Nizoral cream 2%, 15g

Composition

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of 1 g of cream contains:

Active ingredient:  

ketoconazole – 20 mg;

Auxiliary substances:  

propylene glycol – 200 mg (EQ. 193 µl),

stearyl alcohol – 75 mg,

Sirte cetyl 20 mg,

sorbitan stearate – 20 mg,

Polysorbate 60 (tween 60) – 15 mg,

Polysorbate 80 (tween 80) – 1 mg,

methyl ethyl ketone 10 mg,

sodium sulfite anhydrous 2 mg,

purified water – up to 1 g (637 µl).

Clinical Pharmacology

Pharmacodynamics : Ketoconazole is a synthetic derivative of imidazoldioxolan that has a fungicidal or mycostatic effect against dermatophytes such as Trichophyton sp., Epidermophyton floccosum, and Microsporum sp., and against yeast, especially Malassezia spp. Nizoral ® cream 2% has a very rapid effect on itching in dermatophytic and yeast infections, while symptomatic improvement is observed even before the first signs of recovery appear. Pharmacokinetics: Ketoconazole concentrations were not detected in the blood plasma of adult patients after topical application of Nizoral ® cream 2% to the skin. In a study involving 19 children with seborrheic dermatitis, in which about 40 g of Nizoral® cream 2% was applied daily to a skin surface area of more than 40% of the body surface, plasma concentrations of ketoconazole were determined in 5 children and ranged from 32 to 133 ng / ml. If the cream is repeatedly used in children in large quantities (more than 3 g), there is a possibility of drug interactions – inhibition of the metabolism of drugs metabolized by CYP3A4 enzymes, in particular cisapride, and an increase in allergic reactions is also possible.

Indications

Dermatophytic skin infections caused by Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis and Epidermophyton fl occosum: * smooth skin dermatomycosis• * inguinal epidermophytosis, • hand and foot epidermophytosis• * skin candidiasis• * Pityriasis versicolor, • seborrheic dermatitis caused by Pityrosporumovale.

Use during pregnancy and lactation

Although Nizoral ® ketoconazole cream does not penetrate the skin, adequate and well-controlled studies have not been conducted in pregnant women and during breastfeeding. Plasma concentrations of ketoconazole were not detected after applying 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% can be dangerous when used in pregnant women and during breastfeeding. During pregnancy and lactation, use only if the intended benefit to the mother exceeds the potential risk to the fetus and child, after consulting a doctor.

Contraindications

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

Side effects

The following data summarizes information on side effects reported in 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 MedDRA classification of Organs and Organ Systems (Medical Dictionary for Regulatory Activities). Criteria for evaluating the frequency of side effects: very common (≥ 1/10), common (≥ 1/100 and < 1/10), infrequent (≥ 1/1000 and < 1/100), rare (≥ 1/10000 and < 1/1000), very rare (Since in the post-marketing period, reports of side effects are received on a voluntary basis from a population of indeterminate size, it is not possible to reliably estimate the frequency of their occurrence, and therefore “frequency unknown”is indicated for these side effects. Immune system disorders: infrequently – hypersensitivity. Skin and subcutaneous tissue disorders: often-burning of the skin; infrequently-bullous rash, contact dermatitis, rash, peeling of the skin, stickiness of the skin; frequency unknown-urticaria. General disorders and disorders at the application site: often-erythema and itching at the application site; infrequently-bleeding, discomfort, dry skin, inflammation, irritation, paresthesia, reactions at the application site. If any of the side effects listed in the instructions get worse, or any other side effects that are not listed in the instructions are noted, you should immediately inform your doctor.

Interaction

Not studied.

How to take, course of use and dosage

Candidiasis of the skin, smooth skin dermatomycosis, inguinal epidermophytosis, hand and foot epidermophytosis, pityriasis versicolor: it is recommended to apply Nizoral ® cream once a day to the affected skin and immediately adjacent area. 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 a few days after all symptoms of the disease have disappeared. The diagnosis should be reviewed if there is no clinical improvement after 4 weeks of treatment. General hygiene measures should be followed to control sources of infection and reinfection. The usual duration of treatment is as follows: pityriasis versicolor-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 for seborrheic dermatitis is 2-4 weeks. For maintenance therapy for seborrheic dermatitis, the cream is applied once or twice a week.

Overdose

Applying too much cream can cause the development of erythema, swelling and burning sensation, which disappear after stopping therapy. In case of accidental ingestion, maintenance and symptomatic therapy is performed.

Description

White homogeneous cream.

Special instructions

For external use only. Nizoral cream should not be used in ophthalmic practice. In order to prevent withdrawal symptoms after discontinuation of 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, discontinue steroid therapy. If the medicine has fallen into disrepair or the expiration date has expired, do not throw it into the sewer or on the street! Place the medicine in a plastic bag and put it in the trash can. These measures will help protect the environment!

Form of production

Cream for external use

Storage conditions

Store at a temperature of 15 to 30° C. Keep out of the reach of children.

Active ingredient

Ketoconazole

Dosage form

cream

Description

Nursing mothers as prescribed by a doctor, Pregnant women as prescribed by a doctor, For adults

Indications

Skin Fungus, Fungus, Seborrhea