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 (acute): Oral rinse: Gargle with 15 mL (undiluted solution) every 11/2 to 3 hours until symptoms resolve.
There are no dosage adjustments provided in the manufacturer’s labeling; use with caution (some absorption may occur and elimination is renal).
There are no dosage adjustments provided in the manufacturer’s labeling.
Mucositis: Children ≥6 years and Adolescents: Oral rinse: Refer to adult dosing.
Pharyngitis (acute): Children ≥6 years and Adolescents: Oral rinse: Refer to adult dosing.
There are no dosage adjustments provided in the manufacturer’s labeling; use with caution (some absorption may occur and elimination is renal).
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
Yes
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)
Not available in the US
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.
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.
Note: Not approved in the US
Mucositis: Symptomatic relief of oropharyngeal mucositis due to radiation therapy
Pharyngitis (acute): Relief of acute sore throat pain
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
Hypersensitivity to benzydamine or any component of the formulation
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).
None known.
Note: 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
Adverse effects were observed in animal reproduction studies.
It is not known if benzydamine is excreted in breast milk.
Nonsteroidal anti-inflammatory drug; inhibits production of proinflammatory cytokines to reduce local pain and inflammation (MASCC/ISOO [Lalla 2014]). Also has local anesthetic activity.
Absorption: Oral rinse may result in some absorption through oral mucosa
Time to peak: 2 hours
Excretion: Urine (primarily as unchanged drug)
