Rexaphenac

This section provides information on the proper use of a number of products that contain diclofenac. It may not be specific to Rexaphenac. Please read with care.

Keep using this medicine for the full time of treatment. However, do not use this medicine more often or for a longer time than your doctor ordered. This medicine is not for long-term use.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

To use the skin patch:

• Use this medicine exactly as directed by your doctor. It will work only if applied correctly.
• Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands. If it gets into your eyes, wash the eyes right away with water or saline. If eye irritation persists for more than one hour, call your doctor.
• Apply the patch right away after removing it from the protective pouch. Do not cut it into smaller pieces and do not touch the sticky surface of the patch.
• Apply the patch to a clean, dry, intact skin area. Choose an area with little or no hair and free of scars, cuts, or irritation. Avoid putting the patch on areas where it could be rubbed off by tight clothing.
• Press the patch firmly in place with your fingertips to make sure that the edges of the patch stick well. If the patch begins to peel off, the edges of the patch may be taped down.
• If the patch still peels off, it may be used with a mesh netting sleeve (eg, Curad® Hold Tite™, Surgilast® Tubular Elastic Dressing) to hold the patch applied to the ankles, knees, or elbows. The mesh netting sleeve must not be occlusive and must allow air to pass through.
• Do not use the patch when you take a bath or shower.
• To help you remember to use your medicine, try to get into the habit of using it at regular times. If you are using the skin patch, try to change it at the same time and day of the week.

To use the topical gel:

• Wash your hands before and after using this medicine.
• For Voltaren® 1% topical gel: Use the enclosed dosing card to measure the correct dose. The gel should be applied within the oblong area of the dosing card up to the 2 or 4 gram line (2 grams for each elbow, wrist, or hand, and 4 grams for each knee, ankle, or foot).
• Apply the medicine very carefully to clean, dry skin, and avoid getting any in your eyes, nose, or mouth.
• Do not apply this medicine to areas with broken skin or open wounds, infection, or severely peeling skin.
• Apply enough medicine each time to cover the entire affected area.
• Do not use heating pads or cover the treated area with a bandage unless your doctor has told you to.
• Do not use cosmetics (eg, makeup or sunscreens) or other skin care products on the same skin areas where you have applied this medicine.
• For Voltaren® 1% topical gel: After applying this medicine, do not shower, bathe, or wash the affected area for at least 1 hour. Wait for at least 10 minutes before covering the treated skin with gloves or clothing.

To use the topical solution:

• Use this medicine exactly as directed by your doctor. It will work only if applied correctly. Do not apply this medicine anywhere on your body other than where your doctor tells you.
• Wash your hands with soap and water before and after applying the solution. If you get this medicine in your eyes, wash the eyes right away with water or saline. If eye irritation persists for more than 1 hour, call your doctor.
• Apply the solution to a clean, dry, intact skin area. Choose an area free of open wounds scars, cuts, or irritation.
• Put 10 drops of the solution at a time on your hand or directly to your knee. Apply the solution evenly on the front, back, and sides of your knee.
• After using the Pennsaid® solution, wait for at least 30 minutes before showering or bathing.
• Do not use external heat or dressings to the treated knee. Avoid wearing clothing or applying skin care products, such as sunscreen, insect repellant, lotion, moisturizer, or cosmetics, over the treated knee until the skin is completely dry.
• Avoid skin-to-skin contact between other people and the treated knee until the skin is completely dry.
• Protect the treated knee from sunlight.

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 (gel):
  • For actinic keratosis using Solaraze® 3% gel:
    • Adults—Apply to affected skin area two times a day.
    • Children—Use and dose must be determined by your doctor.
  • For osteoarthritis of the hands, elbows, or wrists using Voltaren® 1% gel:
    • Adults—Apply 2 grams to the affected skin areas four times a day (a total of 8 grams each day). However, the total dose should not exceed 32 grams per day over all affected joints. Use the enclosed dosing card to measure the appropriate dose.
    • Children—Use and dose must be determined by your doctor.
  • For osteoarthritis of the knees, ankles, or feet using Voltaren® 1% gel:
    • Adults—Apply 4 grams to the affected skin areas four times a day (a total of 16 grams each day). However, the total dose should not exceed 32 grams per day over all affected joints. Use the enclosed dosing card to measure the appropriate dose.
    • Children—Use and dose must be determined by your doctor.
• For topical dosage form (solution):
  • For osteoarthritis of the knee:
    • Adults—40 drops (10 drops at a time) on each affected knee four times a day.
    • Children—Use and dose must be determined by your doctor.
• For transdermal dosage form (skin patch):
  • For acute pain:
    • Adults—One patch applied to the painful area two times a day.
    • 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.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage

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

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.

After removing a used patch, fold the patch in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to make sure this medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid medicine or a blood thinner).

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while using this medicine: blistering, peeling, loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Some possible warning signs of serious side effects that can occur during treatment with this medicine may include black, tarry stools, decreased urination, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, vomiting of blood or material that looks like coffee grounds, or yellow skin or eyes. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Check with your doctor immediately if you notice any of these warning signs.

This medicine may cause a serious allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once.

It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine. Using this medicine while you are pregnant can harm your unborn baby. Do not use this medicine during the latter part of a pregnancy unless your doctor tells you to.

If your symptoms become worse, check with your doctor.

Diclofenac may cause redness, soreness, scaling, and peeling of the affected skin. Do not stop using this medicine without first checking with your doctor. If the reaction is very uncomfortable, check with your doctor.

While using this medicine, your skin may become more sensitive to sunlight than usual, and too much sunlight may increase the effects of the medicine. During this period of time:

• Stay out of direct sunlight, especially between the hours of 10 AM and 3 PM, if possible.
• Wear protective clothing, including a hat and sunglasses.
• Do not use a sunlamp or tanning bed or booth.
• Make sure you have discussed the use of a sun block product with your doctor.

If you have a severe reaction from the sun, check with your doctor.

Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop treatment for awhile, or to change to a different nonsteroidal antiinflammatory drug before your procedure.

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.

• If you have an allergy to diclofenac or any other part of Rexaphenac.
• If you have an allergy to aspirin or NSAIDs.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: GI (gastrointestinal) bleeding or kidney problems.
• If you are having trouble getting pregnant or you are having your fertility checked.
• If you are pregnant or may be pregnant. Do not take this medicine if you are in the third trimester of pregnancy. You may also need to avoid Rexaphenac at other times during pregnancy. Talk with your doctor to see when you need to avoid taking this medicine during pregnancy.
• If you are taking any other NSAID.
• If you are taking a salicylate drug like aspirin.
• If you are taking pemetrexed.

This is not a list of all drugs or health problems that interact with Rexaphenac.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take Rexaphenac. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
• If you smoke, talk with your doctor.
• If you have asthma, talk with your doctor. You may be more sensitive to this medicine.
• Talk with your doctor before you drink alcohol.
• Do not use on skin that has any problems.
• Do not use more than told. Unsafe side effects may happen.
• Do not use longer than you have been told by the doctor.
• Avoid sunlight on treated area.
• The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
• The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
• If you are taking aspirin to help prevent a heart attack, talk with your doctor.
• This medicine may cause harm if swallowed. If Rexaphenac is swallowed, call a doctor or poison control center right away.
• This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
• If you are 65 or older, use Rexaphenac with care. You could have more side effects.
• NSAIDs like this medicine may affect egg release (ovulation) in women. This may cause you to not be able to get pregnant. This goes back to normal when Rexaphenac (diclofenac cream) is stopped. Talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use Rexaphenac as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take this medicine by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Do not use sunscreen, insect repellant, or other drugs on affected part.
• If putting Rexaphenac on the hand, do not wash your hands for at least 1 hour after putting on.
• Do not use heat or bandages on the treated part.
• Let the drug dry for at least 10 minutes before you cover it with clothes or gloves.
• Do not bathe, shower, or swim for 1 hour after putting on.
• Do not use on open wounds or infected skin.
• If you get this medicine in your eyes, wash right away with water. If you have eye irritation that lasts or a change in eyesight, call your doctor.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Skin irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature. Do not freeze.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Protect gel from heat.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.