Spinosa60 ml

Spinosa is a topical ectoparasiticide used as part of an overall lice or scabies management program (which also includes environmental measures such as laundering clothing, bedding, and personal items).

FDA-approved indications

• Head lice infestation (Pediculosis capitis): Topical treatment of head lice in patients 6 months of age and older.
• Scabies: Topical treatment of scabies infestation in patients 4 years of age and older.

Spinosa is not indicated for use on eyebrows, eyelashes, or for infestations of body or pubic lice unless specifically directed by a physician.

Each container of topical suspension contains Spinosad 0.9% w/w (9 mg per gram) as the active ingredient, in a vehicle containing benzyl alcohol and other inactive suspending and stabilizing agents suitable for external application to the scalp, hair, or skin.

Spinosa is a naturally derived pediculicide and scabicide obtained from the fermentation of the soil bacterium Saccharopolyspora spinosa. It is formulated as a 0.9% topical suspension intended for application to the scalp and hair (for head lice) or to the skin (for scabies).

Spinosa belongs to the spinosyn class of insecticidal compounds and works by disrupting the nervous system of lice and mites, leading to their paralysis and death, while showing minimal systemic absorption when applied to intact human skin.

Spinosa belongs to the topical pediculicide and scabicide (ectoparasiticide) class, specifically the spinosyn group of naturally derived insecticidal agents.

Mechanism of Action

Spinosad acts on the nervous system of insects and mites. It causes activation of nicotinic acetylcholine receptors and also affects gamma-aminobutyric acid (GABA)-gated chloride channels, producing involuntary muscle contractions, tremors, and prolonged neuronal hyperexcitation. This leads to paralysis and death of lice and mites.

Pharmacokinetics

Following topical application to intact scalp or skin, Spinosad shows no clinically relevant systemic absorption in humans, which limits the potential for systemic adverse effects.

Spinosa is for external (topical) use only. Apply directly to dry hair/scalp (for head lice) or dry skin (for scabies) using the amount recommended by the label or physician. Avoid contact with the eyes, mouth, and mucous membranes during application; if accidental contact occurs, rinse immediately with water. Wash hands thoroughly after application. Application in young children should be supervised by an adult to prevent accidental ingestion or eye contact.

No clinically significant drug-drug interactions have been established for Spinosa, largely because it is not meaningfully absorbed into the systemic circulation after topical use. As a precaution, avoid applying other topical scalp or skin products (e.g., other pediculicides, strong irritants, or occlusive agents) at the same time as Spinosa unless directed by a physician, as this may increase local irritation or alter absorption.

Head lice treatment

• Application site redness (erythema) - reported in approximately 3% of patients
• Eye redness (ocular erythema) - reported in approximately 2% of patients

Scabies treatment

• Application site irritation, including pain or burning sensation - reported in approximately 3% of patients
• Dry skin - reported in approximately 2% of patients

Most reactions associated with Spinosa are mild, local, and self-limiting. Discontinue use and consult a physician if severe irritation, rash, or signs of an allergic reaction occur.

Pregnancy: Spinosa is not absorbed systemically to a clinically relevant extent following topical application, and maternal use is not expected to result in meaningful fetal exposure. However, as with any medicine, Spinosa should be used during pregnancy only if clearly needed and the potential benefit justifies the potential risk; consult a physician before use.

Lactation: There is no data on the presence of Spinosa in human milk. If applying Spinosa to or near the chest area, remove the product thoroughly with soap and water before breastfeeding to prevent inadvertent ingestion by the infant. Consult a physician before use while breastfeeding.

• Spinosa is for external/topical use only; it is not intended for oral, ophthalmic, vaginal, or rectal use.
• Avoid contact with the eyes and mucous membranes; if contact occurs, rinse thoroughly with water.
• Spinosa contains benzyl alcohol and is not approved for use in neonates or infants below 6 months of age, due to the risk of increased systemic absorption and serious adverse effects (including "gasping syndrome") associated with benzyl alcohol in this age group.
• Use only as directed; avoid unnecessary repeated or prolonged application beyond what is recommended, as this does not improve efficacy and may increase the risk of local irritation.
• As part of an effective lice or scabies management program, identify and treat close contacts and household members as needed, and wash bedding, clothing, combs, and other personal items to prevent reinfestation or spread.
• Application in infants, young children, and dependent adults should be supervised by a caregiver.

Spinosa is intended for external use only. If the product is accidentally ingested, or if excessive application leads to signs of toxicity (such as marked skin irritation, vomiting, or unusual drowsiness), seek immediate medical attention or contact a poison control center/emergency services without delay. There is no specific antidote for Spinosa; management of overdose or accidental ingestion should be supportive and directed by a physician. Do not attempt home treatment for suspected ingestion beyond following emergency guidance.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

• Renal impairment: No dose adjustment is expected to be necessary, as Spinosa is not significantly absorbed systemically after topical application; however, use should still be guided by a physician.
• Hepatic impairment: No specific dose adjustment is established; given minimal systemic absorption, clinically significant effects are not anticipated, but caution and physician guidance are advised.
• Elderly patients: No specific dosage adjustment is required; general precautions for topical application apply.
• Immunocompromised patients: May require closer monitoring and physician supervision, as scabies infestations can be more extensive or resistant to treatment in this population.

See Pediatric Uses for age-specific information on Spinosa.

For head lice, a single application of Spinosa is often sufficient; retreatment is recommended only if live lice are observed 7 days after the initial application. For scabies, a single whole-body application left on the skin for the recommended contact time is typically used; a physician may advise a repeat application if signs of infestation persist, since post-scabetic itching can continue for several weeks even after successful treatment. Do not use Spinosa for longer or more frequently than directed.

Spinosad is classified as a topical pediculicide and scabicide, belonging to the spinosyn class of naturally derived insecticidal/ectoparasiticidal agents.

Spinosad works by activating nicotinic acetylcholine receptors and affecting GABA-gated chloride channels in the nervous system of lice and mites, causing sustained neuronal excitation, involuntary muscle activity, paralysis, and eventual death of the parasites. See Pharmacology for further detail.

• Head lice: Spinosa is approved for use in patients 6 months of age and older.
• Scabies: Spinosa is approved for use in patients 4 years of age and older.
• Spinosa is not approved for use in neonates or infants below 6 months of age due to the benzyl alcohol content of the formulation and the associated risk of serious adverse effects from increased systemic absorption in this age group; safety and efficacy below this age have not been established.
• Application in children should be performed or directly supervised by an adult to avoid accidental ingestion or contact with the eyes.