Overview
11 DESCRIPTION Spinosad Topical Suspension is a slightly opaque, light orange-colored, viscous topical suspension. Spinosad Topical Suspension is a pediculicide and scabicide. Spinosad, the active ingredient, is derived from the fermentation of a soil actinomycete bacterium, Saccharopolyspora spinosa .
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Spinosad causes neuronal excitation in insects. After periods of hyperexcitation, lice and mites become paralyzed and die. 12.2 Pharmacodynamics The pharmacodynamics of Spinosad Topical Suspension has not been studied. 12.3 Pharmacokinetics Head Lice Infestations An open-label, single-center trial was conducted over a period of seven days to determine the pharmacokinetic profile of spinosad 1.8% in pediatric subjects with head lice infestation. Fourteen (14) subjects, 4 – 15 years of age, with head lice were enrolled into the trial. All subjects applied a single topical (scalp) treatment of spinosad 1.8% for 10 minutes, after which the test article was washed off, and subjects underwent plasma sampling.
Indications
- 1 INDICATIONS AND USAGE Spinosad 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. ( 1.1 ) Spinosad Topical Suspension is a scabicide indicated for the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older. ( 1.2 ) 1.1 Head Lice Infestations Spinosad Topical Suspension is indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older.
Common Doses
- 120 mL
Dosage
2 DOSAGE AND ADMINISTRATION For topical use only. Not for oral, ophthalmic, or intravaginal use. ( 2 ) Treatment of head lice infestations ( 2.2 ): Shake bottle well Apply a sufficient amount to cover dry scalp, then apply to dry hair Rinse off with warm water after 10 minutes Repeat treatment only if live lice are seen 7 days after first treatment Treatment of scabies infestations ( 2.3 ): Shake bottle well Apply product to skin by rubbing it in to completely cover the body from the neck down to the soles of the feet Patients with balding scalp should also apply product to the scalp,...
Contraindications
- 4 CONTRAINDICATIONS None. None. ( 4 )
Side Effects
- 6 ADVERSE REACTIONS Most common adverse events for lice treatment (>1%) were application site erythema and ocular erythema. ( 6.1 ) Most common adverse reactions for scabies treatment (>1%) were application site irritation (pain and burning) and dry skin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ParaPRO LLC at 1-855-628-7622 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates...
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.