Pharmacological properties
Pharmacodynamics. Ketoconazole is a synthetic imidazole dioxolan derivative that has a pronounced fungicidal and fungistatic effect against dermatophytes such as trichophyton spp., epidermophyton spp., microsporum spp., and yeasts such as candida spp. and malassezia furfur (pityro). ketoconazole cream very quickly eliminates itching, usually accompanying infections caused by dermatophytes and yeasts.
Ketoconazole shampoo quickly reduces the flaking and itching associated with dandruff, seborrheic eczema and pityriasis.
Pharmacokinetics. With local application of Nizoral cream and shampoo, the content of ketoconazole in the blood plasma is not determined. Plasma levels after topical application of Nizoral shampoo were determined only after application to the entire body surface.
Indications
Nizoral cream: treatment of fungal infections of the skin such as athlete's foot, inguinal athlete's foot, treatment of skin fold candidiasis (intertrigo).
Nizoral Shampoo: Treatment and prevention of skin and hair lesions caused by the yeast Malassezia (formerly called Pityrosporum), such as dandruff and pityriasis versicolor (localized), seborrheic dermatitis.
Application
Cream: for the treatment of athlete's foot, nizoral cream is applied to the affected skin and adjacent areas 2 times a day. usually, treatment of skin lesions should be continued for 1 week. with more severe skin lesions, treatment should be continued for another 2-3 days after the disappearance of all symptoms in order to avoid recurrence of the disease.
For the treatment of epidermophytosis inguinal and candidiasis of skin folds, it is recommended to apply the cream to the affected skin and surrounding areas 2 times a day. Treatment should be continued for a sufficient time, at least for 2-3 days after the disappearance of all symptoms in order to avoid recurrence of the disease. Treatment, if necessary, can last up to 6 weeks. If symptoms persist after 4 weeks of treatment, you should see your doctor.
Shampoo: apply Nizoral shampoo to the affected areas for 3-5 minutes, then rinse with water.
Treatment: dandruff and seborrheic dermatitis (seborrheic eczema) - 2 times a week for 2-4 weeks; pityriasis versicolor - daily for 5 days.
Prevention: dandruff and seborrheic dermatitis (seborrheic eczema) - weekly or once every 2 weeks; pityriasis versicolor - daily for 3 days (one-time course of treatment) before the start of the summer season.
Contraindications
Hypersensitivity to ketoconazole or any component of the preparation.
Side effects
Cream. The safety of nizoral cream was determined in 30 clinical studies involving 1079 patients in whom the preparation was applied topically to the skin.
Adverse reactions that occurred in ≥1% of patients:
general disorders and reactions in the area of application - erythema, itching;
disorders of the skin and subcutaneous tissue - burning sensation.
Adverse reactions that occurred in 1% of patients:
- general disorders and reactions in the area of application - bleeding, discomfort, dryness, inflammation, irritation, paresthesia;
- disorders of the immune system - hypersensitivity reactions;
- disorders of the skin and subcutaneous tissue - bullous rash, contact dermatitis, peeling or stickiness of the skin.
Post-marketing observations. Adverse reactions when using Nizoral cream, which were first reported in the post-registration period, are given below. The incidence of adverse reactions is distributed as follows: very often ≥1 / 10; often ≥1 / 100 and 1/10; infrequently ≥1 / 1000 and 1/100; rarely ≥1 / 10,000 and 1/1000; very rarely 1/10 000, including individual messages.
On the part of the skin and subcutaneous tissue: very rarely - urticaria.
Special instructions
Nizoral cream is not used in ophthalmic practice. if nizoral cream is applied to the affected areas immediately after long-term treatment with ointments containing GCS, irritation may occur. in such cases, it is recommended to continue to apply local corticosteroids to the affected area in the morning, and nizoral cream - in the evening, and then gradually stop corticosteroid therapy within 2-3 weeks.
Propylene glycol can cause itchy skin. Cetyl alcohol and stearyl alcohol can cause local skin reactions (eg contact deramatitis).
When using shampoo, avoid contact with the eyes. In case of contact with eyes, rinse with water.
To prevent withdrawal syndrome with long-term local treatment of corticosteroids, it is recommended to continue local administration of corticosteroids in combination with Nizoral shampoo, followed by gradual withdrawal of corticosteroids within 2-3 weeks.
During pregnancy and breastfeeding. There have been no adequate and well-controlled studies in women during pregnancy and lactation. There are no known risks associated with the use of the preparation during pregnancy and lactation. After topical application of Nizoral shampoo to the skin in non-pregnant women, the concentration of ketoconazole in the blood plasma was not determined. Plasma levels after topical application of Nizoral shampoo were determined after application to the entire body surface. Due to the absence of known risk factors, the use of the preparation during pregnancy and lactation is not contraindicated.
Children. There is no experience with Nizoral cream and shampoo in children.
The ability to influence the reaction rate when driving or working with other mechanisms. Neither Nizoral cream nor Nizoral shampoo affect the ability to drive vehicles and work with other mechanisms.
Interactions
Not marked.
Overdose
Cream: topical application. when the cream is applied topically in an excessive amount, erythema, edema, and skin burn sensation may occur, which quickly disappear after discontinuation of therapy.
Accidental use inside. In case of accidental ingestion, supportive and symptomatic therapeutic measures should be carried out.
In case of an overdose, the necessary treatment is to carry out supportive and symptomatic measures. To prevent aspiration, do not induce vomiting or use gastric lavage.
Storage conditions
Cream: at a temperature of 15 to 30 ° C; shampoo: at a temperature not higher than 25 ° C.