Esdepallethrin/ Piperonyl Butoxide

Registered South African indications:

• Scabies

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy (unless potential benefits have been deemed to outweigh any risk that may be associated with the use of the product)
• Breastfeeding (unless potential benefits have been deemed to outweigh any risk that may be associated with the use of the product)

Cautions

• Renal impairment
• Hepatic impairment
• Elderly
• Children <2 years of age
• Contact with mucous membranes
• Contact with open wounds
• Contact with face or scalp
• Exposure of container to sunlight or high temperatures >50^oC
• Use near a naked flame or any incandescent material
• Smoking near container
• Piercing or burning container
• Inhalation of product

Forms avail. in SA and covered in this monograph: spo

South African manufacturer recommendations

Scabies

• Topical (spo): Spray entire body surface except for face and scalp, holding the can at 20-30cm from the skin; Spray from top to bottom on the trunk, then the limbs, without leaving any part untreated (treated areas immediately become glossy); Leave product on for ≥12hrs; Wash with soap and rinse thoroughly after the 12hrs

Apply in a well ventilated area away from any flame. Patients should stand on a towel since the product is slightly greasy and droplets of the spray may render the floor slippery

Spray abundantly on spaces between fingers, toes, under arms and feet, genitals and the most affected areas

Keep the product in contact with the skin for at least 12hrs. Do not wash, even your hands, for at least 12hrs

For lesions on the face, rub with absorbent cotton soaked with the formulation

See additional prescribing points for directions of use

For maximal efficacy and tolerance, the directions for use should be adhered to:
All persons living in the same house must be treated on the same day, at the same time. Spray the formulation preferably in the evening around 6pm in order to leave the product to act the whole night

Paed. forms avail. in SA and covered in this monograph: spo

South African manufacturer recommendations

Scabies

• See adult dosage

Esdepallethrin/ piperonyl butoxide should not be used in children <2 years without first consulting a physician

Apply in a well ventilated area away from any flame. Patients should stand on a towel since the product is slightly greasy and droplets of the spray may render the floor slippery

Protect the nose and mouth of children <5 years old with a handkerchief during spraying

Spray abundantly on spaces between fingers, toes, under arms and feet, genitals and the most affected areas

Keep the product in contact with the skin for at least 12hrs. Do not wash, even your hands, for at least 12hrs

For lesions on the face, rub with absorbent cotton soaked with the formulation

See additional prescribing points for directions of use

For maximal efficacy and tolerance, the directions for use should be adhered to:
All persons living in the same house must be treated on the same day, at the same time. Spray the formulation preferably in the evening around 6pm in order to leave the product to act the whole night

Pregnancy

• Contraindicated
• Esdepallethrin/ piperonyl butoxide should not be used in pregnant women unless potential benefits have been deemed to outweigh any risk that may be associated with the use of the product

Breastfeeding

• Contraindicated
• Esdepallethrin/ piperonyl butoxide should not be used in breastfeeding women unless potential benefits have been deemed to outweigh any risk that may be associated with the use of the product

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• Caution; no information available

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headaches
• Restlessness

Gastrointestinal Disorders

• Nausea and vomiting

Skin and Subcutaneous Tissue Disorders

• Rash
• Skin irritation

No information available

None routine

Directions for use

In order to get rid of scabies efficiently, one must:

• Treat the persons complaining from itching, and members of the household, with a scabicidal product
• Disinfect clothes and bed linen in order to avoid decontamination and spreading of the infection
• The spray has been specifically designed to treat the affected subjects (complaining from itching ) and household members, including infants
• The spray contents allow for treatment of 1 -3 persons (1 adult, 1 couple or 1 adult and 2 children under 12 years of age). The formulation has been shown to pass through the skin and reach female sarcopt and its eggs, in a single application
• It is mandatory to change to clean clothing and bedding that might be contaminated
• Even if the treatment is a success, some itching may persist for 6-8 days after treatment
• If these symptoms last for >8 days, the patient should be advised to consult a doctor before applying this product a second time

Mandatory complementary disinfection

• This disinfection is mandatory to avoid recontamination
• All clothes worn by the members of the family during 3-4 days before treatment with esdepallethrin/ piperonyl butoxide spray must be disinfected, including gloves, slippers, shoes, motorcycle helmets and bed linen
• All materials resistant to high temperatures may be disinfected by washing with hot water (55^oC)
• For fabrics that cannot be washed, dry cleaning is sufficient
• All other non-washable garments must be stored in a sealed plastic bag and left for at least 8 days

Esdepallethrin is a pyrethroid pesticide possessing potent scabicidal activity with low mammalian toxicity. The low toxicity of pyrethroids in mammals is due largely to their rapid transformation by ester hydrolysis and/or hydroxylation. The slow biotransformation pyrethrum in insects is further decreased by its transformation with piperonyl butoxide (which inhibits cytochrome P450), which increases insecticidal efficacy. Esdepallethrin destroys and eliminates the parasite and piperonyl butoxide acts by blocking the defense system that the parasite uses to counteract the activity of esdepallethrin.

COMBINATION PREPARATIONS

Esdepallethrin/Piperonyl Butoxide

Spray (per g) 6.3mg/50.4mg

• Spregal (Cipla) originator