Nizoral, medicated shampoo 2% 120 ml

Pharmacodynamics

Ketoconazole, a synthetic imidazole-dioxolane derivative, has antifungal action against dermatophytes such as Trichophyton sp, Epider-mophyton sp., Microsporum sp., and yeasts such as Candida sp. and Malassezia furfur (Pityrosporum ovale).

Ketoconazole shampoo quickly reduces the flaking and itching usually associated with dandruff, seborrheic eczema and pityriasis.

Pharmacokinetics

Ketoconazole absorption through the skin when used topically is negligible.

Since even with long-term use ketoconazole content in blood is not determined, we can conclude that the drug has no systemic action.

Indications

Treatment and prevention of skin lesions caused by yeast-like microorganisms Malassezia furfur (Pityrosporum ovale), such as dandruff and pityriasis versicolor (local).

Pharmacological effect

Pharmacodynamics

Ketoconazole, a synthetic derivative of imidazole-dioxolane, has antifungal activity against dermatophytes such as Trichophyton sp., Epidermophyton sp., Microsporum sp., and yeasts such as Candida sp. and Malassezia furfur (Pityrosporum ovale).

Ketoconazole shampoo quickly reduces the flaking and itching commonly associated with dandruff, seborrheic eczema and pityriasis versicolor.

Pharmacokinetics

Absorption of ketoconazole through the skin when applied topically is negligible.

Since the level of ketoconazole in the blood cannot be determined even with long-term use, we can conclude that the drug does not have a systemic effect.

Special instructions

When using shampoo, avoid getting it into your eyes. If shampoo gets into your eyes, rinse them with water.

To prevent withdrawal syndrome during long-term topical treatment with corticosteroids, it is recommended to continue topical use of corticosteroids in combination with Nizoral 2% shampoo, followed by gradual withdrawal of corticosteroids over 2-3 weeks.

Seborrheic dermatitis and dandruff are often accompanied by increased hair loss. In rare cases, increased hair loss was observed when using Nizoral 2% shampoo.

Active ingredient

Ketoconazole

Composition

Active substance:

Ketoconazole, 21 mg/g (including 5% excess).

Excipients:

Macrogol methyldextrose dioleate,

Imidourea,

Cocoyl diethanolamide,

Collagen hydrolyzate,

Sodium hydroxide,

Sodium lauryl sulfate,

Sodium lauryl sulfosuccinate,

Sodium chloride,

hydrochloric acid,

Flavoring,

Charming red dye (E 129),

Water.

Contraindications

Hypersensitivity to any of the components of the shampoo.

Side Effects

Nizoral 2% shampoo is generally well tolerated.

As with other shampoos, local irritation, itching or contact dermatitis (due to irritation or an allergic reaction) may occur. Hair may become greasy or dry.

However, when using Nizoral 2% shampoo, such phenomena are rarely observed.

In isolated cases, mostly in patients with chemically damaged or gray hair, changes in hair color have been reported.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Manufacturer

Janssen Pharmaceuticals N.V., Belgium