Sertamicol - instructions for use, dose, side effects, contraindications

Active substanceSertaconazoleSertaconazole

Similar drugsTo uncover

Zalain®

suppositories the vagina.

EGIS ZAO Pharmaceutical Plant Hungary

Zalain®

cream externally

EGIS ZAO Pharmaceutical Plant Hungary

Optiginal®

suppositories the vagina.

BIOCAD, CJSC Russia

Sertamicol®

solution externally

Glenmark Pharmaceuticals Co., Ltd. India

Sertamicol®

cream externally

Glenmark Pharmaceuticals Co., Ltd. India

Dosage form: & nbspsolution for external use

Composition:

100 ml of solution contains:

Active ingredient: sertaconazole nitrate 2.0 g

Auxiliary components: (propylene glycol - 102 g, trolamine - 0.1 g) - 100 ml

Description:Transparent liquid from colorless to light yellow color

Pharmacotherapeutic group:Antifungal agent.

ATX: & nbsp

D Dermatology

Pharmacodynamics:

Sertaconazole is an antifungal agent belonging to the class of imidazoles. The exact mechanism of action of this class of antifungal agents is not known, but it is believed that their effect is mainly due to the inhibition of cytochrome P450-dependent ergosterol synthesis. Ergosterol is a key component of the cell membrane of fungi, the absence of this component leads to damage to the fungal cell and the release of key constituents from the cell into the cytoplasm. The geometric minimum inhibitory concentration (MIC) of sertaconazole is from 0.06 to 1 μg / ml against a variety of strains of dermatophytes.

Has a broad spectrum of action against dermatophytes (Trichophyton spp.,

Microsporum spp.), Yeast fungi (Candida spp., Including Candida albicans, Candida

tropicalis, Pityrosporum orbiculare), mycelial fungi and bacteria that cause skin infections.

Pharmacokinetics:

During the pharmacokinetic study of multiple doses involving patients with interdigital foot dermatophyte (area range of the affected area: 42-140 cm2, mean - 93 cm2), the solution of Sertaconazole was applied externally every 12 hours (only 13 times) to the affected skin (0.5 g sertaconazole nitrate per 100 cm2). The plasma concentrations of sertaconazole measured by a series of blood samples taken within 72 hours after the thirteenth dose were below the quantification limit (2.5 ng / ml) of the analytical method used.

Thus, with external application sertaconazole in the blood and urine is not found.

Indications:

candidiasis,

dermatomycosis,

dermatophytosis (foot, shin, body, beard, hands),

pityriasis lichen in immunocompetent patients older than 12 years.

Contraindications:

Hypersensitivity to the components of the drug, incl. to other derivatives of imidazole, lactation period, children under 12 years of age.

Carefully:

Pregnancy, children age from 12 years.

Pregnancy and lactation:

When pregnancy is used only if the intended benefit for the mother exceeds the potential risk to the fetus. During lactation, the solution should not be applied to the area of the mammary glands. If you need to use the drug during lactation, you should consider stopping breastfeeding.

Dosing and Administration:

Outwardly.

The solution is evenly applied to the affected areas of the skin with a thin layer 2 times a day, grabbing approximately 1 cm of the surface of healthy skin. The duration of treatment depends on the etiology of the disease and the localization of the infection, on average - 4 weeks.

When treating pityriasis, apply a sufficient amount of Sertaconazole solution on dry skin from the neck down, excluding the genitals, wait for drying and rinse after 10 minutes, repeat twice a day for 4 weeks

Side effects:

Contact dermatitis, allergic reactions are possible, local erythema (does not require drug withdrawal).

Overdose:Given the method of administration, an overdose of the drug is unlikely. In case of accidental ingestion - symptomatic treatment.

Interaction:Not found

Special instructions:

Do not use in ophthalmic practice.After application of the preparation, the use of acidic detergents is not recommended (in the acidic environment, multiplication of Candida spp.) Is intensified. There are no data on the use of children.

Form release / dosage:Solution for external use 2%.

Packaging:

15 ml each in a polyethylene bottle.

One vial with instructions for use in a cardboard pack.

Storage conditions:

Store in a tightly closed bottle in a dark place at a temperature of 2 to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001521

Date of registration:16.02.2012

The owner of the registration certificate:Glenmark Pharmaceuticals Co., Ltd.Glenmark Pharmaceuticals Co., Ltd. India

Manufacturer: & nbsp

GLENMARK PHARMACEUTICALS, Ltd. India

Information update date: & nbsp20.09.2015

Illustrated instructions

Instructions

Sertamicol® (Sertamicol)