Spray-Pax (Spray) Instructions for Use

Marketing Authorization Holder

Pharmygiene-Scat Laboratories (France)

ATC Code

P03AC51 (Pyrethrum in combination with other drugs)

Active Substances

Pyrethrum extract (USP Pharmacopoeia)

Piperonyl butoxide (BAN British Approved Name)

Dosage Form

Spray-Pax

External use spray 8 g: 1 pc. canister

Dosage Form, Packaging, and Composition

Excipients : isododecane.

8 g – aluminum aerosol cans (1) – cardboard packs.

Clinical-Pharmacological Group

Drug for the treatment of pubic lice

Pharmacotherapeutic Group

Ectoparasiticide

Pharmacological Action

A combined drug for the treatment of pubic lice. The pyrethrins that are part of the drug are a neurotoxic poison for insects; their mechanism of action is to disrupt the cation exchange of the membranes of insect nerve cells.

Piperonyl butoxide acts as a synergist of pyrethrin because it blocks detoxification enzymes secreted by insects.

Pharmacokinetics

Studies have not been conducted because the drug is intended for topical application and its exposure is short-term.

Indications

• Treatment of pubic lice.

ICD codes

Dosage Regimen

Apply the spray with short bursts to the entire pubic hair area until it is thoroughly moistened.

Leave the preparation on the skin for exactly 30 minutes to ensure complete eradication of lice and nits.

After the exposure time, wash the treated areas thoroughly with soap and rinse with copious amounts of water. A single application is typically sufficient for complete treatment.

Adverse Reactions

Adverse reactions are infrequent and generally mild in nature.

Transient skin irritation, such as localized redness, itching, or a burning sensation, may occur at the application site. These effects are usually self-limiting and resolve without intervention.

Drug Interactions

No specific drug interactions have been identified or reported for this topical ectoparasiticide.

Due to the localized application and minimal systemic absorption, the potential for pharmacokinetic interactions with concurrently administered systemic medications is considered negligible.

Contraindications

• Hypersensitivity to the components of the drug.

Overdose

No cases of overdose have been reported with this product. Excessive topical application may increase the risk of local adverse skin reactions, such as irritation.

In case of accidental ingestion, which is unlikely due to the formulation, seek immediate medical attention and provide symptomatic and supportive care as there is no specific antidote.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and lactation (breastfeeding) is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or child.

Special Precautions

It is recommended to simultaneously treat sexual partners. One can of Spray-Pax is enough to treat two people.

Simultaneously with the use of the drug Spray-Pax, it is necessary to disinfect underwear and bed linen with the drug A-PAR.

Avoid getting the drug in the eyes and on the mucous membranes. In case of contact with eyes, rinse them thoroughly with water.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

The can is under pressure: protect from sunlight and do not expose to temperatures above 50°C (122°F). Do not puncture or incinerate, even after use. Do not spray on an open flame or a hot object.

Use and store away from fire, heat sources, and switched-on electrical appliances.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.