SB-Sol 0.002

INDICATIONS

Chlorhexidine Gluconate Mouthwash is an antimicrobial solution which inhibits the formation of dental plaque. It is indicated as an aid in 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, in mentally or physically handicapped patients). It may also be used in a post-peridontal surgery or treatment regimen to promote gingival healing.

PHARMACOLOGY

Chlorhexidine is a very potent cationic chemoprophylactic agent that has a broad-spectrum of activity against gm+ve and gm-ve bacteria. It is both bacteriostatic and bactericidal depending on its concentration. The bactericidal effect, which is achieved at high concentrations, is due to the binding of the cationic to negatively charged bacterial cell walls and extramicrobial complexes. Bacteriostatic effect is achieved at low concentrations which causes an alteration of bacterial cell osmotic equilibrium and leakage of potassium and phosphorus.

DOSAGE & ADMINISTRATION

Adults: Thoroughly rinse the mouth for about one minute with 10 ml twice daily. In the dental surgery the patient should be instructed to rinse the mouth for one minute prior to treatment. Chlorhexidine Gluconate is incompatible with anionic agents which are usually present in conventional dentifrices. These should therefore be used before Chlorhexidine Gluconate (rinsing the mouth between applications) or at a different time of day.For the treatment of gingivitis a course of about one month is advisable although some variation in response is to be expected. In the case of aphthous ulceration and oral candidal infections treatment should be continued for 48 hours after clinical resolution. For the treatment of dental stomatitis the dentures should be cleansed and soaked in Chlorhexidine Gluconate mouthwash for fifteen minutes twice daily.Children and the Elderly: The normal adult dose is appropriate for elderly patients and children of 12 years and over unless otherwise recommended by the dentist or the physician. Children under 12 years of age should not use the product unless recommended by a healthcare professional. Route of administration: External (oral) use.

INTERACTION

Chlorhexidine is incompatible with anionic agents.

SIDE EFFECTS

Discoloration: 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 reducing the consumption of tea, coffee and red wine and brushing with a conventional toothpaste daily.Before using the mouthwash or, in the case of dentures, cleaning with a conventional denture cleanser. However, in certain cases a professional prophylaxis (scaling and polishing) may be required to remove this stain completely. Stained anterior toothcoloured restorations with poor margins or rough surfaces which are not adequately cleaned by professional prophylaxis may require replacement. Similarly where normal toothbrushing is not possible, for example with intermaxillary fixation, or with extensive orthodontic appliances, scaling and polishing may also be required once the underlying condition has been resolved. Taste: Transient disturbance of taste sensation and a burning sensation of the tongue may occur on initial use of the mouthwash. These effects usually diminish with continued use. Oral desquamation: In cases where oral desquamation occurs dilution of the mouthwash with an equal volume of tap water, freshly mixed, will often allow continued use of the mouthwash. Parotid gland swelling: Very occasionally, swelling of the parotid glands during the use of chlorhexidine mouthrinses has been reported. In all cases spontaneous resolution has occurred on discontinuing treatment.Irritative skin reactions: Irritative skin reactions to chlorhexidine preparations can occasionally occur.Generalised reactions: Allergic reactions, hypersensitivity & anaphylaxis to chlorhexidine have also been reported but are extremely rare.

PREGNANCY & LACTATION

There is no evidence of any adverse effects on the foetus arising from the use of Chlorhexidine Gluconate during pregnancy or on infants during lactation. Therefore no special precautions are recommended.

PRECAUTIONS & WARNINGS

For oral (external) use only. Do not swallow. Keep out of the eyes and ears. If the mouthwash comes into contact with the eyes, wash out promptly and thoroughly with water. In case of soreness, swelling or irritation of the mouth, stop using the product and consult a healthcare professional.

THERAPEUTIC CLASS

Other antibacterial preparation

STORAGE CONDITIONS

Store in a cool and dry place, protected from light.