Diclofenac Topical (osteoarthritis pain)
(dye kloe' fen ak)
People who use nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as topical diclofenac (Pennsaid, Voltaren) 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 (Pennsaid, Voltaren) right before or right after the surgery.
NSAIDs such as topical diclofenac (Pennsaid, Voltaren) 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 (Pennsaid, Voltaren). 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.
WHY is this medicine prescribed?
Diclofenac topical gel (Voltaren) 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 topical liquid (Pennsaid) 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; generic) 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 gel (Voltaren) and liquid (Pennsaid) for osteoarthritis. If you are using diclofenac gel (Solaraze, generic) for actinic keratosis, read the monograph entitleddiclofenac topical (actinic keratosis)..
HOW should this medicine be used?
Topical diclofenac for osteoarthritis comes as gel (Voltaren) and liquid (Pennsaid) to apply to the skin four times a day to treat arthritis pain. Apply diclofenac gel (Voltaren) or liquid (Pennsaid) 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(Pennsaid, Voltaren) 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 gel (Voltaren) or liquid (Pennsaid) to clean, dry skin. Do not apply the medication to skin that is broken, peeling, infected, swollen, or covered with a rash.
Diclofenac gel (Voltaren) and liquid (Pennsaid) 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 gel (Voltaren) or liquid (Pennsaid), 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 (Pennsaid) and for at least 1 hour after you apply the gel (Voltaren). Do not cover the treated area with clothes or gloves for 10 minutes after you apply the gel (Voltaren), or until the liquid (Pennsaid) has dried if you are using the liquid.
To use topical diclofenac gel (Voltaren), follow these steps:
To use topical diclofenac1.5 % liquid (Pennsaid), follow these steps:
To use topical dicofenac 2% liquid (Pennsaid), follow these steps:
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before using diclofenac gel (Voltaren) or liquid (Pennsaid),
- tell your doctor and pharmacist if you are allergic to diclofenac (Cambia, Cataflam, Flector, Voltaren, Solaraze, Zipsor, in Arthrotec), aspirin, or other NSAIDs; any other medications; or any of the ingredients in diclofenac gel (Voltraen) or liquid (Pennsaid). Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: acetaminophen (Tylenol, in other products); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril (Capoten, in Capozide), enalapril (Vasotec, in Lexxel and Vaseretic), fosinopril (Monopril), lisinopril (Prinivil, Zestril, in Prinzide and Zestoretic), moexipril (Univasc, in Uniretic), perindopril (Aceon), quinapril (Accupril, in Accuretic and Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); certain antibiotics, cyclosporine (Gengraf, Neoral, Sandimmune); diuretics ('water pills'); lithium (Eskalith, Lithobid); medications for seizures, and methotrexate (Rheumatrex, Trexall). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- you should know that you should not apply sunscreens, cosmetics, lotions, moisturizers, insect repellents, or other topical medications to areas treated with diclofenac gel (Voltaren). If you have been prescribed diclofenac liquid (Pennsaid), wait until the area of application is completely dry before applying any of these products or other substances.
- tell your doctor if you have severe diarrhea or vomiting or think you may be dehydrated; if you drink or have a history of drinking large amounts of alcohol, and if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); swelling of the hands, feet, ankles, or lower legs; or kidney or liver disease.
- tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breast-feeding. If you become pregnant while using diclofenac 1% gel or liquid, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using diclofenac gel (Voltaren) or liquid (Pennsaid).
plan to avoid unnecessary or prolonged exposure to real or artificial sunlight (tanning beds or lamps, ultraviolet light) and to wear protective clothing to cover areas treated with diclofenac gel (Voltaren) or liquid (Pennsaid). Diclofenac may make your skin sensitive to sunlight.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
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 gel (Voltaren) or liquid (Pennsaid) to make up for a missed dose.
What SIDE EFFECTS can this medicine cause?
Diclofenac 1gel (Voltaren) or liquid (Pennsaid) may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- dryness, redness, itching, swelling, pain, hardness, irritation, swelling, scaling, or numbness at application site
- stomach pain
- numbness, burning, or tingling in the hands, arms, feet, or legs
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- difficulty breathing or swallowing
- swelling of the face, throat, arms, hands, feet, ankles, or lower legs
- unexplained weight gain
- worsening of asthma
- yellowing of the skin or eyes
- 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
- blisters on skin
- pale skin
- fast heartbeat
- excessive tiredness
Diclofenac gel (Voltaren) or liquid (Pennsaid) 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].
What should I know about STORAGE and DISPOSAL of this medication?
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.
What should I do in case of OVERDOSE?
If someone swallows diclofenac 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.
Symptoms of overdose may include the following:
- lack of energy
- stomach pain
- bloody, black, or tarry stools
- vomiting a substance that is bloody or looks like coffee grounds
- slow, shallow, or irregular breathing
- difficulty breathing or swallowing
- loss of consciousness
What OTHER INFORMATION should I know?
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.
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