Ivermectin 1% Cream 45gm
It is used to treat rosacea.
Drug Class
Anti-inflammatory agent; Anti-parasitic
Pharmacologic Class
Avermectin
Pregnancy Category
Category C
FDA Approved
Dec 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ivermectin 1% cream is a topical medication used to treat the bumps and redness (inflammatory lesions) caused by rosacea, a common skin condition. It works by reducing inflammation and possibly by targeting tiny mites on the skin 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. Before and after applying the medication, wash your hands thoroughly.
This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Do not ingest it, as it is not intended for oral use. Avoid getting the medication in your eyes, nose, mouth, or vagina, as it may cause irritation or burning. If you accidentally get the medication in your eyes, rinse them with water immediately.
Before applying the medication, clean the affected area and dry it thoroughly. Then, apply a thin layer of the medication to the affected skin and gently rub it in. After use, replace the cap to maintain the medication's potency.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures. Keep all medications in a secure location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not apply extra doses or two doses at once to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Before and after applying the medication, wash your hands thoroughly.
This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Do not ingest it, as it is not intended for oral use. Avoid getting the medication in your eyes, nose, mouth, or vagina, as it may cause irritation or burning. If you accidentally get the medication in your eyes, rinse them with water immediately.
Before applying the medication, clean the affected area and dry it thoroughly. Then, apply a thin layer of the medication to the affected skin and gently rub it in. After use, replace the cap to maintain the medication's potency.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures. Keep all medications in a secure location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not apply extra doses or two doses at once to make up for a missed dose.
Lifestyle & Tips
- Apply a thin layer to the affected areas of the face once daily, avoiding eyes, lips, and mucous membranes.
- Wash hands after application.
- Do not apply cosmetics or other topical products until the cream has dried.
- Continue to use sunscreen and protective clothing, and avoid rosacea triggers (e.g., spicy foods, alcohol, hot beverages, extreme temperatures) as advised by your doctor.
- It may take several weeks to see improvement; continue treatment as prescribed.
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.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in pediatric patients under 18 years of age).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
The mechanism of action of ivermectin cream in treating inflammatory lesions of rosacea is not fully understood. It is thought to have both anti-inflammatory effects by inhibiting inflammatory cytokines (e.g., TNF-alpha, IL-6, IL-8) and anti-parasitic effects against Demodex mites, which are implicated in the pathogenesis of rosacea.
Pharmacokinetics
Absorption:
Bioavailability:
Low systemic absorption (mean Cmax of 0.9 ng/mL after 2 weeks of daily application)
Tmax:
Approximately 10 hours (systemic)
FoodEffect:
Not applicable for topical administration
Distribution:
Vd:
Not available (systemic distribution is low)
ProteinBinding:
Approximately 99% (systemic)
CnssPenetration:
Limited (due to low systemic absorption)
Elimination:
HalfLife:
Approximately 5.6 days (systemic, after topical application)
Clearance:
Not available
ExcretionRoute:
Primarily fecal (systemic)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 4 weeks
PeakEffect:
Maximal effect may take up to 12 weeks
DurationOfAction:
Sustained improvement with continued use
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following severe side effects, contact your doctor immediately or seek emergency medical attention. Although rare, some individuals may be at risk of life-threatening reactions when taking this medication. Be aware of the following signs and symptoms that may indicate a serious side effect:
- Allergic reaction symptoms, such as rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever)
- Respiratory issues, including wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking
- Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
As with any medication, side effects can occur. While many people may not experience any side effects or only mild ones, it's essential to monitor your response to the drug. If you notice any of the following side effects or any other unusual effects, consult your doctor for advice:
- Irritation at the site of application
- Burning sensation
Please note that this list is not exhaustive, and you may experience other side effects not mentioned here. If you have concerns or questions about side effects, don't hesitate to reach out to your doctor.
Reporting Side Effects
If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is also available to provide guidance and support regarding side effects.
If you experience any of the following severe side effects, contact your doctor immediately or seek emergency medical attention. Although rare, some individuals may be at risk of life-threatening reactions when taking this medication. Be aware of the following signs and symptoms that may indicate a serious side effect:
- Allergic reaction symptoms, such as rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever)
- Respiratory issues, including wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking
- Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
As with any medication, side effects can occur. While many people may not experience any side effects or only mild ones, it's essential to monitor your response to the drug. If you notice any of the following side effects or any other unusual effects, consult your doctor for advice:
- Irritation at the site of application
- Burning sensation
Please note that this list is not exhaustive, and you may experience other side effects not mentioned here. If you have concerns or questions about side effects, don't hesitate to reach out to your doctor.
Reporting Side Effects
If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is also available to provide guidance and support regarding side effects.
Seek Immediate Medical Attention If You Experience:
- Severe burning, stinging, or itching after application
- Worsening of rosacea symptoms
- Allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, 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 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 identify 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 with all your current medications and health conditions. Never start, stop, or adjust the dose 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 identify 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 with all your current medications and health conditions. Never start, stop, or adjust the dose 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 drug is accidentally ingested, it can be harmful, so it is crucial to contact a doctor or a poison control center immediately if swallowing occurs. If you are pregnant, planning to become pregnant, or are currently breast-feeding, you must discuss this with your doctor. This discussion will help you understand the potential benefits and risks of using this medication during pregnancy or breast-feeding, allowing you to make an informed decision about your care and the well-being of your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with topical application due to minimal systemic absorption. However, if ingested, symptoms could include nausea, vomiting, diarrhea, abdominal pain, dizziness, ataxia, seizures, or coma.
What to Do:
If accidental ingestion occurs, seek immediate medical attention or call a Poison Control Center (1-800-222-1222).
Drug Interactions
Monitoring
Baseline Monitoring
Diagnosis of Rosacea
Rationale: To confirm appropriate indication for treatment.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical improvement of inflammatory lesions (papules and pustules)
Frequency: Monthly during initial treatment, then as clinically indicated
Target: Reduction in lesion count and erythema
Action Threshold: If no improvement after 12 weeks, reassess diagnosis or treatment plan.
Skin irritation (e.g., burning, stinging, dryness, pruritus)
Frequency: Regularly, especially during initial weeks
Target: Minimal to no irritation
Action Threshold: If severe or persistent irritation occurs, consider temporary discontinuation or reduced frequency.
Symptom Monitoring
- Reduction in inflammatory lesions (papules and pustules)
- Reduction in erythema (redness)
- Absence of burning or stinging sensation
- Absence of dryness or pruritus
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Animal studies have shown some developmental toxicity at high oral doses, but systemic exposure from topical application is minimal.
Trimester-Specific Risks:
First Trimester:
Limited data, but systemic exposure is low.
Second Trimester:
Limited data, but systemic exposure is low.
Third Trimester:
Limited data, but systemic exposure is low.
Lactation
It is not known whether ivermectin is excreted in human milk following topical application. Due to the low systemic absorption, exposure to the infant is expected to be minimal. However, caution should be exercised. Consider the developmental and health benefits of breastfeeding, 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, but monitor for potential adverse effects.
Pediatric Use
Safety and effectiveness in pediatric patients under 18 years of age have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects. No dosage adjustment is needed.
Clinical Information
Clinical Pearls
- Ivermectin cream is specifically indicated for the inflammatory lesions (papules and pustules) of rosacea, not for erythema (redness) alone, although some improvement in redness may be observed.
- Patients should be advised that clinical improvement may not be seen for several weeks, and full therapeutic effect may take up to 12 weeks.
- Transient worsening of rosacea symptoms (e.g., burning, stinging, itching, or worsening of lesions) can occur during the initial weeks of treatment, often referred to as a 'die-off' reaction, as Demodex mites are affected. This is usually mild and resolves with continued use.
- Emphasize the importance of consistent, once-daily application for optimal results.
- Avoid contact with eyes, lips, and mucous membranes. If accidental contact occurs, rinse thoroughly with water.
Alternative Therapies
- Metronidazole topical (cream, gel, lotion)
- Azelaic acid topical (cream, gel, foam)
- Brimonidine topical (for erythema)
- Oxymetazoline topical (for erythema)
- Doxycycline (oral, low-dose for anti-inflammatory effects)
- Oral isotretinoin (for severe, refractory cases)
Cost & Coverage
Average Cost:
$400 - $600 per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
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 your 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.