Unix-S 0.9% Topical Suspension 60ml

Spinosad acts on the nervous system of insects by causing excessive neuronal stimulation. This prolonged excitation eventually leads to paralysis and death of lice and mites.

Pharmacokinetics: When applied to the skin or scalp, spinosad is absorbed into the bloodstream only in very small amounts. Clinical studies have found that plasma concentrations are generally very low or undetectable after topical treatment for head lice, including in children. Consequently, systemic distribution and exposure are minimal. The medicine primarily acts on the treated area and remains on the skin or scalp until it is washed off. Because absorption is limited, metabolism and elimination through the body's circulation are expected to be minimal. The systemic half-life of spinosad in humans has not been clearly established.

Unix-S Topical Suspension is intended for external use only. Do not take it orally, apply it to the eyes, or use it intravaginally.

Treatment of Scabies Infestation

• Shake the bottle thoroughly before application.
• Apply the suspension over the entire body, from the neck down to the soles of the feet, as directed.
• For individuals with a balding scalp, application to the scalp, hairline, temples, and forehead may also be required according to the product instructions.
• Allow the medicine to dry for approximately 10 minutes before putting on clothing.
• Avoid bathing for at least 6 hours after application.

Treatment of Head Lice Infestation

• Shake the bottle well before use.
• Apply the suspension thoroughly to dry hair and the scalp, ensuring complete coverage.
• Leave it on for 10 minutes, then rinse the hair with warm water.
• If live lice are still present 7 days after the initial treatment, consult your physician about whether repeat treatment is appropriate.

Use in Children and Adolescents

1. Scabies: The safety and effectiveness of spinosad topical suspension have not been established in children younger than 4 years for this indication.
2. Head lice: Its safety and effectiveness have been established in children aged 6 months and older.

Spinosad has a low potential for systemic drug interactions because only small amounts are absorbed through the skin. However, applying it alongside other topical medicines, such as corticosteroids or retinoids, may increase the risk of local irritation or skin sensitivity. Inform your doctor about any other medicines or skin-care products you are using.

Specific contraindications have not been established in the provided information. Individuals with a known allergy to spinosad or any ingredient in the formulation should seek medical advice before using the product.

Common adverse reactions reported with treatment include:

1. For scabies: Irritation at the application site and dry skin.
2. For head lice: Redness at the application site and eye redness.

Consult a healthcare professional if side effects persist, worsen, or cause significant discomfort.

The supplied information lists spinosad as Pregnancy Category B under the former FDA classification system. However, clinical data in pregnant women are limited, so medical advice should be obtained before use during pregnancy.

Significant exposure of a breastfed infant to spinosad is not expected following topical application. If the suspension is applied to the breast area, wash it off thoroughly with soap and water before breastfeeding.

Unix-S Topical Suspension contains benzyl alcohol and is not approved for use in newborns or infants younger than 6 months. Systemic exposure to benzyl alcohol has been associated with serious adverse reactions, including death, in neonates and low-birth-weight infants, particularly following intravenous administration.

Use this medicine only according to the product label and professional advice. Avoid contact with the eyes and do not swallow the suspension.

Store below 25°C in a dry place, protected from light. Keep out of the reach of children.