Molecular Formula : C 26H 38C1 2N 10O 4
Molecular Weight: 625.6
Chemical Name : 1,6-di (N-p-chlorophenyldiguanidino) hexane diacetate
Chlorhexidine acetate is a white to pale cream microcrystalline powder, odourless or almost odourless. It is soluble (at 20ºC) in 55 parts of water and 15 parts of alcohol.
Composition of Dressing : Chlorhexidine Acetate BP 0.5% in white soft paraffin BP.
The action of chlorhexidine acetate is both bacteriostatic and bactericidal. Chlorhexidine Acetate has been shown to be active, in vitro, against a wide range of Gram-positive and Gram-negative bacteria at concentrations of 10-50 µg/ml. These include: B. subtilis Sal. pullorum Strep. lactis V. choleroe Strep. pyogenes (4 strains) Strep. faecalis Coryn. diphtheriae Sal. dublin Strep. pneumoniae Sal. typhimurium Staph. aureus (20 strains) A. aerogenes Pr. vulgaris E. coli P. aeruginosa (10 strains) Chlorhexidine has been found to be ineffective against heat resistant spores and acid-fast bacilli.
BACTIGRAS is indicated for adjunctive treatment and prevention of infection in skin loss lesions, including wounds, burns and ulcers.
BACTIGRAS is contraindicated in patients with a known, or suspected, sensitivity to chlorhexidine. Due to the cationic properties of chlorhexidine, BACTIGRAS is incompatible with anionic surfactants and other anionic compounds. One layer of tulle gras only should be applied directly to the surface of lesions being treated, and this should be done with forceps under sterile conditions. Avoid contact with eyes, the middle ear, meninges and brain.
BACTIGRAS should not be used if the seal or wrapper is broken. 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. As a topical preparation, there have been no reports of chlorhexidine acetate overdosage by a systemic route. Accidental systemic administration of chlorhexidine solutions has failed to yield any specific ill effects, which were attributed to chlorhexidine. Gastric lavage is indicated for acute ingestion of chlorhexidine solutions.
BACTIGRAS dressing is for administration to adults and children; it may be changed daily but frequency of application will depend upon the clinical circumstances (average: every 2-4 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, one 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.
BACTIGRAS should be stored flat under controlled room temperature ( < 25ºC).
BACTIGRAS Tulle Gras is presented as a gauze of leno weave impregnated with white soft paraffin BP containing 05% chlorhexidine acetate BP. Each sterile dressing is sealed separately in a foil-laminated pack. Dressings are available in 10 cm x 10 cm, 5 cm x 5 cm and 15 cm x 20 cm sizes. Cartons contain 10 or 50 individually wrapped sterile dressings.
||5cm X 5cm
||case/12 boxes/50 dressings
||10cm X 10cm
||case/12 boxes/10 dressings
||10cm X 10cm
||case/18 boxes/50 dressings
||15cm X 20cm
||case/12 boxes/10 dressings