Instructions Nizoral shampoo 20 mg/g bottle 60 ml
Composition
active ingredient: ketoconazole;
1 g of shampoo contains 20 mg of ketoconazole;
excipients: sodium lauryl ether sulfate, disodium monolauryl ether sulfosuccinate, fatty coconut acid diethanolamide, hydrolyzed lauridimonium animal collagen, macrogol 120-methylglucose dioleate, sodium chloride, concentrated hydrochloric acid, imidourea, perfume bouquet - 2, sodium hydroxide, sodium erythrosine (E 127), purified water.
Dosage form
Shampoo.
Main physicochemical properties: viscous, transparent pink liquid with a herbal odor.
Pharmacotherapeutic group
Antifungal agents for topical use. Imidazole and triazole derivatives. ATX code D01A C08.
Pharmacological properties
Pharmacodynamics
Ketoconazole is a synthetic imidazoledioxolane 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 the flaking and itching often associated with dandruff, seborrheic eczema, and lichen planus.
Pharmacokinetics
Plasma levels of ketoconazole following topical application of Nizoral® Shampoo were not detectable. Plasma levels following topical application of Nizoral® Shampoo were determined after application to the entire body surface.
Indication
Treatment and prevention of skin and hair lesions caused by yeast microorganisms Malassezia (previous name Pityrosporum), such as dandruff, lichen planus (local), seborrheic dermatitis.
Contraindication
Nizoral® shampoo is contraindicated in case of hypersensitivity to ketoconazole or any of the excipients.
Interaction with other medicinal products and other types of interactions
Interaction studies have not been conducted.
Application features
To avoid any adverse effects, it is recommended to gradually discontinue steroid therapy over a period of 2–3 weeks while using Nizoral® shampoo in patients who have been on long-term topical corticosteroid treatment.
Avoid contact with eyes. If shampoo gets into eyes, rinse with water.
Use during pregnancy or breastfeeding
Adequate and well-controlled studies in pregnant and lactating women have not been conducted. Data from studies in a limited number of pregnant women who used the drug indicate no adverse effects of ketoconazole on pregnancy or on the health of the fetus/newborn child when used topically. Animal studies have shown reproductive toxicity at doses not relevant to topical use of ketoconazole (see section "Pharmacokinetic properties").
Plasma concentrations of ketoconazole were not determined after topical application of Nizoral® Shampoo to the scalp in non-pregnant women. Plasma levels after topical application of Nizoral® Shampoo were determined after application to the entire body. There are no known risk factors for use during pregnancy or lactation.
Ability to influence reaction speed when driving vehicles or other mechanisms
Nizoral® shampoo does not affect the ability to drive or operate machinery.
Method of administration and doses
For topical use.
Nizoral® Shampoo is used for adults and adolescents.
Apply Nizoral® shampoo to the affected areas for 3–5 minutes, then rinse with water. Usually, a palm-sized amount of shampoo is enough for one treatment.
Treatment:
dandruff and seborrheic dermatitis: wash hair 2 times a week for 2–4 weeks;
lichen planus: daily for 1–5 days.
Prevention:
dandruff and seborrheic dermatitis: every week or once every two weeks.
Children
Safety and efficacy in neonates and children under 12 years of age have not been established.
Overdose
In case of accidental ingestion, the necessary treatment is supportive and symptomatic. To prevent aspiration, do not induce vomiting or perform gastric lavage.
Side effects
The safety of Nizoral® Shampoo was evaluated in 22 clinical trials involving 2890 patients who received topical application of the product to the skin. Based on the pooled safety data from these clinical trials, no adverse reactions were reported in ≥ 1% of patients.
The following adverse reactions have been observed with Nizoral® shampoo in clinical trials or during post-marketing use.
The following conditional categories were used to assess the frequency 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), unknown (cannot be estimated from available clinical trial data).
On the part of the immune system: rarely - hypersensitivity.
Nervous system: rarely - dysgeusia.
On the part of the organs of vision: infrequently - increased lacrimation; rarely - eye irritation.
Skin and subcutaneous tissue disorders: infrequently - alopecia, dry skin, change in hair structure, rash, burning sensation of the skin; rarely - acne, contact dermatitis, skin changes, increased skin peeling; unknown - urticaria, angioedema, change in hair color.
General disorders and administration site conditions: uncommon - erythema, irritation, itching, application site reaction; rare - hypersensitivity, pustular rash at the application site.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after the approval of a medicinal product is important. This allows for continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Packaging
25 ml or 60 ml in a polyethylene bottle. 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
STADA Arzneimittel AG / STADA Arzneimittel AG (series release);
Janssen Pharmaceutica NV (series release).
Location of the manufacturer and address of its place of business
Stadastrasse 2-18, Bad Vilbel, Hessen, 61118, Germany/ Stadastrasse 2-18, Bad Vilbel, Hessen, 61118, Germany;
Turnhoutseweg 30, Beerse, B-2340, Belgium.
