Nizoral

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NIZORAL® (NIZORAL®)

Composition:

Active ingredient: ketoconazole;

1 g of shampoo contains 20 mg of ketoconazole;

Excipients: sodium lauryl ether sulfate, disodium monolauryl ether sulfosuccinate, diethanolamide of coconut fatty acids, collagen animal lauridimonium hydrolysate, polyethylene glycol 120-methylglucose dioleate, sodium chloride, hydrochloric acid concentrated, imidourea, perfume bouquet - 2, sodium hydroxide, sodium erythrosine (E 127), purified water.

Pharmaceutical form. Shampoo.

Main physicochemical properties: viscous transparent pink liquid with a herbal odor.

Pharmacotherapeutic group. Antifungal agents for topical use. Imidazole and triazole derivatives. ATC code D01A C08.

Pharmacological properties.

Pharmacodynamics.

Ketoconazole is a synthetic imidazolodioxolane derivative that exhibits fungicidal and fungistatic activity against dermatophytes such as Trichophyton sp., Epidermophyton sp., Microsporum sp., and yeasts such as Candida sp. and Malassezia furfur (Pityrosporum ovale). Ketoconazole shampoo rapidly reduces scaling and itching commonly associated with dandruff, seborrheic dermatitis, and pityriasis versicolor.

Pharmacokinetics.

After topical application of Nizoral® shampoo, ketoconazole plasma levels are not detectable. Plasma levels following topical application of Nizoral® shampoo were measured after application to the entire body surface.

Clinical characteristics.

Indications.

Treatment and prevention of skin and hair disorders caused by yeast microorganisms Malassezia (previously named Pityrosporum), such as dandruff, pityriasis versicolor (localized), and seborrheic dermatitis.

Contraindications.

Nizoral® shampoo is contraindicated in cases of hypersensitivity to ketoconazole or to any excipient.

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been conducted.

Special precautions for use

To avoid any rebound effect, it is recommended to gradually discontinue corticosteroid therapy over a period of 2–3 weeks when using Nizoral® shampoo in patients who have been receiving prolonged topical corticosteroid treatment.

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Use during pregnancy or breastfeeding

Adequate and well-controlled studies in pregnant and breastfeeding women have not been conducted. Data from a limited number of pregnant women treated with the drug indicate no adverse effects of ketoconazole on pregnancy or on fetal/neonatal health with its topical use. Animal studies have shown reproductive toxicity at doses irrelevant to the topical application of ketoconazole (see section "Pharmacokinetic properties").

After topical application of Nizoral® shampoo to the scalp in non-pregnant women, plasma concentrations of ketoconazole were undetectable. Plasma levels following topical use of Nizoral® shampoo were measured only after application over the entire body surface. There are no known risk factors associated with the use of the drug during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery

Nizoral® shampoo does not affect the ability to drive or operate machinery.

Method of Administration and Dosage.

For topical use only.

Nizoral® shampoo is intended for use by adults and adolescents.

Apply Nizoral® shampoo to affected areas for 3–5 minutes, then rinse thoroughly with water. Usually, the amount of shampoo that fits in the palm of the hand is sufficient for one application.

Treatment:

• Dandruff and seborrheic dermatitis: wash hair twice a week for 2–4 weeks;
• Pityriasis versicolor: daily for 1–5 days.

Prophylaxis:

• Dandruff and seborrheic dermatitis: once a week or once every two weeks.

Children.

Safety and efficacy in newborns and children under 12 years of age have not been established.

Overdose.

In case of accidental ingestion, treatment should consist of supportive and symptomatic measures. Induction of vomiting or gastric lavage is contraindicated to prevent aspiration.

Adverse Reactions

The safety of Nizoral® shampoo was evaluated in 22 clinical studies involving 2890 patients who received topical application of the product to the skin. Based on pooled safety data from these clinical studies, no adverse reactions occurring in ≥1% of patients were reported.

The adverse reactions listed below were observed during clinical studies or post-marketing use of Nizoral® shampoo.

The following frequency categories were used to assess the incidence of adverse reactions: 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), and not known (cannot be estimated from available clinical study data).

Immune system disorders:
Rare – hypersensitivity.

Nervous system disorders:
Rare – dysgeusia.

Infections and infestations:
Uncommon – folliculitis.

Eye disorders:
Uncommon – increased lacrimation; rare – eye irritation.

Skin and subcutaneous tissue disorders:
Uncommon – alopecia, dry skin, change in hair texture, rash, skin burning sensation;
Rare – acne, contact dermatitis, skin disorders, increased skin desquamation;
Not known – urticaria, angioneurotic edema, hair color changes.

General disorders and administration site conditions:
Uncommon – erythema, irritation, pruritus, application site reaction;
Rare – hypersensitivity, pustular eruption at application site.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after medicine authorization is important. It allows continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals are encouraged to report any suspected adverse reactions via the national reporting system.

Shelf life.
3 years.

Storage conditions.
Store at temperatures not exceeding 25 °C. Keep out of reach of children.

Packaging.
25 ml or 60 ml in a polyethylene bottle. One bottle per cardboard box.

7.5 ml in a sachet. Eight sachets per cardboard box.

Prescription status.
Over-the-counter (without prescription).

Manufacturer.

STADA Arzneimittel AG / STADA Arzneimittel AG (batch release);
Janssen Pharmaceutica NV / Janssen Pharmaceutica NV (batch release).

Manufacturer's address and location of operations.

Stadastrasse 2-18, Bad Vilbel, Hessen, 61118, Germany;
Turnhoutseweg 30, Beerse, B-2340, Belgium.