Oflomikol cream for external use 2%, 20g

Composition

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of 1 g of cream contains:

Active ingredient: sertaconazole nitrate-0.020 g;

Auxiliary substances:  

cetyl alcohol 0.035 g, stearyl alcohol 0.035 g ministrowie alcohol (Sepeziol 14) 0,020 g, glyceryl monostearate (NSE) 0,020 g, sorbitan stearate 0,010 g, Polysorbate-60 (Tween 60) 0.035 g octyldodecanol 0,040 g, liquid paraffin 0,040 g, benzyl alcohol 0,010 g, purified water 0,735 G.

Pharmacological action

Pharmacodynamics

An antifungal agent derived from imidazole and benzothiophene with a broad spectrum of action. The mechanism of action consists in inhibiting the synthesis of ergosterol (the main sterol of fungal and yeast membranes) and increasing the permeability of the cell membrane, which leads to lysis of the fungal cell.

In therapeutic doses, it has a fungistatic and fungicidal effect against pathogenic fungi (Candida spp., including Candida albicans, Candida tropicalis, Pityrosporum orbiculare, Malassezia furfur), dermatophytes (Trichophyton, Microsporum, Epidermophyton floccosum) and is active against pathogens of skin and mucous membranes infections (gram – positive strains of Staphylococcus aureus). and streptococci).

Pharmacokinetics

When applied externally, sertaconazole is not detected in the blood and urine.

Indications

Treatment of superficial skin mycoses: dermatomycosis, Tinea pedis (athlete’s foot), Tinea crusis (inguinal dermatomycosis), Tinea corporis (smooth skin mycosis), Tinea barbae (beard mycosis), Tinea manus (hand dermatophytosis), candidiasis (Monolisiasis), and Pityiriasis versicolor (Pityrosporum orbiculare) (pityriasis versicolor).

Use during pregnancy and lactation

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

Before using OFLOMICOL, if you are pregnant, or believe that you might be pregnant, or are planning to become pregnant, you should consult your doctor.

During breastfeeding, you should consult your doctor before using OFLOMIKOL.

Contraindications

Hypersensitivity to sertaconazole and other components of the drug, including other imidazole derivatives.

Side effects

Contact dermatitis, rapid erythematous reactions at the site of application are possible, which does not require discontinuation of the drug. If you experience any of the side effects listed in the instructions, or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Interaction with other drugs was not detected.

How to take, course of use and dosage

Externally.

The cream is applied to the affected areas of the skin in a uniform thin layer 2 times a day, capturing approximately 1 cm of the surface of healthy skin. Before applying the drug, the skin at the site of application should be cleaned with soap and water, dried.

The duration of treatment depends on the etiology (pathogen) and location of the infection. As a rule, the symptoms of the disease disappear after 2-4 weeks. The recommended duration of treatment is 4 weeks.

If there is no improvement after treatment, or if the symptoms worsen or new symptoms appear, you should consult your doctor.

Use the drug only according to the indications, the method of use and in the doses indicated in the instructions.

Overdose

Given the method of use, overdose with the drug is unlikely.

If the drug is accidentally taken orally, it is necessary to conduct symptomatic treatment.

Description

Homogeneous cream of white color.

Special instructions

Do not use in ophthalmic practice. After applying the product, it is not recommended to use acidic detergents (Candida spp. multiplies in an acidic environment).

There are no data on the use of the drug in children.

The drug contains cetyl alcohol and stearyl alcohol, which can cause local skin reactions (for example, contact dermatitis).

The drug contains benzyl alcohol, which can cause allergic reactions.

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

Form of production

Cream for external use,2%.

20 g each in laminated aluminum tubes.

One tube with instructions for use in a cardboard box.

Storage conditions

In a tightly closed tube in a place protected from light at a temperature not exceeding 25°C. Do not freeze it. Keep out of reach of children.

Shelf

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

Active ingredient

Sertaconazole

Dosage form

cream