Canesten^® (Cream) Instructions for Use

Marketing Authorization Holder

Bayer HealthCare AG (Germany)

Manufactured By

Troponwerke GmbH (Germany)

ATC Code

D01AC01 (Clotrimazole)

Active Substance

Clotrimazole (Rec.INN registered by WHO)

Dosage Forms

	Canesten®	Cream for external use 1%: 20 g tube
		Spray for external use 1%: 30 ml bottle with dosing device

Dosage Form, Packaging, and Composition

Cream for external use 1% homogeneous, white in color.

Excipients: benzyl alcohol, cetyl palmitate, cetearyl alcohol, purified water, 2-octyldodecanol, polysorbate 60, sorbitan stearate.

20 g – aluminum tubes (1) – cardboard packs.

Spray for external use 1% in the form of a transparent solution from colorless to slightly yellowish.

Excipients: isopropyl myristate, macrogol 400, isopropanol.

30 ml – polyethylene bottles with a dosing device (1) – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Antifungal drug. Clotrimazole, the active substance of Canesten^® spray, is an imidazole derivative and has a broad spectrum of antifungal action.

The mechanism of action of clotrimazole is associated with the inhibition of ergosterol synthesis, which leads to disruption of the structure and functions of the fungal cytoplasmic membrane.

It has fungistatic or fungicidal activity depending on the concentration at the site of infection.

Canesten^® is active against dermatophytes, yeasts, molds, as well as the causative agents of pityriasis versicolor (Pityriasis vers.) and the causative agent of erythrasma.

In addition to its antifungal action, Canesten^® has an antimicrobial effect against Trichomonas vaginalis, gram-positive (streptococci, staphylococci) and gram-negative microorganisms (Bacteroides, Gardnerella vaginalis).

In vitro at concentrations of 0.5-10 µg/ml, Clotrimazole suppresses the reproduction of bacteria of the Corynebacteria family and gram-positive cocci (except for enterococci) and has a trichomonacidal effect at a concentration of 100 µg/ml.

Primarily resistant strains of fungi sensitive to clotrimazole are very rare; the development of secondary resistance is observed only in isolated cases and only under certain therapeutic conditions.

Pharmacokinetics

Clotrimazole is practically not absorbed through intact and inflamed skin.

The resulting peak plasma concentrations of clotrimazole are below 0.001 µg/ml, which confirms the fact that Clotrimazole, when applied topically to the skin, does not lead to significant systemic or side effects.

Indications

Fungal diseases of the skin and mucous membranes caused by dermatophytes, yeasts, molds, as well as pathogens sensitive to clotrimazole

• Mycoses of the feet, hands, trunk, skin folds;
• Pityriasis versicolor, erythrasma.

ICD codes

Dosage Regimen

Apply externally.

Spray Canesten^® in a thin layer onto the affected areas of the skin 2 times/day.

The duration of therapy is individual and depends on the severity and localization of the disease.

To achieve complete recovery, treatment with the cream should not be stopped immediately after the acute symptoms of inflammation or subjective complaints disappear.

The duration of therapy should be on average about 4 weeks.

Dermatomycoses are cured, mainly, within 3-4 weeks, erythrasma – 2-4 weeks, pityriasis versicolor – 1-3 weeks.

For fungal diseases of the skin of the feet, it is recommended to continue therapy for about 2 weeks after the symptoms of the disease have subsided.

Adverse Reactions

Body as a whole: allergic reactions; pain.

Skin: local reactions in the form of itching, rash.

Contraindications

• Hypersensitivity to clotrimazole or other components of the drug.

With caution first trimester of pregnancy and lactation period.

Use in Pregnancy and Lactation

Although it has not been established that Canesten^® spray has a negative effect on the body of the mother and fetus during pregnancy and lactation, nevertheless, in the first 3 months of pregnancy, the drug can be used only after consultation with a doctor.

Special Precautions

Effect on ability to drive vehicles and mechanisms

Not observed.

Overdose

Use of the spray in increased doses does not cause any life-threatening reactions.

Drug Interactions

Interactions with other drugs have not been identified.

Storage Conditions

Store at a temperature not exceeding 25°C (77°F), in a place inaccessible to children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

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.