Soolantra: Targeted Topical Treatment for Inflammatory Rosacea Lesions
| Product dosage: 30 g | |||
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Synonyms | |||
Soolantra (ivermectin) Cream, 1% is a prescription-only topical medication specifically formulated for the treatment of inflammatory lesions of rosacea. It represents a significant advancement in dermatological therapy, offering a mechanism of action that targets both the inflammatory and potential parasitic components of this chronic skin condition. Developed through rigorous clinical research, it provides a well-tolerated, once-daily treatment option that simplifies patient routines while delivering clinically proven efficacy. This product card provides a comprehensive overview for healthcare professionals to aid in patient consultation and treatment decisions.
Features
- Contains 1% ivermectin as the active pharmaceutical ingredient.
- Formulated in a gentle, oil-in-water emulsion cream base.
- Designed for topical application to the face once daily.
- Presented in a 30-gram pump dispenser for precise dosing and hygiene.
- Prescription-only medication, ensuring supervised use.
- Demonstrated efficacy in reducing inflammatory lesion counts in pivotal Phase 3 studies.
Benefits
- Dual-Action Efficacy: Possesses both anti-inflammatory and anti-parasitic properties, targeting key suspected pathways in rosacea pathogenesis, including potential Demodex folliculorum mite involvement and subsequent inflammation.
- Sustained Improvement: Clinical trials show continuous improvement in inflammatory lesion count reduction over the entire 12-week treatment period, with many patients achieving and maintaining clear or almost clear skin.
- Superior Patient Tolerance: The non-comedogenic, hypoallergenic cream formulation is generally well-tolerated, minimizing treatment-related irritation which is a common cause of therapy discontinuation with other agents.
- Simplified Dosing Regimen: A once-daily application supports enhanced patient adherence compared to more complex multi-agent or multi-daily regimens, leading to better long-term outcomes.
- Positive Impact on Quality of Life: Effective reduction of papules and pustules associated with rosacea leads to significant improvements in patient self-esteem and quality of life measures.
Common use
Soolantra is indicated specifically for the topical treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients. It is not indicated for the treatment of other rosacea subtypes, such as erythematotelangiectatic rosacea (characterized primarily by flushing and persistent central facial erythema) or phymatous rosacea. Diagnosis should be confirmed by a healthcare professional to ensure appropriate treatment selection. It is intended for chronic use, as rosacea is a chronic condition, and patients may use it for extended periods under medical supervision.
Dosage and direction
- Dosage: Apply a pea-sized amount of Soolantra Cream, 1% once daily to the entire face (forehead, chin, nose, and each cheek). Avoid application to the eyes, lips, and mucous membranes.
- Administration: Dispense the pea-sized amount onto a fingertip. Divide into smaller amounts and apply to each of the five areas of the face (forehead, chin, nose, each cheek). Spread smoothly and evenly in a thin layer. The pump dispenser is designed to deliver an appropriate amount per actuation.
- Duration: Use once daily for the full duration prescribed. Clinical improvement may be observed as early as 2-4 weeks, with continued improvement through 12 weeks of treatment.
- Preparation: The face should be clean and dry before application. Patients may use moisturizers; if applied concurrently, it is generally recommended to apply Soolantra first and allow it to absorb before applying other products. Make-up can be applied after the cream has dried.
Precautions
- For Topical Use Only: Soolantra is for external use on the skin only. It must not be taken orally or applied intravaginally.
- Ocular Exposure: Avoid contact with the eyes and the immediate peri-ocular area. If contact occurs, rinse thoroughly with water.
- Irritation: If severe skin irritation or hypersensitivity occurs, treatment should be discontinued and appropriate therapy instituted.
- Sun Exposure: While the vehicle cream is not known to be phototoxic, patients with rosacea are generally advised to avoid excessive sun exposure, use sunscreen (minimum SPF 30), and wear protective clothing as part of overall skin management.
- Patient Information: Advise patients to read the accompanying Patient Information leaflet for complete instructions.
Contraindications
Soolantra Cream, 1% is contraindicated in patients with a known hypersensitivity to ivermectin or to any of the excipients in the formulation. The excipients include: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, sodium hydroxide, sorbitan monostearate, stearyl alcohol, and water.
Possible side effect
The most common adverse reactions reported in clinical trials were:
- Skin burning sensation (≤ 1%)
- Skin irritation (≤ 1%)
- Pruritus (itching) (≤ 1%)
- Dry skin (≤ 1%) These reactions were typically mild to moderate in severity. Other less common side effects may occur. Patients should be advised to report any persistent or severe local skin reactions (e.g., severe erythema, scaling, severe burning) to their healthcare provider.
Drug interaction
Formal drug interaction studies have not been conducted with topically applied Soolantra. Due to minimal systemic absorption following topical application (plasma concentrations are less than 1% of those achieved after a standard oral dose for parasitic infections), clinically significant drug interactions are not anticipated. However, as a precaution, patients should inform their healthcare provider of all prescription and over-the-counter medications they are using.
Missed dose
If a dose is missed, the patient should apply it as soon as remembered on that day. If a day is missed, the patient should not apply a double dose the next day to make up for the missed dose. Instead, they should resume the usual once-daily application schedule the following day.
Overdose
Topical application of Soolantra in excess of the recommended amount may lead to increased skin irritation, such as erythema, scaling, and discomfort. The product is intended for local use only and has low systemic absorption. Accidental oral ingestion may lead to systemic effects associated with ivermectin overdose (e.g., dizziness, nausea, vomiting, diarrhea). In case of accidental ingestion, seek medical attention or contact a Poison Control center immediately. Symptomatic and supportive care is recommended.
Storage
- Store at room temperature, between 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F and 86°F).
- Keep the tube and pump in the original carton to protect from light.
- Keep the container tightly closed.
- Keep out of reach of children and pets.
- Do not freeze.
Disclaimer
This information is intended for educational purposes of healthcare professionals and is a summary of key product characteristics. It is not a substitute for the full Prescribing Information or for the professional judgment of a healthcare provider. Please consult the official full Prescribing Information for complete details on indications, dosage, administration, contraindications, warnings, precautions, and adverse reactions before prescribing. Treatment decisions must be based on the individual patient’s clinical presentation and medical history.
Reviews
Soolantra has been evaluated in multiple large-scale, randomized, double-blind, vehicle-controlled clinical trials. In these studies, it demonstrated statistically significant superior efficacy over the vehicle cream (placebo) in reducing inflammatory lesion counts. A significantly greater proportion of patients achieved Investigator’s Global Assessment (IGA) scores of “clear” or “almost clear” compared to vehicle. The efficacy and safety profile has been consistently demonstrated, leading to its approval by regulatory authorities like the FDA and EMA. It is widely regarded in dermatological circles as a valuable first-line topical treatment for papulopustular rosacea.