Mycospor^® Onychoset (Ointment) Instructions for Use

Marketing Authorization Holder

Bayer, AG (Germany)

Manufactured By

Kern Pharma S.L. (Spain)

ATC Code

D01AC60 (Bifonazole in combination with other drugs)

Active Substances

Bifonazole (Rec.INN registered by WHO)

Urea (Ph.Eur. European Pharmacopoeia)

Dosage Form

Mycospor® Set

Ointment for external use 1 g+40 g/100 g: tube 10 g in a set with a package of waterproof plaster and a scraper

Dosage Form, Packaging, and Composition

Ointment for external use white with a yellowish tint, homogeneous.

Excipients: white beeswax – 5 g, white petrolatum – 34 g, lanolin – 20 g.

10 g – aluminum tubes (1) – individual cardboard packs (1) in a set with a package of waterproof plaster and a scraper – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Combined antifungal agent for external use.

Bifonazole is an antifungal agent, an imidazole derivative, with a broad spectrum of antimycotic action. Bifonazole has a fungicidal effect against dermatophytes (in particular, against Trichophyton spp.). The full fungicidal effect is achieved at a bifonazole concentration of 5 µg/ml and an exposure duration of at least 6 hours. Bifonazole has a fungistatic effect against yeast and mold fungi, as well as Malassezia furfur. In case of infection with yeast fungi, for example, Candida spp., at a concentration of 1-4 µg/ml, a predominantly fungistatic effect of bifonazole is noted; for a fungicidal effect, a bifonazole concentration of 20 µg/ml is required. Bifonazole is also active against Corynebacterium minutissimum (MIC 0.5-2 µg/ml), gram-positive cocci, except for enterococci (MIC 4-16 µg/ml). Resistant fungal strains are very rare. Bifonazole inhibits the biosynthesis of ergosterol at two different levels, which leads to structural and functional damage to the fungal cytoplasmic membrane.

Urea performs a keratoplastic function: it softens the keratin of the infected nail and increases the depth of penetration of bifonazole.

The combination of bifonazole with urea enhances the antimycotic effect of this combination.

Pharmacokinetics

When applied to the affected skin as an ointment, absorption is 2-4% of the dose. The concentration of bifonazole in blood plasma is always below the limit of detection (i.e. < 1 ng/ml); accordingly, no systemic effects are observed. Bifonazole penetrates the placental barrier in rats.

Indications

Onychomycosis (non-surgical removal of fingernails and toenails affected by fungus with simultaneous antimycotic action).

ICD codes

Dosage Regimen

For external use only.

Apply the ointment once daily according to the following method.

First, prepare the affected nail. Wash the area thoroughly with soap and water and dry completely.

Apply a thin layer of the ointment to the entire surface of the infected nail.

Cover the treated nail with the provided waterproof plaster and leave it for 24 hours.

The next day, remove the plaster. Wash the nail area again and dry it thoroughly.

Before the next application, use the provided scraper to remove the softened, infected nail material.

Repeat this entire process daily until the infected nail is completely removed and a new, healthy nail has grown in.

Continue treatment for at least two weeks after the clinical symptoms have resolved to prevent recurrence.

Treatment duration is typically 1 to 2 weeks for fingernails and 2 to 3 weeks for toenails.

Do not apply the ointment to skin areas surrounding the nail unless specifically directed.

Avoid contact with eyes and mucous membranes. In case of accidental contact, rinse immediately with plenty of water.

Wash hands before and after each application.

Adverse Reactions

Skin and subcutaneous tissue disorders contact dermatitis, maceration, desquamation, nail lesions (local reactions of the nail and nail bed – such as redness, irritation of the nail bed, splitting of the nail plate), nail pigmentation disorder, erythema, skin irritation, itching, rash (including allergic).

Side effects are reversible and disappear after discontinuation of treatment.

Contraindications

First trimester of pregnancy; hypersensitivity to bifonazole, urea.

With caution

Second and third trimesters of pregnancy, period of breastfeeding, childhood.

Use in Pregnancy and Lactation

The use of this combination is contraindicated in the first trimester of pregnancy. In the second and third trimesters of pregnancy, use is possible if the expected benefit to the mother outweighs the potential risk to the fetus or child.

It is not known whether Bifonazole penetrates into breast milk in women. If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

The drug is approved for use in case of impaired liver function

Use in Renal Impairment

The drug is approved for use in case of impaired renal function

Pediatric Use

Use with caution in children.

Geriatric Use

The drug is approved for use in elderly patients

Special Precautions

Use with caution in patients with hypersensitivity to other antifungal drugs from the group of imidazole derivatives (econazole, clotrimazole, miconazole).

Drug Interactions

Absorption of bifonazole with external use of the drug is insignificant. Cases of interaction with other drugs are unknown.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.