Pediculicide

Natroba

Approved 18 Jan 2011TopicalSuspension

Indications

NATROBA 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 ) NATROBA is a scabicide indicated for the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older, ( 1.2 )

1.1Head Lice Infestations

NATROBA TM 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 NATROBA 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.

1.2Scabies Infestations

NATROBA 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 Wash in hot water or dry-clean any bedding, clothing and towels used by anyone having scabies.

Contraindications

None. None. ( 4 )

Warnings and precautions

Benzyl Alcohol Toxicity: Not recommended in infants below the age of 6 months; potential for increased systemic absorption. ( 5.1 )

5.1Benzyl Alcohol Toxicity

NATROBA 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 )] .

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Spinosad,

At a glance

Brand name: Natroba
Active substance: spinosad
Pharmacologic class: Pediculicide
Route: Topical
Dosage form: Suspension
Applicant: Cipher
Status: Prescription
FDA approval: 18 Jan 2011
Application: NDA022408-001
RxCUI: 1085817

Indications

1.1Head Lice Infestations

A fine-tooth comb or special nit comb may be used to remove dead lice and nits.

1.2Scabies Infestations

Warnings and precautions

Benzyl Alcohol Toxicity: Not recommended in infants below the age of 6 months; potential for increased systemic absorption. ( 5.1 )

5.1Benzyl Alcohol Toxicity

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.

6.1Clinical 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 in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Head Lice Infestations NATROBA was studied in two randomized, active-controlled trials (N=552) in subjects with head lice; Table 1 presents selected adverse events, regardless of relationship to NATROBA, that occurred in at least 1% of subjects.

Table 1: Selected Adverse Events Occurring in at least 1% of Subjects with Head Lice Infestation Signs Natroba (N=552) Permethrin 1% (N=457) Application site erythema 17 (3%) 31(7%) Ocular erythema 12 (2%) 15 (3%) Application site irritation 5 (1%) 7 (2%) Other less common reactions (less than 1% but more than 0.1%) were application site dryness, application site exfoliation, alopecia, and dry skin. Scabies Infestations NATROBA was studied in three randomized, double-blind, vehicle-controlled trials (Trial 1, Trial 2, and Trial 3) in 592 subjects with scabies infestation, of which 165 were ages 4-17 and 427 were adults.

Subjects received a single application of NATROBA to the skin from the neck to the soles of the feet, which was washed off after a minimum of 6 hours. Table 2 presents adverse reactions related to NATROBA treatment that occurred in at least 1% of subjects. Table 2: Adverse Reactions Occurring in at least 1% of Subjects with Scabies Infestation (Trials 1, 2 and 3) Signs Natroba (N=322) Vehicle (N=270) Application site irritation* 8 (3%) 0 (0%) Dry skin 6 (2%) 0 (0%) *Application site irritation also includes application site pain and burning sensation.

Natroba

Indications

1.1Head Lice Infestations

1.2Scabies Infestations

Contraindications

Warnings and precautions

5.1Benzyl Alcohol Toxicity

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Spinosad,

At a glance

Two medicines in one question?

Natroba

Indications

1.1Head Lice Infestations

1.2Scabies Infestations

Contraindications

Warnings and precautions

5.1Benzyl Alcohol Toxicity

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Spinosad,

At a glance

Two medicines in one question?

Adverse reactions

6.1Clinical Studies Experience

Composition

Official product information