proven effective

natroba™ (spinosad) topical suspension, 0.9% was approved by the u.s. food and drug administration on january 18, 2011. natroba™ is indicated for the topical treatment of head lice (pediculosis capitis) infestations in patients four (4) years of age and older. natroba™ should be used in context of an overall lice management program.

spinosad, the active ingredient in natroba™, is derived from a naturally occurring soil bacterium, saccharopolyspora spinosa.

product description

natroba™ (spinosad) topical suspension, 0.9% is a light orange, slightly opaque, viscous liquid, topical prescription medication that is applied to dry hair and scalp by starting at the scalp and working toward the ends of the hair. natroba™ is available by prescription in a 4 oz. (120 ml) bottle. only the amount needed to cover the scalp and hair is used. once applied, natroba™ should be left on for 10 minutes and then thoroughly rinsed away with warm water. nit combing is not required with natroba™. see patient information, full prescribing information and instructions for use guide for more information.

one treatment is needed. if live lice are seen 7 days after first treatment

 

other safety information

natroba™ contains benzyl alcohol and is not recommended 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.

 

mechanism of action

the mode of action for the active ingredient spinosad is unique. spinosad causes neuronal excitation in insects. after periods of hyper-excitation the head lice become paralyzed and die.

mechanism of action

effective

 

possible side effects

the most common side effects with natroba™ were application site and eye redness and irritation occurring in 3% of patients or less.

 

indication

natroba™ topical suspension is a pediculicide indicated for the topical treatment of head lice infestations in patients four (4) years of age and older.

adjunctive measures

natroba™ 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-toothed comb or special nit comb may be used to remove dead lice and nits.

important safety information

natroba™ topical suspension contains benzyl alcohol and is not
recommended 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. most common adverse events were: application site redness (3%), eye redness (2%) and application site irritation (1%).

consult the patient information, full prescribing information and your doctor for more complete information on natroba™ topical suspension.

you are encouraged to report negative side effects of prescription drugs to the fda. visit www.fda.gov/medwatch or call
1-800-fda-1088.

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