Permethrin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PERMETHRIN

Composition:

Active substance: permethrin;

1 g of the medicinal product contains 5 mg of permethrin;

Excipients: ethanol (96%), etonyl, benzalkonium chloride, purified water.

Pharmaceutical form. Topical solution.

Main physicochemical properties: clear, colorless or slightly yellow liquid with a characteristic alcoholic odor.

Pharmacotherapeutic group. Agents against ectoparasites, including agents against scabies mites, insecticides and repellents. Pyrethrins, including synthetic compounds. Permethrin.

ATC Code P03AC04.

Pharmacological Properties

Pharmacodynamics

A contact-acting insecticide belonging to the group of synthetic pyrethroids. Has pediculicidal activity and exerts a lethal effect on nits, larvae, and adult forms of head and pubic lice. Disrupts the permeability of sodium channels in the nerve cell membranes of insects, inhibits the process of polarization (repolarization) of nerve cells, leading to a paralyzing effect.

Pharmacokinetics

When applied topically, less than 2% of the dose of permethrin is absorbed. Permethrin is highly lipophilic, and its toxicity is increased by organic solvents. According to animal studies, permethrin is metabolized in the liver by conjugation with glucuronides, glycine, and sulfates. The half-life is several hours. Permethrin is rapidly hydrolyzed into inactive metabolites and is excreted predominantly in the urine.

Clinical characteristics.

Indications.

Pediculosis (head, pubic).

Contraindications.

Hypersensitivity to permethrin and to excipients of the medicinal product.

Hypersensitivity to plants of the chrysanthemum genus or to other plants of the Compositae family.

Impaired skin integrity, inflammatory processes, and secondary skin infections.

Pregnancy or breastfeeding. Children under 3 years of age.

Permethrin is not recommended for patients with bronchial asthma, obstructive bronchitis, including in medical history, due to the risk of bronchospasm upon inhalation of the medicinal product.

Interaction with other medicinal products and other types of interactions.

Not established.

Instructions for use.

Before using the medicinal product, consult a physician, as there is cross-sensitivity between synthetic pyrethroids such as permethrin.

Healthcare personnel handling Permethrin should use protective gloves. Permethrin should be applied externally only.

Apply in a well-ventilated room or outdoors. During application, avoid contact of Permethrin with mucous membranes of the eyes, nose, oral cavity, and urogenital organs. In case of accidental contact with mucous membranes, rinse thoroughly with large amounts of water. After application, wash hands thoroughly with soap and rinse mouth with running water.

To prevent reinfestation, all family members should be examined for parasites, and clothing, headwear, scarves, bed linen, combs, and hair of individuals who had contact with the infected person should be disinfected and treated.

Use during pregnancy or breastfeeding.

Studies on the safety of Permethrin use during pregnancy or breastfeeding have not been conducted; therefore, the medicinal product should not be used during these periods.

Effect on the ability to drive or operate machinery.

Not established.

Method of Administration and Dosage.

Topical use. Thoroughly wet the hair with the solution using a cotton swab, rubbing the medicinal agent into the hair roots. After application, leave Permethrin on the hair for 10–40 minutes (the head may be covered with a scarf), then rinse thoroughly with warm running water using soap or shampoo and dry in the usual manner. After washing, comb the hair with a fine-toothed comb to remove dead parasites; if live lice are detected, repeat the treatment before the next hair washing or after 7 days.

The amount of Permethrin required depends on hair density and length — from 10 ml to 60 ml.

For pubic pediculosis, generously wet the hairy area of the pubic region with the undiluted solution using a cotton swab. After 30 minutes, wash the treated areas with soap and thoroughly rinse with water.

Children.

Do not use in children under 3 years of age.

Overdose.

In case of overdose, symptoms described in the section "Adverse Reactions" may be intensified. In case of overdose, discontinue use of Permethrin, wash the skin thoroughly with large amounts of warm water, and antihistamines may be used. In case of poisoning due to inhalation of Permethrin vapors, treatment should begin with moving the patient to fresh air. If Permethrin gets into the eyes or onto the skin, the affected areas must be rinsed with sufficient amounts of water.

In case of accidental ingestion of Permethrin, spontaneous vomiting is highly likely; therefore, further use of emetics is not recommended due to the risk of rapid development of seizures and coma. Absorption of Permethrin can be prevented by gastric lavage and administration of activated charcoal or a laxative. Treatment is primarily supportive and includes monitoring the patient for signs of allergic reactions.

Side effects.

Immune system: allergic reactions, including skin rashes and swelling.

Local effects: burning sensation, tingling or stinging, skin numbness, increased itching, erythema, pain, eczema.

Shelf life. 3 years.

Storage conditions.

Keep out of reach of children. Store at a temperature not exceeding 25 °C.

Protect from falls, impacts, and exposure to direct sunlight.

Packaging.

50 g in a bottle; 1 bottle per carton.

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

Manufacturer. JSC "STOMA".

Manufacturer's address and place of business.

3 Newton Street, Kharkiv, 61105, Ukraine