Nizoral^® (Cream, Shampoo) Instructions for Use

ATC Code

D01AC08 (Ketoconazole)

Active Substance

Ketoconazole (Rec.INN registered by WHO)

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Ketoconazole, a synthetic derivative of imidazoledioxolane, has an antifungal effect against dermatophytes such as Trichophyton spp., Epidermophyton spp., Microsporum spp., and yeasts such as Candida spp. and Malassezia spp. (Pityrosporum spp.).

Nizoral^® shampoo 2% quickly reduces flaking and itching, which usually accompany seborrheic dermatitis, dandruff, and pityriasis versicolor.

Pharmacokinetics

Ketoconazole concentrations are not detected in blood plasma after external application of Nizoral^® shampoo 2% to the scalp, but are detected after external application of the shampoo to the entire body at a concentration of 11.2-33.3 ng/ml. It is unlikely that such concentrations can cause any drug interaction, but an increase in allergic reactions is possible.

Indications

• Treatment and prevention of infections caused by Malassezia spp. (Pityrosporum spp.) yeasts, such as seborrheic dermatitis and dandruff;
• Treatment of pityriasis versicolor (localized).

ICD codes

Dosage Regimen

Shampoo

Externally.

Adolescents from 12 years and adults: apply the drug Nizoral^® medicated shampoo 2% to the affected areas of the skin for 3-5 minutes, then rinse with water.

Treatment

• pityriasis versicolor once a day for 1-3 days;
• seborrheic dermatitis and dandruff 2 times a week for 2-4 weeks.

Prevention:

• seborrheic dermatitis and dandruff weekly or once every 2 weeks.

The safety and efficacy of the drug Nizoral^® medicated shampoo 2% in children under 12 years have not been established.

Cream

Skin candidiasis, dermatomycosis of smooth skin, tinea cruris, tinea of the hands and feet, pityriasis versicolor it is recommended to apply Nizoral^® cream once a day to the affected skin and the area directly adjacent to it.

Seborrheic dermatitis: Nizoral^® cream is applied to the affected area 1 or 2 times 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 observed 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 versicolor – 2-3 weeks, yeast infections – 2-3 weeks, tinea cruris – 2-4 weeks, dermatomycosis of smooth skin – 3-4 weeks, tinea pedis – 4-6 weeks.

The usual duration of treatment for seborrheic dermatitis is 2-4 weeks. For maintenance therapy of seborrheic dermatitis, the cream is applied 1 or 2 times a week.

Adverse Reactions

No adverse reactions observed in ≥1% of patients after application of the drug Nizoral^® medicated shampoo 2% to the scalp or skin were identified.

The data below summarize information on side effects recorded during clinical studies, 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 organ systems. Criteria for assessing the frequency of side effects: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10000 and <1/1000), very rare (<1/10000, including isolated reports). Since reports of side effects in the post-registration period are received voluntarily from a population of uncertain size, it is not possible to reliably estimate the frequency of their occurrence, therefore, for these side effects, the frequency is indicated as “frequency unknown”.

Infections and infestations uncommon – folliculitis.

Immune system disorders rare – hypersensitivity.

Nervous system disorders rare – taste disturbance.

Eye disorders uncommon – increased lacrimation; rare – eye irritation.

Skin and subcutaneous tissue disorders uncommon – alopecia, dry skin, impaired hair texture, rash, burning sensation; rare – acne, contact dermatitis, skin lesion, skin peeling; frequency unknown – hair discoloration, urticaria.

General disorders and administration site conditions uncommon – application site erythema, application site irritation, application site pruritus, application site skin reactions; rare – application site hypersensitivity, application site pustules; frequency unknown – angioedema.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, the patient should immediately inform the doctor.

Contraindications

• Known hypersensitivity to any component of the shampoo.

Use in Pregnancy and Lactation

Adequate and well-controlled studies in pregnant women and during breastfeeding have not been conducted.

Plasma concentrations of ketoconazole were not detected after external application of Nizoral^® shampoo to the scalp of non-pregnant women. Ketoconazole was detected in blood plasma after external application of Nizoral^® shampoo to the entire body surface. The risks associated with the use of the drug Nizoral^® in the dosage form of medicated shampoo 2% during pregnancy and breastfeeding are unknown.

Since the absorption of ketoconazole into the systemic circulation is negligible, no effects on pregnant women and breastfed children are expected.

Use during pregnancy and breastfeeding only if the intended benefit to the mother outweighs the potential risk to the fetus and child.

Pediatric Use

The safety and efficacy of the drug Nizoral^® shampoo 2% in children under 12 years have not been established.

Special Precautions

When using the shampoo, avoid contact with eyes. If shampoo gets into the eyes, rinse them with water.

To prevent withdrawal syndrome during long-term topical corticosteroid treatment, it is recommended to continue topical application of corticosteroids in combination with Nizoral^® shampoo 2% followed by gradual withdrawal of corticosteroids over 2-3 weeks.

If the medicine is unusable or has expired, it should not be disposed of in wastewater or on the street. It is necessary to place the medicine in a bag and put it in a trash container. These measures will help protect the environment.

Effect on ability to drive vehicles and operate machinery

The drug does not affect the ability to drive a car and work with machinery.

Overdose

Overdose is not expected when using the drug Nizoral^® medicated shampoo 2%, because the drug is intended for external use only.

In case of accidental ingestion, symptomatic and supportive therapy should be prescribed. To prevent aspiration, do not induce vomiting or perform gastric lavage.

Drug Interactions

No data on interaction with other medicines are available.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.