UNGUSAN - instructions for use, doses, side effects, contraindications

Excipients: isopropyl myristate 80 mg; cetostearyl alcohol [cetyl alcohol 60%, stearyl alcohol 40 %] - 80 mg; sorbitan stearate - 60 mg; cetyl palmitate - 20 mg; polysorbate-60 - 20 mg; gasoline alcohol - 10 mg; sodium hydroxide - 1.2 mg; purified water - up to 1 g.

Description:Homogeneous cream white or almost white with a specific smell.

Pharmacotherapeutic group:Antifungal agent.

ATX: & nbsp

D.01.A.E.15 Terbinafine

Pharmacodynamics:

Antifungal drug for external use. In low concentrations it has fungicidal activity against dermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton floccosum), yeast fungi (mainly Candida albicans) and Pityrosporum orbiculare.

Activity with respect to yeast is fungicidal or fungistatic in nature depending on the type of fungi.

Terbinafine, inhibiting squalene epoxidase in the cell membrane of the fungus (not related to the cytochrome P450 system), specifically suppresses the early stage of the synthesis of sterols in the fungal cell, which leads to ergosterol deficiency, intracellular accumulation of squalene and death of the fungal cell.

Terbinafine has no effect on the metabolism of hormones or other drugs.

The minimum inhibitory concentration (MPC) for Trychophyton rubrum - 0.001-0.06 μg / ml.

In chronic dermatophytias of smooth skin, remission is achieved in 75-95% of patients. Subjective improvement in the treatment of progressive candidiasis of smooth skin and lesions of large and interdigital folds, paronychia caused by Candida albicans and resistant to therapy nystatin, levorin in combination with clotrimazole and miconazole, comes on 3-4 days, and the full resolution of the process - after 3-5 weeks.

Pharmacokinetics:At external application absorption - 5%, renders insignificant system action.

Indications:

Fungal skin diseases caused by sensitive pathogens (trichophytosis, microsporia, epidermophytia, rubrophytic and candidiasis of the skin), multi-colored lichen.

Contraindications:Hypersensitivity to terbinafine or any auxiliary substance of the cream, children under 12 years.

Carefully:

Renal / hepatic insufficiency, alcoholism, oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the extremities, pregnancy, lactation.

Pregnancy and lactation:

When pregnancy is used only if the intended benefit for the mother exceeds the potential risk to the child. During breastfeeding, the use is contraindicated. Terbinafine excreted in breast milk, but with external application, due to absorption of a small amount of active substance, the effect on infants is unlikely.

Dosing and Administration:

Outwardly. The cream is applied to the affected areas of the skin and adjacent areas with a thin layer, lightly rubbing, 1 or 2 times a day. The duration of treatment depends on the indication and severity of the disease.

Duration and frequency of application:

- dermatomycosis of the trunk, shins, feet: 1 time per day for 1 week, skin candidiasis: 1-2 times a day for 1-2 weeks,

- multi-colored lichen: 1-2 times a day for 2 weeks.

The cream should be applied to clean, dry skin. When intertriginoznyh infections (areas under the mammary glands, between the fingers and toes, the perineum and inguinal region), you can apply a gauze bandage to the affected area, especially at night.

If you forgot to apply the drug

If you forget to apply the next dose of cream, apply it immediately. But if the time of application of the next dose approaches, skip the forgotten dose and continue to use as recommended. Do not use a double dose instead of a forgotten dose or more than 2 times a day.

Side effects:

In the place of application, itching and burning of the skin, hyperemia at the site of application, which usually does not require discontinuation of treatment, can sometimes occur.These phenomena must be distinguished from allergic reactions, which are rare, but require discontinuation of treatment.

Overdose:

Overdose with external application is unlikely. If you accidentally swallow the cream, you may experience systemic side effects from the digestive tract (nausea, gastralgia, lack of appetite, diarrhea), as well as headache, dizziness, frequent urination and rash.

Treatment: to reduce the absorption of the active substance, it is possible to rinse the stomach and take Activated carbon. If necessary, use symptomatic and supportive treatment.

Interaction:The drug interaction terbinafine in the drug form of the cream is not described.

Special instructions:

Elderly patients. Data that elderly patients need to use the drug in a different dose or have other side effects than younger patients are not available.

If you have any questions about the use of this drug, consult your doctor.

Irregular application or premature discontinuation of treatment increases the risk of recurrence.

If after 2-week treatment there is no improvement, it is necessary to repeatedly identify the pathogen and its sensitivity to the drug.

During the treatment, it is necessary to follow the general rules of hygiene to prevent reinfection (through underwear, shoes).

To increase the effectiveness of treatment it is recommended to avoid contact with a possible external source of fungal infection.

Avoid getting the cream on the mucous membranes.

Effect on the ability to drive transp. cf. and fur:

The drug does not affect the ability to drive vehicles and work with technical devices.

Form release / dosage:

Cream for external use 1 %.

For 15 g or 30 g in aluminum tubes with an internal surface lacquered, with a protective aluminum membrane on the neck and a cone-shaped device for puncturing the membrane in a screwed Bushon made of polyethylene or polypropylene. Tubu together with the instruction for medical use is placed in a pack of cardboard box.

Packaging:tubes, aluminum (1) - packs, cardboard

Storage conditions:

Store at a temperature not exceeding 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001051

Date of registration:24.10.2011

The owner of the registration certificate:GRINDEX, JSC GRINDEX, JSC Latvia

Manufacturer: & nbsp

Grindeks, JSC Latvia

Representation: & nbspGrindeks Rus, Open CompanyGrindeks Rus, Open CompanyRussia

Information update date: & nbsp19.09.2015

Illustrated instructions

Instructions

UNGUSAN® (Ungusan®)