Spinosad 0.9%

• Approved Indications:
• Treatment of head lice (Pediculosis capitis) infestation in patients aged 6 months and older.
• Off-label/Clinically Accepted Uses:
• Occasionally used for treatment of cutaneous myiasis caused by fly larvae (less common).
• Other ectoparasitic infestations as determined by clinical judgment.

• Adults and Children (≥6 months):
• Apply spinosad 0.9% topical suspension to dry hair and scalp until thoroughly saturated.
• Leave on for 10 minutes, then rinse thoroughly with water.
• Typically, a single application is sufficient; a second application may be used after 7 days if live lice persist.
• Pediatrics:
• Same as adult dosing; safety confirmed for children 6 months and older.
• Elderly:
• No dosage adjustment necessary.
• Renal/Hepatic Impairment:
• Not applicable due to minimal systemic absorption.
• Route:
• Topical, external use only.

Spinosad is a naturally derived insecticide that targets the nervous system of lice. It acts by binding to nicotinic acetylcholine receptors and GABA-gated chloride channels in the lice, causing hyperexcitation of neurons. This results in involuntary muscle contractions, paralysis, and death of the parasites. The selective action spares human neuronal receptors, making it safe for topical use.

• Absorption: Minimal systemic absorption through intact skin; plasma levels generally undetectable after topical application.
• Distribution: Due to topical administration, systemic distribution is negligible.
• Metabolism: Not significant in humans for topical use.
• Elimination: Not applicable for topical use; any absorbed drug is expected to be metabolized and excreted primarily via feces.
• Half-life: Not established for topical human use due to minimal systemic absorption.

• Pregnancy: No adequate well-controlled studies in pregnant women. Animal studies have not demonstrated teratogenic effects. Use during pregnancy only if clearly needed.
• Lactation: Unknown if excreted in human breast milk. Use with caution in breastfeeding mothers; avoid direct infant exposure.

• Topical pediculicide
• Natural insecticide (spinosyn class)

• Known hypersensitivity to spinosad or any component of the formulation.
• Application on inflamed or broken skin is contraindicated.

• Avoid contact with eyes; rinse immediately if contact occurs.
• Do not apply to mucous membranes or broken skin.
• Caution in patients with scalp conditions such as eczema or psoriasis.
• Monitor for hypersensitivity reactions including rash or swelling.
• Keep out of reach of children when not in use.

• Common: Mild scalp irritation, redness, itching, or dryness at the application site.
• Rare: Allergic contact dermatitis, eye irritation upon accidental exposure.
• No systemic adverse effects reported due to minimal absorption.

• No known drug-drug interactions due to negligible systemic absorption.
• No significant interactions with food or alcohol.

• Recommended as a first-line treatment for head lice by dermatology and pediatric guidelines.
• Recognized for effectiveness with single application, reducing the need for retreatment.
• Lower risk of resistance compared to traditional pediculicides such as permethrin.

• Store at controlled room temperature between 20°C to 25°C (68°F to 77°F).
• Protect from freezing, excessive heat, and direct sunlight.
• Keep container tightly closed when not in use.
• For external use only.