Diclofenac Topical (actinic keratosis)

People who use nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as topical diclofenac (Solaraze) may have a higher risk of having a heart attack or a stroke than people who do not use these medications. These events may happen without warning and may cause death. This risk may be higher for people who use NSAIDs for a long time. Do not take an NSAID such as topical diclofenac if you have recently had a heart attack, unless directed to do so by your doctor. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke; if you smoke; and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of your body, or slurred speech.

If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not use topical diclofenac (Solaraze) right before or right after the surgery.

NSAIDs such as topical diclofenac (Solaraze) may cause swelling, ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who use NSAIDs for a long time, are older in age, have poor health, smoke, or drink alcohol while using topical diclofenac. Tell your doctor if you have any of these risk factors and if you have or have ever had ulcers or bleeding in your stomach or intestines, or other bleeding disorders. Tell your doctor if you take any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin; other NSAIDs such as ibuprofen (Advil, Motrin) or naproxen (Aleve, Naprosyn); oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); or serotonin norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor XR). If you experience any of the following symptoms, stop using topical diclofenac and call your doctor: stomach pain, heartburn, vomiting a substance that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.

Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably take your blood pressure and order certain tests to check your body's response to topical diclofenac (Solaraze). Be sure to tell your doctor how you are feeling so that the doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with topical diclofenac and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

Diclofenac topical gel (Solaraze) is used to treat actinic keratosis (flat, scaly growths on the skin caused by too much sun exposure). Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). The way diclofenac gel works to treat actinic keratosis is not known.

Diclofenac is also available as a liquid (Pennsaid) and a gel (Voltaren) that are applied to the skin to treat arthritis pain. This monograph only gives information about diclofenac gel (Solaraze) for actinic keratosis. If you are using either of the products for osteoarthritis, read the monograph entitled diclofenac topical (osteoarthritis pain).

Topical diclofenac for actinic keratosis comes as a gel (Solaraze) to apply to the skin. It is applied to the affected area two times a day for 60 to 90 days. Apply diclofenac gel at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use diclofenac gel exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not apply diclofenac gel to open skin wounds, burns, infections, or red, scaly, or peeling skin.

Diclofenac gel is only for use on the skin. Be careful not to get the medication in your eyes, nose, or mouth. If you do get the medication in your eyes, nose, or mouth, wash with plenty of water or saline. If your eye(s), nose, or mouth are still irritated after one hour, call your doctor.

Wash your hands before applying diclofenac gel. Then use your fingers to gently smooth the gel onto each affected area. Use enough gel to cover the areas completely. When you are finished applying the gel, wash your hands again. Be careful not to touch your eyes or nose before you wash your hands.

Your condition may begin to improve after 30 days of treatment, but it may take up to 30 days after the end of treatment before you see complete healing of the affected area or the full benefit of diclofenac gel. Continue to use diclofenac gel even if your condition has begun to improve. Do not stop using the medication without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using diclofenac gel,

• tell your doctor and pharmacist if you are allergic to diclofenac (Cambia, Cataflam, Flector, Licart, Voltaren, Pennsaid, Zipsor, in Arthrotec), aspirin, or other NSAIDs; any other medications; or any of the ingredients in diclofenac gel. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• The following nonprescription or herbal products may interact with diclofenac gel: aspirin or other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); and other medications that are applied to the skin. Be sure to let your doctor and pharmacist know that you are taking these medications before you start using diclofenac gel. Do not start any of these medications while using diclofenac gel without discussing with your healthcare provider.
• tell your doctor if you have or have ever had asthma, especially if you have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose), heart failure, or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant; or are breast-feeding. Diclofenac may harm the fetus and cause problems with delivery if it is used around 20 weeks or later during pregnancy. Do not use diclofenac gel around or after 20 weeks of pregnancy, unless you are told to do so by your doctor. If you become pregnant while using diclofenac gel, call your doctor.
• plan to avoid exposure to real and artificial sunlight (sun lamps) and to wear protective clothing and sunglasses during your treatment with diclofenac gel.

Unless your doctor tells you otherwise, continue your normal diet.

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra gel to make up for a missed dose.

Diclofenac gel may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, itching, peeling or dry skin, irritation, swelling, or rash at the area where you applied the medication
• pain, burning, numbness, or tingling of the treated skin
• muscle, joint, or back pain
• headache

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately:

• hives, rash, itching, swelling of the face or throat, difficulty swallowing, or hoarseness
• rash or blisters with fever
• unexplained weight gain
• shortness of breath or difficulty breathing
• swelling in the arms, hands, ankles, feet, or legs
• excessive tiredness, pain in the upper right part of the stomach, nausea, diarrhea, yellowing of the skin or eyes,or flu-like symptoms

Diclofenac gel may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat, and moisture (not in the bathroom). Do not allow diclofenac gel to freeze.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

If someone swallows diclofenac gel, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Solaraze^® Gel