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spinosad (Natroba)

 

Classes: Scabicidal Agents

Dosing and uses of Natroba (spinosad)

 

Adult dosage forms and strengths

suspension, topicaL

  • 0.9%

 

Lice

Apply suspension to dry scalp and hair using only the amount needed to cover the scalp and hair, after 10 minutes, rinse off with warm water

May repeat if live lice are seen 7 days after first treatment

 

Administration

Does not require combing and nit removaL

For topical use only

Shake bottle well before application

 

Pediatric dosage forms and strengths

suspension, topicaL

  • 0.9%

 

Lice

<6 months

  • Do not use
  • See benzyl alcohol warning in neonates and infants

≥6 months

  • Apply suspension to dry scalp and hair using only the amount needed to cover the scalp and hair, after 10 minutes, rinse off with warm water
  • May repeat if live lice are seen 7 days after first treatment

 

Administration

Does not require combing and nit removaL

For topical use only

Shake bottle well before application

 

Natroba (spinosad) adverse (side) effects

1-10%

Application site erythema (3%)

Ocular erythema (2%)

Ocular hyperemia (2%)

Application site irritation (1%)

 

<1%

Application site dryness

Application site exfoliation

Alopecia

Dry skin

 

Warnings

Contraindications

Hypersensitivity

 

Cautions

Contains benzyl alcohol; toxicity and deaths reported in neonates and infants below the age of 6 months with systemic exposure to benzyl alcohol (ie, neonatal gasping syndrome)

 

Pregnancy and lactation

Pregnancy category: B; low systemic exposure

Lactation: Active ingredient (spinosad) is not distributed in breast milk; however, caution advised because the benzyl alcohol component may be systemically absorbed; lactating women may choose to pump and discard breast milk for 8 hr (5 half-lives of benzyl alcohol) following application

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Natroba (spinosad)

Mechanism of action

Causes neuronal excitation in insects, followed by hyperexcitation, paralysis, and death

 

Pharmacokinetics

Absorption: Not absorbed topically