Medical Editor: John P. Cunha, DO, FACOEP
What Is Solage?
Solage (mequinol, tretinoin) Topical Solution is a combination of a depigmentation agent and a form of Vitamin A used to treat brown age spots, liver spots, or sun spots (solar lentigines). The brand name Solage is discontinued, but generic versions may be available.
What Are Side Effects of Solage?
Common side effects of Solage (mequinol, tretinoin) include:
- temporary skin stinging
- swelling, or
Dosage for Solage
Apply Solage to the solar lentigines using the applicator tip while avoiding application to the surrounding skin. Use twice daily, morning and evening at least 8 hours apart, or as directed by a physician. Patients should not shower or bathe the treatment areas for at least 6 hours after application of Solage.
What Drugs, Substances, or Supplements Interact with Solage?
Solage may interact with sulfa drugs, diuretics, antibiotics, or phenothiazines. Tell your doctor all medications and supplements you use.
Solage During Pregnancy and Breastfeeding
Solage must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Solage (mequinol, tretinoin) Topical Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Solage (Mequinol and Tretinoin)
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The initial clinical trials for Solagé included 1794 subjects of Skin Type I-V, 94.5% of whom were Caucasian. The trials also included 5% of subjects who were Asian/Pacific Islander (1.2%), African-American (0.8%), and Hispanic/Latino (3.5%).
In the pivotal clinical trials, adverse reactions were primarily mild to moderate in intensity, occurring in 66% and 30% of subjects, respectively. The majority of these events were limited to the skin and 64% had an onset of a skin related adverse reaction early in treatment (by week 8).
The most frequent adverse reactions in subjects treated with Solagé were erythema (49%), burning, stinging, or tingling (26%), desquamation (14%), pruritus (12%), and skin irritation (5%). Some subjects experienced temporary hypopigmentation of treated lesions (5%) or of the skin surrounding treated lesions (7%). Ninety-four of 106 subjects (89%) had resolution of hypopigmentation upon discontinuation of treatment to the lesion, and/or re-instruction on proper application to the lesion only. Another 8% (9/106) of subjects with hypopigmentation events had resolution within 120 days after the end of treatment. Three of the 106 subjects (2.8%) had persistence of hypopigmentation beyond 120 days. Hypopigmentation of the skin surrounding treated lesions occurs even in the setting of proper application of the drug within the lesion border. One subject in the trials, whose brother had vitiligo, experienced hypopigmentation in areas that had not been treated with study medication. Some of these areas continued to worsen for at least one month post treatment with Solagé. Six weeks later the severity of the hypopigmentation had decreased from moderate to mild and 106 days post treatment, subject had resolution of some but not all lesions.
Approximately 6% of subjects discontinued study participation due to adverse reactions. These discontinuations were due primarily to skin redness (erythema) or related cutaneous adverse reactions.
Adverse drug reactions that were reported in greater than 1% of subjects appear in Table 1 below.
Table 1. Adverse Reactions Occurring in >1% of the Population – All Studies
|Body System||Solagé (mequinol 2% tretinoin 0.01%)||Tretinoin, 0.01%||Mequinol, 2%,||Vehicle|
|Skin and Appendages||N||%||N||%||N||%||N||%|
|Rash Vesicular Bullae||18||1.2||8||1.7||0||0.0||0||0.0|
|*In study RD.06.SRE.18091 irritant dermatitis included signs & symptoms of scaling, dryness, stinging/burning, and erythema.|
Over 150 subjects used Solagé twice daily for 52 weeks in an open label clinical study. The safety profile for Solagé in this long-term study was similar to that seen in the 24-week studies.
Over 90 subjects used Solagé twice daily and a concomitant sunscreen daily for up to 24 weeks in an open label clinical study. The safety profile for Solagé in this study was similar to that seen in studies which prohibited sunscreen use.
An additional open label study was conducted in 259 subjects in the Asian (24.3%), Hispanic/Latino (62.2%), and African American (13.5%) ethnic groups with skin types II to V. This number reflects approximately three times as many subjects in this population as were represented in the initial clinical trials. In this study, as in the earlier studies, Solagé was used twice daily for a period of 24 weeks. The overall safety profile in this study was generally consistent with the initial clinical trials.
Read the entire FDA prescribing information for Solage (Mequinol and Tretinoin)
© Solage Patient Information is supplied by Cerner Multum, Inc. and Solage Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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