Scabies Infestations: Spinosad Topical Suspension is a scabicide indicated for the topical treatment of scabies infestations in adult and pediatric patients aged 4 years and older.
Head Lice Infestations: Spinosad Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in adult and pediatric patients aged 6 months and older.

Spinosad causes neuronal excitation in insects. Following a period of hyperexcitation, lice and mites become paralyzed and die.

Pharmacokinetics: When applied topically, spinosad shows minimal systemic absorption. Detectable plasma levels are either very low or absent. In clinical studies, most subjects had plasma concentrations below the limit of quantification after a single scalp application for head lice treatment. Pediatric absorption follows a similar pattern with minimal systemic exposure. Spinosad remains localized to the application site, acting on lice and scabies on the skin and scalp surface. Due to minimal absorption, systemic distribution is negligible. Limited absorbed amounts, if any, are metabolized in the liver via the CYP450 enzyme system. Excretion primarily occurs through the skin or by washing off the product. Minimal quantities, if absorbed, may be excreted via urine or feces. Because systemic absorption is extremely low, the systemic half-life in humans is not well defined. The drug remains active on the skin surface until removed.

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

Treatment of Scabies Infestations:

• The bottle should be shaken well before use.
• The medication should be thoroughly rubbed into the entire body from the neck down to the soles of the feet.
• Patients with balding scalp should also apply the medication to the scalp, hairline, temples, and forehead.
• Sufficient time should be allowed for the medication to absorb into the skin and dry for 10 minutes before dressing.
• Bathing should be avoided for at least 6 hours after application.

Treatment of Head Lice Infestations:

• The bottle should be shaken well before use.
• The medicine should be applied thoroughly so that the scalp is completely covered. Then the medication should be applied to dry hair.
• After 10 minutes, the hair should be rinsed with warm water.
• If live lice are observed 7 days after the first treatment, the treatment should be repeated or as directed by the physician.

Use in Children & Adolescents

Scabies Infestation: The safety and effectiveness of Spinosad Topical Suspension have not been established in pediatric patients less than 4 years of age with scabies infestation.
Head Lice Infestation: The safety and effectiveness of Spinosad Topical Suspension for the topical treatment of head lice infestation have been established in pediatric patients 6 months of age and older. Drug Interactions

Due to its minimal systemic absorption, Spinosad has very few clinically significant drug interactions. When used together with other topical medications such as corticosteroids or retinoids, there may be an increased risk of local skin irritation or hypersensitivity. However, this is generally considered an additive local effect rather than a true drug–drug interaction. Overall, Spinosad 0.9% topical suspension is considered safe with minimal interaction concerns when used as directed.

No specific contraindications have been established.

Most common adverse reactions include:

• Scabies treatment (>1%) – application site irritation, dry skin
• Lice treatment (>1%) – application site erythema, ocular erythema

Pregnancy Category B. Breastfeeding is not expected to expose the infant to significant amounts of Spinosad. Nursing mothers should wash off Spinosad Topical Suspension from the breast with soap and water before breastfeeding.

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

Topical Antifungal preparations

Keep out of reach of children. Store in a dry place below 25°C and protect from light.