| BACTIGRAS® |
|Smith & Nephew |
|Chlorhexidine Acetate |
|Topical Antibacterial |
|Action And Clinical Pharmacology: Chlorhexidine inhibits the growth of vegetative gram-positive and gram-negative organisms in vitro. Acid fast bacilli and heat resistant bacterial spores are not susceptible to the lethal action of chlorhexidine even in strong concentrations at room temperature. Chlorhexidine has greater activity in alkaline media. Adsorption of chlorhexidine on organic matter, pus, serum, blood, etc. will cause a reduction in the amount of chlorhexidine available for reaction with bacterial cells. Less than 0.25% of the chlorhexidine administered is absorbed into the body. With systemic doses, rats passed 85% of the amount administered in the feces and urine within 48 hours and 95% within 144 hours. tag_IndicationsIndications
Indications And Clinical Uses: For adjunctive treatment and prevention of infection in skin loss lesions, including wounds, burns and ulcers.
Contra-Indications: In patients with a known, or suspected, sensitivity to chlorhexidine.
Precautions: Due to the cationic properties of chlorhexidine, Bactigras is incompatible with anionic surfactants and other anionic compounds. One layer of Tulle Gras dressing only should be applied directly to the surface of lesions being treated, and this should be done with forceps under sterile conditions. Bactigras should not be used if the seal or wrapper is broken.
Adverse Reactions: Photosensitivity, hypersensitivity and contact eczema have been observed, but the incidence has been very low. Since its introduction on the market in the U.K., reports indicate that the tulle presentation of chlorhexidine acetate causes only slight skin irritation or sensitization and that there is no pain on application.
Symptoms And Treatment Of Overdose: Symptoms and Treatment: As a topical preparation, there have been no reports of chlorhexidine acetate overdosage by a systemic route. Accidental systemic administration of chlorhexidine solutions have failed to yield any specific ill effects which were attributed to chlorhexidine.
Reports indicate that chlorhexidine soaks have been used in the U.K. on body area wounds of up to 50% with no evidence of toxicity. Cases of accidental systemic administration of chlorhexidine of 6 to 40 mg have been reported and no symptoms of toxicity were evident.
Dosage And Administration: Adults and Children: Dressings may be changed daily but frequency of application will depend upon the clinical circumstances (average: every 2 to 4 days).
It is intended that the dressing will be principally used on up to 15% body area wounds for adults, (10% body area wounds for children). Although there is insufficient evidence to establish the safety of more extensive use, such use on larger area wounds may be considered when in the opinion of the physician, the expected benefit outweighs the potential risks. (Reports indicate that chlorhexidine acetate 0.1% solutions have been used on body area wounds of up to 50% without ill effect.) The dressing is to be applied directly to the wound surface, 1 layer only, with forceps, under sterile conditions.
Duration of administration will range from a few days to several months in extreme cases, depending upon the nature and severity of the wound. Treatment should be continued until satisfactory healing has occurred or until the wound site is ready for grafting. The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection unless overt infection occurs, requiring specific alternative therapy, or a significant adverse reaction occurs.
Availability And Storage: Tulle Gras as a gauze of leno weave impregnated with soft paraffin USP containing 0.5% chlorhexidine acetate BP. Dressings are available in an individually wrapped, sterile format of 10 cm´10 cm, 15 cm´20 cm in cartons of 10, and 5 cm´5 cm, 10 cm´10 cm in cartons of 50. Store flat at controlled room temperature (15 to 25°C).