Spinosad - Spinosad suspension
(Spinosad)Spinosad - Spinosad suspension Prescribing Information
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. 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, Spinosad Topical Suspension is indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older. Adjunctive Measures for Head Lice Infestations Spinosad Topical Suspension should be used in the context of an overall lice management program:
Spinosad Topical Suspension is indicated for the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older. Adjunctive Measures for Scabies Infestations
| 04/2021 |
Dosage and Administration (
| 04/2021 |
Warnings and Precautions (Benzyl Alcohol Toxicity: Not recommended in infants below the age of 6 months; potential for increased systemic absorption. Spinosad Topical Suspension contains benzyl alcohol and is not approved for use in neonates and infants below the age of 6 months. Systemic exposure to benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants when administered intravenously [See Use in Specific Populations (8.4)] . | 04/2021 |
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. (
Spinosad Topical Suspension is indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older.
Spinosad Topical Suspension should be used in the context of an overall lice management program:
- Wash in hot water or dry-clean all recently worn clothing, hats, used bedding and towels.
- Wash personal care items such as combs, brushes and hair clips in hot water.
- A fine-tooth comb or special nit comb may be used to remove dead lice and nits.
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, (
- Wash in hot water or dry-clean any bedding, clothing and towels used by anyone having scabies.
- For topical use only. Not for oral, ophthalmic, or intravaginal use. ()
2 DOSAGE AND ADMINISTRATION- For topical use only. Not for oral, ophthalmic, or intravaginal use.
- Treatment of head lice infestations :
- 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 :
- 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, hairline, temples, and forehead
- Allow to absorb in the skin and dry for 10 minutes before getting dressed
- Leave on the skin for at least 6 hours before showering or bathing
2.1 Important Administration Instructions- For topical use only. Spinosad Topical Suspension is not for oral, ophthalmic, or intravaginal use.
- Avoid contact with eyes. If Spinosad Topical Suspension gets in or near the eyes, rinse thoroughly with water.
2.2 Treatment of Head Lice Infestations- Shake bottle well.
- Apply a sufficient amount of Spinosad Topical Suspension to cover dry scalp, then apply to dry hair. Depending on hair length, apply up to 120 mL (one bottle) to adequately cover scalp and hair.
- Leave on for 10 minutes, then thoroughly rinse off with warm water.
- Wash hands after use.
- If live lice are seen 7 days after the first treatment, a second treatment should be applied.
- Apply Spinosad Topical Suspension on pediatric patient only under direct supervision of an adult[see Warnings and Precautions (5.1)].
2.3 Treatment of Scabies Infestations- Shake bottle well.
- Apply a sufficient amount of Spinosad Topical Suspension to skin to completely cover the body from the neck to the toes (including the soles of the feet).
- For patients with balding scalp, also apply product to the scalp, hairline, temples, and forehead.
- Allow to absorb into the skin and dry for 10 minutes before getting dressed.
- Leave on the skin for at least 6 hours before showering or bathing.
- Apply Spinosad Topical Suspension on pediatric patient only under direct supervision of an adult.
- Treatment of head lice infestations ():
2.2 Treatment of Head Lice Infestations- Shake bottle well.
- Apply a sufficient amount of Spinosad Topical Suspension to cover dry scalp, then apply to dry hair. Depending on hair length, apply up to 120 mL (one bottle) to adequately cover scalp and hair.
- Leave on for 10 minutes, then thoroughly rinse off with warm water.
- Wash hands after use.
- If live lice are seen 7 days after the first treatment, a second treatment should be applied.
- Apply Spinosad Topical Suspension on pediatric patient only under direct supervision of an adult[see Warnings and Precautions (5.1)].
- 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 Treatment of Scabies Infestations- Shake bottle well.
- Apply a sufficient amount of Spinosad Topical Suspension to skin to completely cover the body from the neck to the toes (including the soles of the feet).
- For patients with balding scalp, also apply product to the scalp, hairline, temples, and forehead.
- Allow to absorb into the skin and dry for 10 minutes before getting dressed.
- Leave on the skin for at least 6 hours before showering or bathing.
- Apply Spinosad Topical Suspension on pediatric patient only under direct supervision of an adult.
- 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, hairline, temples, and forehead
- Allow to absorb in the skin and dry for 10 minutes before getting dressed
- Leave on the skin for at least 6 hours before showering or bathing
Topical suspension: 0.9% w/w; each gram contains 9 mg of spinosad in a viscous, slightly opaque (white soft particles may be visible), light orange-colored suspension in 120 mL bottles.
Spinosad, the active ingredient in Spinosad Topical Suspension, is not absorbed systemically following topical application, and maternal use is not expected to result in fetal exposure to the drug. Spinosad Topical Suspension contains benzyl alcohol. Topical benzyl alcohol is unlikely to be absorbed through the skin in clinically relevant amounts; therefore, maternal use is not expected to result in fetal exposure to the drug [
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. Results demonstrated that spinosad was below the limit of quantitation (3 ng/mL) in all samples. Plasma concentration of benzyl alcohol was not determined in these subjects.
An open-label, two-center trial was conducted over a period of 23 days to determine the pharmacokinetic profile of spinosad 0.9% and the ingredient benzyl alcohol in pediatric subjects with a head lice infestation. Twenty-six (26) subjects between 6 months to 4 years of age were enrolled into the study per protocol. All subjects applied a single topical (scalp) treatment of spinosad 0.9% for 10 minutes, after which the test article was washed off, and subjects underwent plasma sampling over a 12 hour period. Plasma spinosad concentrations were below the limit of quantitation (3 ng/mL) in all samples.
Benzyl alcohol was quantifiable (above 1 μg/mL) in a total of 8 plasma samples in 6 out of 26 subjects (25%): four out of 12 subjects in the 6 months to <2 years age group and two out of 14 subjects in the 2 to 4 years age group. The highest observed concentration was 2.37 μg/mL. Benzyl alcohol concentrations at 12 hours post-treatment were below limit of quantification (1 μg/mL) for all subjects.
An open-label multi-center trial was conducted to determine the pharmacokinetic profile of spinosad 0.9% and the ingredient benzyl alcohol in pediatric subjects with scabies infestation. The PK bioavailability study was completed in 19 pediatrics subjects 5 to 16 years of age. All subjects applied a single topical body treatment of spinosad 0.9% from the neck down to the soles of the feet and allowed treatment to remain on the body for a minimum of 6 hours after which the test article was washed off. Subjects underwent plasma sampling over a 12-hour period after treatment. Plasma spinosad concentrations were below the limit of quantification (3 ng/mL) in all samples.
Benzyl alcohol was quantifiable (above 1 μg/mL) in a total of 9 plasma samples in 6 out of 19 subjects (32%): in 3 out of 10 subjects in the 5 to 9 year age group and in 3 out of 9 subjects in the 10 to 16 years age group. The highest observed concentration was 3.94 μg/mL at 0.5 hours post-treatment but was below limit of quantification at 1 hour post-treatment for one subject in the 10 to 16 years age group. There were two subjects with a benzyl alcohol concentration at 3 hours post-treatment with the highest value of 3.53 μg/mL for one subject in the 5 to 9 years age group. Plasma concentrations were below limit of quantification (1 μg/mL) at 3 hours for all other subjects; no subject had measurable concentrations at the 6 and12 hour time points. The mean (SD) Cmax, Tmax, and AUC0-12h values for benzyl alcohol were 2.737 (1.107) μg/mL, 1.42 (1.242) hours, and 19.240 μg∙h/mL, respectively.
In animal reproduction studies, no adverse embryofetal effects were seen at oral doses of spinosad up to 200 mg/kg/day in pregnant rats or 50 mg/kg/day in pregnant rabbits administered during the period of organogenesis (
Systemic embryofetal development studies were conducted in rats and rabbits. Oral doses of 10, 50 and 200 mg/kg/day spinosad were administered during the period of organogenesis (gestational days 6 – 15) to pregnant female rats. No adverse embryofetal effects were noted at any dose. Maternal toxicity occurred at 200 mg/kg/day. Oral doses of 2.5, 10, and 50 mg/kg/day spinosad were administered during the period of organogenesis (gestational days 7 – 19) to pregnant female rabbits. No adverse embryofetal effects were noted at any dose. Maternal toxicity occurred at 50 mg/kg/day.
A two-generation dietary reproduction study was conducted in rats. Oral doses of 3, 10, and 100 mg/kg/day spinosad were administered to male and female rats from 10-12 weeks prior to mating and throughout mating, parturition, and lactation. No reproductive/developmental toxicity was noted at doses up to 10 mg/kg/day. In the presence of maternal toxicity, increased dystocia in parturition, decreased gestation survival, decreased litter size, decreased pup body weight, and decreased neonatal survival occurred at a dose of 100 mg/kg/day.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk for birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
None.