pronounced as (farv kloe' ends with)
- Why is this drug prescribed?
- How should this medicine be used?
- Other uses of this medicine
- What special precautions should I take?
- What special dietary instructions do I need to follow?
- What should I do if I miss a dose?
- What side effects can this drug cause?
- What should I know about the storage and disposal of this medicine?
- In case of emergency/overdose
- What other information do I need to know?
- brand names
IMPORTANT WARNING:
People who take 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 stroke than people who do not take these drugs. These events can occur without warning and can result in death. This risk may be higher in people who use NSAIDs for a long time. Do not use an NSAID such as topical diclofenac if you have recently had a heart attack unless your doctor has told you to. Tell your doctor if you or anyone in your family has or has ever had heart disease, heart attack or 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 have any of the following symptoms: chest pain, shortness of breath, weakness in any part or side of your body, or slurred speech.
If you are having a coronary artery bypass graft (CABG; a type of heart surgery), you should not use topical diclofenac (Pennsaid, Voltaren) immediately before or immediately after the surgery.
NSAIDs such as topical diclofenac (Pennsaid, Voltaren) can cause swelling, ulcers, bleeding, or holes in the stomach or intestines. These problems can occur at any time during treatment without warning symptoms and can result in death. The risk may be higher for people who use NSAIDs for a long time, are 60 years or older, have poor health, smoke, or drink alcohol while using diclofenac topical. 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 are taking any of the following medicines: 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), 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 diclofenac topical and call your doctor: stomach pain, heartburn, vomiting a bloody or coffee grounds-like substance, blood in your stool, or black and tarry stools.
Keep all appointments with your doctor and the laboratory. Your doctor will closely monitor your symptoms and will likely measure 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 feel so they can prescribe the right amount of medication to treat your condition with the least risk of serious side effects.
Your doctor or pharmacist will give you the manufacturer's Patient Information Leaflet (Medication Guide) when you start treatment with prescription topical diclofenac and each time you refill your prescription. Read the information carefully and contact 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 get the medication instructions.
Why is this drug prescribed?
Over-the-counter (OTC) Diclofenac Topical Gel (Voltaren Arthritis Pain) is used to relieve arthritis pain in certain joints such as knees, ankles, feet, elbows, wrists, and hands. Prescription diclofenac topical solution (Pennsaid) is used to relieve osteoarthritis pain in the knees. Diclofenac belongs to a class of medicines called non-steroidal 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 provides information only about diclofenac over-the-counter topical gel (Voltaren Arthritis Pain) for arthritis and prescription topical solution (Pennsaid) for osteoarthritis of the knee. If you are using diclofenac gel (Solaraze, generic) for actinic keratosis, see the monograph entitled Diclofenac Topical (Actinic Keratosis).
How should this medicine be used?
Prescription topical diclofenac is available as a 1.5% topical solution (liquid) that is applied to the knee four times a day and a 2% topical solution (Pennsaid) that is applied to the knee twice a day. Prescription (over-the-counter) topical diclofenac is available as a 1% gel (Voltaren Arthritis Pain) and can be applied to up to 2 areas of the body (eg, 1 knee and 1 ankle, 2 knees, 1 foot and 1 ankle, or 2 hands). ) 4 times daily for up to 21 days or as recommended by your doctor. Apply diclofenac gel (Voltaren Arthritis Pain) or a topical solution (Pennsaid) at about the same time each day. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any parts you do not understand. Use topical diclofenac (Pennsaid, Voltaren Arthritis Pain) exactly as directed. Do not use more or less of it, or use it more often or for longer than prescribed by your doctor. Do not apply the gel or topical solution to areas of your body that your doctor has not prescribed for you to treat.
Apply diclofenac gel (Voltaren Arthritis Pain) or a topical solution (Pennsaid) to clean, dry skin. Do not apply the medicine to broken, peeling, infected, swollen or rash-covered skin.
Diclofenac gel (Voltaren Arthritis Pain) and topical solution (Pennsaid) are for cutaneous use only. Be careful not to get the medicine in your eyes, nose or mouth. If the medicine gets into your eyes, rinse the eyes with plenty of water or saline. Call your doctor if your eyes are still irritated after an hour.
After applying diclofenac gel (Voltaren Arthritis Pain) or a topical solution (Pennsaid), you should not cover the treated area with any bandage or bandage, and you should not heat the area. You should not shower or bathe for at least 30 minutes after applying the topical solution (Pennsaid) and at least 1 hour after applying the gel (Voltaren Arthritis Pain). Do not cover the treated area with clothing or gloves for 10 minutes after applying the gel (Voltaren Arthritis Pain) or until the topical solution (Pennsaid) has dried if you are using the topical solution.
It may take up to 7 days before you feel the full benefit of over-the-counter topical diclofenac gel (Voltaren Arthritis Pain). If you do not feel any relief from your arthritis pain after 7 days of use, stop use and contact your doctor.
Follow these steps to apply Diclofenac Gel (Voltaren Arthritis Pain) topically:
- Before using a new tube of Diclofenac Gel (Voltaren Arthritis Pain) for the first time, open the safety cap covering the tube and then prick the opening of the tube with the tip of the cap. Do not open the seal with scissors or sharp objects.
- Place one of the dosage cards from the package on a flat surface so that you can read the label.
- Using the lines on the dosage card, press the correct amount of gel evenly onto the dosage card. Make sure the gel covers the entire area marked for the correct dose, depending on whether it is upper body (hand, wrist, elbow) or lower body (foot, ankle, knee). Put the cap back on the tube.
- Clean and dry the area of skin where you will apply the medicine. Do not apply to skin that has wounds, open sores, infections or rashes.
- Apply the gel to the relevant areas of the skin, use the dosage card to apply the gel to the skin on up to two areas of the body. Do not apply to more than 2 areas of the body. Gently rub the gel into the skin with your hands. Be sure to cover the entire affected area with the gel. Do not use on the same area as other products.
- Hold the end of the dispensing card with your fingertips and rinse and dry the card. Keep the dosage card out of the reach of children until the next use. Do not give the dosage card to other people.
- Wash your hands thoroughly after applying the gel unless you are treating your hands. If you treat your hands, do not wash them for at least an hour after applying the gel.
To use Diclofenac 1.5% topical solution topically, do the following:
- Clean and dry the area of skin where you will apply the medicine.
- Apply the topical solution to your knee, 10 drops at a time. You can do this by dripping the topical solution directly onto the knee or by first dripping it onto your palm and then spreading it onto the knee.
- Use your hand to spread the topical solution evenly on the front, back and sides of the knee.
- Repeat this step until 40 drops of the topical solution have been applied and the knee is completely covered with the topical solution.
- If your doctor has instructed you to apply the topical solution to both knees, repeat steps 2 through 4 to apply the medication to your other knee.
- Wash and dry your hands well after applying the topical solution. Avoid skin contact with other people and the treated knee area.
Follow these steps to use topical diclofenac 2% topical solution (Pennsaid):
- You must prime the pump that contains this medicine before you use it for the first time. Remove the cap from the pump and hold the pump upright. Press the top of the pump four times and use a paper towel or handkerchief to catch the spilled medicine. Throw the paper towel or handkerchief in a trash can.
- When you are ready to use your medicine, wash your hands thoroughly with soap and water.
- Hold the pump at an angle and press down on the top of the pump to dispense the medication into the palm of your hand. Press the top down a second time to release another burst of medication into your palm.
- Use the palm of your hand to apply the medication evenly to the front, back and sides of your knee.
- If your doctor has told you to apply the medication to both knees, repeat steps 3 to 4 to apply the medication to your other knee.
- Wash your hands thoroughly with soap and water after you have finished using the medicine.
- Put the cap back on your pump and store the pump vertically.
Other uses of this medicine
This drug may be prescribed for other purposes; Ask your doctor or pharmacist for more information.
What special precautions should I take?
Before using diclofenac topical,
- tell your doctor and pharmacist if you are allergic to diclofenac (Cambia, Flector, Voltaren Arthritis Pain, Solaraze, Zipsor, Zorvolex, in Arthrotec), aspirin, or other NSAIDs; any other medication; or any of the ingredients in topical diclofenac preparations. Ask the pharmacy or look in the medication guide for a list of ingredients.
- Tell your doctor and pharmacist what prescription and nonprescription drugs, vitamins, supplements, and herbal products you are taking or plan to take. Be sure to mention the drugs listed in the IMPORTANT WARNING section and one of the following: Acetaminophen (Tylenol, in other products); Angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (Prinivil, Zestril, in Prinzide and Zestoretic), moexipril (Univasc, in Uniretic) perindopril (Aceon, in Prestalia), quinapril (Accupril, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); Angiotensin receptor blockers such as candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta) and valsartan (in Exforge HCT); certain antibiotics, beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, Innopran); cyclosporine (Gengraf, Neoral, Sandimmune); digoxin (Lanoxin); diuretics ("water tablets"); lithium (lithobid); Anti-seizure medications, methotrexate (Otrexup, Rasuvo, Trexall) or pemetrexed (Alimta). Your doctor may need to change the dosage of your medication or closely monitor you for side effects.
- You should know that you should not apply sunscreen, cosmetics, lotions, moisturizers, insecticides, or other topical medications to areas treated with topical diclofenac. If you have been prescribed diclofenac topical solution (Pennsaid), wait until the application area 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 alcohol or have drunk large amounts of alcohol in the past and if you suffer or have ever suffered from any of the diseases mentioned in the "IMPORTANT WARNINGS" section or asthma, especially if you often suffer from a blocked or runny nose or nasal polyps (swelling), nasal mucosa; swelling of the hands, feet, ankles, or lower legs; heart failure; or kidney or liver disease.
- Tell your doctor if you are pregnant or planning to become pregnant. or breastfeeding. Diclofenac can harm the fetus and cause problems during birth if used around 20 weeks of pregnancy or later. Do not use topical diclofenac during or after the 20th week of pregnancy unless your doctor has told you to. If you become pregnant while using diclofenac topical, contact your doctor.
- You should know that this medicine can affect fertility in women. Talk to your doctor about the risks of using diclofenac topical.
- Avoid unnecessary or prolonged exposure to direct or artificial sunlight (tanning beds or lamps, ultraviolet light) and use protective clothing to cover areas treated with diclofenac topical. Topical diclofenac can make your skin sensitive to sunlight.
What special dietary instructions do I need to follow?
Unless your doctor tells you otherwise, continue with your normal diet.
What should I do if I miss a dose?
Apply the missed dose as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not apply extra diclofenac gel (Voltaren Arthritis Pain) or topical solution (Pennsaid) to make up for a missed dose.
What side effects can this drug cause?
Topical diclofenac can have side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- Application site dryness, redness, itching, swelling, pain, hardness, irritation, swelling, peeling or numbness
- Acne
- abdominal pains
- constipation
- Gas
- dizziness
- Numbness, burning or tingling in your hands, arms, feet or legs
Some side effects can be serious. If you experience any of these symptoms or the symptoms listed in the IMPORTANT WARNING section, contact your doctor immediately:
- hives
- itch
- difficulty swallowing
- swelling of the face, neck, arms or hands
- unexplained weight gain
- shortness of breath or difficulty breathing
- Swelling in the abdomen, ankles, feet or legs
- breathing
- exacerbation of asthma
- yellowing of the skin or eyes
- nausea
- extreme fatigue
- unusual bleeding or bruising
- Lack of energy
- Appetitverlust
- Pain in the upper right part of the abdomen
- flu-like symptoms
- dark colored urine
- rash
- blisters on the skin
- Fever
- pale skin
- fast heartbeat
- excessive fatigue
Topical diclofenac 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 can submit a report online to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about the storage and disposal of this medicine?
Keep this medicine in the original container, tightly closed and out of the reach of children. Store at room temperature and protect from frost or excessive heat.
It is important to keep all medicines out of the reach of children, as many containers (eg weekly pill boxes and those for eye drops, creams, patches and inhalers) are not child-resistant and can be easily opened by young children. To protect young children from poisoning, always lock safety caps and place medicine in a safe place immediately - somewhere high up and out of sight and reach.http://www.upandaway.org
Unnecessary medicines should be disposed of in a special way to ensure that pets, children and other people cannot ingest them. However, you should not flush this medicine down the toilet. Instead, the best way to dispose of your medication is through a medication take-back program. Talk to your pharmacist or contact your local waste/recycling department to learn more about take-back programs in your community. For more information, visit the FDA's Safe Drug Disposal website (http://goo.gl/c4Rm4p) for more information if you do not have access to a return program.
In case of emergency/overdose
If someone swallows diclofenac topical, 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.
Overdose symptoms may include the following:
- sleepiness
- Lack of energy
- nausea
- Vomiting
- abdominal pains
- bloody, black or tarry stools
- Vomiting of a substance that is bloody or looks like coffee grounds
- slow, shallow or irregular breathing
- hives
- itch
- Difficulty breathing or swallowing
- unconsciousness
What other information do I need to know?
Do not let anyone take your medicine. Ask questions at the pharmacy about refilling your prescription.
It is important that you keep a written list of all prescription and non-prescription (over-the-counter) medicines you take, as well as any products such as vitamins, minerals or other nutritional supplements. You should bring this list with you to any doctor's appointment or hospital stay. It is also important information to have with you in case of an emergency.
brand names
- Pennsaid®
- Voltaren Arthritis Pain®
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