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

Excipients: sodium laumacromagolasulfate 150 mg, disodium laumacarholasulfosuccinate 140 mg, coconut oil diethanolamide 45 mg, lauryl dimony hydroxypropyl collagen hydrolyzate 20 mg, macrogol methyldextrose dioleate 10 mg, sodium chloride 10 mg, sodium hydroxide 2.29 mg, hydrochloric acid concentrated 2 mg, imidazolidinyl urea 1.70 mg, azorubin dye 0.01 mg, purified water up to 1 g.

Description:

Transparent or almost transparent from light pink to dark red color viscous liquid, with a specific smell.

Pharmacotherapeutic group:antifungal agent

ATX: & nbsp

J.02.A.B.02 Ketoconazole

D.01.A.C.08 Ketoconazole

Pharmacodynamics:

Ketoconazole is a synthetic derivative of imidazolidioxole, has an antifungal effect against dermatophytes, such as Trichophyton sp., Epidermophyton sp., Microsporum sp., and yeast such as Candida sp. and Malassezia furfur (Pityrosporum ovale). Shampoo with ketoconazole quickly reduces peeling and itching, which are usually associated with dandruff, seborrheic dermatitis.

The mechanism of action of ketoconazole is based on the inhibition of the cytochrome P450 system in fungi, which reduces the synthesis of ergosterol, the main component of the fungal cell membrane.

Pharmacokinetics:

Absorption of ketoconazole through the skin with local application is negligible.

Because even with prolonged; the content of ketoconazole in the blood is not determined, it can be concluded that the drug does not have a systemic effect.

Indications:

Treatment and prevention of seborrheic dermatitis of the scalp and dandruff.

Contraindications:

Hypersensitivity to the active substance or to any auxiliary substance of the drug.

Children under 18 years.

Pregnancy and lactation:

Since the topical application of the active ingredient ketoconazole practically not absorbed, the use of MIKANISAL® shampoo in this period is possible.

When pregnancy and during breastfeeding are used only if the intended benefit to the mother exceeds the potential risk to the fetus and the baby.

Dosing and Administration:

Outwardly.

Apply shampoo to the affected skin and leave for 3-5 minutes, then rinse with water.

To treat dandruff and seborrheic dermatitis apply twice a week for 2-4 weeks.

For prophylaxis apply once a week or a week.

If the recommended dose is exceeded, see "Overdose".

Side effects:

The drug is well tolerated.

As with other shampoos containing ketoconazole, local irritation, pruritus or contact dermatitis (due to irritation or allergic reaction) may be noted.

During treatment with MIKISANAL®, hair can become fatty or dry. It is possible to change hair color, mainly in patients with chemically damaged or gray hair.

Overdose:

When applying shampoo MIKICISAL®, an overdose is unlikely. In case of accidental ingestion of special measures is not required. To prevent aspiration, do not induce vomiting or use gastric lavage.

Interaction:

With external application of ketoconazole, no interaction with other drugs was noted.

When using shampoo immediately after prolonged external use of potent glucocorticosteroids, symptoms may occur skin irritation. Babout avoid this it is desirable to continue treatment with weak glucocorticosteroids and complete the treatment gradually within 2-3 weeks. MIKANISAL® can be used after 2 weeks, after the cessation of external treatment with glucocorticosteroids.

Special instructions:

It is not recommended to use the drug in children and adolescents (under 18 years of age), since there is insufficient information about the use in this age group.

As with other shampoos, avoid contact with MIKISANAL® in the eyes. If this still happens, you should immediately rinse your eyes with water.

Seborrhea and dandruff, for which MIKISILAL® is used, are often associated with hair loss. Hair loss may also occur with the use of MIKISANAL®, but this is rare.

Do not use Miknisal® if you are allergic (hypersensitivity) to ketoconazole or to any other shampoo component.

MIKANISAL® is intended for external use only. Do not swallow.

The drug contains a dye azorubin, which can cause allergic reactions.

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

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

Form release / dosage:Shampoo 20 mg / g.

Packaging:

60 g or 100 g shampoo in white plastic bottles (75 ml or 125 g) ml) with a screw cap white.

For 1 filled plastic bottle with instruction for use put in a pack of cardboard box.

Storage conditions:

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 expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001427

Date of registration:12.01.2012

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

Manufacturer: & nbsp

TALLINN PHARMACEUTICAL COMPANY Estonia

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

Information update date: & nbsp12.01.2012

Illustrated instructions

Instructions

Mikanisal® (Mikanisal®)