Faction

Overdose

Cream; Cream for external use; Medicinal shampoo; Pills; ShampooSubstance; 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.

Faction price

We have no data on the cost of the drug.
However, we will provide data for each active ingredient

Contraindications

Cream; Cream for external use; Medicinal shampoo; Pills; ShampooSubstance; Substance-powder; Vaginal suppository

Known hypersensitivity to ketoconazole or any of the excipients.

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

Incompatibilities

Not applicable

Undesirable effects

Cream; Cream for external use; Medicinal shampoo; Pills; ShampooSubstance; 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 Faction 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 Faction Cream developed a painful allergic reaction.

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

Preclinical safety data

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.

Therapeutic indications

Cream; Cream for external use; Medicinal shampoo; Pills; ShampooSubstance; 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.

Faction 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.

Pharmacotherapeutic group

Imidazole and triazole derivatives

Pharmacodynamic properties

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

Plasma concentrations of ketoconazole were not detectable after topical administration of Faction 2% shampoo on the scalp. Plasma levels were detected after topical administration of Faction 2% shampoo on the whole body.

Name of the medicinal product

Faction

Qualitative and quantitative composition

Ketoconazole

Special warnings and precautions for use

Cream; Cream for external use; Medicinal shampoo; Pills; ShampooSubstance; 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 Faction 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

Faction Cream 2% is not for ophthalmic use.

Faction 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 Faction; these effects have not been seen with topical Faction.

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 Faction 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

Faction 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. Faction should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether Faction 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

Not relevant

Dosage (Posology) and method of administration

Cream; Cream for external use; Medicinal shampoo; Pills; ShampooSubstance; 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 Faction 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: Faction 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.

Special precautions for disposal and other handling

No special requirements