Indications

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

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

Pharmacology

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

Pharmacokinetics

When applied topically, spinosad demonstrates minimal systemic absorption. Detectable plasma concentrations are generally very low or absent following topical administration. Clinical studies have shown that plasma concentrations remain below the quantification limit in most subjects after a single scalp application for head lice treatment.

Children exhibit a similar absorption pattern, resulting in minimal systemic exposure. Spinosad remains localized to the treated area, specifically targeting lice and scabies mites on the skin and scalp surface. Due to negligible absorption, significant systemic distribution is not expected.

Any trace amount absorbed systemically is likely metabolized by hepatic CYP450 enzymes. Spinosad is primarily eliminated from the skin through washing or natural removal from the treated surface. Because of its minimal systemic absorption, urinary and fecal excretion are negligible. The systemic half-life in humans has not been well established.

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 a balding scalp should also apply the medication to the scalp, hairline, temples, and forehead.
Allow the medication to absorb into the skin and dry for approximately 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 sufficient medication to completely cover the scalp and dry hair.
Leave on for 10 minutes.
Rinse hair thoroughly with warm water.
If live lice are observed 7 days after the initial treatment, repeat treatment 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 younger than 4 years of age with scabies infestation.

Head Lice Infestation:
The safety and effectiveness of Spinosad Topical Suspension for the treatment of head lice infestation have been established in pediatric patients aged 6 months and older.

Drug Interactions

Spinosad generally has minimal potential for drug interactions because of its low systemic absorption. Concurrent use with other topical medications, such as corticosteroids or retinoids, may increase the likelihood of local skin irritation or hypersensitivity reactions. When used as directed, Spinosa Topical Suspension is associated with minimal interaction concerns.