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Components:
Ketoconazole
Method of action:
Antifungal Broad Spectrum
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Medically reviewed by Militian Inessa Mesropovna, PharmD. Last updated on 2019.12.15

Name of the medicinal product

Ketozal

Qualitative and quantitative composition

Ketoconazole

Therapeutic indications

The information provided in Therapeutic indications of Ketozal is based on data of another medicine with exactly the same composition as the Ketozal of the medicine (Ketoconazole). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Ketozal directly from the package or from the pharmacist at the pharmacy.
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Cream; Cream for external use; Medicinal shampoo; Pills; Shampoo
Substance; Substance-powder; Vaginal suppository

Prevention and treatment of infections in which the yeast Malassezia (previously called Pityrosporum) is likely to be involved, such as dandruff, seborrhoeic dermatitis and tinea (pityriasis) versicolor.

Ketozal Cream 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Ketozal is based on data of another medicine with exactly the same composition as the Ketozal of the medicine (Ketoconazole). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Ketozal directly from the package or from the pharmacist at the pharmacy.
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Cream; Cream for external use; Medicinal shampoo; Pills; Shampoo
Substance; Substance-powder; Vaginal suppository

For topical administration.

Ketoconazole shampoo 2% is for use in adolescents and adults:

Wash affected areas and leave for 3-5 minutes before rinsing.

Treatment:

Dandruff and seborrhoeic dermatitis:

Wash hair twice weekly for 2-4 weeks.

Tinea versicolor:

Once daily for a maximum of 5 days.

Prophylaxis:

Dandruff and seborrhoeic dermatitis:

Use once every 1-2 weeks.

Tinea versicolor:

Once daily for a maximum of 3 days before exposure to sunshine.

Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis and tinea (pityriasis) versicolor: It is recommended that Ketozal Cream 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment. Seborrheic dermatitis: Ketozal Cream 2% should be applied to the affected area twice daily for four weeks or until clinical clearing.

If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.

Contraindications

The information provided in Contraindications of Ketozal is based on data of another medicine with exactly the same composition as the Ketozal of the medicine (Ketoconazole). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Ketozal directly from the package or from the pharmacist at the pharmacy.
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Cream; Cream for external use; Medicinal shampoo; Pills; Shampoo
Substance; Substance-powder; Vaginal suppository

Known hypersensitivity to ketoconazole or any of the excipients.

Ketozal Cream 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Ketozal is based on data of another medicine with exactly the same composition as the Ketozal of the medicine (Ketoconazole). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Ketozal directly from the package or from the pharmacist at the pharmacy.
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Cream; Cream for external use; Medicinal shampoo; Pills; Shampoo
Substance; Substance-powder; Vaginal suppository

In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Ketozal 2% shampoo, to prevent any potential rebound effect.

Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with water.

WARNINGS

Ketozal Cream 2% is not for ophthalmic use.

Ketozal Cream 2% contains sodium sulfite anhydrous, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

PRECAUTIONS

General

If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. Hepatitis (1:10,000 reported incidence) and, at high doses, lowered testosterone and ACTH induced corticosteroid serum levels have been seen with orally administered Ketozal; these effects have not been seen with topical Ketozal.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

A long-term feeding study in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity. The dominant lethal mutation test in male and female mice revealed that single oral doses of Ketozal as high as 80 mg/kg produced no mutation in any stage of germ cell development. The Ames'Salmonella microsomal activator assay was also negative.

Pregnancy

Teratogenic effects : Pregnancy Category C

Ketozal has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day, (10 times the maximum recommended human oral dose). However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels.

There are no adequate and well-controlled studies in pregnant women. Ketozal should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether Ketozal Cream 2% administered topically could result in sufficient systemic absorption to produce detectable quantities in breast milk. Nevertheless, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children have not been established.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Ketozal is based on data of another medicine with exactly the same composition as the Ketozal of the medicine (Ketoconazole). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Ketozal directly from the package or from the pharmacist at the pharmacy.
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Not relevant

Undesirable effects

The information provided in Undesirable effects of Ketozal is based on data of another medicine with exactly the same composition as the Ketozal of the medicine (Ketoconazole). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Ketozal directly from the package or from the pharmacist at the pharmacy.
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Cream; Cream for external use; Medicinal shampoo; Pills; Shampoo
Substance; Substance-powder; Vaginal suppository

The safety of ketoconazole 2% shampoo was evaluated in 2890 subjects who participated in 22 clinical trials. Ketoconazole 2% shampoo was administered topically to the scalp and/or skin. Based on pooled safety data from these clinical trials, there were no ADRs reported with an incidence >1%.

The following table displays ADRs that have been reported with the use of Ketoconazole 2% Shampoo from either clinical trial or postmarketing experiences.

The displayed frequency categories use the following convention:

Very common (>1/10)

Common (>1/100 to <1/10)

Uncommon (>1/1,000 to <1/100)

Rare (>1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated form the available clinical trial data).

System Organ Class

Adverse Drug Reactions

Frequency Category

Uncommon

(>1/1,000 to <1/100)

Rare

(>1/10,000 and <1/1,000)

Not Known

Immune System disorders

Hypersensitvity

Nervous System Disorders

Dysgeusia

Infections and Infestations

Folliculitis

Eye Disorders

Increased lacrimation

Eye irritation

Skin and Subcutaneous Tissue Disorders

Alopecia

Dry skin

Hair texture abnormal

Rash

Skin burning sensation

Acne

Dermatitis contact

Skin disorder

Skin exfoliation

Angioedema

Urticaria

Hair colour changes

General Disorders and Administration Site Conditions

Application site erythema

Application site irritation

Application site pruritus

Application site reaction

Application site hypersensitivity

Application site pustules

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard.

During clinical trials 45 (5.0%) of 905 patients treated with Ketozal Cream 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with Ketozal Cream developed a painful allergic reaction.

In worldwide postmarketing experience, rare reports of contact dermatitis have been associated with Ketozal Cream or one of its excipients, namely sodium sulfite or propylene glycol.

Overdose

The information provided in Overdose of Ketozal is based on data of another medicine with exactly the same composition as the Ketozal of the medicine (Ketoconazole). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Ketozal directly from the package or from the pharmacist at the pharmacy.
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Cream; Cream for external use; Medicinal shampoo; Pills; Shampoo
Substance; Substance-powder; Vaginal suppository

In the event of accidental ingestion, supportive and symptomatic measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.

No information provided.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Ketozal is based on data of another medicine with exactly the same composition as the Ketozal of the medicine (Ketoconazole). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Ketozal directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: Imidazole and triazole derivatives

ATC Code: D01AC08

Ketoconazole is an imidazole-dioxolane antimycotic, active against yeasts, including Malassezia and dermatophytes. Its broad spectrum of activity is already well known.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Ketozal is based on data of another medicine with exactly the same composition as the Ketozal of the medicine (Ketoconazole). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Ketozal directly from the package or from the pharmacist at the pharmacy.
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Plasma concentrations of ketoconazole were not detectable after topical administration of Ketozal 2% shampoo on the scalp. Plasma levels were detected after topical administration of Ketozal 2% shampoo on the whole body.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Ketozal is based on data of another medicine with exactly the same composition as the Ketozal of the medicine (Ketoconazole). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Ketozal directly from the package or from the pharmacist at the pharmacy.
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Imidazole and triazole derivatives

Preclinical safety data

The information provided in Preclinical safety data of Ketozal is based on data of another medicine with exactly the same composition as the Ketozal of the medicine (Ketoconazole). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Ketozal directly from the package or from the pharmacist at the pharmacy.
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Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

Incompatibilities

The information provided in Incompatibilities of Ketozal is based on data of another medicine with exactly the same composition as the Ketozal of the medicine (Ketoconazole). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Ketozal directly from the package or from the pharmacist at the pharmacy.
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Not applicable

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Ketozal is based on data of another medicine with exactly the same composition as the Ketozal of the medicine (Ketoconazole). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Ketozal directly from the package or from the pharmacist at the pharmacy.
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