Mykoseptin (Undecylenic Acid) 30g Tube Ointment

Compound

30 g of ointment contain:

Active ingredients: undecylenic acid 1.5 g, zinc undecylenate 6.0 g

Excipients: methyl parahydroxybenzoate, solid paraffin, liquid paraffin, solid paraffin (melting point 64 - 68 ° C), white paraffin, stearic acid, white beeswax, distilled monoglyceride, natural ethoxylated alcohols C16 - C18, purified water

 

Pharmacological properties

Pharmacokinetics

There is no data

Pharmacodynamics

Undecylenic acid and its salts have a fungistatic effect and at high concentrations (Mykoseptin contains 5% undecylenic acid and 20% zinc salt), they have a fungicidal (antifungal) effect on the dermatophytes Trichophyton rubrum, Trichophyton mentagriphynes, Epidermophyton floccosum, and Microsporon audouini. They also have a bacteriostatic effect on certain microbes such as Pseudomonas aeruginosa, Proteus rettgeri, Aeromonas hydrophila, and Yersinia enterocolitica. The zinc present in the zinc undecylenic part has an astringent effect, thus reducing the appearance of irritation and speeding up healing.

 

Indications for use

Treatment of fungal skin diseases:

- superficial skin mycoses (fungal diseases) caused by organisms sensitive to active substances, incl. trichophytosis of smooth skin, trichophytosis of the perineum, trichophytosis of the feet, interdigital trichophytosis, including a mixed lesion of candidal and bacterial nature.

Prevention of fungal diseases of the skin:

- with prickly heat, signs of irritation in places of increased sweating, in the area of ​​​​skin folds (submammary, inguinal).

 

Dosage and administration

The ointment should be applied to clean and dry skin twice a day for at least 1 week; after the symptoms have subsided, the ointment should be applied for another week once a day, and then every other day or twice a week, for a total of a month. If the course of treatment is shortened, there is a risk of recurrence of the disease.

Use in children

Mikoseptin is contraindicated for use in children under 2 years of age.

 

Possible side effects

Mykoseptin is usually well tolerated.

Side effects caused by undecylenic acid and zinc undecylenate in the form of a medicinal ointment are given according to the terminology of the Medical Regulatory Dictionary (MedDRA) and correspond to the frequency of occurrence: very often (≥1/10), often (≥1/100 to <1/ 10), uncommon (≥1/1000 to >1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), not known (estimation based on available data is not possible ).

Rarely

- slight skin irritation, eczema (disappears spontaneously after stopping the use of the ointment)

Reports of possible adverse reactions

Reporting suspected adverse reactions after drug registration is an important tool to continue monitoring drug safety. Healthcare professionals are asked to report any suspected adverse reactions through the national reporting system

 

Contraindications

- hypersensitivity to undecylenic acid or any auxiliary component of the drug
- children's age up to 2 years

The ointment should not be applied to weeping surfaces, ulcers, blisters, it is necessary to avoid contact with the eyes and the area around the eyes, etc.

 

Overdose

If the ointment is accidentally swallowed by a child, nausea or vomiting may occur. May induce or provoke vomiting.

 

Storage conditions

Store below 25°C.
Keep out of the reach of children!

Shelf life - 3 years
Do not use after the expiration date