Hexlosol
Composition :
phenytoin 2%
Pharmacology :
The mechanism by which Phenytoin accelerate wound healing is unknown, clinical animal and invitro studies suggest that Phenytoin
may be involved in the healing process at several levels including stimulation fibroblast proliferation, enhancing the formation of
granulation tissue, decreasing collaqenase activity ( by reducing its production or secretion or both ), promoting deposition of collagen and other connective tissue components, decreasing wound exudate. Biopsis of Phenytoin treated open wounds show neovascularization, collaginization, and decreased polyrnorphonu-
clear and eosinophil cell infiltration. A number of clinical studies indicate that Phenytoin decreasing bacterial load of wounds. Topical
Phenytoin was reported to eliminate staphyloc- occus aureus,E.Coli, Klebsiella spp. and pseudomonas spp. from wounds within 7 – 9 days in a guinea pig model of wound healing. it was found that Phenytoin more readily cleared gram negative organisms than gram positive bacteria from wounds it is unknown if Phenytoin has intrinsic antibacterial activity, or if the effect of Phenytoin on the baclrial load of wounds is mediated indirectly by effects on inflammatory cells and neovascularization. Local pain relief has also been observed with topical Phenytoin therapy, which can be explained by its membrane stabilizing action; the reduced
inflammatory response may also contribute facilitation of nerve regeneration has also been reported with Phenytoin. side effects from topical Phenytoin are rare. A generalized rash that resolved
when treatment is stopped has also been reported. Hypertrophic granulation tissue was noted in 10·36 percent of patients in two studies. this reversed by stopping treatment, and it is suggested that stopping treatment when the wound area is covered with a granulation base can prevent this effect. Systemic absorplion of topical Phenytoin is not significant. most studies that have monitored serum Phenytoin level during topical application have shown the level to be undetectable. only one case report showed
any significant levels of serum Phenytoin after topical Phenytoin this involved a mssive pressure ulcer that required 12.5 gmper day of Phenytoin to cover the wound. depsite this large topical dose, which exceeded by several fold the estimated lethal oral dose of Phenytoin in adults ( 2- 5 gm ), the serum concentration was only 4.3 mg/L month after initiation of the topical treatment.
Indications :
Topical Healosol has proven useful for a wide variety of soft tissue wounds. some of these include decubitus ulcer, diabetic foot ulcer, burns, traumatic wounds, war related missile wounds, venous stasis
ulcer and abscesses. Topical Phenytoin also appears to be potentially useful in epidermolysis bullosa ·simplex. however, the use of topical Phenytoin for chronic skin ulcer.
Contraindications :
Patients who show hypersensitivity to any of the active ingredients
Side effects :
no significant side effect was noticed in administration of topical Phenytoin but redness at the application area may occur which disappear after stopping treatment.
Dosage and administration :
Apply a thin film powder by pressing the valve with distance about 25 cm from the area to be applied all over the wound area and cover with gauze once or twice daily.
Packaging :
Box containing one aluminum can and leaflet.
Manufactured By :
ACDIMA international
for: Egyptian Company for Advanced Phannaceuticals
