Nizoral - instructions for use, dose, side effects, contraindications

Excipients: macrogol methyldextrose dioleate, imidourea, cocoyl diethanolamide, collagen hydrolyzate, sodium hydroxide, sodium lauryl sulfate, sodium lauryl sulfosuccinate, sodium chloride, hydrochloric acid, flavor, red dye (E 129), water.

Description:Red-orange transparent viscous liquid with a characteristic perfume smell.

Pharmacotherapeutic group:antifungal agent

ATX: & nbsp

J.02.A.B.02 Ketoconazole

D.01.A.C.08 Ketoconazole

Pharmacodynamics:

Ketoconazole, a synthetic derivative of imidazole-dioxolane, has an antifungal effect against dermatophytes such as Trichophyton spp., Epidermophyton spp., Microsporum spp., And yeast such as Candida spp. and Malassezia spp. (Pityrosporum spp.).

NIZORAL® shampoo 2% quickly reduces peeling and itching, which usually accompanies seborrheic dermatitis, dandruff, pityriasis deprive.

Pharmacokinetics:

Concentrations of ketoconazole are not detected in the blood plasma after topical application of NIZORAL® shampoo 2% on the scalp,but determined after local application of shampoo to the whole body at a concentration of 11.2 ng / ml - 33.3 ng / ml. It is unlikely that such concentrations may cause any drug interaction, but it is possible to increase allergic reactions.

Indications:

Treatment and prevention of infections caused by yeast Malassezia spp. (Pityrosporum spp.), Such as pityriasis lichen (local), seborrheic dermatitis and dandruff.

Contraindications:Known hypersensitivity to any of the components of the shampoo.

Pregnancy and lactation:

Studies on pregnant and lactating women were not conducted. There is no evidence that 2% of NIZORAL® shampoo can be dangerous when used in pregnant and lactating women.

Dosing and Administration:

Apply NIZORAL® shampoo 2% to 3-5 minutes for 3-5 minutes, then rinse with water.

Treatment:

- pityriasis lichen: once a day for 5 days;

- seborrheic dermatitis and dandruff: twice a week for 2-4 weeks.

Prevention:

- Pityriasis: once a day for 3 days (one-time course of treatment) before the onset of summer;

- seborrheic dermatitis and dandruff: weekly or 1 time in two weeks.

Side effects:

As with other shampoos, local irritation, itching, or contact dermatitis (due to irritation or an allergic reaction) may occur. Hair can become greasy or dry. However, when using NIZORAL® shampoo 2%, such phenomena are rarely observed.

In some cases, mainly in patients with chemically damaged or gray hair, there was a discoloration of the hair.

Side effects identified during post-marketing studies of NIZORAL® shampoo 2% are listed below.

Classification of the incidence of side effects is provided below: very often (≥ 1/10); often (≥ 1/100, <1/10); infrequently (≥ 1/1000, <1/100); rarely (≥ 1/10 000, <1/1000); very rarely (<1/10 000), including individual messages.

Immune system disorders: very rarely - hypersensitivity, hives.

Disturbances from the skin and subcutaneous tissues: very rarely - alopecia, rash, skin irritation, dry skin.

Overdose:When using shampoo Nizoral 2% development of an overdose is not expected, since the drug is intended only for external use. At casual reception no special measures are required.To prevent aspiration, do not induce vomiting or use gastric lavage.

Special instructions:

When using shampoo, avoid contact with eyes. If shampoo comes into the eyes, rinse them with water.

To prevent withdrawal syndrome with prolonged local treatment with corticosteroids, it is recommended to continue the local use of corticosteroids in combination with Nizoral 2% shampoo followed by the gradual abolition of corticosteroids for 2-3 weeks.

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

Effect on the ability to drive transp. cf. and fur:

Nizoral shampoo does not affect the ability to drive and work with machinery.

Form release / dosage:Shampoo 2%.

Packaging:

For 25, 60 or 120 ml in polyethylene bottles with a screw cap.

Each vial with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N011964 / 02

Date of registration:04.10.2011

The owner of the registration certificate:Johnson & Johnson, LLC Johnson & Johnson, LLC Russia

Manufacturer: & nbsp

JANSSEN PHARMACEUTICA, N.V. Belgium

Representation: & nbspJohnson & Johnson LLC Johnson & Johnson LLC Russia

Information update date: & nbsp12.02.2015

Illustrated instructions

Instructions

Nizoral® (Nizoral®)