(For additional information
see "Benzydamine (United States: Not available): Patient drug information")
For abbreviations, symbols, and age group definitions used in Lexicomp (
show table)
Brand Names: Canada
- Odan-Benzydamine;
- Pharixia;
- Pharixia Alcohol Free;
- PMS-Benzydamine;
- Tantum Oral Rinse
Pharmacologic Category
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Anti-inflammatory, Locally Applied;
-
Local Anesthetic, Oral
Dosing: Adult
Mucositis, due to radiation therapy
Mucositis, due to radiation therapy:
Oral rinse: 15 mL (undiluted solution) as a gargle or rinse 3 or 4 times daily (depending on mucositis severity).
Pharyngitis
Pharyngitis (acute):
Oral rinse: Gargle with 15 mL (undiluted solution) every 11/2 to 3 hours until symptoms resolve.
Dosing: Kidney Impairment: Adult
There are no dosage adjustments provided in the manufacturer’s labeling; use with caution (some absorption may occur and elimination is renal).
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments provided in the manufacturer’s labeling.
Dosing: Older Adult
Refer to adult dosing.
Dosing: Pediatric
Mucositis
Mucositis: Children ≥6 years and Adolescents: Oral rinse: Refer to adult dosing.
Pharyngitis
Pharyngitis (acute): Children ≥6 years and Adolescents: Oral rinse: Refer to adult dosing.
Dosing: Kidney Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer’s labeling; use with caution (some absorption may occur and elimination is renal).
Dosing: Hepatic Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer’s labeling.
Adverse Reactions
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not always defined.
Central nervous system: Localized numbness (10%), drowsiness, headache
Dermatologic: Burning sensation of skin (≤8%), stinging of the skin (≤8%)
Gastrointestinal: Nausea (≤2%), vomiting (≤2%), xerostomia
Respiratory: Cough, pharyngitis
Contraindications
Hypersensitivity to benzydamine or any component of the formulation
Warnings/Precautions
Concerns related to adverse effects:
• Irritation/burning: May cause local irritation and/or burning sensation in patients with altered mucosal integrity; dilution (1:1 in lukewarm water) may attenuate this effect.
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment (may be absorbed from oral mucosa).
Product Availability
Not available in the US
Generic Equivalent Available: US
Yes
Dosage Forms: Canada
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Liquid, Mouth/Throat, as hydrochloride:
Tantum Oral Rinse: 0.15% (100 mL, 250 mL) [contains alcohol, usp]
Solution, Mouth/Throat, as hydrochloride:
Pharixia: 0.15% (100 mL, 250 mL) [contains alcohol, usp, fd&c yellow #6 (sunset yellow), methylparaben, polysorbate 80, propylparaben]
Pharixia Alcohol Free: 0.15% (250 mL) [contains corn starch, fd&c red #40 (allura red ac dye), fd&c yellow #6 (sunset yellow), methylparaben, polysorbate 80, propylparaben]
Generic: 0.15% (100 mL, 250 mL)
Administration: Adult
Oral rinse: Patient should not swallow the liquid. If local irritation or burning sensation occurs, dilute 1:1 in lukewarm water.
Mucositis: Rinse for 30 seconds to maintain contact with inflamed mucosa prior to spitting; begin treatment 1 day before radiation therapy and continue daily during radiation therapy and after the completion of radiation therapy until satisfactory healing occurs.
Pharyngitis: Gargle and spit.
Administration: Pediatric
Oral rinse: Avoid swallowing liquid. If local irritation or burning sensation occurs, dilute 1:1 in lukewarm water.
Mucositis: Gargle and rinse mouth and throat area for 30 seconds to maintain contact with inflamed mucosa prior to spitting; begin treatment 1 day before radiation therapy and continue daily during radiation therapy and after the completion of radiation therapy until satisfactory healing occurs.
Pharyngitis: Gargle and spit solution.
Use: Labeled Indications
Note: Not approved in the US
Mucositis: Symptomatic relief of oropharyngeal mucositis due to radiation therapy
Pharyngitis (acute): Relief of acute sore throat pain
Metabolism/Transport Effects
None known.
Drug InteractionsNote: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy
Pregnancy Considerations
Adverse effects were observed in animal reproduction studies.
Breastfeeding Considerations
It is not known if benzydamine is excreted in breast milk.
Mechanism of Action
Nonsteroidal anti-inflammatory drug; inhibits production of proinflammatory cytokines to reduce local pain and inflammation (MASCC/ISOO [Lalla 2014]). Also has local anesthetic activity.
Pharmacokinetics (Adult Data Unless Noted)
Absorption: Oral rinse may result in some absorption through oral mucosa
Time to peak: 2 hours
Excretion: Urine (primarily as unchanged drug)
Brand Names: International
International Brand Names by CountryFor country code abbreviations (
show table)
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(AE) United Arab Emirates: Difflam | Tanflex | Tantum verde;
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(AR) Argentina: Ernex | Ernex rosa;
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(AT) Austria: Tantum | Tantum Lemon | Tantum rosa | Tantum verde | Wick benzydamin;
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(AU) Australia: Amcal sore throat | Apohealth sore throat spray | Blooms the chemist sore throat spray forte | Chemists own sore throat spray forte | Difflam | Difflam anti-inflammatory | Difflam sore throat gargle & mouth solution | Medix sore throat | Truflam forte;
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(BD) Bangladesh: Benostar | Oryza;
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(BG) Bulgaria: Garganta | Rosalgin easy | Tantum rosa | Tantum verde | Tantum verde p;
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(BR) Brazil: Angino rub | Benzidrol | Benzitrat | Ciflogex | Cloridrato de benzidamina | Flogo rosa | Flogolab | Flogoral | Flogosept | Gargabem | Gargojuice;
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(CH) Switzerland: Bucco-tantum;
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(CO) Colombia: Bencidamina | Bencifar | Benidetil | Benzirin | Benzirin forte | Benzirin rosa ducha | Benzirin Verde | Benzycol | Benzycol verde | Buco far | Bucoseptol | Iseptic | Lonol;
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(CZ) Czech Republic: Ajax citron | Belozyme | Galverde | Garganta | Larymed | Orocalm | Orocalm forte | Rosalgin easy | Tantum rosa | Tantum verde;
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(DE) Germany: Difflam | Neo angin benzydamin | Tantum | Tantum verde;
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(DK) Denmark: Zyx;
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(DO) Dominican Republic: Vantal Bucofaringeo;
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(EG) Egypt: Tantum verde | Tantum verde p | Throcalmine;
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(ES) Spain: Fodonal | Propalgar | Rosalgin | Tantum verde;
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(FI) Finland: Bertolix | Longin kirsikka | Longin sitruuna | Zysils appels huna | Zysils sitruuna | Zyx appelsiini & hunaja | Zyx eukalyptus | Zyx minttu | Zyx sitruuna;
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(FR) France: Opalgyne;
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(GB) United Kingdom: Benzydamine | Benzydamine focus | Difflam | Lozamine | Oral soothe and sore throat | Oroeze;
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(GR) Greece: Physiopaine | Tantum | Tantum verde;
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(HK) Hong Kong: Apo-benzydamine | Dantum | Difflam | Difflam anti-inflammatory | Pharixia | Pms-Benzydamine | Verax pronto;
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(HR) Croatia: Tantum verde | Zynol;
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(HU) Hungary: Faringostop | Lolisept | Tantum verde | Tantum verde citrom | Tantum verde p;
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(ID) Indonesia: Benzydamine | Tanflex | Tantum | Tantum verde;
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(IE) Ireland: Difflam | Orosoothe | Tantum verde;
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(IN) India: Ambenz | Aqubenz | Banzee | Benzin | Benzoclin | Benzomax | Biqol | Coolbenz | Coolora | Garbenz | Maxtra gargle | Mucobenz | O2 fresh mw pr | Oralixir | Radiarel mouthwash | Tantum | Uvdyne;
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(IT) Italy: Afloben | Benzidamina mylan | Benzidamina teva | Benzirin | Ginesal | Ginetantum | Lagin | Multum Giallo | Multum rosa | Saniflor | Tantum rosa | Tantum rosa p | Tantum verde | Tantum verde p | Verax intimo | Verax intimo/p | Xentafid;
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(JO) Jordan: Tantum verde | Tantum verde p;
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(KR) Korea, Republic of: Antis | Benda | Bentol | Benzydamine | Benzymedin | Difflam | Etex benzydamine | Ivapten | Sama Tantum gargle | Tantum | Tantum verde | Yenagen;
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(KW) Kuwait: Difflam | Tantum verde;
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(LT) Lithuania: Tantum verde;
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(LV) Latvia: Nova verde | Tantum verde;
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(MX) Mexico: Artroben | Bencidamida | Bencidamida Loeffler | Beniflant | Biobend | Lonol | Maracina bencidamina | Vantal;
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(MY) Malaysia: B gargle | Difflam | Difflam anti-inflammatory | Easiflam;
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(NO) Norway: Bertolix | Zyx | Zyx Appelsin&Honning | Zyx eukalyptus | Zyx mint | Zyx sitron;
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(NZ) New Zealand: Difflam Forte;
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(PE) Peru: Amigdazol b | Bucodrin | Dentodrin | Flogoral | Gingisona b;
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(PH) Philippines: Benzydamine | Difflam;
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(PK) Pakistan: Benzirin | Niflam;
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(PL) Poland: Actusept | Benevox control | Benzydamine neo angin | Hascosept | Inaldin gardlo | Septogard | Septolux | Tantum verde | Uniben;
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(PT) Portugal: Flogoraft | Flogoral | Gartun | Orovox | Rosalgin | Tantum | Tantum verde;
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(PY) Paraguay: Afonitol nf | Tantum verde;
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(QA) Qatar: Tanflex | Tantum | Tantum Forte | Tantum Verde | Tantum Verde P;
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(RO) Romania: Faringocalm miere si portocala | Garganta | Influsept | Orocalmin;
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(RU) Russian Federation: Angidak sept | Asterisk ent | Benzydamine | Benzydamine akrihin | Bronflex | Oralsept | Tanflex | Tantum Rosae | Tantum verde | Tantum verde forte | Zvezdochka lor;
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(SA) Saudi Arabia: Verd;
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(SE) Sweden: Andolex | Bertolix | Coldyx citron | Coldyx honung apelsin | Zyx | Zyx apelsin & honung | Zyx citron | Zyx eukalyptus | Zyx mint;
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(SG) Singapore: Difflam;
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(SI) Slovenia: Rubisept | Tantum verde;
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(SK) Slovakia: Garganta | Orocalm | Rosalgin easy | Tantum Lemon | Tantum rosa | Tantum verde | Tantum verde orange & honey | Tantum verde p;
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(TH) Thailand: D throat | Difflam;
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(TN) Tunisia: Benzydex | Verax Blu;
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(TR) Turkey: Benpain | Benzidan | Benzydex | Farengil | Gynalgine | Tanflex | Tantum verde p | Ternex;
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(TW) Taiwan: Betacare | Biolin anti inflammatory | Comfflam | Comfflam forte anti inflammatory | Coserrin Forte | Cufflam Anti Inflammatory | Desore anti inflammatory pain relief | Difflam | Difflam Forte | Doubleson | Free End | Fucole anti inflammatory | Phonkhouzsu Anti-inflammatory | Stg Anti-Inflammatory | Throfresh | Twofold | Yuzuinin | Zuhotan;
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(UA) Ukraine: Fari verde | Forteza | Glandum | Helpex lar | T sept | Tantum Rosae | Tantum verde | Zipelor | Zipelor forte;
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(UY) Uruguay: Benciflam | Ernex | Tantum rosa | Tantum verde;
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(VE) Venezuela, Bolivarian Republic of: Amicets | Azutan | Bencidamina clorhidrato | Flodont | Tantum | Timeout;
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(ZA) South Africa: Andolex | Andosept | Cepacol | Throflam | Zidoval douche;
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(ZW) Zimbabwe: Andolex