Chlorhexidine Gluconate Mouthspray
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chlorhexidine Gluconate Mouthspray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient Percentage Formula (%w/w)
Chlorhexidine Gluconate (BP)* 0.20 (w/v)
Inactive Ingredients
Peppermint Flavour E1640-1-N1 (HSE) 1.00
Purified Water (BP) to 100.00
* Charged as chlorhexidine gluconate 20%w/v solution ** Charged as sorbitol 70% solution, non-crystallising
3 PHARMACEUTICAL FORM
Oromucosal Spray
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Chlorhexidine Gluconate Mouthspray is an antimicrobial solution which inhibits the formation of dental plaque. It is indicated as an aid to the treatment and prevention of gingivitis and in the maintenance of oral hygiene, particularly in situations where tooth brushing cannot be adequately employed (e.g. following oral surgery or in physically handicapped patients).
4.2 Posology and method of administration
Children, adults and the elderly:
Chlorhexidine Gluconate Mouthspray should be applied as required to the tooth and gingival surfaces, using up to 12 actuations of the spray (approximately 0.14ml of solution per actuation) twice daily (once in the morning and once in the evening).
The spray should be directed inside the mouth onto the dental and gingival surfaces. For the treatment of gingivitis a course of about one-month is advisable, although some variation in response is to be expected.
4.3 Contraindications
Known hypersensitivity to any of the ingredients
4.4 Special warnings and precautions for use
For oral use only. Do not swallow. Expel from the mouth after each use. Keep away from the eyes and ears. If the spray comes into contact with the eyes, wash out well with water. Keep out of reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Pregnancy and lactation
Chlorhexidine has been in widespread use for many years and no harmful effects in human pregnancy have been reported. However, as with all drugs, caution should be exercised. Chlorhexidine Gluconate Mouthspray should only be used when the benefit to the mother has been assessed by a clinician.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
Irritative skin reactions to chlorhexidine can occur occasionally. Generalised allergic reactions to chlorhexidine have also been reported but are extremely rare.
A superficial discoloration of the dorsum of the tongue may occur. This disappears after treatment is discontinued. Discoloration of the teeth and silicate or composite restorations may also occur. This stain is not permanent and can largely be prevented by brushing with a conventional toothpaste daily before using this spray.
However, in certain cases, a professional prophylaxis (scaling and polishing) may be required to remove this stain completely. Stained anterior tooth-coloured restorations with poor margins or rough surfaces which are not adequately cleaned by professional prophylaxis may require replacement.
Similarly where normal tooth brushing is not possible, as for example with intermaxillary fixation, or with extensive orthodontic appliances, scaling and polishing may also be required once the underlying conditions have been resolved.
Transient disturbances of taste sensation and a burning sensation of the tongue may occur on initial use of the spray. These effects usually diminish with continued use.
In cases where oral desquamation occurs it may be necessary to discontinue treatment. Very occasionally, swelling of the parotid glands during use of oral chlorhexidine has been reported. In all cases spontaneous resolution has occurred on discontinuing treatment.
4.9 Overdose
Chlorhexidine is poorly absorbed by the oral route, therefore systemic effects are unlikely even if large volumes are swallowed. However, gastric lavage followed by supportive measures may be used as appropriate.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Chlorhexidine gluconate is a bisguanide antiseptic and disinfectant which is bacteriocidal or bacteriostatic against a wide range of gram negative and gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophylic viruses.
The antimicrobial activity covers most of the important species occurring in the oral microflora.
5.2 Pharmacokinetic properties
Because of its cationic nature, chlorhexidine (gluconate) binds strongly to skin, mucosa and other tissues and is thus very poorly absorbed. No detectable blood levels have been found following oral use.
5.3 Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Chlorhexidine Gluconate Mouthspray contains the following inactive ingredients:
Ethanol,
Sorbitol,
Cremophor RH60,
Peppermint Flavour,
Purified Water
6.2 Incompatibilities
Chlorhexidine Gluconate Mouthspray is incompatible with anionic agents which are often present in toothpastes. Therefore these should be used before the mouthspray, rinsing the mouth between applications, or at a different time of the day.
Hypochlorite bleaches may cause brown stains to develop in fabrics previously in contact with chlorhexidine.
6.3 Shelf life
Two Years
6.4 Special precautions for storage
Store below 25 °C
6.5 Nature and contents of container
Plastic coated type III bottle with pump valve, polypropylene nozzle actuator and polypropylene overcap, enclosed in a carton, containing chlorhexidine gluconate 0.2%w/v solution (65ml).
6.6 Special precautions for disposal
Direct the spray inside the mouth onto the surface of the teeth and gums. Use twice a day (morning and evening), using up to 12 shots of the spray each time (each shot delivers about 0.14ml of solution).
7 MARKETING AUTHORISATION HOLDER
Ayrton Saunders Ltd
9 Arkwright Road
Astmoor Industrial Estate
Runcorn
Cheshire
WA7 1NU
8 MARKETING AUTHORISATION NUMBER(S)
PL 16431/0122
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9 May 2003
10
DATE OF REVISION OF THE TEXT
28/01/2011