diclofenac potassium: Black Box Warnings

diclofenac potassium: Adult Dosing

Dosage forms: 50

pain, mild-moderate

50 mg PO tid

Start: may consider 100 mg PO x1; Max: 200 mg/day 1st 24h only, 150 mg/day thereafter; Info: use lowest effective dose, shortest tx duration; D/C if abnormal liver or renal tests persist or worsen

dysmenorrhea

50 mg PO tid

Start: may consider 100 mg PO x1; Max: 200 mg/day 1st 24h only, 150 mg/day thereafter; Info: use lowest effective dose, shortest tx duration; D/C if abnormal liver or renal tests persist or worsen

osteoarthritis

50 mg PO bid-tid

Max: 150 mg/day; Info: use lowest effective dose, shortest tx duration; D/C if abnormal liver or renal tests persist or worsen

rheumatoid arthritis

50 mg PO tid-qid

Max: 200 mg/day; Info: use lowest effective dose, shortest tx duration; D/C if abnormal liver or renal tests persist or worsen

renal dosing

see below

advanced renal dz: avoid use or closely monitor renal fxn; HD/CAPD: no supplement

hepatic dosing

adjust dose amount

hepatic impairment: decr. dose, amount not defined

diclofenac potassium: Peds Dosing

This information is currently unavailable or not applicable for this drug.

diclofenac potassium: Contraindications/Cautions

• hypersens. to drug/class/compon.
• ASA/NSAID-induced asthma or urticaria
• aspirin triad
• pregnancy, 3rd trimester
• CABG surgery (periop pain)
• caution if cardiovascular dz
• caution if cardiac risk factors
• caution if HTN
• caution if CHF
• caution if fluid retention
• caution if PUD/GI bleed hx
• caution if corticosteroid use
• caution if anticoagulant use
• caution if coagulopathy
• caution if alcohol use
• caution if smoker
• caution in elderly or debilitated pts
• caution if impaired liver fxn
• caution if impaired renal fxn
• caution if dehydration
• caution if diuretic use
• caution if ACEI or ARB use
• caution if asthma
• caution if prolonged use

diclofenac potassium: Drug Interactions

Contraindicated

• aspirin

• aspirin, buffered/pravastatin

• aspirin/caffeine/CNS depressant combos

• aspirin/caffeine/orphenadrine

• aspirin/dipyridamole

• aspirin/muscle relaxant combos

• aspirin/opiate combos

• cidofovir

• COX 2 inhibitors

• pentoxifylline

• probenecid

Avoid/Use Alternative

• ACE inhibitor/HCTZ combos

• beta blocker/thiazide combos

• beta blockers, systemic

• cyclosporine

• diclofenac topical

• drotrecogin alfa

• ethanol

• fondaparinux

• heparins

• ibritumomab tiuxetan

• lansoprazole/naproxen

• methotrexate

• mycophenolate mofetil

• mycophenolic acid

• pemetrexed

• pentosan polysulfate sodium

• sirolimus

• sumatriptan/naproxen sodium

• tacrolimus

• warfarin

Monitor/Modify Tx

• A2R blocker/HCTZ combos

• ACE inhibitors

• acetaminophen/butalbital

• acetaminophen/caffeine/CNS depressant combos

• acetaminophen/opiate combos

• acetaminophen/propoxyphene

• acetaminophen/tramadol

• acetaminophens

• adefovir

• amlodipine/A2R blocker combos

• angiotensin II receptor blockers

• diuretics, potassium-sparing

• drospirenone

• enalapril/felodipine

• eplerenone

• hydralazine

• hydralazine/isosorbide dinitrate

• lithium

• polyethylene glycol/electrolytes

• sodium phosphate

• zoledronic acid

Caution Advised

• antiplatelets

• bisphosphonates, oral

• budesonide

• corticosteroids, systemic

• darunavir

• dasatinib

• desvenlafaxine

• diuretics, loop

• diuretics, potassium-sparing/HCTZ

• diuretics, thiazide

• donepezil

• erlotinib

• galantamine

• hydrocodone/ibuprofen

• ibuprofen/oxycodone

• iloprost inhaled

• leflunomide

• neostigmine

• NSAIDs, ophthalmic

• olanzapine/fluoxetine

• omega-3-acid

• platelet GP IIb/IIIa inhibitors

• pyridostigmine

• quinolones, all

• rivastigmine

• SSRIs, all

• sulfinpyrazone

• tacrine

• thrombin inhibitors

• thrombolytics

• tipranavir

• treprostinil

• valproic acid derivatives

diclofenac potassium: Adverse Reactions

Serious Reactions

• GI bleed
• GI ulceration/perforation
• MI
• stroke
• thromboembolism
• HTN
• CHF
• renal papillary necrosis
• nephrotoxicity
• hepatotoxicity, incl. fatal (rare)
• anaphylactoid rxns
• bronchospasm
• exfoliative dermatitis
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• erythema multiforme
• anemia
• blood dyscrasias (rare)
• prolonged bleeding time

Common Reactions

• dyspepsia
• nausea
• abdominal pain
• constipation
• headache
• dizziness
• rash
• elevated liver transaminases
• urticaria
• drowsiness
• fluid retention
• peripheral edema
• tinnitus
• ecchymosis

diclofenac potassium: Safety Monitoring

Pregnancy: C, see Contraind/Caut.

Lactation: Probably Safe

Monitoring Parameters: Cr at baseline, then if severe renal dz cont. periodically; ALT/AST w/in 4-8wk of tx initiation, then periodically if long-term tx; CBC, chemistry profile if long-term tx; BP

Noninterchangeable Forms: diclofenac formulations may not be bioequivalent even if milligram strength is the same

diclofenac potassium: Pharmacology

Metabolism: liver extensively; CYP450: 2C9, 3A4 substrate

Excretion: urine 65% (<1% unchanged), bile 35%; Half-life: 1.9h

Class: NSAIDs

Mechanism Of Action
exact mechanism of action unknown; inhibits cyclooxygenase and lipoxygenase and reduces prostaglandin synthesis

diclofenac potassium: Manufacturer/Pricing

Manufacturer: generic DEA/FDA: Rx

diclofenac potassium: Patient Education

• Generic Name: diclofenac

• Pronounced: dye KLOE fen ak

• Brand Names: Cataflam, Voltaren, Voltaren-XR

What is the most important information I should know about diclofenac?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use diclofenac. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking diclofenac. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to diclofenac (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen.

Do not drink alcohol while taking diclofenac. Alcohol can increase the risk of stomach bleeding caused by diclofenac.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Diclofenac can make your skin more sensitive to sunlight and sunburn may result.

What is diclofenac?

Diclofenac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Diclofenac works by reducing hormones that cause inflammation and pain in the body.

Diclofenac is used to treat pain or inflammation caused by arthritis or ankylosing spondylitis.

Diclofenac may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking diclofenac?

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you are allergic to diclofenac, or if you have a history of allergic reaction to aspirin or other NSAIDs.

Before taking diclofenac, tell your doctor if you are allergic to any drugs, or if you have:

• a history of heart attack, stroke, or blood clot;
• heart disease, congestive heart failure, high blood pressure;
• a history of stomach ulcers or bleeding;
• liver or kidney disease,
• asthma;
• polyps in your nose;
• a bleeding or blood clotting disorder; or
• if you smoke.

If you have any of these conditions, you may not be able to use diclofenac, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking diclofenac during the last 3 months of pregnancy may result in birth defects. Do not take diclofenac during pregnancy unless your doctor has told you to.

Diclofenac can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without the advice of a doctor.

How should I take diclofenac?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

If you switch brands of diclofenac, your dose needs may change. Follow your doctor's instructions about how much medicine to take.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

If you take diclofenac for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.

Store diclofenac at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a diclofenac overdose may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

What should I avoid while taking diclofenac?

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to diclofenac (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen.

Do not drink alcohol while taking diclofenac. Alcohol can increase the risk of stomach bleeding caused by diclofenac.

Avoid prolonged exposure to sunlight. Diclofenac may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

What are the possible side effects of diclofenac?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking diclofenac and seek medical attention or call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
• black, bloody, or tarry stools;
• coughing up blood or vomit that looks like coffee grounds;
• swelling or rapid weight gain;
• urinating less than usual or not at all;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
• bruising, severe tingling, numbness, pain, muscle weakness; or
• fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Keep taking diclofenac and talk to your doctor if you have any of these less serious side effects:

• upset stomach, mild heartburn or stomach pain, diarrhea, constipation;
• bloating, gas;
• dizziness, headache, nervousness;
• skin itching or rash;
• blurred vision; or
• ringing in your ears.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect diclofenac?

Before taking diclofenac, tell your doctor if you are taking any of the following drugs:

• a blood thinner such as warfarin (Coumadin);
• cyclosporine (Neoral, Sandimmune);
• lithium (Eskalith, Lithobid);
• methotrexate (Rheumatrex, Trexall);
• diuretics (water pills) such as furosemide (Lasix).
• steroids (prednisone and others);
• aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others; or
• an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others.

If you are using any of these drugs, you may not be able to use diclofenac or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect diclofenac. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has information about diclofenac written for health professionals that you may read.

What does my medication look like?

Diclofenac is available with a prescription under the brand names Cataflam and Voltaren. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Cataflam 50 mg--round, biconvex, light-brown tablets

• Voltaren 25 mg--triangular, biconvex, yellow tablets
• Voltaren 50 mg--triangular, biconvex, light-brown tablets
• Voltaren 75 mg--triangular, biconvex, light-pink tablets
• Voltaren XR 100 mg--round, biconvex, light-pink, coated tablets

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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise.

Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.

The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

diclofenac potassium: Pill Pictures