Strength: 0.15% w/v
Pack Size: 100 ml
Drug Class: Anti-inflammatory
Dosage and Administration:
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)*
Cold Storage: yes
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 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.
Use every 1.5 to 3 hours or as directed by the Physician.
Benzydamine hydrochloride was observed to be effective and delayed the development of severe form of mucositis and appears more efficient in the management of radiation-induced mucositis.
- Store in a cool and dry place, away from sunlight
- Keep out of the reach of children
- Do not dilute or swallow.
- 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.