Indications

Scabies Infestations: Freescab Topical Suspension is a scabicide indicated for the topical treatment of scabies infestations in adult and paediatric patients 4 years of age and older.

Head Lice Infestations: Freescab Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in adult and paediatric patients 6 months of age and older.

Pharmacology

Spinosad causes neuronal excitation in insects. After periods of hyperexcitation, lice and mites become paralyzed and die.

Pharmacokinetics

When applied topically, Spinosad shows minimal absorption into the bloodstream. Detectable plasma levels are either very low or absent. Clinical studies have shown that plasma concentrations remain below the level of quantification in most subjects after a single topical application. It remains localized on the skin and scalp, targeting lice and scabies mites. Due to minimal absorption, systemic distribution and metabolism are negligible. If absorbed in trace amounts, it is likely metabolized by the liver through the CYP450 enzyme system. Spinosad is primarily removed from the skin by washing and is excreted mainly as unchanged drug. Its systemic half-life has not been established because of negligible absorption.

Dosage and Administration

For topical use only. Not for oral, ophthalmic, or intravaginal use.

Treatment of Scabies Infestations

Shake the bottle well before use.
Apply thoroughly to the entire body from the neck down to the soles of the feet.
Patients with balding scalp should also apply to the scalp, hairline, temples, and forehead.
Allow the medication to absorb and dry for 10 minutes before dressing.
Avoid bathing for at least 6 hours after application.

Treatment of Head Lice Infestations

Shake the bottle well before use.
Apply thoroughly to dry hair and ensure complete scalp coverage.
Leave on for 10 minutes.
Rinse hair with warm water.
If live lice are present after 7 days, repeat the treatment or follow the physician’s instructions.

Use in Children and Adolescents

Scabies Infestation: Safety and effectiveness have not been established in children younger than 4 years of age.

Head Lice Infestation: Safety and effectiveness have been established in paediatric patients 6 months of age and older.

Drug Interactions

Freescab generally has minimal drug interaction potential due to its low systemic absorption. Concurrent use with topical corticosteroids or retinoids may increase the risk of local skin irritation or hypersensitivity reactions.

Contraindications

No specific contraindications have been established.

Side Effects

Scabies Treatment (>1%)

Application site irritation
Dry skin

Head Lice Treatment (>1%)

Application site erythema
Ocular erythema

Pregnancy and Lactation

Pregnancy Category B. Breastfeeding is not expected to result in significant infant exposure to Spinosad. Nursing mothers should wash the breast area with soap and water before breastfeeding.

Precautions and Warnings

Freescab Topical Suspension contains benzyl alcohol and is not approved for use in neonates and infants younger than 6 months. Systemic exposure to benzyl alcohol has been associated with serious adverse reactions and death in neonates and low-birth-weight infants when administered intravenously.