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

Excipients: propylene glycol 200 mg (equivalent 193 μl), stearyl alcohol 75 mg, cetyl alcohol 20 mg, sorbitan stearate 20 mg, polysorbate 60 15 mg, isopropyl myristate 10 mg, sodium sulfite anhydrous 2 mg, polysorbate 80 1 mg, purified water up to 1 g (637 μl).

Description:White homogeneous cream.

Pharmacotherapeutic group:antifungal agent

ATX: & nbsp

J.02.A.B.02 Ketoconazole

D.01.A.C.08 Ketoconazole

Pharmacodynamics:

Ketoconazole is a synthetic imidazoledioxole derivative having a fungicidal or mycostatic action against dermatophyte in such as Trichophyton sp., Epidermophyton floccosum and Microsporum sp., and against yeast, especially against Malassezia spp.

NIZORAL® cream 2% very quickly affects the itching of dermatophytic and yeast infections, with a symptomatic improvement even before the first signs of recovery.

Pharmacokinetics:

Concentrations of ketoconazole were not detected in the blood plasma of adult patients after topical application to the skin of NIZORAL® cream 2%.

In a study involving 19 children with seborrheic dermatitis in which about 40 g of NIZORAL® cream 2% were applied daily to the skin surface with an area of more than 40% of the body surface, ketoconazole concentrations in plasma were determined in 5 children and were 32 to 133 ng / ml . With the repeated application of creams in children in large quantities (more than 3 g), there is a possibility of drug interactions - inhibition of the metabolism of drugs metabolized by enzymes of the CYP3A4 system, in particular cisapride, and allergic reactions are also possible.

Indications:

Dermatophyte skin infections, caused by Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis and Epidermophyton floccosum: smooth skin dermatomycosis; inguinal epidermophytia, epidermophytosis of hands and feet.

Candidiasis of the skin.

Peregrine lichen.

Seborrheic dermatitis caused by Pityrosporum ovale.

Contraindications:

Known hypersensitivity to ketoconazole or any of the auxiliary components preparation.

Pregnancy and lactation:

Although using the cream NIZORAL® ketoconazole does not penetrate the skin, adequate and well-controlled studies in pregnant women during breastfeeding have not been conducted.

Plasma concentrations of ketoconazole were not detected after the application of NIZORAL® cream on the skin of non-pregnant women. There are no known risks associated with the use of NIZORAL® 2% cream during pregnancy.

There is no evidence that NIZORAL® cream 2% can be dangerous when used in pregnant women and during breastfeeding.

In pregnancy and during breastfeeding apply only if the intended benefit for the mother exceeds the potential risk to the fetus and the baby, after consulting a doctor.

Dosing and Administration:

Candidiasis of the skin, dermatomycosis of smooth skin, inguinal epidermophytia, epidermophytia of hands and feet, pityriasis

It is recommended to apply NIZORAL® cream once a day to the affected skin and the area immediately adjacent to it.

Seborrheic dermatitis

NIZORAL® cream is applied to the affected area once or twice a day, depending on the severity of the lesion.

Continue treatment for a sufficient period of time, at least for several days after the disappearance of all symptoms of the disease. The diagnosis should be reviewed if there is no clinical improvement after 4 weeks of treatment.General hygiene measures should be observed to control sources of infection and reinfection.

The usual duration of treatment is as follows:

pityriasis lichen - 2-3 weeks, yeast infections - 2-3 weeks, inguinal epidermophytia - 2-4 weeks, dermatomycosis smooth skin - 3-4 weeks, epidermophytia stop - 4-6 weeks.

The usual duration of treatment for seborrheic dermatitis is 2-4 weeks. For maintenance therapy for seborrheic dermatitis, the cream is applied once or twice a week.

Side effects:

The data below summarizes the information on side effects recorded during clinical trials, as well as data on the safety profile of the drug obtained during its use in clinical practice. Side effects are grouped according to the classification of organs and systems of organs MedDRA (medical dictionary for regulatory activities). Criteria for assessing the incidence of side effects: very often (≥ 1/10); often (≥ 1/100, <1/10); infrequently (≥ 1/1000, <1/100); rarely (≥ 1/10 000, <1/1000); very rarely (<1/10 000, including individual messages).

Since in the post-marketing period reports of side effects are received voluntarily from a population of an indeterminate size, it is not possible to reliably estimate the frequency of their occurrence,in connection with which for the given side affects "frequency is unknown" is indicated.

Immune system disorders: infrequently - hypersensitivity.

Disturbances from the skin and subcutaneous tissues: often - burning of the skin; infrequently - bullous rash, contact dermatitis, rash, skin peeling, skin stickiness; frequency unknown - hives.

General disorders and disorders in the place of application: often - erythema and itching at the site of application; infrequently - bleeding, discomfort, dry skin, inflammation, irritation, paresthesia, reactions at the site of application.

If any of the side effects indicated in the manual are aggravated, or any other side effects not indicated in the instructions are noted, you should inform the doctor immediately.

Overdose:

The application of excessive amounts of cream can cause the development of erythema, edema and burning sensation, which disappear after discontinuation of therapy.

With occasional ingestion, supportive and symptomatic therapy is performed.

Interaction:Not studied.

Special instructions:

For external use only.

Cream NIZORAL® can not be used in ophthalmic practice.

In order to prevent withdrawal syndrome after cessation of long-term treatment with local corticosteroids, it is recommended to continue the use of local corticosteroids in the morning and NIZORAL® cream in the evening, and then gradually, within 2-3 weeks, to cancel steroids.

If the medicinal product has become unusable or has expired, do not dispose of it in sewage or on the street. Place the drug in a bag and put it in the trash. These measures will help protect the environment.

Effect on the ability to drive transp. cf. and fur:Not studied.

Form release / dosage:

Cream for external use 2%.

Packaging:

For 15 grams of cream in an aluminum tube.

One tube in a cardboard box, along with instructions for the medical use of the drug.

Storage conditions:

Store at temperatures between 15 and 30 ° C.

Keep out of the reach of children.

Shelf life:3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N011964 / 01

Date of registration:31.08.2010

The owner of the registration certificate:Johnson & Johnson, LLC Johnson & Johnson, LLC Russia

Manufacturer: & nbsp

JANSSEN PHARMACEUTICA, N.V. Belgium

Representation: & nbspJohnson & Johnson LLC Johnson & Johnson LLC Russia

Information update date: & nbsp08.06.2015

Illustrated instructions

Instructions

Nizoral® (Nizoral®)