Nizoral Cream 2% 15g

Mechanism of action

Antifungal drug, imidazoldioxolan derivative. It has fungicidal and fungistatic effect. The mechanism of action is to inhibit the biosynthesis of ergosterol and change the lipid composition of the membrane of fungi. Active against dermatophytes: Trichophyton, Microsporum, Epidermophyton floccosum; yeast and yeast-like fungi Candida, Pityrosporum.

Indications and usage

Treatment and prevention of mycoses caused by microorganisms sensitive to the drug:
- infections of the mucous membranes of the digestive tract;
- Chronic recurrent vaginal candidiasis in the absence of effect from local therapy;
- pronounced damage to the skin and nails;
- systemic mycoses;
- prevention of fungal lesions in debilitated patients.
For external use
Treatment of fungal skin lesions:
- dermatomycosis of smooth skin;
- inguinal athlete's disease;
- athlete's hand and foot;
- skin candidiasis;
- pityriasis versicolor;
- seborrheic dermatitis caused by Pityrosporum ovale.

Cream with ringworm smooth skin, groin athlete, athlete's hand and foot, skin candidiasis and pityriasis put on the affected and immediately adjacent area 1 time / day.
At seborrheic dermatitis for treatment purposes, the cream is applied to the affected area 1-2 times / day, depending on the severity of the lesion; with maintenance therapy cream is applied 1-2 times a week.
The average duration of treatment when using the cream is: when dermatomycosis smooth skin - 3-4 weeks; at groin athlete - 2-4 weeks; at athlete's disease stop - 4-6 weeks; at candidosis - 2-3 weeks; at pityriasis - 2-3 weeks; at seborrheic dermatitis - 2-4 weeks.

Adverse reactions

Nervous system: headache, dizziness, paresthesia, photophobia, reversible increase in intracranial pressure.
Gastrointestinal: nausea, vomiting, diarrhea; very rarely - a reversible increase in the level of transaminases, hepatitis.
Hemic and lymphatic: thrombocytopenia.
From the reproductive system: gynecomastia, oligospermia, menstrual disorders.
Local reactions: when applying the cream rarely - skin irritation, burning sensation, contact dermatitis.

Contraindications

- hypersensitivity to the drug.
To use tablets:
- severe liver dysfunction;
- simultaneous administration of terfenadine, astemizol, cisapride, triazolam, midazolam, quinidine, pimozide, HMG-CoA reductase inhibitors, digested by the CYP3A4 enzyme (simvastatin, lovastatin).

Pregnancy and breastfeeding

The use of Nizoral in the form of pills during pregnancy and lactation is possible only in the casewhen the intended benefit to the mother outweighs the potential risk to the fetus or child.
The use of the drug in the form of a cream is not contraindicated, because when externally administered, Ketoconazole is practically not absorbed into the systemic circulation.

Special notes

With caution nizoral pills prescribed to women over 50 years of age, patients with liver diseases or allergic reactions to drugs in history, with impaired adrenal function; if necessary, long-term therapy and simultaneous use of hepatotoxic drugs.
During the period of taking the drug, a transient decrease in plasma testosterone levels is possible.
When taking antacid drugs at the same time, they should be taken no earlier than 2 hours after taking Nizoral. Patients with achlorhydria (for example, some AIDS patients) or patients taking drugs that suppress the secretion of hydrochloric acid in the stomach (for example, histamine H blockers₂-receptors or "proton pump inhibitors"), it is desirable to take Nizoral with Coke.
Treatment continues for several days after the disappearance of all symptoms of the disease. If there is no effect after 4 weeks of treatment, the diagnosis should be verified.
To control sources of infection and reinfection during treatment, general hygiene measures should be followed.
Nizoral cream is not used in ophthalmic practice.
When prescribing Nizoral cream to patients who have been using topical GCS for a long time, in order to avoid the syndrome, their use should be continued with subsequent gradual withdrawal within 2-3 weeks.
Control of laboratory parameters
When taking Nisoral in the form of pills for 2 weeks or more, it is necessary to regularly monitor indicators of liver function.

Overdosage

Symptoms: cases of overdose with the use of the drug Nizoral in the form of pills are not described. May increase the described side effects.
When using the cream in excessive amounts, local erythema, swelling and burning sensation are possible, disappearing after discontinuation of the drug.
Treatment: in case of accidental ingestion of a cream or a large number of tablets, gastric lavage should be performed. Conduct symptomatic therapy, special measures are not required.

Drug Interactions

When taken orally, Nizoral is capable of engaging in clinically significant interactions with other drugs.
When used concurrently with Nizoral, rifampicin, rifabutin, Carbamazepine, phenytoin, and isoniazid reduce plasma ketoconazole concentration.
With the simultaneous use of Nizoral and ritonavir increases the bioavailability of ketoconazole.
With simultaneous use of Nizoral, it is possible to increase the concentrations of cyclosporine, indirect anticoagulants, HIV protease inhibitors (indinavir, saquinavir),some anticancer drugs (such as Vinca Pink alkaloids, bisulfan, and docetaxel), Calcium channel blockers that are cleaved by CYP3A4 enzyme (such as dihydropyridine, and possibly verapamil), as well as Digoxin, carbamazepine, buspirone, alfentanil, cephine, and cephine, cefacin, cefate, cefacin, cefacin, alfentanil, cyanafine, alfentanil, methylprednisolone, trimexate in plasma. If necessary, their dose should be reduced.

Storage conditions

Tablets and cream should be stored at a temperature of 15 ° to 30 ° C.