Benzylbenzoate emulsion

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT BENZYL BENZOATE EMULSION

Composition:

Active substance: benzyl benzoate;

1 g of the preparation contains benzyl benzoate 200 mg;

Excipients: household soap, emulsifier T-2, purified water.

Pharmaceutical form. Cutaneous emulsion.

Main physicochemical properties: white emulsion with a weak specific odor, which froths when shaken. Stratification 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.

The drug exerts pediculicidal and acaricidal effects against various species of mites, including scabies mites (Sarcoptes scabiei). It penetrates through the chitinous cuticle and accumulates in the ectoparasite's body at toxic concentrations, leading to death of both larvae and adult forms; however, it has no effect on eggs. Death of lice occurs within 2–5 hours, mites – within 7–32 minutes.

Pharmacokinetics.

The drug penetrates into the upper layers of the epidermis and is not absorbed into the systemic circulation.

Clinical characteristics.

Indications.

Pediculosis, scabies, demodicosis.

Contraindications.

Hypersensitivity to the components of the drug. Pyogenic skin diseases and skin injuries.

Safety precautions.

Avoid contact of the drug with eyes and mucous membranes.

During treatment, personal hygiene rules must be observed; smoking, consumption of alcoholic beverages, and eating are prohibited.

In case of accidental exposure:

• into the mouth: rinse mouth with water or warm 2% sodium bicarbonate solution;
• into the stomach: in case of accidental ingestion, seek immediate medical attention;
• into the eyes: thoroughly rinse with water or 1% sodium bicarbonate solution; if irritation of the eye mucosa occurs, instill 30% albucid solution; in case of pain, instill 2% novocaine solution.

After completion of the treatment course, medical monitoring 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.

Interaction with other medicinal products and other forms of interaction.

Data not available.

Special precautions.

Use during pregnancy or breastfeeding. The use of the drug during pregnancy is contraindicated. Breastfeeding should be discontinued during treatment.

Ability to affect reaction speed when driving or operating machinery. Unknown.

Method of Administration and Dosage

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

Treatment of Pediculosis.
Apply the preparation externally, locally (shake well before use). Soak a cotton or gauze pad with the emulsion and apply it to the scalp or hairy parts of the body, gently rubbing it into the skin. Cover the head with a scarf. After 10 minutes of treatment in case of pubic pediculosis, or after 30 minutes in case of head pediculosis, wash off the preparation with running water. When rinsing from the head, avoid contact with the facial skin. After rinsing, soak the scarf in warm 5% vinegar solution (mix one glass of vinegar with an equal amount of water heated to 50°C), wring it out slightly, and wrap it around the head for 1 hour. This helps loosen nits from the hair. After this procedure, wash the hair with soap or shampoo, comb thoroughly with a fine-toothed comb, and remove dead lice and nits. The effectiveness of anti-pediculosis treatment should be assessed after 1 hour or 24 hours. If nits remain, repeat treatment using only 5% vinegar solution.

Treatment of Scabies.
To prevent secondary infestation, all household members and close contacts must be treated simultaneously.

Before applying the emulsion, take a shower. Apply the emulsion (can be applied with a brush) to the entire body, excluding the face and scalp. Pay special attention to the wrists, hands, armpits, buttocks, groin area, under the nails, between the fingers and toes, and the soles of the feet. Allow the emulsion to dry (usually about 10 minutes in a warm room). After the emulsion has dried, put on clean clothing and change bed linen. Do not wash hands for 3 hours after application.

With careful application, a single treatment is usually sufficient. However, repeating the treatment within the following 5 days reduces the risk of residual infestation.

An alternative treatment method involves applying the emulsion to the entire body (except face and scalp) three times at 12-hour intervals. Twelve hours after the last application, take a hot shower and change underclothing and bed linen.

Treatment of 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.

Children.
The preparation is not recommended for children under 3 years of age. For children aged 3 to 5 years, dilute the preparation with boiled water in a 1:1 ratio.

Overdose.

Possible exacerbation of adverse effects, difficulty in urination, contact dermatitis, sudden loss of consciousness, and in children – seizures.

Treatment: symptomatic therapy.

Side effects.

Possible mild skin irritation, skin redness, transient burning sensation, itching, dryness of the skin area treated with the product, allergic reactions (including skin rash, swelling).

If pronounced adverse effects develop, the product should be immediately washed off with soap.

Shelf life. 3 years.

After first opening of the bottle, the product is suitable for use for 7 days.

Storage conditions.

Store at a temperature not exceeding 25 ºC, in a place inaccessible to children.

Packaging. 50 g in a bottle.

Availability. Over-the-counter (without prescription).

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of business activity.

4 Korolyova St., Stanishivka, Zhytomyr region, Zhytomyr district, 12430, Ukraine.