Soolantra

Soolantra 1% Cream is a medicine used in the treatment of rosacea, which is an inflammatory condition that affects face. It helps in reducing the redness, swelling and pimples associated with rosacea.

Product dosage: 30 g
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Synonyms Ivrea

Soolantra (ivermectin) Cream, 1% is a prescription-only topical medication specifically formulated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients. Its mechanism of action is distinct, targeting both the inflammatory and potential parasitic components believed to contribute to this chronic facial skin condition. This cream offers a once-daily, targeted approach to reduce the visible redness and bumpiness associated with rosacea, helping to restore skin clarity and improve quality of life. Clinical studies have demonstrated its efficacy and favorable safety profile for long-term management.

Features

• Contains 1% ivermectin as the active pharmaceutical ingredient.
• Formulated in a soothing, oil-in-water emollient cream base.
• Designed for topical application to the facial skin only.
• Prescription-only medication, ensuring supervised use.
• Supplied in a 30-gram or 45-gram tube with child-resistant closure.

Benefits

• Targeted Anti-inflammatory and Anti-parasitic Action: Ivermectin is believed to reduce rosacea lesions through its dual anti-inflammatory and potential anti-parasitic (demodicidal) effects, addressing key suspected pathophysiological factors.
• Significant Reduction in Inflammatory Lesion Count: Demonstrated in clinical trials to significantly reduce the mean number of inflammatory papules and pustules compared to vehicle (placebo) cream.
• Sustained Efficacy and Long-Term Use: Proven to be effective and well-tolerated in studies lasting up to 52 weeks, making it suitable for the chronic management of rosacea.
• Once-Daily Dosing Regimen: Simplifies the treatment routine, potentially improving patient adherence compared to more complex multi-dose regimens.
• Favorable Local Tolerability Profile: The cream base is generally well-tolerated, with most adverse reactions being mild and transient.
• Improvement in Patient-Reported Outcomes: Patients using Soolantra have reported improvements in their quality of life related to the appearance of their skin.

Common use

Soolantra Cream is indicated specifically for the topical treatment of inflammatory lesions of rosacea. Rosacea is a common chronic dermatosis primarily affecting the convex areas of the face (cheeks, chin, nose, and forehead), characterized by flushing, erythema, telangiectasia, papules, and pustules. It is not used for the erythematotelangiectatic or phymatous subtypes of rosacea unless inflammatory lesions are also present. It is not indicated for the treatment of other skin conditions such as acne vulgaris, perioral dermatitis, or folliculitis.

Dosage and direction

• For topical use only. Not for oral, ophthalmic, or intravaginal use.
• Apply a thin, pea-sized amount of Soolantra Cream once daily to the entire face (forehead, chin, nose, and each cheek).
• Use enough to cover the entire affected area lightly. Avoid application to the eyes, lips, and mucous membranes.
• The cream should be applied to clean, dry skin.
• Dispense the cream onto a fingertip and dot it evenly across the face before gently smoothing it into the skin.
• Wash hands immediately after application.

Precautions

• Patients should be advised to avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
• As with any topical product, patients should discontinue use and consult their physician if signs and symptoms of severe irritation or hypersensitivity occur.
• The effects of Soolantra on inflammatory lesions of rosacea may be seen as early as 2-4 weeks, but full treatment effect can take up to 12 weeks of continuous use. Patients should be counseled on appropriate expectations.
• The safety and efficacy of Soolantra Cream in pediatric patients under the age of 18 years have not been established.
• There are no available data on Soolantra use in pregnant or breastfeeding women to inform any drug-associated risks. A risk-benefit assessment with a physician is required.

Contraindications

Soolantra Cream is contraindicated in patients with a known hypersensitivity to ivermectin or to any of the excipients in the formulation.

Possible side effects

The most common adverse reactions (incidence ≤1%) are skin burning sensation and skin irritation. Other local skin reactions that have been reported include: dryness, itching, and contact dermatitis. These are typically mild and self-limiting. Systemic adverse reactions are unlikely due to minimal percutaneous absorption, but in cases of very severe application to compromised skin, systemic effects similar to those of oral ivermectin (though highly improbable at topical doses) could theoretically include dizziness, nausea, and diarrhea.

Drug interaction

No formal drug interaction studies have been performed with topically applied Soolantra Cream. Given the minimal systemic plasma concentrations of ivermectin following topical application, systemic drug interactions are considered unlikely. Interactions with other topical products applied to the same area have not been studied; to avoid potential irritation, a physician should be consulted before using other topical medications, cosmetics, or medicated cleansers concurrently.

Missed dose

If a dose is missed, the patient should apply it as soon as remembered. However, if it is almost time for the next application, the missed dose should be skipped, and the regular dosing schedule resumed. The patient should not apply a double dose to make up for the missed one.

Overdose

Topical overdose of Soolantra Cream is unlikely to lead to life-threatening effects. Excessive application may increase the potential for skin irritation (e.g., redness, scaling, and discomfort). In the event of accidental ingestion, supportive measures should be taken and the patient should seek medical attention. Symptoms of oral ivermectin overdose may include gastrointestinal distress, neurological effects such as dizziness, and hypotension.

Storage

• Store Soolantra Cream at room temperature, between 20°C to 25°C (68°F to 77°F).
• Excursions are permitted between 15°C to 30°C (59°F to 86°F).
• Keep the tube tightly closed when not in use.
• Keep out of sight and reach of children.
• Do not freeze.

Disclaimer

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here.

Reviews

• “As a dermatologist, Soolantra has become a first-line tool in my arsenal for papulopustular rosacea. Its targeted mechanism and once-daily application support excellent patient compliance and we see consistent, significant reductions in inflammatory lesion counts over a 12-week course.” – Dermatologist, 15 years experience.
• “Clinical trial data is robust. The IVM-ROS-01 study demonstrated a 73% mean reduction in inflammatory lesions at week 12 versus 50% for vehicle, with a number needed to treat (NNT) of 4 for Investigator’s Global Assessment success. This is a statistically and clinically significant result.” – Clinical Research Physician.
• “From a patient perspective, the simplicity is a major benefit. Applying one product once a day and seeing a gradual but definite clearing of the bumps and redness has been life-changing. My skin is calmer and less reactive.” – Patient, 42.
• “The tolerability profile is a key advantage. We see far less dryness and irritation compared to some other topical treatments like metronidazole or azelaic acid, which is crucial for long-term management of this chronic condition.” – Nurse Practitioner, Dermatology.
• “It addresses the demodex hypothesis of rosacea pathophysiology in a way other topicals do not. While the exact mechanism isn’t fully elucidated, the anti-inflammatory and potential anti-parasitic action provides a unique and effective approach.” – Pharmacologist.