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Pronunciation:

(ben ZID a meen)

Synonyms:

Benzydamine Hydrochloride

Generic Available:

Yes

Canadian Brand Names:

Apo-Benzydamine®; Dom-Benzydamine; Novo-Benzydamine; PMS-Benzydamine; ratio-Benzydamine; Sun-Benz®; Tantum®

Use:

Symptomatic treatment of pain associated with acute pharyngitis; treatment of pain associated with radiation-induced oropharyngeal mucositis

Restrictions:

Not available in U.S.

Pregnancy Implications:

Safety has not been established in pregnant women. Use only when potential benefit outweighs possible risk to the fetus.

Lactation:

Excretion in breast milk unknown/use caution

Contraindications:

Hypersensitivity to benzydamine or any component of the formulation

Warnings/Precautions:

May cause local irritation and/or burning sensation in patients with altered mucosal integrity. Dilution (1:1 in warm water) may attenuate this effect. Use caution in renal impairment: systemic absorption/adverse effects may occur. Safety and efficacy have not been established in children 5 years of age.

Adverse Reactions:

Central nervous system: Drowsiness, headache

Gastrointestinal: Nausea and/or vomiting (2%), dry mouth

Local: Numbness (10%), burning/stinging sensation (8%)

Respiratory: Pharyngeal irritation, cough

Drug Interactions:

Substrate (minor) of CYP1A2, 2C19, 2D6, 3A4

No drug interactions established.

Stability:

Store at 15°C to 30°C; protect from freezing

Mechanism of Action:

Local anesthetic and anti-inflammatory, reduces local pain and inflammation. Does not interfere with arachidonic acid metabolism.

Pharmacodynamics/Kinetics:

Absorption: Oral rinse may be absorbed, at least in part, through the oral mucosa

Excretion: Urine (primarily as unchanged drug)

Dosage:

Oral rinse: Adults:

Radiation-associated mucositis: 15 mL as a gargle or rinse 3-4 times/day; contact between the liquid and the oral mucosa should be maintained for at least 30 seconds, followed by expulsion from the mouth. Clinical studies maintained contact for ~2 minutes, up to 8 times/day. Patient should not swallow the liquid. Begin treatment 1day prior to initiation of radiation therapy and continue daily during treatment. Continue oral rinse treatments after the completion of radiation therapy until desired result/healing is achieved.

Acute pharyngitis: Gargle with 15 mL every 1¹/2-3 hours until symptoms resolve. Patient should expel solution from mouth following use; solution should not be swallowed.

Dosage adjustment in renal impairment: No adjustment required.

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Numbness, burning/stinging sensation, and xerostomia (normal salivary flow resumes upon discontinuation).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

None reported

Mental Health: Effects on Psychiatric Treatment:

None reported

Dosage Forms:

Oral rinse, as hydrochloride: 0.15% (100 mL, 250 mL)

International Brand Names:

Afloben® (IT); Andolex® (DK, SE); Apo-Benzydamine® (CA); Benalgin® (PL); Bencidamina® (AR); Benzidan Jel® (TR); Benzidan® (TR); Benzirin® (CO, IT); Benzitrat® (BR); Bucco-Tantum® (CH); Bucofaringe® (BR); Ciclinalgin® (BR); Ciflogex® (BR); Difflam® (AU, GB, HK, IE, LU, MA, NZ, SG, TH, ZA); Dom-Benzydamine (CA); Easy Gel® (IL); Ernex® (AR); Flogi-Ped® (BR); Flogoral® (BR, PT); Flogo-Rosa® (BR); Fulgium® (ES); Ginesal® (IT); Hascosept® (PL); Lonol® (MX); Multum® (IT); Neoflogin® (BR); Novo-Benzydamine (CA); Opalgyne® (FR); Panflogin® (BR); PMS-Benzydamine (CA); ratio-Benzydamine (CA); Rosalgin® (ES, PT); Sandival Desleible® (AR); Saniflor® (IT); Sun-Benz® (CA); Tanflex® (TR); Tantum® (AT, BD, BG, CA, CL, CZ, DE, EG, ES, HK, ID, IT, JO, KW, LB, NL, PL, PT, RO, RU, SI, TR); Tantum Lozenges® (ID); Tantum Rosa® (BG, DE, HU, PL, RO, YU); Tantum Topico® (ES); Tantum Verde® (AT, BG, DE, ES, HU, ID, PL, RO, YU); Ternex® (TR); Top Flog® (BR); Vantal® (CR, DO, GT, HN, MX, PA, SV); Verax® (HK, IT)

References

Epstein JB, Silverman S Jr, Paggiarino DA, et al, "Benzydamine HCl for Prophylaxis of Radiation-Induced Oral Mucositis: Results From a Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial,"Cancer, 2001, 92(4):875-85.

Henschel R, Agathos M, and Breit R, "Photocontact Dermatitis After Gargling With a Solution Containing Benzydamine,"Contact Dermatitis, 2002, 47(1):53.

Lang DH and Rettie AE, "In vitro Evaluation of Potential in vivo Probes for Human Flavin-Containing Monooxygenase (FMO): Metabolism of Benzydamine and Caffeine by FMO and P450 Isoforms,"

Ribldi E, Frascaroli G, Transidico P, "Benzydamine Inhibits Monocyte Migration and MAPK Activation Induced by Chemotactic Agonists,"Br J Pharmacol, 2003, 140(2):377-83.

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