|801-2, Jindong Mansion, No. 536 Xueshi Road, Yinzhou, Ningbo 315100, P.R.China
|Place of Origin:
|Minimum Order Quantity:
|100, 000 tubes
|200, 000 tubes per day
Skin Care Ointment,
skin care medicine
Bifonazole Cream Nail Fungus Skin Care Medicine , Skin Care Ointment
Product : Bifonazole Cream
Specification : 1%, 15g/tube
Standard : BP, USP
Packing : one tube/box
Therapeutic indications :
Treatment of athlete’s foot.
The preparation is not for vaginal use.
Posology and method of administration :
The cream should be thinly applied and rubbed into the affected areas once daily,
preferably at night before retiring, for two to three weeks.
The affected areas should be washed and dried thoroughly before the cream is
A physician or pharmacist should be consulted if symptoms do not improve within
Hypersensitivity to the active substance or to any of the excipients.
Treatment of infants with nappy rash.
Treatment of nail and scalp infections.
Special warnings and precautions for use :
This product contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
If unsure of diagnosis, the patient should seek the advice of a doctor or pharmacist before using this product.
Patients with a history of hypersensitivity reactions to other imidazole antifungal agents (e.g. econazole, clotrimazole, miconazole) must take bifonazole-containing products with caution.
Interaction with other medicinal products and other forms of interaction :
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.
Closer monitoring may be required in cases of occlusion and/or application to a large surface area or to broken and damaged skin.
Fertility, pregnancy and lactation
There are no clinical data from the use of bifonazole in pregnant women. Studies in animals have shown reproductive toxicity at high oral doses however these effects should not be anticipated at the low systemic exposures observed following topical bifonazole administration.
Bifonazole should only be used during pregnancy after an evaluation by a doctor of the
benefit to the patient and the risk to the fetus.
It is unknown whether bifonazole is excreted in human breast milk after topical application.
Bifonazole is excreted in milk after intravenous administration in animals.
A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue bifonazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
During the lactation period bifonazole should not be applied to the chest area.
Preclinical studies gave no evidence that bifonazole can impair male or female fertility
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 overdose become apparent (e.g. dizziness, nausea or vomiting). Gastric lavage should be carried out only if the airway can be protected adequately..
Pharmacotherapeutic group: Antifungals for dermatological use – Bifonazole
ATC Code: D01A C10
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. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane.
The resistance situation for bifonazole is favourable. 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.
Pharmacokinetic properties :
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.
After a single application (topical) of 15.2mg [14C] bifonazole cream, and subsequent occlusion for six hours, 0.6±0.3% of the dose was absorbed. The absorption rate was approximately 0.008mg/100cm2 per hour. In inflamed skin these values were higher by a factor of four. Similar results were obtained after the application of bifonazole as a 1% solution.
Plasma levels up to 16ng/ml were obtained in babies with nappy rash after a single 5g application of the cream.
After intravenous administration of 0.016mg/kg [14C] bifonazole, tissue uptake was rapid. Bifonazole is, however, rapidly metabolised with only 30% of an intravenous dose remaining unaltered 30 minutes post-dose.
Elimination of the metabolites is biphasic (T½ of eight and 50 hours). Within five days of administration 45% of the administered dose has been excreted renally, with 40% being eliminated via the liver and bile (faeces).
Contact Person: Mr. Luke Liu