Solage (Topical)

Mequinol and tretinoin combination solution is used along with a complete skin care routine and sun avoidance to treat skin areas that have darkened due to repeated sun exposure. These areas are known as solar lentigines, or age or liver spots.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to make sure this medicine is working properly and to look for any unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy. If you think you might be pregnant while using this medicine, tell your doctor immediately.

You may notice redness, stinging, burning, or irritation when you first start using this medicine. It may take up to 6 months before you see full benefits, even if you use the medicine every day. Check with your doctor if skin irritation becomes severe or if your age spots get darker.

Unless your doctor advises you otherwise, it is especially important to avoid using the following skin products on the same area as mequinol and tretinoin topical solution:

• Hair products that are irritating (e.g., permanents, hair removal products).
• Skin products that cause sensitivity to the sun (e.g., products containing spices or limes).
• Skin products containing a large amount of alcohol (e.g., astringents, shaving creams, after-shave lotions).
• Skin products that are too drying or abrasive (e.g., cosmetics, soaps, or skin cleansers).

Avoid overexposing the treated areas to sunlight, wind, or cold weather. The skin will be more likely to get sunburned, dry, or irritated. Do not use a sunlamp.

Regularly use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15. Also, wear protective clothing and hats, and apply creams, lotions, or moisturizers frequently.

Check with your doctor if your skin becomes too dry and irritated. Your doctor can help you choose the right skin products to reduce dryness and irritation, which may include:

• Joining a program to prevent further skin damage from the sun. This program should emphasize staying out of the sun when possible and wearing proper clothing or hats to protect your skin.
• Regularly using oil-based creams or lotions to help reduce skin irritation or dryness caused by mequinol and tretinoin topical solution.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it may provide. This decision should be made together with your doctor. For this medicine, consider the following:

Allergies

Let your doctor know if you have had any unusual or allergic reactions to this medicine or any other medicines. Also inform your health care professional about any other allergies you have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Research has not been done to determine how age affects the effects of Solage® in children. Its safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems for older adults that would limit the usefulness of Solage®.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be taken together even if an interaction could happen. In such cases, your doctor may adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions are based on their potential significance and do not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Aminocaproic Acid
• Aprotinin
• Chlortetracycline
• Demeclocycline
• Doxycycline
• Eravacycline
• Lymecycline
• Meclocycline
• Methacycline
• Minocycline
• Omadacycline
• Oxytetracycline
• Palovarotene
• Rolitetracycline
• Sarecycline
• Tetracycline
• Tigecycline
• Tranexamic Acid

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Fluconazole
• Ketoconazole
• Voriconazole

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around mealtime or with certain foods because interactions may occur. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to inform your doctor if you have any other medical conditions, especially:

• Eczema or
• Frequent exposure to sunlight or sunlamps or
• Sunburn—These conditions may cause or worsen skin irritation.

• Vitiligo, or a family history—Using this medicine may lighten untreated areas of the skin.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Burning feeling or stinging skin (severe)
• itching (severe)
• peeling of the skin (severe)
• redness of the skin (severe)

Less common

• Large blisters on the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning feeling, stinging, or tingling of the skin (mild)
• chapping or slight peeling of the skin (mild)
• itching (mild)
• lightening of the skin on or around the treated area
• redness of the skin (mild)
• skin irritation
• unusually warm skin (mild)

Less common

• Crusting of the skin
• dry skin
• skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Solage

Chemical Class: Retinoid

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause irritation of the skin.

This medicine usually comes with patient information leaflet. Read the instructions carefully and make sure you understand them before using this medicine. If you have any questions, ask your doctor.

This medicine is for use only in the skin. Do not get any of it in your eyes, nose, mouth, or vagina. Rinse it off right away if it does get on these areas.

Do not apply this medicine to windburned or sunburned skin or on open wounds.

To use this medicine:

• Using the applicator tip, apply enough medicine only to the spots identified by your doctor. Be careful not to get any medicine on the skin surrounding these spots, on your lips, or in your eyes, nose, or mouth. Avoid areas of normally colored skin.
• Do not shower or bathe for at least 6 hours after applying the medicine.
• Wait for 30 minutes before applying makeup to any treated area.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (solution): For age or liver spots: Adults—Apply to the affected areas of the skin two times a day (once in the morning and once in the evening), at least 8 hours apart. Children—Use and dose must be determined by your doctor..

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

The product is flammable and should be kept away from fire or excessive heat.