital-Nahariya
Target Recruit Count
60
Registration Number
NCT02190162
Locations
🇮🇱

Galillee medical center, Naharia, Israel

Benzydamine HCl for Postoperative Sore Throat

Phase 3
Conditions
For Intervention
Interventions
First Posted Date
2012-07-11
Last Posted Date
2012-07-26
Lead Sponsor
Prince of Songkla University
Target Recruit Count
86
Registration Number
NCT01637883
Locations
🇹🇭

Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand

Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrochloride for the Treatment of Radiation-induced Mucositis

Phase 3
Completed
Conditions
Head and Neck Cancer
Mucositis
Interventions
Drug: Combination of Magic Mouthwash Plus Sucralfate
First Posted Date
2008-12-24
Last Posted Date
2011-01-20
Lead Sponsor
Juravinski Cancer Centre Foundation
Target Recruit Count
67
Registration Number
NCT00814359
Locations
🇨🇦

Juravinski Cancer Centre, Hamilton, Ontario, Canada

Safety & Efficacy Study of Benzydamine Oral Rinse for the Treatment of Oral Mucositis (Mouth Sores) Resulting From Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, or Nasopharynx

Phase 3
Completed
Conditions
Stomatitis
Radiation Effects
First Posted Date
2003-01-13
Last Posted Date
2011-05-19
Lead Sponsor
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Target Recruit Count
605
Registration Number
NCT00051441
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