Soolantra 1% Cream 45gm
It is used to treat rosacea.
Drug Class
Anti-inflammatory, Anti-parasitic
Pharmacologic Class
Avermectin
Pregnancy Category
Category C
FDA Approved
Dec 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Soolantra Cream is a prescription medicine used on the skin to treat bumps and pimples (inflammatory lesions) of rosacea. It contains ivermectin, which helps reduce inflammation and may also target tiny mites on the skin that are thought to 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 accompanying information carefully. Before and after applying the medication, wash your hands thoroughly.
Application Instructions
Do not take this medication by mouth. It is for topical use on the skin only.
Avoid getting the medication in your eyes, nose, mouth, or on your lips, as it may cause burning.
Do not apply the medication to the vaginal area.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Replace the cap after using the medication.
Storage and Disposal
Store the medication at room temperature, avoiding freezing.
Keep all medications in a safe 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. Consult your pharmacist for guidance on disposal or check for drug take-back programs in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. Before and after applying the medication, wash your hands thoroughly.
Application Instructions
Do not take this medication by mouth. It is for topical use on the skin only.
Avoid getting the medication in your eyes, nose, mouth, or on your lips, as it may cause burning.
Do not apply the medication to the vaginal area.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Replace the cap after using the medication.
Storage and Disposal
Store the medication at room temperature, avoiding freezing.
Keep all medications in a safe 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. Consult your pharmacist for guidance on disposal or check for drug take-back programs in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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 over the entire face, avoiding the eyes, lips, and mucous membranes.
- Wash hands immediately after applying the cream.
- Do not apply to open wounds or irritated skin.
- Cosmetics can be applied after the cream has dried.
- Avoid triggers that worsen rosacea (e.g., sun exposure, hot beverages, spicy foods, alcohol, stress, extreme temperatures).
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
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
Adolescent:
Not 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 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
The mechanism of action of Soolantra Cream in treating inflammatory lesions of rosacea is not fully understood. It is thought to have both anti-inflammatory effects by inhibiting LPS-induced production of inflammatory cytokines (e.g., TNF-alpha, IL-6, IL-8) and anti-parasitic effects by targeting *Demodex* mites, which are implicated in the pathogenesis of rosacea.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (Cmax ~1.1 ng/mL after 2 weeks of daily application)
Tmax:
Approximately 8-12 hours (systemic, after topical application)
FoodEffect:
Not applicable for topical administration
Distribution:
Vd:
Not precisely quantified for topical use, but widely distributed after systemic absorption.
ProteinBinding:
Approximately 99% (primarily to plasma proteins)
CnssPenetration:
Limited (due to low systemic absorption)
Elimination:
HalfLife:
Approximately 6 days (systemic, after topical application)
Clearance:
Not precisely quantified for topical use
ExcretionRoute:
Primarily fecal (via bile), <1% renal
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 4 weeks, with continued improvement up to 12 weeks.
PeakEffect:
Peak efficacy observed around 12 weeks of treatment.
DurationOfAction:
Effects persist as long as treatment is continued; relapse may occur after discontinuation.
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
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 drug was applied
- Burning
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. 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
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 drug was applied
- Burning
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact 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:
- Worsening of rosacea symptoms (e.g., increased redness, burning, stinging, itching)
- Severe skin irritation or allergic reaction (e.g., rash, hives, swelling)
- Eye irritation if cream gets into eyes
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 is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that this medication can be taken with all your current 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 is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that this medication can be taken with all your current 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 of 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 you are pregnant, planning to become pregnant, or are currently breast-feeding, you must discuss this with your doctor to carefully weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Due to minimal systemic absorption, overdose from topical application is unlikely. However, if accidentally ingested, symptoms could include nausea, vomiting, diarrhea, abdominal pain, dizziness, ataxia, tremor, seizures, or coma (based on systemic ivermectin overdose).
What to Do:
If accidental ingestion occurs, contact a poison control center immediately (Call 1-800-222-1222 in the US). Treatment is supportive.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of rosacea lesions
Rationale: To establish baseline severity and track treatment response.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical assessment of rosacea lesions (inflammatory papules and pustules)
Frequency: Every 4-12 weeks or as clinically indicated
Target: Reduction in lesion count and severity
Action Threshold: Lack of improvement after 12 weeks may warrant re-evaluation of diagnosis or treatment.
Skin irritation (e.g., burning, stinging, dryness, erythema)
Frequency: Regularly during treatment
Target: Minimal to no irritation
Action Threshold: Persistent or severe irritation may require temporary discontinuation or reduced frequency.
Symptom Monitoring
- Reduction in inflammatory lesions (papules and pustules)
- Improvement in skin redness (erythema)
- Absence of burning or stinging sensation
- Absence of dryness or itching
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown developmental toxicity at high oral doses, but systemic exposure from topical application is minimal.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show risk at high systemic doses.
Second Trimester:
Limited human data; animal studies show risk at high systemic doses.
Third Trimester:
Limited human data; animal studies show risk at high systemic doses.
Lactation
Ivermectin is excreted in human milk following oral administration. It is unknown whether topical application results in sufficient systemic absorption to produce detectable quantities in breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Low risk due to minimal systemic absorption, but caution advised. Monitor infant for potential adverse effects (e.g., diarrhea, lethargy).
Pediatric Use
Safety and effectiveness of Soolantra Cream in pediatric patients (under 18 years of age) have not been established for the treatment of rosacea.
Geriatric Use
No specific dose adjustment is required for elderly patients. Clinical studies included patients 65 years and older, and no overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Clinical Information
Clinical Pearls
- Soolantra is specifically indicated for the inflammatory lesions (papules and pustules) of rosacea, not for erythema (redness) alone.
- Patients should be advised that it may take several weeks (typically up to 12 weeks) to see the full therapeutic effect.
- A transient worsening of rosacea symptoms (e.g., increased redness, burning, stinging) can occur in some patients during the initial weeks of treatment, often referred to as a 'die-off' reaction, as *Demodex* mites are affected. This is usually temporary.
- Emphasize consistent daily application for optimal results.
- Advise patients to avoid contact with eyes, lips, and mucous membranes, and to wash hands after application.
Alternative Therapies
- Metronidazole topical (cream, gel, lotion)
- Azelaic acid topical (cream, gel, foam)
- Brimonidine topical (for erythema only)
- Oxymetazoline topical (for erythema only)
- Doxycycline (oral, low-dose for anti-inflammatory effects)
- Minocycline (oral)
Cost & Coverage
Average Cost:
$500 - $700 per 45gm tube
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's a good idea to check with your pharmacist. If you have any questions or concerns about your medication, don't hesitate to discuss them 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 detailed information, including the name of the medication taken, the amount, and the time it occurred.