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Spinosad: Drug information

Spinosad: Drug information
(For additional information see "Spinosad: Patient drug information" and see "Spinosad: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Natroba
Pharmacologic Category
  • Antiparasitic Agent, Topical;
  • Pediculocide
Dosing: Adult
Head lice

Head lice: Topical: Apply sufficient amount to cover dry scalp and completely cover dry hair; 120 mL may be necessary depending on the length of hair. If live lice are seen 7 days after first treatment, repeat with second application.

Scabies

Scabies: Topical: Apply sufficient amount to completely cover body from the neck to the toes (including soles of the feet); apply to forehead, hairline, scalp, and temples in patients who are balding. Leave on skin for ≥6 hours prior to bathing or showering.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Spinosad: Pediatric drug information")

Head lice

Head lice: Infants ≥6 months, Children, and Adolescents: Topical: Suspension: Apply sufficient amount to cover dry scalp and completely cover dry hair (maximum single application dose: 120 mL); leave on for 10 minutes and then rinse out with warm water. If live lice are seen 7 days after first treatment, repeat with second application.

Scabies

Scabies: Children ≥4 years and Adolescents: Topical: Suspension: Apply sufficient amount to cover body from neck to toes (including soles of feet). If patient is bald, apply to forehead, hairline, scalp, and temples. Allow to absorb into the skin for 10 minutes before putting on clothes. Leave on skin for ≥6 hours prior to bathing or showering.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Dermatologic: Erythema of eyelid (2%), xeroderma (2%)

Local: Application site burning (≤3%), application site erythema (3%), application site irritation (≤3%), application site pain (≤3%)

<1%:

Dermatologic: Alopecia

Local: Application site reactions (dryness, exfoliation)

Contraindications

There are no contraindications listed in the manufacturer's labeling

Warnings/Precautions

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.

Other warnings/precautions:

• Appropriate use: For topical use only; not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes. Wash hands after application. Should be used as a part of an overall lice or scabies management program.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, External:

Natroba: 0.9% (120 mL) [contains benzyl alcohol, cetearyl alcohol, fd&c yellow #6 (sunset yellow), isopropyl alcohol, propylene glycol]

Generic: 0.9% (120 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Suspension (Natroba External)

0.9% (per mL): $2.76

Suspension (Spinosad External)

0.9% (per mL): $2.64

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Topical: For external use only; not for intravaginal, ophthalmic, or oral use. Avoid contact with eyes; rinse thoroughly with water if contact occurs. Shake bottle well. Wash hands after application.

Head lice: Apply to dry scalp and rub gently until the scalp is thoroughly moistened, then apply to dry hair; completely covering scalp and hair. Leave on for 10 minutes (start timing treatment after the scalp and hair have been completely covered). The hair should then be rinsed thoroughly with warm water. Shampoo may be used immediately after the product is completely rinsed off. If live lice are seen 7 days after the first treatment, repeat with second application. Nit combing is not required, although a fine-tooth comb may be used to remove treated lice and nits.

Scabies: Apply to dry skin covering body from the neck to the toes (including soles of the feet); apply to forehead, hairline, scalp, and temples in patients who are balding. Allow to absorb into skin and dry for 10 minutes prior to getting dressed. Do not bath or shower for at least 6 hours after applying.

Spinosad should be a portion of a whole lice removal program, which should include washing in hot water or dry cleaning all clothing, hats, bedding and towels recently worn or used by the patient and washing combs, brushes, and hair accessories in hot water. For scabies, wash in hot water or dry clean any bedding, clothing, and towels used by anyone infected with scabies.

Administration: Pediatric

Topical: Suspension: For external use only. Not for intravaginal, ophthalmic, or oral use. Avoid contact with eyes; rinse thoroughly with water if contact occurs. Apply to pediatric patients with direct adult supervision.

Head lice: Infants ≥6 months, Children, and Adolescents: Shake bottle well before use. Apply to dry scalp and rub gently until the scalp is thoroughly moistened, then apply to dry hair, completely covering scalp and hair. Leave on for 10 minutes (start timing treatment after the scalp and hair have been completely covered). The hair should then be rinsed thoroughly with warm water. Shampoo may be used immediately after the product is completely rinsed off. Wash hands after application. If live lice are seen 7 days after the first treatment, repeat with second application. Avoid contact with the eyes; wash hands after use. Nit combing is not required, although a fine-tooth comb may be used to remove treated lice and nits from hair and scalp.

Spinosad should be a portion of a whole lice removal program, which should include washing or dry cleaning all clothing, hats, bedding, and towels recently worn or used by the patient and washing combs, brushes, and hair accessories in hot water.

Scabies: Children ≥4 years and Adolescents: Shake bottle well before use. Apply to dry skin covering body from the neck to the toes (including soles of the feet); if patient is bald, apply to forehead, hairline, scalp, and temples. Allow to absorb into skin and dry for 10 minutes prior to getting dressed. Wash hands after application. Do not bathe or shower for at least 6 hours after applying.

Spinosad should be a portion of a scabies removal regimen that includes washing (hot water) or dry cleaning bedding, clothing, and towels worn or used by the patient during the 3 days before treatment.

Use: Labeled Indications

Head lice: Topical treatment of head lice (Pediculosis capitis) infestation in adults and pediatric patients ≥6 months of age.

Scabies: Topical treatment of scabies infestation in adults and pediatric patients ≥4 years of age.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

The amount of spinosad absorbed systemically following topical administration is below the limit of quantification (<3 ng/mL). Human studies did not assess the absorption of benzyl alcohol, an ingredient in the product; however, maternal use is not likely to result in fetal exposure.

Breastfeeding Considerations

It is not known if spinosad is present in breast milk following topical application.

The amount of spinosad absorbed systemically following topical administration is below the limit of quantification (<3 ng/mL). Maternal use is not likely to result in infant exposure to spinosad or benzyl alcohol via breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Spinosad should be removed from the breast area with soap and water prior to breastfeeding to avoid direct infant exposure.

Monitoring Parameters

Monitor scalp for lice

Mechanism of Action

Insect paralysis and death is caused by central nervous system excitation and involuntary muscle contractions. Spinosad is thought to be both pediculicidal and ovicidal (Stough, 2009).

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Not absorbed topically (<3 ng/mL in a pediatric patient plasma sampling study); absorption of the benzyl alcohol was not analyzed in this study.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (PR) Puerto Rico: Natroba
  1. Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319. [PubMed 11487763]
  2. Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm [PubMed 6810084]
  3. Frankowski BL, Bocchini JA Jr; Council on School Health and Committee on Infectious Diseases. Head lice. Pediatrics. 2010;126(2):392-403. [PubMed 20660553]
  4. "Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  5. Natroba (spinosad) [prescribing information]. Carmel, IN: ParaPRO; April 2021.
  6. Natroba (spinosad) [prescribing information]. Canton, MS: Allegis Pharmaceuticals; June 2015.
  7. Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259. [PubMed 19188870]
  8. Stough D, Shellabarger S, Quiring J, Gabrielsen AA Jr. Efficacy and safety of spinosad and permethrin creme rinses for pediculosis capitis (head lice). Pediatrics. 2009;124(3):e389-395. [PubMed 19706558]
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