Hexidine

Hexidine

chlorhexidine

Manufacturer:

ICPA Health Products

Distributor:

Unimed
Full Prescribing Info
Contents
Chlorhexidine gluconate.
Description
Mouthwash: Chlorhexidine gluconate solution BP diluted to chlorhexidine gluconate 0.2% w/v.
Oromucosal gel: Chlorhexidine gluconate solution BP 5% v/w equivalent to chlorhexidine gluconate 1.0% w/w.
Indications/Uses
Mouthwash: Hexidine 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).
Oromucosal gel: For oral hygiene, relief of gingivitis, mouth ulcers and oral infections.
Dosage/Direction for Use
Mouthwash: 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.
Hexidine is incompatible with anionic agents which are usually present in conventional dentifrices. These should therefore be used before 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 Hexidine mouthwash for fifteen minutes twice daily.
Children and the elderly: There are no special dosage recommendations for either elderly patients or children. The normal adult dose is appropriate unless otherwise recommended by the dentist or the physician.
Route of administration: External (oral) use. This product is not intended to be swallowed.
Oromucosal gel: To be brushed on the teeth once or twice daily for oral hygiene, plaque inhibition and gingivitis. To be applied on the affected areas, once or twice daily, for management of aphthous and other oral ulcers.
Overdosage
Symptoms and treatment of overdose: This has not been reported. Accidental ingestion: Chlorhexidine taken orally is poorly absorbed.
Systemic effects are unlikely even if large amounts are ingested. However, gastric lavage may be advisable using milk, raw egg, gelatin or mild soap. Employ supportive measures as appropriate.
Contraindications
Hexidine is contraindicated for patients who have previously shown a hypersensitivity reaction to chlorhexidine. However, such reactions are extremely rare.
Special Precautions
If any signs or symptoms of a suspected hypersensitivity reaction such as itching, skin rash, redness, swelling, breathing difficulties, light headedness and rapid heart rate develop, immediately stop using the product. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
Mouthwash: The most common side effect of oral chlorhexidine mouth rinse is the formation of a yellow-brown staining of tongue and teeth and temporary alteration in taste perception. The oral rinse may cause a temporary, harmless, superficial staining on teeth. Long term use should be under professional advice.
External (Oral) use. This product is not intended to be swallowed.
Hexidine mouthwash contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalized allergic reaction and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is unknown, but available literature suggests this is likely to be very rare. Hexidine mouthwash should not administered to anyone with a possible history of an allergic reaction to chlorhexidine.
Oromucosal gel: Brown staining may be reported with extended use in some cases, which may be removed by brushing or polishing. NOT TO BE SWALLOWED.
Avoid contact with eyes - if Chlorhexidine solutions come into contact with eyes, wash out promptly and thoroughly with water. As toothpastes may contain anionic surfactants such as sodium laurilsulfate, which are incompatible with chlorhexidine, it has been recommended that at least 30 minutes should be allowed to elapse between the use of toothpaste and oral chlorhexidine preparations.
Hexigel contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, Including generalized allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is unknown, but available literature suggests this is likely to be very rare. Hexigel should not be administered to anyone with a possible history of an allergic reaction to chlorhexidine.
Side Effects
Immune system disorders: Frequency not known: Hypersensitivity including anaphylactic shock.
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. The stain is not permanent and can largely be prevented by brushing with conventional toothpaste daily before using Hexidine. However, in certain cases of professional prophylaxis (scaling and polishing) may be required to remove the stain completely. Stained anterior tooth coloured restorations with poor margins or rough surfaces, which are not adequately cleaned by professional prophylaxis, may require replacement.
Transient disturbance of taste sensation and a burning sensation of the tongue may occur on initial use of the Hexidine. These effects usually diminish with continued use.
Mouthwash: Irritative skin reactions to chlorhexidine preparations can occasionally occur. Generalized allergic reactions to chlorhexidine have also been reported but are extremely rare.
Drug Interactions
Chlorhexidine is incompatible with anionic agents.
Storage
Mouthwash: Store below 30°C. Protect from light.
Shelf life: 36 months from the date of manufacture.
Oromucosal gel: Store below 30°C in a dry place. Protect from light. Do not freeze. KEEP TUBE CAPPED WHEN NOT IN USE.
Shelf life: 24 months from the date of manufacture.
MIMS Class
Preparations for Oral Ulceration & Inflammation
ATC Classification
A01AB03 - chlorhexidine ; Belongs to the class of local antiinfective and antiseptic preparations. Used in the treatment of diseases of the mouth.
Presentation/Packing
Form
Hexidine mouthwash 0.2% w/v
Packing/Price
160 mL x 1's;500 mL x 1's;80 mL x 1's
Form
Hexidine topical gel 1% w/w
Packing/Price
15 g x 12 × 1's;7.5 g x 12 × 1's
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