Nizoral, 2% cream 15 g

Seborrheic dermatitis, Skin fungus, Dermatophytic skin infections caused by Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis and Epidermophyton fl occosum:

– smooth skin dermatomycosis,
– inguinal epidermophytia,
– hand and foot epidermophytia,
– skin candidiasis,
– pityrosporum lichen,
– seborrheic dermatitis caused by Pityrosporumovale.

Active ingredient

Ketoconazole

Composition

1 g of the cream contains:

The active ingredient:

ketoconazole – 20 mg;

Excipients:

Propylene glycol – 200 mg (eq. 193 µl),

Stearyl alcohol – 75 mg,

Cetyl sirt – 20 mg,

sorbitan stearate – 20 mg,

polysorbate 60 (Twin 60) – 15 mg,

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Polysorbate 80 (Twin 80) – 1 mg,

Isopropyl myristate – 10 mg,

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Sodium sulfite anhydrous – 2 mg,

Purified water – up to 1 g (637 µl).

How to take, the dosage

Skin candidiasis, smooth skin dermatomycosis, inguinal epidermophytosis, epidermophytosis of hands and feet, pityriasis: It is recommended to apply Nizoral® cream once a day to the affected skin and the immediate area 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. Treatment should be continued for a sufficient period of time, at least for several days after all symptoms of the disease have disappeared.

The diagnosis should be reconsidered if no clinical improvement is noted 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: thrush lichen – 2-3 weeks, yeast infections – 2-3 weeks, inguinal epidermophytosis – 2-4 weeks, smooth skin dermatomycosis – 3-4 weeks, foot epidermophytosis – 4-6 weeks.

The usual duration of treatment in case of seborrheic dermatitis is 2-4 weeks.

For maintenance therapy in seborrheic dermatitis the cream is applied once or twice a week.

Special Instructions

Only for external use.

Cream Nizoral® should not be used in ophthalmic practice.

In order to prevent withdrawal syndrome after discontinuing long-term treatment with topical corticosteroids, it is recommended to continue using topical corticosteroids in the morning and Nizoral® cream in the evening and then gradually over 2-3 weeks to discontinue steroid therapy.

If the medication is out of date or expired – do not throw it in the sewage or on the street! Place the medication in a bag and put it in a trash container. These measures will help protect the environment!

Synopsis

White homogeneous cream.

Contraindications

Known hypersensitivity to ketoconazole or any of the excipients of the drug.

Side effects

The following data summarizes the information on the side effects registered in clinical trials, as well as data on the safety profile of the drug obtained during its use in clinical practice.

The side effects are grouped according to the classification of organs and organ systems MedDRA (Medical Dictionary for Regulatory Affairs).

Criteria for evaluating the incidence of side effects: very frequently (≥ 1/10), frequently (≥ 1/100 and < 1/10), infrequently (≥ 1/1000 and < 1/100), rarely (≥ 1/10000 and < 1/1000), very rarely (< 1/10000, including individual reports).

Because post-registration reports of side effects come voluntarily from a population of uncertain size, it is not possible to reliably estimate the incidence of these side effects, therefore, “frequency unknown” is indicated for these side effects.

Immune system disorders: infrequent – hypersensitivity.

Skin and subcutaneous tissue disorders: frequent – skin burning; infrequent – bullous rash, contact dermatitis, rash, skin peeling, sticky skin; frequency is unknown – urticaria.

General disorders and disorders at the application site: often – erythema and itching at the application site; infrequent – bleeding, discomfort, dry skin, inflammation, irritation, paresthesia, reactions at the application site.

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

Overdose

Application of excessive amounts of cream may cause erythema, swelling and burning sensation, which disappear after discontinuation of therapy. In case of accidental ingestion, supportive and symptomatic therapy is carried out.

Pregnancy use

Although ketoconazole does not penetrate the skin when Nizoral® cream is used, adequate and well-controlled studies have not been performed in pregnant women or during breastfeeding.

Plasma concentrations of ketoconazole have not been detected after application of Nizoral® cream to 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% may be dangerous when used in pregnant women and during breastfeeding.

During pregnancy and breastfeeding, use only if the expected benefits to the mother exceed the potential risk to the fetus and child, after consultation with the doctor.

Similarities

Nisoral, Mycosoral, Livarol, Perchotal, Ketoconazole Shampoo, Ketoconazole DS, Ketoconazole