Natroba (spinosad)
Scabicides and Pediculocides Topical Suspension, Topical (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Spinosad, a mixture of spinosyn A and spinosyn D, is an insecticide used as a topical pediculicide.
Spinosad is a 5:1 mixture of spinosyn A and spinosyn D, natural macrocyclic lactones derived from fermentation of Saccharopolyspora spinosa, a soil actinomycete. Spinosad causes neuronal excitation in insects, including lice, by interfering with insect nicotinic acetylcholine receptors and, to a lesser extent, gamma-amino butyric acid (GABA) receptors. Following prolonged periods of neuronal hyperexcitation, lice experience neuromuscular fatigue resulting in louse paralysis, inability to feed, and death.
Spinosad historically has been used as an agricultural insecticide, and more recently has been used as an antiparasitic agent in veterinary medicine. Although spinosad is active against many pest species, resistance to spinosad in some agriculturally important pests has been documented. Spinosad is active against human head lice and is ovicidal at all stages of louse egg development.
Spinosad resistance has not been documented to date in lice, and the drug has exhibited activity against permethrin-resistant human head lice. Cross-resistance with other pediculicides is not expected.
For the topical treatment of pediculosis capitis (head lice infestation), spinosad is commercially available as a 0.9% suspension in a vehicle that includes isopropyl alcohol, benzyl alcohol, hexylene glycol, propylene glycol, cetearyl alcohol, stearalkonium chloride, and other ingredients. The suspension is viscous, slightly opaque, and light orange in color.
Spinosad does not appear to be absorbed systemically following topical application. In a limited number of children 4-15 years of age with head lice infestation, a single 10-minute application of spinosad 1.8% (twice the concentration of the commercially available topical suspension) did not result in detectable plasma concentrations of spinosad (quantifiable limit 3 ng/mL). Although the commercially available spinosad 0.9% topical suspension contains benzyl alcohol, bioavailability of benzyl alcohol following topical application of the suspension has not been evaluated to date. (See Benzyl Alcohol Toxicity under Cautions: Warnings/Precautions.)
USES: This medication is used to treat head lice, tiny insects that infest and irritate your scalp. Head lice lay small white eggs (nits) at the roots of hair close to the scalp, especially on the hairline at the back of the neck and behind the ears. This medication is also used to treat scabies.
Scabies is caused by tiny insects called mites that infest and irritate your skin. Spinosad works by paralyzing and killing lice/mites and their eggs. This medication should not be used on infants younger than 6 months due to the increased risk for serious side effects.
Generic name: spinosad
Pronunciation: (SPIN-oh-sad)
Drug class: Scabicides and Pediculocides
Therapeutic class: Dermatological
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Natroba
Indications
The following indications are listed for Natroba:
- Pediculosis Capitis
- Scabies
Also known as: Infestation By Sarcoptes Scabiei Var Hominis, Phthiriasis Capitis, Sarcoptic Itch.
Dosing
For the topical treatment of pediculosis capitis (head lice infestation) in adults and children 4 years of age or older, the manufacturer recommends 1 or 2 applications given 7 days apart. The second application is necessary only if live lice are observed 7 days after the initial application.
Spinosad 0.9% topical suspension should be applied to dry scalp and scalp hair in a volume sufficient to completely saturate the scalp and hair. The amount of suspension required for each application depends on hair length; up to 1 full bottle (120 mL) may be required for very thick, medium-length hair or long hair. After 10 minutes, the suspension should be thoroughly rinsed off with warm water. If live lice are observed 7 days after the initial application, the topical application should be repeated.
No dosing information is available for this tab.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Natroba 0.9% Topical Susp | Maintenance | Apply 30 - 120 milliliters by topical route to dry hair, saturating hair and scalp. After 10 min rinse with warm water. May repeat in 7 days. |
| Drug label | Dosing type | Instructions |
|---|---|---|
| Spinosad 0.9% Topical Susp | Maintenance | Apply 30 - 120 milliliters by topical route to dry hair, saturating hair and scalp. After 10 min rinse with warm water. May repeat in 7 days. |
Drug interactions
Drug interaction studies have not been performed with spinosad 0.9% topical suspension.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
The manufacturer states there are no contraindications to use of spinosad 0.9% topical suspension.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- No disease contraindications
Adverse reactions
Adverse effects reported in 1% or more of patients receiving spinosad 0.9% topical suspension in clinical trials include application site erythema (3%), ocular erythema (2%), and application site irritation (1%).
There are no severe adverse reactions for this drug.
Less Frequent
- Erythema
- Ocular redness
- Treatment site sequelae
Rare or Very Rare
- Alopecia
- Dry skin
- Exfoliative dermatitis
Precautions
No enhanced messaging available.
Safety of spinosad 0.9% topical suspension has not been established in children younger than 4 years of age. Because the topical suspension contains benzyl alcohol, it should not be used in infants younger than 6 months of age. (See Benzyl Alcohol Toxicity under Cautions: Warnings/Precautions.)
Category B. (See Users Guide)
Because there is no evidence that spinosad is systemically absorbed following topical application, the drug is not expected to be present in breast milk. However, spinosad 0.9% topical suspension contains benzyl alcohol. Because it is not known if benzyl alcohol is distributed into milk following topical application of spinosad 0.9% suspension, caution is advised if the topical suspension is used in nursing women. (See Benzyl Alcohol Toxicity under Cautions: Warnings/Precautions.)
The manufacturer suggests that if spinosad 0.9% topical suspension is used in a lactating woman, she may choose to pump and discard her breast milk for 8 hours (i.e., 5 half-lives of benzyl alcohol) after topical application of the suspension to avoid infant ingestion of benzyl alcohol.
Clinical studies of spinosad 0.9% topical suspension did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients; other clinical experience has not revealed age-related differences in response.
ICD codes
| Code | Type | Description |
|---|---|---|
| Pediculosis capitis | ||
| B85.0 | ICD10CM | Pediculosis due to pediculus humanus capitis |
| Scabies | ||
| B86 | ICD10CM | Scabies |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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