Indications

Scabies Infestation:
Unix-S Topical Suspension is a scabicidal preparation indicated for the topical treatment of scabies infestation in adults and pediatric patients aged 4 years and above.

Head Lice Infestation:
Unix-S Topical Suspension is a pediculicidal preparation indicated for the topical treatment of head lice infestation in adults and pediatric patients aged 6 months and above.

Pharmacology

Spinosad causes neuronal excitation in insects. Following prolonged hyperexcitation, lice and mites become paralyzed and eventually die.

Pharmacokinetics

When applied topically, spinosad is minimally absorbed into the bloodstream. Detectable plasma concentrations are generally very low or absent after topical application. Clinical studies have shown that plasma levels remained below the limit of quantification in most subjects following a single application for head lice treatment.

Absorption in children follows a similar pattern, resulting in minimal systemic exposure. Spinosad remains localized to the treated skin or scalp and primarily targets lice and scabies mites on the surface. Due to negligible systemic absorption, significant distribution throughout the body does not occur.

If trace amounts are absorbed, spinosad is likely metabolized by hepatic CYP450 enzymes. The drug is predominantly removed through washing and shedding from the skin. Very small amounts, if any, are excreted in urine or feces. Because systemic absorption is minimal, the systemic half-life of spinosad in humans has not been well established.

Dosage and Administration

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

Treatment of Scabies

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 scalps should also apply the medication to the scalp, hairline, temples, and forehead.
Allow the medication to absorb and dry for approximately 10 minutes before dressing.
Avoid bathing for at least 6 hours after application.

Treatment of Head Lice

Shake the bottle well before use.
Apply sufficient medication to completely cover the scalp and dry hair.
Leave on for 10 minutes.
Rinse thoroughly with warm water.
If live lice are present 7 days after treatment, a second treatment may be applied as directed by the physician.

Use in Children and Adolescents

Scabies Infestation:
Safety and effectiveness have not been established in pediatric patients younger than 4 years.

Head Lice Infestation:
Safety and effectiveness have been established in pediatric patients aged 6 months and older.

Drug Interactions

Spinosad generally has minimal drug interaction potential due to its low systemic absorption. Concurrent use with other topical medications, such as corticosteroids or retinoids, may increase the risk of local skin irritation or hypersensitivity reactions. When used as directed, Unix-S 0.9% Topical Suspension is considered to have minimal interaction concerns.

Contraindications

No specific contraindications have been established.

Side Effects

Scabies Treatment (>1%):

Application site irritation
Dry skin

Head Lice Treatment (>1%):

Application site erythema (redness)
Ocular erythema (eye redness)

Pregnancy and Lactation

Pregnancy Category B.
Breastfeeding is not expected to result in significant exposure of the infant to spinosad. Breastfeeding mothers should wash the medication from the breast with soap and water before nursing.

Precautions and Warnings

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