Spinosad 0.9% Topical Susp 120ml
It is used to treat head lice.It is used to treat scabies.
Drug Class
Pediculicide
Pharmacologic Class
Spinosyn
Pregnancy Category
B
FDA Approved
Jan 2011
DEA Schedule
Not Controlled
Overview
What is this medicine?
Spinosad is a medicine used on the scalp and hair to kill head lice. It works by affecting the nervous system of the lice, causing them to die. It's applied to dry hair, left on for 10 minutes, and then rinsed off.
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 this is not necessary, as the medication also kills 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 all areas 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 this is not necessary, as the medication also kills 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 all areas 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
- Apply to dry hair only.
- Ensure entire scalp and all hair are thoroughly covered.
- Leave on for exactly 10 minutes, then rinse thoroughly with warm water.
- Do not use a conditioner immediately after rinsing.
- Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
- Do not swallow. For external use only.
- Wash hands thoroughly after applying.
- Check for live lice 7 days after the first treatment; if live lice are still present, apply a second treatment.
- Clean personal items (combs, brushes) and wash bedding/clothing in hot water (130°F/54°C) or dry clean to prevent reinfestation.
Available Forms & Alternatives
Available Strengths:
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:
Single application, repeat in 7 days if needed.
Pediatric Dosing
Neonatal:
Not established (contraindicated in infants under 6 months due to potential for benzyl alcohol toxicity)
Infant:
Approved for infants 6 months of age and older. Apply sufficient amount 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.
Child:
Approved for children 6 months of age and older. Apply sufficient amount 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 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 (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 insects, leading to involuntary muscle contractions, prostration, and death. It is thought to activate nicotinic acetylcholine receptors in the insect nervous system, but at a novel binding site.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<0.003% in clinical trials)
Tmax:
Not clinically relevant due to minimal systemic absorption
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not clinically relevant due to minimal systemic absorption
ProteinBinding:
Not clinically relevant due to minimal systemic absorption
CnssPenetration:
Limited (not clinically relevant due to minimal systemic absorption)
Elimination:
HalfLife:
Not clinically relevant due to minimal systemic absorption
Clearance:
Not clinically relevant due to 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:
Within 10 minutes of application (duration of contact)
DurationOfAction:
Sufficient to kill lice during the 10-minute application; residual activity not significant after rinsing.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening 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
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you have side effects that bother you or persist, contact your doctor for guidance.
Reporting Side Effects
If you have questions or concerns about side effects, don't hesitate to reach out to your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening 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
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you have side effects that bother you or persist, contact your doctor for guidance.
Reporting Side Effects
If you have questions or concerns about side effects, don't hesitate to reach out to your doctor for medical advice. 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
- Redness or swelling of the scalp
- Burning or stinging sensation that worsens
- Signs of allergic reaction (rash, hives, difficulty breathing)
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, including allergies to this medication, its components, or other substances, such as foods or 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 suitable for infants younger than 6 months.
If the patient is being treated for scabies and is under 4 years of age, as this medication is not approved for use in children younger than 4 years.
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions.
To guarantee safe use, consult your doctor and pharmacist about all your medications and health issues before starting, stopping, or changing the dose of any medication, including this one.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or 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 suitable for infants younger than 6 months.
If the patient is being treated for scabies and is under 4 years of age, as this medication is not approved for use in children younger than 4 years.
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions.
To guarantee safe use, consult your doctor and pharmacist about all your medications and health issues before starting, stopping, or changing the dose of any medication, including this one.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all 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 or infants if administered via intravenous injection. As a result, this drug is not approved for use in children under 6 months of age.
If this medication is ingested, it can cause harm. In the event of accidental ingestion, immediately contact a doctor or poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication to ensure the best outcome for 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 minimize exposure.
When taking this medication, it is essential to inform all 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 or infants if administered via intravenous injection. As a result, this drug is not approved for use in children under 6 months of age.
If this medication is ingested, it can cause harm. In the event of accidental ingestion, immediately contact a doctor or poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication to ensure the best outcome for 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 minimize exposure.
Overdose Information
Overdose Symptoms:
- Unlikely with topical use due to minimal absorption. If ingested, symptoms could include nausea, vomiting, abdominal pain.
What to Do:
If ingested, call a Poison Control Center immediately (1-800-222-1222) or seek emergency medical attention. For topical overdose, rinse thoroughly with water.
Drug Interactions
Monitoring
Baseline Monitoring
Presence of live lice
Rationale: To confirm diagnosis and need for treatment
Timing: Prior to first application
Routine Monitoring
Presence of live lice
Frequency: 7 days after first application
Target: No live lice
Action Threshold: If live lice are still observed, repeat treatment.
Skin irritation/adverse reactions
Frequency: During and after application
Target: No significant irritation
Action Threshold: Discontinue if severe irritation occurs.
Symptom Monitoring
- Scalp itching
- Redness
- Irritation
- Burning sensation
Special Patient Groups
Pregnancy
Category B. Animal studies have not shown harm to the fetus, and systemic absorption in humans is minimal, suggesting low risk. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
L3 (Moderately Safe). Minimal systemic absorption makes it unlikely to cause adverse effects in a breastfed infant. Caution is advised, and benefits of breastfeeding should be weighed against potential risks.
Infant Risk:
Low risk due to minimal maternal systemic absorption.
Pediatric Use
Approved for use in infants 6 months of age and older. Not recommended for infants under 6 months due to the benzyl alcohol content, which may cause serious adverse reactions (e.g., 'gasping syndrome').
Geriatric Use
No specific dose adjustments are necessary for geriatric patients. The safety and efficacy profile is expected to be similar to that in younger adults due to minimal systemic absorption.
Clinical Information
Clinical Pearls
- Spinosad is effective against both lice and nits (eggs), often eliminating the need for nit-combing, though combing can be done to remove dead lice and nits.
- It is a non-neurotoxic alternative to some other pediculicides, making it a good option for resistance management.
- Ensure the hair is dry before application for optimal efficacy.
- The 10-minute contact time is crucial for effectiveness; do not leave on for longer or shorter periods.
- Benzyl alcohol content makes it contraindicated in infants younger than 6 months.
Alternative Therapies
- Permethrin (Nix, Elimite)
- Malathion (Ovide)
- Ivermectin topical (Sklice)
- Benzyl alcohol lotion (Ulesfia)
- Dimethicone (various brands)
- Pyrethrins with piperonyl butoxide (Rid, A-200)
Cost & Coverage
Average Cost:
Varies widely, typically high per 120 mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (may require prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.