Oronazol

Oronazol Medicine

Overdose

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.

Oronazol price

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

Contraindications

Known hypersensitivity to ketoconazole or any of the excipients.

Incompatibilities

Not applicable

Pharmaceutical form

Pills

Undesirable effects

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.

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

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.

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 Oronazol 2% shampoo on the scalp. Plasma levels were detected after topical administration of Oronazol 2% shampoo on the whole body.

Qualitative and quantitative composition

Ketoconazole

Special warnings and precautions for use

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 Oronazol 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.

Effects on ability to drive and use machines

Not relevant

Dosage (Posology) and method of administration

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.

Special precautions for disposal and other handling

No special requirements