Ivermectin 0.5% Lotion
It is used to treat head lice.
Drug Class
Anti-inflammatory, Anti-parasitic
Pharmacologic Class
Avermectin
Pregnancy Category
Not available
FDA Approved
Dec 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ivermectin lotion is a medication applied to the skin to treat rosacea, a common skin condition that causes redness and bumps on the face. It works by reducing inflammation and targeting tiny mites that may contribute to rosacea.
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 use this medication only as directed.
Application Instructions
Apply this medication only to your scalp and hair. Avoid getting it in your mouth, nose, ears, or eyes, as it may cause burning.
If you accidentally get the medication in any of these areas, rinse them thoroughly with water.
If you have lice in your eyebrows or eyelashes, consult your doctor before using this medication. Do not apply it to these areas.
To apply the medication, cover your eyes and face with a towel and keep your eyes closed tightly.
Do not wet your hair before applying the medication. Instead, rub it into your dry hair and scalp thoroughly.
After application, wash your hands with soap and water.
Leave the medication on your hair and scalp for 10 minutes, then rinse your hair and scalp with water only.
After rinsing, discard any remaining medication.
Post-Treatment Instructions
Wait 24 hours after treatment before shampooing your hair and scalp.
Use a special nit comb or tweezers to remove dead nits (lice eggs) from your hair.
Wash all bedding, towels, and recently worn clothing in hot water or have them dry cleaned.
Wash all combs, brushes, and hair clips in hot water to prevent re-infestation.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures.
Missed Dose
Typically, only one dose of this medication is needed. If you forget to apply the 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 use this medication only as directed.
Application Instructions
Apply this medication only to your scalp and hair. Avoid getting it in your mouth, nose, ears, or eyes, as it may cause burning.
If you accidentally get the medication in any of these areas, rinse them thoroughly with water.
If you have lice in your eyebrows or eyelashes, consult your doctor before using this medication. Do not apply it to these areas.
To apply the medication, cover your eyes and face with a towel and keep your eyes closed tightly.
Do not wet your hair before applying the medication. Instead, rub it into your dry hair and scalp thoroughly.
After application, wash your hands with soap and water.
Leave the medication on your hair and scalp for 10 minutes, then rinse your hair and scalp with water only.
After rinsing, discard any remaining medication.
Post-Treatment Instructions
Wait 24 hours after treatment before shampooing your hair and scalp.
Use a special nit comb or tweezers to remove dead nits (lice eggs) from your hair.
Wash all bedding, towels, and recently worn clothing in hot water or have them dry cleaned.
Wash all combs, brushes, and hair clips in hot water to prevent re-infestation.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures.
Missed Dose
Typically, only one dose of this medication is needed. If you forget to apply the dose, apply it as soon as you remember.
Lifestyle & Tips
- Apply a pea-sized amount to each of the five areas of the face (forehead, chin, nose, and each cheek) once daily.
- Spread thinly and evenly across the entire face, avoiding the eyes, lips, and mucous membranes.
- Wash hands immediately after applying the lotion.
- Do not apply to open wounds or irritated skin.
- Cosmetics can be applied after the lotion has dried.
- Continue treatment as prescribed, as improvement may take several weeks.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a pea-sized amount to each of the five areas of the face (forehead, chin, nose, and each cheek) once daily.
Condition-Specific Dosing:
rosacea:
Apply once daily to affected areas of the face.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and effectiveness in pediatric patients under 18 years of age have not been established).
Adolescent:
Not established (Safety and effectiveness in pediatric patients under 18 years of age have not been established).
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).
Confidence:
Medium
Pharmacology
Mechanism of Action
Ivermectin is a member of the avermectin class of drugs. Its mechanism of action in treating inflammatory lesions of rosacea is not fully understood but is thought to be multifactorial. It is believed to have both anti-inflammatory effects (e.g., by inhibiting pro-inflammatory cytokine production) and anti-parasitic effects against Demodex mites, which are implicated in the pathogenesis of rosacea.
Pharmacokinetics
Absorption:
Bioavailability:
Low (minimal systemic absorption after topical application)
Tmax:
Approximately 8-12 hours (for plasma concentrations after topical application)
FoodEffect:
Not applicable for topical formulation
Distribution:
Vd:
Not precisely quantified for topical use due to minimal systemic absorption
ProteinBinding:
Approximately 99% (primarily to plasma proteins, based on oral data)
CnssPenetration:
Limited (minimal systemic exposure)
Elimination:
HalfLife:
Approximately 6 days (for plasma concentrations after topical application, due to slow elimination from skin)
Clearance:
Not precisely quantified for topical use
ExcretionRoute:
Primarily fecal (as metabolites and unchanged drug)
Unchanged:
Less than 1% in urine
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 4 weeks, with continued improvement over 12 weeks.
PeakEffect:
Peak efficacy observed around 12 weeks of continuous use.
DurationOfAction:
Effects persist as long as treatment is continued; relapse may occur after discontinuation.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- 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
- 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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Irritation at the site where the medication was applied
- Burning sensation
- Dry skin
- Dandruff
Additional Information
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- 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
- 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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Irritation at the site where the medication was applied
- Burning sensation
- Dry skin
- Dandruff
Additional Information
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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 burning, stinging, or itching after application
- Worsening of rosacea symptoms
- Allergic reactions such as rash, hives, swelling of the face/lips/tongue, difficulty breathing (rare, seek immediate medical attention)
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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
If this medication is accidentally swallowed, it can be harmful. In such cases, immediately contact a doctor or a poison control center for assistance.
To ensure the medication's effectiveness, follow up with your doctor if you still see live lice 7 days after treatment.
This medication is not recommended for infants under 6 months of age. Do not administer it to children of this age group.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of using this medication, both for you and your baby.
If this medication is accidentally swallowed, it can be harmful. In such cases, immediately contact a doctor or a poison control center for assistance.
To ensure the medication's effectiveness, follow up with your doctor if you still see live lice 7 days after treatment.
This medication is not recommended for infants under 6 months of age. Do not administer it to children of this age group.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of using this medication, both for you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely due to minimal systemic absorption.
- If accidentally ingested, symptoms could include nausea, vomiting, diarrhea, abdominal pain, dizziness, ataxia, seizures, or coma (based on oral overdose data).
What to Do:
If accidental ingestion occurs, contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention. Treatment is generally supportive.
Drug Interactions
Monitoring
Routine Monitoring
Clinical assessment of rosacea lesions (erythema, papules, pustules)
Frequency: Periodically (e.g., at 4, 8, 12 weeks, then as needed)
Target: Reduction in lesion count and severity
Action Threshold: Lack of improvement after 12 weeks may warrant re-evaluation of diagnosis or treatment plan.
Skin irritation/adverse reactions (e.g., burning, stinging, dryness, pruritus)
Frequency: During initial weeks of treatment and as needed
Target: Minimal to no irritation
Action Threshold: Persistent or severe irritation may require temporary discontinuation or reduction in frequency.
Symptom Monitoring
- Reduction in inflammatory lesions (papules and pustules)
- Improvement in erythema (redness)
- Absence of skin irritation, burning, stinging, dryness, or pruritus
Special Patient Groups
Pregnancy
Available data from published case reports and an observational study on ivermectin use in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Systemic exposure to ivermectin following topical administration is low. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Insufficient data to establish risk; low systemic exposure suggests low risk.
Second Trimester:
Insufficient data to establish risk; low systemic exposure suggests low risk.
Third Trimester:
Insufficient data to establish risk; low systemic exposure suggests low risk.
Lactation
It is not known whether ivermectin is excreted in human milk following topical administration. Orally administered ivermectin is excreted in human milk. Due to minimal systemic absorption, the amount transferred to breast milk is expected to be very low. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.
Infant Risk:
Low risk (L3) due to minimal systemic absorption.
Pediatric Use
Safety and effectiveness in pediatric patients under 18 years of age have not been established. Use is generally not recommended in this population.
Geriatric Use
No dosage adjustment is necessary for elderly 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 specific geriatric-related precautions are generally needed.
Clinical Information
Clinical Pearls
- Ivermectin lotion is specifically formulated for inflammatory lesions of rosacea, not for other skin conditions.
- Patients should be advised that improvement may not be seen for several weeks, and continued use is necessary for optimal results.
- Transient worsening of rosacea symptoms (e.g., redness, stinging, burning) can occur during the initial weeks of treatment, which is often a sign of the medication working (mite die-off reaction). Patients should be counseled on this possibility to encourage adherence.
- Avoid contact with eyes, lips, and mucous membranes. If accidental contact occurs, rinse thoroughly with water.
- This product is for external use only.
Alternative Therapies
- Metronidazole topical (cream, gel, lotion)
- Azelaic acid topical (gel, foam, cream)
- Brimonidine topical (for erythema)
- Oxymetazoline topical (for erythema)
- Doxycycline (oral, low-dose for anti-inflammatory effects)
- Oral isotretinoin (for severe, refractory rosacea)
Cost & Coverage
Average Cost:
Varies widely, typically $400-$600+ per 45g tube of brand-name Soolantra
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 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.