Benzyl benzoate

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT BENZYL BENZOATE (BENZYLBENZOATE)

Composition:

Active substance: benzyl benzoate;

1 g of emulsion contains benzyl benzoate 200 mg;

Excipients: emulsifier No. 1, purified water.

Pharmaceutical form. Topical emulsion.

Main physicochemical properties: white emulsion with a weak specific odor. Layering of the emulsion may occur, which is eliminated upon shaking.

Pharmacotherapeutic group. Agents acting on ectoparasites, including scabies mites. ATC code P03AX01.

Pharmacological properties.

Pharmacodynamics. Benzyl benzoate is an agent with pediculicidal activity and acaricidal action against various species of mites, including scabies mites (Acarus scabiei).

Benzyl benzoate penetrates through the chitinous covering of ectoparasites, accumulates in their bodies at toxic concentrations, causing death of adult individuals and larvae; it has no effect on eggs.

Death of lice occurs within 2–5 hours, mites – within 7–32 minutes.

Pharmacokinetics. When applied to the skin, benzyl benzoate penetrates into the upper layers of the epidermis; it is not absorbed into the systemic circulation.

Clinical characteristics.

Indications. Scabies, demodicosis, pediculosis.

Contraindications. Hypersensitivity to the components of the drug, purulent skin diseases, and skin lesions.

Interaction with other medicinal products and other forms of interaction. No pharmacological interactions of benzyl benzoate with other drugs have been identified; however, as with all antiparasitic agents, concomitant use with other topical medicinal products is not recommended. Local or systemic use of corticosteroids may lead to the disappearance or reduction of certain symptoms (pruritus, hyperemia) while the infestation persists; therefore, during treatment with benzyl benzoate, the use of such agents should be avoided.

Special precautions.

Avoid contact of the drug with eyes and mucous membranes.

When handling the drug, personal hygiene rules must be observed; smoking, consumption of alcoholic beverages, and eating are prohibited.

In case of accidental exposure:

• into the mouth: rinse thoroughly with water or warm 2 % sodium hydrocarbonate solution;
• into the stomach: in case of accidental ingestion, seek immediate medical attention;
• into the eyes: thoroughly rinse with water or 1 % sodium hydrocarbonate solution; in case of mucous membrane irritation, instill 30 % albucid solution, and in case of pain – 2 % novocaine solution.

After completion of treatment course, medical supervision is required for 2 weeks (and longer if complications occur).

Treatment of patients within the same focus, as well as of contact persons, should be carried out simultaneously.

Complications such as pyoderma or eczema should be treated concurrently with scabies and continued after its elimination.

Before initiating scabies treatment, it is advisable for the patient to take a shower to mechanically remove mites from the skin surface and to soften the superficial layer of the epidermis (to facilitate drug penetration). After each necessary hand washing, hands must be re-treated. It is mandatory to treat undergarments, bed linen, outer clothing, and headwear.

Use during pregnancy or breastfeeding. The medicinal product is contraindicated during pregnancy.

If it is necessary to use the drug, breastfeeding should be discontinued during the treatment period.

Ability to influence reaction rate when driving or operating machinery. Treatment with this drug does not affect reaction speed when driving or operating machinery.

Method of Administration and Dosage.

Apply externally, locally. Shake the preparation well before use. For use in children aged 3 to 5 years, dilute the preparation with boiled water in a 1:1 ratio.

Scabies. To prevent secondary infestation, simultaneous treatment of all household members and close contacts is required.

Before application, take a shower. Apply the emulsion (a brush or applicator may be used) to the entire body, excluding the face and hairy areas of the head. Pay special attention to the wrists, hands, armpits, buttocks, groin area, under the nails, spaces between fingers and toes, and soles of the feet. Allow the emulsion to dry (usually 10 minutes in a warm room). After the emulsion has dried, put on clean clothes and change bed linen. Do not wash hands for 3 hours after treatment.

With careful application of the emulsion, a single treatment of the skin is usually sufficient. However, repeating the treatment over the next 5 days reduces the likelihood of residual infestation.

An alternative treatment method involves applying the emulsion to the entire body, excluding the face and hairy areas of the head, 3 times at 12-hour intervals. Twelve hours after the last application, take a hot shower and change underclothes and bed linen.

Demodicosis. Apply the preparation in the evening. Wash the face with warm water and soap, then apply the preparation in a thin layer to the facial skin, avoiding contact with eyes, nose, and mouth. In the morning, wash the face with warm water and soap. The duration of treatment depends on the dynamics of skin clearance, resolution of inflammation, and cessation of itching, and usually lasts 2–3 weeks.

Pediculosis. Apply the preparation to the affected area, gently rubbing it into the skin and hair; cover the head with a scarf. After 30 minutes, wash off with soap. In severe cases, repeat the procedure 2–3 times. Treatment efficacy should be assessed one week after the last application.

Children. Contraindicated in children under 3 years of age. For use in children aged 3 to 5 years, dilute the preparation with boiled water in a 1:1 ratio.

Overdose. Accidental ingestion or application of a very large amount may result in: increased side effects of the drug, difficulty in urination, contact dermatitis, sudden loss of consciousness, and seizures in children.

Treatment: symptomatic therapy.

The skin must be cleaned of the emulsion. If any adverse reaction occurs at the site of application, wash the area thoroughly with water and soap.

In case of ingestion, perform gastric lavage; treatment is symptomatic. If necessary, administer anticonvulsant agents.

Side effects.

Possible mild skin irritation, skin redness, sensation of short-term burning, itching, dryness of the skin area treated with the medication, allergic reactions (including skin rash, swelling). Skin sensitivity was particularly increased on damaged areas and genitalia. Occasionally, contact dermatitis may occur.

If pronounced adverse effects develop, the medication should be immediately washed off with soap and use discontinued.

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 50 g in a bottle in a box; 50 g or 100 g in bottles.

Availability. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVOYA".

Manufacturer's address and place of business. Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenko Street, building 22.