SMILE-MILE is Benzydamine Mouthwash, available as the hydrochloride salt, 0.15% w/v. Benzydamine is a locally-acting nonsteroidal anti-inflammatory drug (NSAID) with local anesthetic and analgesic properties for pain relief and treatment of inflammatory conditions of the mouth such as oral mucositis, mouth ulcers, and oral discomfort. Unlike aspirin-like NSAIDs which are acids or metabolized to acids, benzydamine is in fact a weak base. Thus, it prevents the growth of bacteria which can cause dental caries and tooth decay.
Studies have shown that as compared to Chlorhexidine (0.2%) and Povidone-iodine (5%), Benzydamine hydrochloride (0.15%) is more effective in decreasing the severity of oral mucositis and reducing the pain, particularly in radiation-induced oral mucositis. In chemotherapy patients, Benzydamine may bring relief from oral discomfort within a week of use. Benzydamine is safe and well-tolerated
Benzydamine Hydrochloride BP ………..0.15% w/v
In a flavored aqueous base ……………q.s
Colors: Brilliant Blue FCF and Tartrazine
Benzydamine exerts an anti-inflammatory and analgesic action by stabilising the cellular membrane and inhibiting prostaglandin synthesis.
The indazole analogue benzydamine has physicochemical properties and pharmacological activities which differ from those of the aspirin-like NSAIDs. Unlike aspirin-like NSAIDs which are acids or metabolised to acids, benzydamine is a weak base. In further contrast, benzydamine is a weak inhibitor of the prostaglandin synthesis. Only at a concentration of 1mM and above benzydamine effectively inhibits cyclooxygenase and lipooxygenase enzyme activity. It mostly exerts its effects through inhibition of the synthesis of proinflammatory cytokines including tumour necrosis factor-alpha (TNF-α) and Interleukin-1β (IL-1β) without significantly affecting other pro-inflammatory (IL-6 and 8) or anti-inflammatory cytokines (IL-10, IL-1 receptor antagonist). Further mechanisms of action are hypothesised including the inhibition of the oxidative burst of neutrophils as well as membrane stabilisation as demonstrated by the inhibition of granule release from neutrophils and the stabilization of lysosomes. The local anaesthetic activity of the compound has been related to an interaction with cationic channels.
Benzydamine topically applied demonstrates anti-inflammatory activity reducing oedema as well as exudate and granuloma formation. Further, it exhibits analgesic properties if the pain is caused by an inflammatory condition and local anaesthetic activity. Hyperthermia, which is indicative of systemic functional involvement, is poorly affected by benzydamine.
Oral doses of benzydamine are well absorbed and plasma drug concentrations reach a peak fairly rapidly and then decline with a half-life of about 13 hours. Less than 20% of the drug is bound to plasma proteins.
Although local drug concentrations are relatively large, the systemic absorption of mouthwash-gargle doses of benzydamine is relatively low compared to oral doses. This low absorption should greatly diminish the potential for any systemic drug side-effects when benzydamine is administered by this route.
Benzydamine is metabolised primarily by oxidation, conjugation and dealkylation.
Benzydamine 0.15% w/v Mouthwash is indicated in adults and children aged 13 years and over.
- A locally acting analgesic and anti-inflammatory treatment for the relief of painful inflammatory conditions of the mouth and throat including:
- Traumatic conditions: Pharyngitis following tonsillectomy or the use of a nasogastric tube.
- Inflammatory conditions: Pharyngitis, aphthous ulcers, and oral ulceration due to radiation therapy.
- Dentistry: For use after dental operations.
General Dosage for ADULTS AND ELDERLY: Gargle* or rinse* with 15 ml (approximately 1 tablespoonful) every 1½ to 3 hours as required for pain relief. The solution should be expelled from the mouth after use.
For prophylactic and palliative treatment of Oral Mucositis: Gargle* or rinse* 15 mL in mouth (for 30 seconds, followed by expulsion from mouth) 3 to 4 times per day depending on the severity of the condition. Do not swallow.
Radiation therapy: Before and during radiation therapy, and for at least 2 weeks after completion of radiation therapy.
Chemotherapy: For at least 4 weeks upon chemotherapy.
For Acute Pharyngitis: Gargle* or rinse* with 15 mL in mouth (for 30 seconds, followed by expulsion from mouth) every 1.5 to 3 hours.
Benzydamine 0.15% w/v Mouthwash should generally be used undiluted, but if ‘stinging’ occurs the rinse may be diluted with water.
Uninterrupted treatment should not exceed seven days, except under medical supervision.
Paediatrics: Benzydamine 0.15% w/v Mouthwash should not be used in children aged 12 years or under.
Method of administration
Oromucosal administration. (as described above)*
- Benzydamine use is not advisable in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs
- Caution should be exercised in patients suffering from or with a previous history of bronchial asthma.
- Benzydamine 0.15% w/v Mouthwash should generally be used undiluted, but if ‘stinging’ occurs the rinse may be diluted with water.
- Avoid contact with eyes.
- Benzydamine 0.15% w/v Mouthwash contains propylene glycol and bronopol which may cause skin irritation.
- To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Benzydamine 0.15% w/v Mouthwash should not be used in pregnancy
Benzydamine 0.15% w/v Mouthwash should not be used during lactation unless considered essential by the physician.
There is no evidence of a teratogenic effect in animal studies.
Frequencies are defined using the following convention:
Very common (>1/10), Common (>1/100, <1/10), Uncommon (>1/1000, <1/100), Rare (>1/10000, <1/1000), Very rare (<1/10000), Not known (cannot be estimated from available data).
The most common side effects are numbness and a stinging feeling in the mouth.
|System organ class||Frequency||Undesirable effects|
|Immune system disorders||Not known||Anaphylactic reaction which can be potentially life-threatening and hypersensitivity reactions|
|Respiratory, thoracic and mediastinal disorders||Very rare||Laryngospasm or bronchospasm|
|Gastrointestinal disorders||Uncommon||Oral numbness (Hypoesthesia) and a stinging feeling in the mouth (oral pain)|
|Skin and subcutaneous tissue disorders||Very rare||Hypersensitivity reactions which may be associated with pruritus, urticaria, photosensitivity reaction and rash|
Benzydamine 0.15% w/v Mouthwash is unlikely to cause adverse systemic effects, even if accidental ingestion should occur. Intoxication is only expected in case of accidental ingestion of large quantities of benzydamine (> 300 mg) Intoxication is only to be expected if large quantities of Benzydamine 0.15% w/v Mouthwash are swallowed.
Symptoms associated with ingested overdose of benzydamine are mainly gastrointestinal symptoms and symptoms of the central nervous system. Most frequent gastrointestinal symptoms are nausea, vomiting, abdominal pain and oesophageal irritation. Symptoms of the central nervous system include dizziness, hallucinations, agitation, anxiety and irritability.
In acute overdose only symptomatic treatment is possible. Patients should be kept under close observation and supportive treatment should be given. Adequate hydration must be maintained.
Hypersensitivity to the active substance or to any of the excipients.
Store in a cool and dry place.
200ml meter dose mouthwash bottle. A clear blue solution with mint flavour
- Cancer 2001;92: 875–85. © 2001 American Cancer Society.