Instructions Keto Plus shampoo bottle 60 ml
Composition
active ingredients: ketoconazole, zinc pyrithione;
100 ml of shampoo contains ketoconazole 2 g, zinc pyrithione 1 g (in the form of a 48% suspension);
excipients: aluminum-magnesium silicate, propylene glycol, hydroxypropylmethylcellulose, colloidal anhydrous silicon dioxide, imidourea, concentrated hydrochloric acid, Swiss Bouquet fragrance RZ043, carmoisine dye (E 122), purified water, pearlescent homogeneous shampoo base.
Dosage form
Shampoo.
Main physicochemical properties: viscous pink shampoo with a pleasant smell.
Pharmacotherapeutic group
Antifungal drugs for topical use. ATX code D01A C.
Pharmacological properties
Pharmacodynamics
The pharmacological properties of the shampoo are due to the properties of the active substances included in its composition: ketoconazole and zinc pyrithione. Ketoconazole is an antifungal drug from the group of imidazole derivatives. It has a fungistatic and fungicidal effect by inhibiting the biosynthesis of an important component of fungal membranes, ergosterol, which leads to changes in the lipid composition of the membranes and cell destruction. Active against dermatophytes of the genus Trichophyton, Microsporum, Epidermophyton floccosum; yeast and yeast-like fungi of the genus Candida, Malassezia furfur and Pityrosporum ovale. Zinc pyrithione inhibits the growth of a number of gram-positive and gram-negative bacteria, certain types of fungi. Zinc pyrithione causes the anti-seborrheic effect of the drug and acts against dandruff. Ketoconazole shampoo reduces flaking and itching, which is often associated with dandruff, seborrheic dermatitis and lichen planus.
Pharmacokinetics
Special studies of the pharmacokinetics of the shampoo have not been conducted, but it is known that ketoconazole and zinc pyrithione are almost not absorbed into the systemic bloodstream when applied externally and do not have a systemic effect.
Indication
Treatment and prevention of fungal diseases of the scalp, accompanied by peeling and itching of the skin, such as:
dandruff;
seborrheic dermatitis;
Localized tinea versicolor of the scalp.
Contraindication
Hypersensitivity to ketoconazole, zinc pyrithione or any other component of the drug.
Interaction with other medicinal products and other types of interactions
When prescribing shampoo to patients who have been treated with topical glucocorticosteroids for a long time, treatment with the latter should be continued and discontinued gradually over 2-3 weeks (to avoid withdrawal syndrome).
Given the lack of significant systemic absorption, interactions with other drugs are unlikely.
It is not recommended to use simultaneously with dermatological preparations containing glucocorticosteroids.
Application features
The drug is intended for external use only.
When using the drug, avoid contact with eyes and mucous membranes.
If the drug gets into your eyes, rinse them thoroughly with water.
Seborrheic dermatitis and dandruff are often accompanied by increased hair loss, which can in some cases continue for some time even at the beginning of shampoo use.
The product contains propylene glycol, which may cause skin reactions, and the dye carmoisine (E 122), which may cause allergic reactions.
Use during pregnancy or breastfeeding
During pregnancy or breastfeeding, the drug can be used only in cases where the expected benefit to the mother outweighs the potential risk to the fetus/child.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Method of administration and doses
The shampoo should be shaken well before use.
Apply the shampoo to wet hair and scalp for 3-5 minutes, then rinse with water. In the treatment of dandruff and seborrheic dermatitis, the shampoo should be used 2 times a week for 2-4 weeks, in the treatment of lichen planus - daily for 5 days.
To prevent dandruff and seborrheic dermatitis, use the shampoo once a week or once every 2 weeks. To prevent lichen planus – once a day for 3 days before the start of the summer season (a single course of treatment).
Children
There is no experience with the use of the drug in children.
Overdose
Since the shampoo is intended for external use only and ketoconazole is almost not absorbed into the systemic bloodstream, the development of overdose symptoms is unlikely. In case of accidental ingestion of shampoo, only supportive and symptomatic measures should be used. It is forbidden to induce vomiting and perform gastric lavage to prevent aspiration.
Side effects
On the part of the skin appendages: folliculitis, change in hair structure, increased dryness or oiliness of hair, hair loss (alopecia), change in hair color (usually in patients with chemically damaged or gray hair), discoloration of nails. There are known cases of straightening of hair, which is naturally curly.
From the nervous system and sensory organs: eye irritation, eyelid swelling, increased lacrimation, taste disturbance (dysgeusia), paresthesia, peripheral neuritis.
Immune system disorders: hypersensitivity reactions, including anaphylactoid reactions, angioedema.
Infections and infestations: folliculitis.
Expiration date
2 years.
Storage conditions
Store in a place protected from light at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
60 ml or 150 ml of shampoo in a bottle; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
Glenmark Pharmaceuticals Ltd./Glenmark Pharmaceuticals Ltd.
Address
Plot No. E-37/39, MIDC, Industrial Estate, Satpur, Nasik – 422 007, India.
