Canespro Once Daily Bifonazole Anti-Fungal Cream 1%w/w contains: Bifonazole 1%.
Pharmacotherapeutic group: Anti-fungals for dermatological use - Bifonazole. ATC Code: DD1AC10.
Pharmacology: Pharmacodynamics: Mode of action: Bifonazole is an imidazole derivative with a broad antimycotic spectrum, which includes dermatophytes, yeasts, moulds and other fungi such as Malassezia furfur. It is also effective against Corynebacterium minutissimum. Bifonazole exerts its anti-fungal action by inhibiting the biosynthesis of ergosterol on two different levels, thereby distinguishing bifonazole both from other azole derivatives and from other anti-fungals which act only on a single level. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane. The resistance situation for bifonazole is favorable. Primary resistant variants of sensitive fungal species are very rare. Investigations so far did not provide any evidence of a development of secondary resistance in primarily sensitive strains.
Pharmacokinetics: Absorption: Bifonazole penetrates well into infected skin layers. 6 hours after administration concentrations in the various skin layers reach from 1000 μg/cm3 in the top layer of the epidermis (stratum corneum) to 5 μg/cm3 in the stratum papillare. All concentrations determined are thus within a range of reliable antimycotic activity.
Toxicology: Preclinical safety data: Preclinical data reveals no special hazards for humans based on conventional studies of single dose toxicity and genotoxicity.
Effects on the liver (enzyme induction, fatty degeneration) were observed in repeated dose toxicity studies with oral administration but only at exposures in excess of the maximum human exposure indicating little relevance to clinical use. No carcinogenicity studies were performed with bifonazole. In reproduction toxicology studies in rabbits, oral doses of 30 mg/kg body weight resulted in embryotoxicity including lethality. In the rats, bifonazole at oral doses up to 100 mg/kg body weight was not embryotoxic, but a retarded skeletal development in the fetuses was observed at the dose of 100 mg/kg. This fetal effect on the skeletal development can be considered as a secondary effects resulting from the maternal toxicity (a reduction in body weight). Given the low absorption of the active ingredient via the skin these results have little relevance to clinical use. No impairment of male or female fertility was observed in rats at oral doses up to 40 mg/kg body weight. Bifonazole passes through the placental barrier in rats.
Treatment of skin mycoses caused by dermatophytes, yeasts, moulds, and other fungi (e.g. athlete's foot, fungal infection of the hand, ringworms, jock itch, white spots, superficial fungal skin infections & other tinea conditions).
Treatment of erythrasma (skin redness).
To achieve a lasting cure, treatment with bifonazole must be carried out reliably and over an adequate period. The usual periods of treatment are summarized in the table as follows:
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Method of administration: Once a day, preferably in the evening, before going to bed. It should be applied thinly to the affected skin area and rubbed in.
A small amount of cream is generally sufficient to treat an area of about the size of the palm of hand.
No risk of acute intoxication is seen as it is unlikely to occur following a single dermal application of an overdose (application over a large area under conditions favorable to absorption) or inadvertent oral ingestion.
However, in the event of accidental oral ingestion, routine measures such as gastric lavage should be performed only if clinical symptoms of overdosage become apparent (e.g. dizziness, nausea or vomiting). Gastric lavage should be carried out only if the airway can be protected adequately
Hypersensitivity to the active substance or to any of the excipients.
Patients with a history of hypersensitivity reactions to other imidazole antifungal agents (e.g. econazole, clotrimazole, miconazole) must take bifonazole containing products with caution. If symptoms continue/persist after treatment, seek medical advice.
Avoid contact with eyes. Do not swallow.
Use in Children: No in-depth studies have been performed in children. From a survey of the clinical data reported there is no indication that harmful effects should be anticipated in children. However, in infants and toddlers, the medicinal product should only be used under medical supervision.
Pregnancy: Preclinical safety data and pharmacokinetic data in humans give no indication that harmful effects on the mother and child should be anticipated when bifonazole is used during pregnancy. However, no clinical data are available. As a precautionary measure, it is preferable to avoid the use of bifonazole during the first trimester of pregnancy.
Lactation: It is unknown whether bifonazole is excreted in human breast milk. The excretion of bifonazole in milk has been studied in animals. Available pharmacodynamic/toxicological data in animals have shown excretion of bifonazole/metabolites in milk. Breastfeeding should be discontinued during treatment with bifonazole.
The following adverse reactions have been identified during post-approval use of bifonazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
General disorders and administration site conditions: Administration site pain, oedema peripheral (at administration site).
Skin and subcutaneous tissue disorders: Dermatitis contact, dermatitis allergic, erythema, pruritus, rash, urticaria, blister, skin exfoliation, eczema, dry skin, skin irritation, skin maceration, skin burning sensation.
These side effects are reversible after discontinuation of the treatment.
Limited data suggest that an interaction between topical bifonazole and warfarin may be possible, leading to increases in INR. If bifonazole is used in a patient on warfarin therapy, they should be appropriately monitored.
D01AC10 - bifonazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Canespro cream 1% w/w
15 g x 1's
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