Parasidose (Shampoo) Instructions for Use

Marketing Authorization Holder

Laboratoires Gilbert (France)

ATC Code

P03AC03 (Phenothrin)

Active Substance

Phenothrin (Rec.INN registered by WHO)

Dosage Form

Parasidose

Shampoo 0.2%: 100 ml bottle

Dosage Form, Packaging, and Composition

100 ml – plastic bottles.

Clinical-Pharmacological Group

Drug for the treatment of pediculosis

Pharmacotherapeutic Group

Ectoparasiticide

Pharmacological Action

An anti-pediculosis agent from the pyrethroid insecticide group. It has a neurotoxic effect on adult individuals and larvae.

The mechanism of action is associated with the disruption of cation exchange in the membranes of insect nerve cells.

Indications

• Treatment of head lice infestation (pediculosis capitis).

Apply for eradication of adult lice and their nits (eggs) on the scalp and hair in affected individuals.

Use in both adult and pediatric populations aged 2.5 years and older following confirmed diagnosis.

ICD codes

Dosage Regimen

Apply the shampoo twice with a strict 24-hour interval between applications to ensure eradication of newly hatched larvae.

Apply a sufficient amount to thoroughly wet the entire scalp and hair. Massage vigorously into the hair and scalp until a rich lather forms. Reapply shampoo and leave on for exactly 5 minutes.

Rinse hair thoroughly with warm water. Use a fine-toothed comb ( nit comb) to remove all dead lice and nits.

Adverse Reactions

Localized allergic reactions, including skin rash, pruritus, and erythema, may occur at the application site.

Transient scalp irritation, tingling, or burning sensation is possible. Discontinue use immediately if severe irritation or signs of hypersensitivity develop.

Drug Interactions

No specific drug interactions are currently known. Avoid concurrent use with other topical pediculicides or medicated shampoos unless directed by a physician.

Do not apply other hair care products (e.g., conditioners, oils) immediately before treatment as they may create a barrier and reduce efficacy.

Contraindications

• Known hypersensitivity to phenothrin, any other pyrethroid, or any component of the shampoo formulation.

• Patients with a history of severe allergic reactions (e.g., contact dermatitis) to similar insecticidal agents.

• Children under 2.5 years of age due to insufficient safety and efficacy data in this age group.

Overdose

Excessive topical application may lead to intensified adverse effects, including severe skin irritation. Ingestion is hazardous and requires immediate medical attention.

Symptoms of ingestion may include nausea, vomiting, abdominal pain, and neurological excitation. Provide symptomatic and supportive care; there is no specific antidote.

Pediatric Use

Contraindicated for use in children under 2.5 years of age.

Special Precautions

Avoid contact of the product with eyes and mucous membranes.

Phenothrin may be used for disinsection of premises.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.