Pennsaid

Diclofenac is a prescription medication used to treat inflammation and pain caused by a variety of conditions such as arthritis and migraines. It is also used treat actinic keratoses (AK), a condition caused by long-term sun exposure in which the skin grows rough, dry, or scaly patches.

Diclofenac belongs to a group of drugs called NSAIDs, which work by stopping the substances in the body that cause inflammation and pain. The exact way it works for AK is not known.

Diclofenac comes in a variety of forms including capsules, tablets (regular and delayed-release), powders, patches, gels, an injectable, liquid, and eye drops. The directions for taking it will depend on which form you are prescribed. Follow the directions carefully.

Common side effects of topical diclofenac (liquid drops, eye drops, patch, gel) include irritation and redness at the site of application.

Common side effects of oral diclofenac (powder, capsule, tablet) include nausea, upset stomach, stomach pain, and dizziness. Do not drive or operate heavy machinery until you know how diclofenac can affect you.

Diclofenac is a prescription medication used to treat inflammation and pain due to due to a variety of conditions such as arthritis, migraines, sprains, and dysmenorrhea. It is also used treat actinic keratoses (AK). This is a condition when the skin grows rough, dry, or scaly patch due to long-term sun exposure.

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

• Lake Erie Medical DBA Quality Care Products LLC

• Mallinckrodt Inc (Brand Pharmaceuticals)

• Mallinckrodt, Inc.

• Quality Care Products, LLC

• Stat Rx Usa Llc

• Unit Dose Services, LLC

The most common side effects of diclofenac include the following:

Oral:

• swelling
• nausea
• headache
• dizziness
• vomiting
• constipation
• pruritus
• pain in extremity
• upset stomach

Topical:

• itching
• redness
• irritation
• rash
• dryness
• scaling or peeling

This is not a complete list of diclofenac side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other NSAIDs such as aspirin, ibuprofen, or naproxen
• 'blood thinners' such as warfarin (Coumadin, Jantoven)
• voriconazole (Vfend)
• angiotensin-converting enzyme (ACE) blockers such as
  • benazepril (Lotensin, Lotensin HCT)
  • captopril (Capoten, Capozide)
  • enalapril (Vasotec, Vaseretic)
  • fosinopril (Monopril, Monopril HCT)
  • lisinopril (Prinivil, Prinzide, Zestril, Zestoretic)
  • moexipril (Univasc, Uniretic)
  • quinapril (Accupril, Accuretic, Quinaretic)
  • ramipril (Altace)
  • trandolapril (Mavik, Tarka)
• diuretics such as
  • acetazolamide (Diamox)
  • amiloride (Midamor)
  • bumetanide (Bumex)
  • chlorothiazide (Diuril)
  • chlorthalidone (Thalitone)
  • ethacrynic acid (Edecrin)
  • furosemide (Lasix)
  • hydrochlorothiazide (Microzide, HCTZ)
  • metolazone (Zaroxolyn)
  • torsemide (Demadex)
  • triamterene (Dyrenium, Dyazide, Maxzide)
• methotrexate (Trexall)
• lithium (Eskalith, Lithobid)
• cyclosporine (Gengraf, Neoral, Sandimmune)

This is not a complete list of diclofenac drug interactions. Ask your doctor or pharmacist for more information.

• Do not use diclofenac if you are allergic to diclofenac (the active ingredient), any inactive ingredient, or aspirin.
• Diclofenac is an NSAID medication. Although some forms of diclofenac can be applied to the skin, some of the medication is absorbed into the blood stream. NSAIDs have been linked to stomach and intestinal bleeding, ulcers, heart attack, stroke, congestive heart failure, allergic reactions, and worsening asthma.
• Tell your doctor right away if you experience symptoms of ulcers or bleeding including:
  • black, tarry stools
  • blood in stools
  • stomach pain
  • vomiting blood
• Call 911 if you experience heart attack symptoms:
  • chest discomfort (uncomfortable pressure, fullness, or pain in chest)
  • shortness of breath
• Diclofenac can also cause or worsen existing hypertension. Blood pressure should be monitored closely during treatment with diclofenac treatment.
• Fluid retention and swelling have been observed in those who have taken NSAIDs. Diclofenac should be used with caution in patients with fluid retention or heart failure.
• Kidney injury may occur with long-term use. Diclofenac should be used with caution in patients at greatest risk of this, including the elderly, those with impaired kidney function, heart failure, liver dysfunction, and those taking diuretics and ACE inhibitors.
• Severe allergic reactions have occurred in patients with the aspirin triad or in patients without prior exposure to diclofenac. Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include the following:
  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing or swallowing
  • rash
• Serious skin adverse events have occurred with diclofenac use. Discontinue diclofenac if rash or other signs of a skin reaction occur.
• Diclofenac can cause dizziness. Do not drive or operate heavy machinery until you know how diclofenac can affect you.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of diclofenac there are no specific foods that you must exclude from your diet when receiving diclofenac.

Before using diclofenac, tell your doctor if you:

• are allergic to any medications, foods, or dyes
• have asthma or nasal polyps
• have heart, liver, or kidney disease
• have ulcers or stomach bleeding
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. NSAIDs can adversely affect the development of the unborn baby's cardiovascular system. Use during pregnancy (particularly late pregnancy) should be avoided.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if diclofenac is excreted in human breast milk or if it will harm your nursing baby.

Oral:

• Capsule: take 3 times a day, with or without food.
• Tablet: take 3 or 4 times a day, with or without food.
• Extended-release tablet: take 1 or 2 times a day, with or without food. Do not crush, chew, split, or break extended-release tablets. Swallow tablets whole.
• Powder for oral solution: mix with 1 to 2 ounces (30 to 60 mL) of water and taken by mouth once a day, without food.

Topical:

• Gel
  • Diclofenac gel is to be applied to the skin twice daily for 60 to 90 days. Use exactly as prescribed. Do not use more or less of it, or use it more often than prescribed by your doctor.
  • Wash your hands.
  • Apply a small amount of gel on the affected skin, covering it completely, gently smoothing the gel on affected area.
  • Use this gel twice daily; apply it in the morning before dressing and at night before going to bed.
  • Wash your hands after applying the gel. Do not rub or touch your eyes before washing your hands.
    • What to avoid:
      • Be careful not to get this medication in your eyes if you are applying it to your face.
      • Do not apply to open wounds (broken skin), infections, or red, scaly skin.
      • Wear protective clothing, and avoid prolonged sun exposure.
      • Do not use sunscreens, cosmetics, or other medications applied to the skin during treatment.
      • Do not cover treated areas with dressings or bandages.
• Patch
  • Diclofenac also comes in patch form to be applied to the most painful area twice a day. Be sure to remove the old patch before applying the next one.
  • If diclofenac patch begins to peel-off, the edges of the patch may be taped down. If problems with adhesion persist, you may cover the patch with a mesh netting sleeve, where appropriate (e.g. to secure patches applied to ankles, knees, or elbows). The mesh netting sleeve (e.g. Curad Hold Tite, Surgilast Tubular Elastic Dressing) must allow air to pass through and not be occlusive (non-breathable).
  • Do not apply diclofenac patch to non-intact or damaged skin (e.g. exudative dermatitis, eczema, infected lesion, burns, or wounds).
  • Do not wear a diclofenac patch when bathing or showering.
  • Wash your hands after applying, handling or removing the patch.
  • Avoid eye contact.
• Topical Liquid
  • Apply diclofenac topical liquid to clean, dry skin.
  • Dispense diclofenac topical liquid 10 drops at a time either directly onto the knee or first into the hand and then onto the knee. Spread diclofenac topical liquid evenly around front, back and sides of the knee. Repeat this procedure until 40 drops have been applied and the knee is completely covered with solution.
  • Wash hands completely after administering the product.
  • Wait until the area is completely dry before covering with clothing or applying sunscreen, insect repellent, cosmetics, topical medications, or other substances.
  • Do not get diclofenac topical liquid in your eyes, nose or mouth.
• Eye drop solutions
  • One drop should be applied to the affected eye, 4 times daily beginning 24 hours after cataract surgery and continuing throughout the first 2 weeks of the postoperative period.
  • One or two drops should be applied to the operative eye within the hour prior to corneal refractive surgery. Within 15 minutes after surgery, one or two drops should be applied to the operative eye and continued 4 times daily for up to 3 days.

Oral:

• Capsule: The dosage is 18 mg or 35 mg orally three times a day.
• Tablet
  • For the relief of osteoarthritis the recommended dosage is 100-150 mg/day in divided doses, 50 mg 2 or 3 times a day.
  • For the relief of rheumatoid arthritis the recommended dosage is 150-200 mg/day in divided doses, 50 mg 3 or 4 times a day.
• Extended-release tablet
  • For the relief of osteoarthritis, the recommended dosage is 100 mg a day.
  • For the relief of rheumatoid arthritis, the recommended dosage is 100 mg 1 or 2 times a day.
• Powder for oral solution
  • Mix with 1 to 2 ounces (30 to 60 mL) of water with one packet (50 mg) diclofenac and taken by mouth once a day, without food. Do not use liquids other than water.

Topical:

• Gel: Apply to lesion areas twice daily. It is to be smoothed onto the affected skin gently.
  • The amount needed depends upon the size of the lesion site.
  • Assure that enough gel is applied to adequately cover each lesion. Normally 0.5 grams of gel is used on each 5 cm x 5 cm lesion site.
  • The recommended duration of therapy is from 60 days to 90 days. Complete healing of the lesion(s) or optimal therapeutic effect may not be apparent for up to 30 days following cessation of therapy.
• Patch: diclofenac gel is to be applied to the skin twice daily for 60 to 90 days. Use exactly as prescribed. Do not use more or less of it, or use it more often than prescribed by your doctor.
• Topical Liquid: for the relief of the signs and symptoms of osteoarthritis of the knee(s), the recommended dose is 40 drops per knee, 4 times a day.
• Eye drop solutions
  • One drop should be applied to the affected eye, 4 times daily beginning 24 hours after cataract surgery and continuing throughout the first 2 weeks of the postoperative period.
  • One or two drops should be applied to the operative eye within the hour prior to corneal refractive surgery. Within 15 minutes after surgery, one or two drops should be applied to the operative eye and continued 4 times daily for up to 3 days.

If you take too much diclofenac, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If diclofenac is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Cardiovascular Risk

• Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
• Diclofenac is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

• NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.