Natroba 0.9% Topical Suspension
It is used to treat head lice.It is used to treat scabies.
Drug Class
Pediculicide
Pharmacologic Class
Spinosyn
Pregnancy Category
Not assigned (Risk Summary available)
FDA Approved
Jan 2011
DEA Schedule
Not Controlled
Overview
What is this medicine?
Natroba is a medicine used to treat head lice in people 6 months of age and older. It works by killing the lice and their eggs (nits). You apply it to dry hair, leave it on for 10 minutes, and then rinse it off. A second application may be needed after 7 days.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully to ensure safe and effective treatment.
Treatment for Lice:
Apply the medication only to your scalp and hair. Avoid getting it in your mouth, nose, ears, or eyes, as it may cause burning.
Wash your hands before and after applying the medication.
Cover your eyes and face with a towel and keep your eyes closed tightly during application.
Shake the medication well before use.
Do not wet your hair before applying the medication.
Coat your hair and scalp evenly with the medication.
Leave the medication on for 10 minutes, then rinse your hair thoroughly with warm water. You can use shampoo after rinsing out the medication.
To remove dead nits (lice eggs) from your hair, you can use a special nit comb or tweezers, but it is not necessary to remove them, as the medication will also kill the nits.
Wash all hair combs, brushes, hair clips, bedding, towels, and recently worn clothes in hot water or have them dry cleaned to prevent re-infestation.
Treatment for Scabies:
Apply the medication only to your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
Shake the medication well before use.
Apply a thin layer of the medication to your skin, covering the area from the neck to the toes. Be sure to apply it to skin folds, creases, and the spaces between your fingers and toes, as well as the soles of your feet.
If you are balding, apply the medication to your scalp, hairline, temples, and forehead.
Allow the medication to dry for at least 10 minutes before covering the treated area with clothes or gloves.
Avoid bathing, showering, or swimming for 6 hours after applying the medication.
Apply the medication under your fingernails as well.
Wash all bedding, towels, and recently worn clothes in hot water or have them dry cleaned to prevent re-infestation.
Storage and Disposal
Store the medication at room temperature.
Missed Dose
If you miss a dose, apply it as soon as you remember.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully to ensure safe and effective treatment.
Treatment for Lice:
Apply the medication only to your scalp and hair. Avoid getting it in your mouth, nose, ears, or eyes, as it may cause burning.
Wash your hands before and after applying the medication.
Cover your eyes and face with a towel and keep your eyes closed tightly during application.
Shake the medication well before use.
Do not wet your hair before applying the medication.
Coat your hair and scalp evenly with the medication.
Leave the medication on for 10 minutes, then rinse your hair thoroughly with warm water. You can use shampoo after rinsing out the medication.
To remove dead nits (lice eggs) from your hair, you can use a special nit comb or tweezers, but it is not necessary to remove them, as the medication will also kill the nits.
Wash all hair combs, brushes, hair clips, bedding, towels, and recently worn clothes in hot water or have them dry cleaned to prevent re-infestation.
Treatment for Scabies:
Apply the medication only to your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
Shake the medication well before use.
Apply a thin layer of the medication to your skin, covering the area from the neck to the toes. Be sure to apply it to skin folds, creases, and the spaces between your fingers and toes, as well as the soles of your feet.
If you are balding, apply the medication to your scalp, hairline, temples, and forehead.
Allow the medication to dry for at least 10 minutes before covering the treated area with clothes or gloves.
Avoid bathing, showering, or swimming for 6 hours after applying the medication.
Apply the medication under your fingernails as well.
Wash all bedding, towels, and recently worn clothes in hot water or have them dry cleaned to prevent re-infestation.
Storage and Disposal
Store the medication at room temperature.
Missed Dose
If you miss a dose, apply it as soon as you remember.
Lifestyle & Tips
- Do not use a regular conditioner or shampoo immediately before applying Natroba, as this may reduce its effectiveness.
- Do not use a hair dryer after treatment, as this may reduce effectiveness.
- Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
- Wash hands thoroughly after applying the product.
- Comb out dead lice and nits with a fine-toothed comb after treatment.
- Wash all clothing, bedding, and towels that have been in contact with the infested person in hot water (at least 130°F or 54°C) and dry on high heat.
- Vacuum carpets and upholstered furniture.
- Seal non-washable items in a plastic bag for two weeks.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply sufficient amount (up to 120 mL) to dry hair to thoroughly cover the scalp and hair. Leave on for 10 minutes, then rinse thoroughly with warm water. Repeat treatment in 7 days if live lice are still observed.
Condition-Specific Dosing:
headLice:
Apply to dry hair, leave for 10 minutes, rinse. Repeat in 7 days if needed.
Pediatric Dosing
Neonatal:
Not established (Safety and efficacy not established in infants younger than 6 months of age).
Infant:
Not established (Safety and efficacy not established in infants younger than 6 months of age).
Child:
For children 6 months of age and older: Apply sufficient amount (up to 120 mL) to dry hair to thoroughly cover the scalp and hair. Leave on for 10 minutes, then rinse thoroughly with warm water. Repeat treatment in 7 days if live lice are still observed.
Adolescent:
Apply sufficient amount (up to 120 mL) to dry hair to thoroughly cover the scalp and hair. Leave on for 10 minutes, then rinse thoroughly with warm water. Repeat treatment in 7 days if live lice are still observed.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Pharmacology
Mechanism of Action
Spinosad is a pediculicide that causes neuronal excitation in lice, leading to involuntary muscle contractions, prostration, and paralysis, ultimately resulting in their death. It is thought to act by targeting nicotinic acetylcholine receptors and GABA-gated chloride channels in insects.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 0.003% of applied dose)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Rapid (lice begin to die shortly after exposure)
PeakEffect:
Not precisely defined for topical application, but efficacy observed after 10-minute application.
DurationOfAction:
Single application effective for killing lice and nits; a second application is recommended in 7 days to kill newly hatched lice.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you notice any of the following symptoms, which could indicate a serious reaction:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Irritation at the site where the medication was applied
* Eye irritation
Other Possible Side Effects
As with any medication, side effects can occur. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any side effects that bother you or persist, contact your doctor for guidance.
Please note that this list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you notice any of the following symptoms, which could indicate a serious reaction:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Irritation at the site where the medication was applied
* Eye irritation
Other Possible Side Effects
As with any medication, side effects can occur. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any side effects that bother you or persist, contact your doctor for guidance.
Please note that this list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe scalp irritation or redness
- Swelling of the face or tongue
- Difficulty breathing (rare, but seek immediate medical attention)
- Signs of allergic reaction
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have to this medication, its components, or other substances, including foods and drugs. Be sure to describe the symptoms you experienced.
If the patient is a child under 6 months of age, as this medication is not recommended for infants younger than 6 months.
If the patient is being treated for scabies and is under 4 years of age, since this medication is not approved for use in children younger than 4 years.
Additionally, to ensure safe use, tell your doctor and pharmacist about:
All medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
* Any health problems you have, as this medication may interact with other drugs or health conditions.
It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have to this medication, its components, or other substances, including foods and drugs. Be sure to describe the symptoms you experienced.
If the patient is a child under 6 months of age, as this medication is not recommended for infants younger than 6 months.
If the patient is being treated for scabies and is under 4 years of age, since this medication is not approved for use in children younger than 4 years.
Additionally, to ensure safe use, tell your doctor and pharmacist about:
All medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
* Any health problems you have, as this medication may interact with other drugs or health conditions.
It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use.
This medication contains benzyl alcohol, which can cause severe and potentially life-threatening side effects in newborns and infants under 6 months of age if administered via intravenous injection. As a result, this drug is not approved for use in this age group.
Ingestion of this medication can be harmful. If you accidentally swallow this drug, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential benefits and risks to you and your baby.
Special Considerations for Scabies Treatment
If you are breastfeeding and apply this medication to your breast or nipple, be sure to wash the area thoroughly before nursing your child to avoid any potential exposure.
When taking this medication, it is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use.
This medication contains benzyl alcohol, which can cause severe and potentially life-threatening side effects in newborns and infants under 6 months of age if administered via intravenous injection. As a result, this drug is not approved for use in this age group.
Ingestion of this medication can be harmful. If you accidentally swallow this drug, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential benefits and risks to you and your baby.
Special Considerations for Scabies Treatment
If you are breastfeeding and apply this medication to your breast or nipple, be sure to wash the area thoroughly before nursing your child to avoid any potential exposure.
Overdose Information
Overdose Symptoms:
- Not expected with topical use due to minimal systemic absorption. Ingestion could lead to gastrointestinal upset.
What to Do:
Call 1-800-222-1222 (Poison Control Center) for advice. If ingested, seek medical attention. For topical overuse, rinse thoroughly with water.
Drug Interactions
Monitoring
Routine Monitoring
Presence of live lice
Frequency: 7 days after initial treatment
Target: No live lice
Action Threshold: If live lice are observed, repeat treatment.
Scalp irritation/redness
Frequency: During and after treatment
Target: No significant irritation
Action Threshold: Discontinue if severe irritation occurs.
Symptom Monitoring
- Scalp itching
- Scalp redness
- Skin irritation
- Eye irritation (if contact occurs)
Special Patient Groups
Pregnancy
Limited data on Spinosad use in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal studies did not show adverse developmental effects at clinically relevant exposures. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies suggest low risk at therapeutic doses.
Second Trimester:
Limited human data; animal studies suggest low risk at therapeutic doses.
Third Trimester:
Limited human data; animal studies suggest low risk at therapeutic doses.
Lactation
Spinosad and its metabolites are minimally absorbed systemically following topical application, making infant exposure via breast milk unlikely. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Natroba and any potential adverse effects on the breastfed infant from Natroba or from the underlying maternal condition.
Infant Risk:
Low risk due to minimal systemic absorption.
Pediatric Use
Approved for use in children 6 months of age and older. Safety and efficacy not established in infants younger than 6 months.
Geriatric Use
No specific dose adjustments or precautions are necessary for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, due to minimal systemic absorption, no age-related differences in safety or efficacy are expected.
Clinical Information
Clinical Pearls
- Natroba is effective against both lice and nits (eggs), reducing the need for extensive nit-picking, though combing out dead lice and nits is still recommended.
- It is important to apply the suspension to DRY hair, as water can dilute the product and reduce its effectiveness.
- A second application 7 days after the first is crucial to kill any newly hatched lice that may have emerged from eggs that survived the initial treatment.
- Unlike some other pediculicides, Natroba does not require special shampoos or conditioners before or after use, but avoid using them immediately before application.
- Ensure thorough coverage of the scalp and all hair strands for optimal efficacy.
Alternative Therapies
- Permethrin (Nix, Elimite)
- Malathion (Ovide)
- Ivermectin topical (Sklice)
- Benzyl alcohol (Ulesfia)
- Lindane (Kwell - generally not recommended due to toxicity)
- Dimethicone (various OTC products)
- Pyrethrins with piperonyl butoxide (Rid, A-200)
Cost & Coverage
Average Cost:
Price varies widely, typically $200-$300+ per 120 mL bottle
Insurance Coverage:
Tier 2 or 3 (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.