Mequinol and tretinoin (Topical)

Mequinol and tretinoin combination solution is used along with a complete skin care routine and avoiding sun exposure to treat skin areas that have darkened due to 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 that your doctor check your progress at regular visits to make sure this medicine is working properly and to check 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 getting pregnant. If you think you might be pregnant while using this medicine, tell your doctor right away.

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 beneficial effects, 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 tells 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 prone to sunburn, dryness, or irritation. 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 often.

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 and may include:

• Taking part in an ongoing program to avoid further damage to your skin from the sun. The program should stress staying out of the sun when possible and wearing proper clothing or hats to protect your skin from sunlight.
• Regular use of oil-based creams or lotions to help reduce skin irritation or dryness caused by the use of mequinol and tretinoin (Topical) solution.

Do not take other medicines unless they have been discussed 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 and your doctor must consider the risks of taking the medicine against the benefits it may provide. For this medicine, the following points should be taken into account:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the use of Solage® in children. Safety and effectiveness have not been established.

Geriatric

So far, appropriate studies have not shown any specific problems related to older adults that would limit the usefulness of Solage® in this age group.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines can be used together even if there is a chance of interaction. In these situations, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when using this medicine. The following interactions are significant and do not include all possible interactions.

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

• 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 taking both may be the best option for you. If both medicines are prescribed together, your doctor may change the dose or frequency for one or both.

• Fluconazole
• Ketoconazole
• Voriconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used while eating or around the time of eating certain foods due to potential interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor about any other medical problems, especially:

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

• Vitiligo, or a family history—Using this medicine may lighten areas of skin that have not been treated.

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.