Sertamycol solution 2% 15ml

Sertamycol instruction for use

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Release form, composition and packaging

Solution for external use in the form of a clear liquid from colorless to light yellow color.
100 ml
sertaconazole nitrate 2 g
Excipients: (propylene glycol - 102 g, trolamine - 0.1 g) - 100 ml.
15 ml - polyethylene bottles (1) - packs cardboard.

pharmachologic effect

Antifungal agent for external use, a derivative of imidazole and benzothiophene with a broad spectrum of action.
The mechanism of action is to inhibit the synthesis of ergosterol (the main sterol membranes of fungi and yeast) and increase the permeability of the cell membrane, which leads to the lysis of the cell of the fungus.
In therapeutic doses, it has fungistatic and fungicidal action against pathogenic fungi (Candida spp., Including Candida albicans, Candida tropicalis, Pityrosporum orbiculare), dermatophytes (Trichophyton and Microsporum) and is active against pathogens of the skin and mucous membranes (gram). strains of staphylococci and streptococci).

Pharmacokinetics

With the external use of sertaconazole in the blood and urine is not detected.
During the pharmacokinetic study of multiple doses involving patients with interdigital foot dermatophytosis (area range of the affected area: 42-140 cm2; average - 93 cm2), the solution was applied externally every 12 hours (a total of 13 times) on the affected skin (0.5 g sertaconazole nitrate per 100 cm2). Plasma sertaconazole concentration, measured by a series of blood samples taken within 72 hours after the thirteenth dose, was below the limit of quantification (2.5 ng / ml) of the analytical method used.

Indications for Sertamycol solution

Treatment of superficial mycoses of the skin:
- dermatomycosis - Tinea pedis (athlete's foot), Tinea crusis (inguinal dermatitis), Tinea corporis (smooth skin mycosis), Tinea barbae (beard mycosis), Tinea manus (dermatophytosis of the hands);
- candidiasis (Monolisiasis);
- Pityiriasis versicolor (Pityrosporum orbiculare) (pityriasis versus versicolor).
Pityriasis versicolor in immunocompetent patients older than 12 years (solution for external use).

Contraindications

- Hypersensitivity to sertaconazole and other components of Sertamycol, including other imidazole derivatives;
- lactation period;
- children's age up to 12 years (solution for external use).

Dosage

Outwardly.
Solution for external use
For adults and children older than 12 years, the external solution is applied on the affected skin with a uniform thin layer 2 times / day, capturing approximately 1 cm of the surface of healthy skin. The duration of treatment depends on the etiology (pathogen) and the localization of the infection, on average, 4 weeks.
In the treatment of pityriasis versicolor, a sufficient amount of the solution for external use should be applied on the dry skin from the neck down, excluding the genitals. Repeat twice a day for 4 weeks.

Side effects of Sertamycol

Local reactions: contact dermatitis, rapid erythematous reactions are possible at the site of use, which does not require discontinuation of Sertamycol.
If any of the above side effects are exacerbated, or any other side effects occur, the patient should inform the physician.

Overdose

Given the method of use, overdose of Sertamycol is unlikely.
In case of accidental ingestion of Sertamycol, it is necessary to carry out symptomatic treatment.

Drug interaction

Not found.

special instructions

Do not use in ophthalmic practice.
After applying Sertamycol is not recommended the use of acidic detergents (in an acidic environment increases the reproduction of Candida spp.).

Use in pediatrics

Data on the use of Sertamycol in children do not.

Influence on ability to drive motor transport and control mechanisms

The use of Sertamycol in accordance with the instructions for use does not affect the performance of potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions (driving, working with moving mechanisms).

Pregnancy and lactation

In pregnancy, apply only if the intended benefit to the mother outweighs the potential risk to the fetus.
During lactation, Sertamycol should not be applied to the area of ​​the mammary glands. If necessary, the use of the drug during lactation should consider stopping breastfeeding.

Pharmacy sales terms

You don't need a prescription to buy Sertamycol.

Terms and conditions of storage

Store in a tightly closed tube in a dark place at a temperature not exceeding 25 ° C. Shelf life - 2 years. Do not use Sertamycol after the expiration date.
Keep out of the reach of children.