spinosad (Rx)

Brand and Other Names:Natroba
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

suspension, topical

  • 0.9%

Lice

Indicated for topical treatment of head lice infestations

Apply a sufficient amount of product needed to cover the dry scalp, then apply to dry hair

Rinse off with warm water after 10 minutes

Repeat only if live lice are seen 7 days after first treatment

Scabies

Indicated for topical treatment of scabies infestations

Apply product to skin by rubbing it in to completely cover the body from neck down to feet

Patients with balding scalp: Apply product to scalp, hairline, temples, and forehead as well

Allow to absorb in the skin and dry for 10 minutes before getting dressed

Leave on the skin for ≥6 hr before showering or bathing

Dosing Considerations

Adjunctive measures

  • Head lice infestations
    • Use 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 (eg, combs, brushes, hair clips) in hot water
    • May use a fine-tooth comb or special nit comb to remove dead lice and nits
  • Scabies infestations
    • Wash in hot water or dry-clean any bedding, clothing and towels used by anyone having scabies

Dosage Forms & Strengths

suspension, topical

  • 0.9%

Lice

Indicated for topical treatment of head lice infestations in adults and children aged ≥6 months

<6 months

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

≥6 months

  • Apply a sufficient amount of product needed to cover the dry scalp, then apply to dry hair
  • Rinse off with warm water after 10 minutes
  • Repeat only if live lice are seen 7 days after first treatment

Scabies

Indicated for topical treatment of scabies infestations in adults and children aged ≥4 years

Apply product to skin by rubbing it in to completely cover the body from neck down to feet

Patients with balding scalp: Apply product to scalp, hairline, temples, and forehead as well

Allow to absorb in the skin and dry for 10 minutes before getting dressed

Leave on the skin for ≥6 hr before showering or bathing

Dosing Considerations

Adjunctive measures

  • Head lice infestations
    • Use 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 (eg, combs, brushes, hair clips) in hot water
    • May use a fine-tooth comb or special nit comb to remove dead lice and nits
  • Scabies infestations
    • Wash in hot water or dry-clean any bedding, clothing and towels used by anyone having scabies
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Adverse 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

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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)

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Pregnancy & Lactation

Pregnancy

Active ingredient (spinosad) is not absorbed systemically following topical application, and maternal use is not expected to result in fetal drug exposure

Contains benzyl alcohol; topical benzyl alcohol is unlikely to be absorbed through the skin in clinically relevant amounts; therefore, maternal use is not expected to result in fetal drug exposure

Animal data

  • No adverse embryofetal effects were seen at oral doses of spinosad up to 200 mg/kg/day in pregnant rats or 50 mg/kg/day in pregnant rabbits administered during organogenesis

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.

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Pharmacology

Mechanism of Action

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

Pharmacokinetics

Absorption: Not absorbed topically

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Administration

Topical Administration

Topical use only; not for oral, ophthalmic, or intravaginal use

Avoid contact with eyes; if it gets in or near eyes, rinse thoroughly with water

Pediatric patients: Apply only under direct supervision of an adult

Storage

Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Natroba topical
-
0.9 % suspension
spinosad topical
-
0.9 % suspension

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
spinosad topical

SPINOSAD SUSPENSION - TOPICAL

(SPIN-oh-sad)

COMMON BRAND NAME(S): Natroba

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.

HOW TO USE: Read the Patient Information Leaflet and Patient Instructions for Use if available from your pharmacist before you start using spinosad and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is for external use only. Shake the bottle well just before using.For lice treatment: Apply this medication to scalp hair and scalp only. Use this medication when your hair is dry. Do not wet your hair before applying. Cover your face and eyes with a towel and keep your eyes closed tightly while applying this medication and during the time it remains on your scalp and hair. Avoid getting spinosad in your eyes. If the medication gets in or near the eye, flush with plenty of water right away. Since you should keep your eyes closed during application, you may need to have another person help you apply this medication. Children will need an adult to apply this medication for them.Completely cover the scalp with spinosad first, and then apply outward toward the ends of the hair. If you do not use enough spinosad, some lice may escape treatment. It is important to use enough medication to cover your entire scalp and scalp hair. Leave the medication on your hair for 10 minutes. Use a timer or clock and start timing after you have completely covered your hair and scalp with medication. After 10 minutes, rinse thoroughly with warm water. You or anyone who helps you apply this medication should wash hands after application. You may shampoo your hair any time after treatment.After treatment with this medication, you may use a fine-tooth comb or a special comb for removing treated lice and nits. However, combing is not required. If you see live lice 7 days or more after treatment, a second treatment should be given. Do not repeat treatment more than once unless otherwise directed by your doctor.To avoid giving lice to another person or getting them again, wash all head wear, clothing, bed linens, and towels with hot water, then dry in a dryer at high setting for at least 20 minutes. Personal articles such as pillows or stuffed animals that cannot be washed should be dry cleaned, sealed in a plastic bag for at least 2 weeks, or sprayed with a disinfectant that kills lice. Brushes or combs should be soaked in hot water for at least 10 minutes. Furniture and floors should be thoroughly vacuumed.For scabies treatment: Apply enough to completely cover your body from your neck to the soles of your feet. Make sure you apply to folds of skin, between fingers and toes, and under your finger and toe nails. If you are balding, also apply to the scalp, hairline, temples, and forehead. If you accidentally get this medication in your eyes, flush with plenty of water right away. Children will need an adult to apply this medication for them. Wash your hands after applying this medication to someone else. Allow this medication to soak into skin and dry for a full 10 minutes before getting dressed. Use a timer or clock and start timing after you have completely covered your body with spinosad. Wait at least 6 hours before showering or bathing.To help prevent spread of scabies from one person to another, get household members checked by their health care professional. Avoid direct body-to-body contact with anyone who has scabies. Do not share clothing, towels, bedding, or linens with anyone else. Wash any bedding, clothing, and towels that you have used any time during the 3 days before treatment by washing in hot water and drying in a hot dryer, or by sealing in a plastic bag for at least 72 hours.Tell your doctor if your condition lasts or gets worse.

SIDE EFFECTS: Skin or eye irritation/redness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using spinosad, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: skin conditions or sensitivities.Constant or forceful scratching of the skin/scalp may lead to a bacterial skin infection. Tell your doctor right away if you develop worsening redness or pus.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant before using this medication.Spinosad does not pass into breast milk. However, it is unknown if an inactive ingredient in this medication, benzyl alcohol, may pass into breast milk and harm a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with another person unless directed to do so by your doctor.People who are in close contact with the infected person, such as members of the same household, should also be checked. Be sure to talk with your doctor about treatment for close contacts.

MISSED DOSE: Not applicable.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.