People who use nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as topical diclofenac 1% 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. 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 1% right before or right after the surgery.
NSAIDs such as topical diclofenac 1% 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 ulcersor 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); aspirin; other NSAIDs such as ibuprofen (Advil, Motrin) or naproxen (Aleve, Naprosyn); or oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone). 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 1%. 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 1% 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 (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.
Diclofenac 1% topical gel is used to relieve pain from osteoarthritis (arthritis caused by a breakdown of the lining of the joints) in certain joints such as those of the knees, ankles, feet, elbows, wrists, and hands. Diclofenac 1% topical liquid is used to relieve osteoarthritis pain in the knees. Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the body's production of a substance that causes pain.
Diclofenac is also available as a 3% gel (Solaraze) that is applied to the skin to treat actinic keratosis (flat, scaly growths on the skin caused by too much sun exposure). This monograph only gives information about diclofenac 1% gel and liquid. If you are using the 3% product, read the monograph entitled Diclofenac 3% Topical (actinic keratosis) that has been written about this product.
Topical diclofenac 1% comes as gel and liquid to apply to the skin. The gel and liquid are usually applied four times a day to treat arthritis pain. Apply diclofenac 1% gel or liquid at around the same time(s) 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 topical diclofenac 1% exactly as directed. Do not use more or less of it or use it more often or for a longer period of time than prescribed by your doctor. Do not apply the gel or liquid to any area of your body that your doctor did not tell you to treat.
Apply diclofenac 1% gel or liquid to clean, dry skin. Do not apply the medication to skin that is broken, peeling, infected, swollen, or covered with a rash.
Diclofenac 1% gel and liquid are 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, rinse your eyes with plenty of water or saline. If your eye(s) are still irritated after one hour, call your doctor.
After you apply diclofenac 1% gel or liquid, you should not cover the treated area with any type of dressing or bandage and you should not apply heat to the area. You should not shower or bathe for at least 30 minutes after you apply the liquid and for at least 1 hour after you apply the gel. Do not cover the treated area with clothes or gloves for 10 minutes after you apply the gel, or until the liquid has dried if you are using the liquid.
Before you use a new tube of diclofenac 1% gel for the first time, open the foil seal that covers the tube and then puncture the opening of the tube using the spiked top of the cap.
Place one of the dosing cards from the package on a flat surface so that you can read the print. If the print is backward, flip the dosing card over.
Using the lines on the dosing card as a guide, squeeze the correct amount of gel onto the dosing card evenly. Make sure the gel covers the entire area marked for your correct dose. Put the cap back on the tube.
Clean and dry the skin area where you will apply the medication.
Apply the gel to the directed skin areas, using the dosing card to help apply the gel to the skin. Use your hands to gently rub the gel into the skin. Make sure to cover the entire affected area with the gel.
Hold the end of the dosing card with your fingertips, and rinse and dry the card. Store the dosing card until next use, out of reach of children. Do not share the dosing card with another person.
Wash your hands well after you apply the gel, unless you are treating your hands. If you are treating your hands, do not wash them for at least one hour after you apply the gel.
Clean and dry the skin area where you will apply the medication.
Apply the liquid to your knee ten drops at a time. You can do this by dropping the liquid directly onto the knee or by first dropping it onto the palm of your hand and then spreading it onto the knee.
Use your hand to evenly spread the liquid around the front, back, and sides of the knee.
Repeat this step until 40 drops of liquid have been applied and the knee is completely covered with the liquid.
Wash and dry your hands well after you apply the liquid.
Continue to use diclofenac 1% gel or liquid even if you feel well. 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.
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 your next scheduled application, skip the missed dose and continue your regular dosing schedule. Do not apply extra diclofenac 1% gel or liquid to make up for a missed dose.
dryness, redness, itching, swelling, pain, hardness, irritation, swelling, scaling, or numbness at application site
acne
stomach pain
constipation
gas
dizziness
numbness, burning, or tingling in the hands, arms, feet, or legs
hives
itching
difficulty breathing or swallowing
swelling of the face, throat, arms, hands, feet, ankles, or lower legs
unexplained weight gain
wheezing
worsening of asthma
yellowing of the skin or eyes
nausea
extreme tiredness
unusual bleeding or bruising
lack of energy
loss of appetite
pain in the upper right part of the stomach
flu-like symptoms
dark-colored urine
rash
blisters on skin
fever
pale skin
fast heartbeat
excessive tiredness
Diclofenac 1% gel or liquid 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 [at http://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 keep it from freezing or excess heat. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
If someone swallows diclofenac 1% gel or liquid, 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.
drowsiness
lack of energy
nausea
vomiting
stomach pain
bloody, black, or tarry stools
vomiting a substance that is bloody or looks like coffee grounds
slow, shallow, or irregular breathing
hives
itching
difficulty breathing or swallowing
loss of consciousness
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.
Last Revised - 09/15/2011
AHFS® Consumer Medication Information. © Copyright, 2012. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.