BENZYLBENZOATE-DARNITSA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BENSILBENZOATE-DARNITSA (BENZYLBENZOATE-DARNITSA)

Composition:

Active substance: benzyl benzoate;

1 g of the ointment contains 250 mg of medical benzyl benzoate;

Excipients: cetylpyridinium chloride, propylene glycol, cetostearyl alcohol, purified water.

Pharmaceutical form. Ointment.

Main physicochemical characteristics: white ointment with a specific odor. Should be homogeneous in appearance.

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

Pharmacological properties.

Pharmacodynamics.

Benzylbenzoate-Darnytsia ointment exerts acaricidal activity against various species of mites, including scabies mites (Sarcoptes scabiei) and mites of the genus Demodex, and has anti-pediculosis activity. The medicinal product exhibits bacteriostatic action due to the presence of the antimicrobial preservative cetylpyridinium chloride.

It exerts toxic effects on all types of lice (lice die within 2–5 hours, mites within 7–32 minutes). It penetrates through the chitinous exoskeleton and accumulates within the mite's body at toxic concentrations. It causes death of larvae and adult forms of scabies mites; it has no effect on eggs.

Pharmacokinetics.

When applied topically, benzyl benzoate practically does not enter the systemic circulation.

Clinical characteristics.

Indications.

Treatment of scabies and pediculosis.

Contraindications.

Hypersensitivity to benzyl benzoate or to any other components of the medicinal product. Skin lesions, including purulent skin diseases.

Interaction with other medicinal products and other forms of interaction.

No pharmacological interaction of Benzylbenzoate-Darnitsia ointment with other medicinal products has been identified. However, as with all antiparasitic agents, this medicinal product is not recommended for concomitant use with other topical preparations. 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 Benzylbenzoate-Darnitsia ointment, the use of such medicinal products should be avoided.

Cetylpyridinium chloride, included in the formulation as an antimicrobial preservative and emulsifier, interacts with anionic surfactants, particularly soaps. This interaction may result in loss of the bacteriostatic properties of the medicinal product and its coagulation.

Special precautions for use

Before starting treatment, it is advisable for the patient to take a hot shower to mechanically remove mites from the skin surface and to soften the superficial layer of the epidermis (to facilitate penetration of the medicinal product). Hands must be re-treated after each forced washing. It is mandatory to treat undergarments, bed linen, outer clothing, and headwear.

Avoid contact of the ointment with eyes and mucous membranes. In case of accidental exposure:

• Eyes: thoroughly rinse with water or a 1 % solution of sodium hydrocarbonate; in case of mucous membrane irritation, instill 30 % albucid solution; for pain, instill 2 % novocaine solution;
• Mouth: rinse mouth with water or warm 2 % sodium hydrocarbonate solution;
• Stomach: in case of accidental ingestion, seek immediate medical attention.

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

Treatment of all patients within the same focus, as well as of close contacts, should be carried out simultaneously.

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

Important information about excipients

The medicinal product contains propylene glycol, which may cause skin irritation.

The medicinal product contains cetylstearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).

Use during pregnancy or breastfeeding

There is no data available on the use of this medicinal product during pregnancy; therefore, its use is not recommended in this patient category.

Breastfeeding should be discontinued during treatment.

Ability to influence reaction rate while driving or operating machinery

The medicinal product does not affect the ability to drive or operate machinery.

Method of Administration and Dosage

Apply Benzylbenzoate-Darnytsia ointment topically. Apply 10–15 g of ointment per single application. In children, apply the ointment to all skin areas; in adults, apply to all skin areas except the face and scalp.

When treating scabies, patients should take a hot soap shower prior to applying the medication to remove scales and crusts, thoroughly rinse off the soap, and dry with a towel. Initially, apply the ointment to the palms and hands, then sequentially to all other body parts from top to bottom (do not apply to the face or mucous membranes). Apply the ointment to the feet, soles, and interdigital spaces last. Exercise caution when applying the ointment to areas with delicate skin (inguinal area, genitals, mammary glands), as well as in cases of eczema, dermatitis, or pyoderma; do not rub in.

Hands should not be washed for 3 hours after application. In some cases, after the applied ointment has dried (usually after 1 hour), a second layer of the medication may be applied. After completing the procedure, patients should put on clean underclothes and clothing, and change bed linens. After 24–48 hours, patients should take a shower and again change underclothes and bed linens.

Apply the ointment to the skin 4 times over a period of 2 weeks, with intervals of 3–4 days between applications. The average amount of ointment used per treatment course is 60–90 g.

For the treatment of scabies in children aged 3 to 5 years, Benzylbenzoate-Darnytsia ointment must be diluted immediately before use with warm boiled water (30–35 °C) in a 1:1 ratio and mixed until a homogeneous emulsion is formed. Treatment is usually performed without prior warm bathing, twice with a 12-hour interval.

For the treatment of "Norwegian scabies," prior to applying Benzylbenzoate-Darnytsia ointment, skin surfaces must first be cleared of crusts using keratolytic agents (e.g., Carboderm-Darnytsia® cream containing 10% urea). The duration of the treatment course is determined by the dynamics of skin clearance, resolution of the inflammatory process, and cessation of itching.

For the treatment of pediculosis, apply the medication to the hair and scalp, gently rubbing it into the skin; cover the head with a scarf. After 30 minutes, wash off the medication with running water and rinse the hair with warm 5% vinegar solution. After completing this procedure, wash the hair with soap or shampoo and comb with a fine-toothed comb to remove nits. For pubic pediculosis, rub the ointment into the skin of the pubic area, abdomen, inguinal folds, and inner surfaces of the thighs. Assess treatment effectiveness after 24 hours and repeat the procedure if necessary.

Children

The medication is not recommended for children under 3 years of age.

Overdose

Symptoms

In case of overdose, manifestations of adverse effects may intensify, such as contact dermatitis.

Following accidental ingestion of the ointment or application of a very large amount, possible symptoms include: intensified adverse effects of the medication, contact dermatitis, sudden loss of consciousness, central nervous system stimulation (seizures), and urinary retention.

Treatment

Treatment is symptomatic. The skin must be cleaned of the ointment. If any adverse reaction occurs at the site of application, the medication should be washed off with water and soap.

In case of ingestion, gastric lavage should be performed, followed by administration of activated charcoal. Anticonvulsant agents should be used if necessary.

Side effects.

When applying the medicinal product, a sensation of stinging or burning may occur, which usually disappears with continued use of the ointment. In rare cases, local skin reactions (burning sensation or itching, redness or dryness of the skin area treated with the medicinal product) and allergic reactions including skin rashes and swelling may occur in individuals with sensitive skin. If the aforementioned adverse effects do not resolve spontaneously, use of the medicinal product should be discontinued. Skin sensitivity is particularly increased on damaged skin areas and genitalia. Occasionally, contact dermatitis may occur.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after medicinal product registration is an important procedure. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions through the national reporting system.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Packaging. 30 g in a tube, 1 tube per carton.

Supply category. Over-the-counter.

Manufacturer. JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's location and address of its business activity.

13, Boryspylska Street, Kyiv, 02093, Ukraine.