Flurbiprofen

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using flurbiprofen and call your doctor at once if you have:

• changes in your vision;
• the first sign of any skin rash, no matter how mild;
• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, flu-like symptoms, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
• low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• indigestion, stomach pain, nausea, vomiting;
• confusion, tremors, feeling nervous;
• diarrhea, constipation;
• headache, dizziness, drowsiness;
• increased sweating, itching or rash; or
• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tablets: 50 and 100 mg

• Flurbiprofen should be stored at room temperature 20 C to 25 C (68 F to 77 F) in a sealed, moisture-free container.

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TABLE 2: Reported adverse events in patients receiving ANSAID (flurbiprofen) or other nonsteroidal anti-inflammatory drugs

Read the entire FDA prescribing information for Ansaid (Flurbiprofen)

• Lower Back Pain
• Neck Pain (Cervical Pain)
• NSAIDs (Nonsteroidal Antiinflammatory Drugs)
• Pain Management Medication Types
• Rheumatoid Arthritis (RA)

Flurbiprofen is a prescription medication used to treat the symptoms of osteoarthritis and rheumatoid arthritis. It is also used in liquid form to prevent or reduce changes in the eye that can occur during eye surgery.

Flurbiprofen belongs to a group of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). These work by stopping the body's production of a substance that causes pain and inflammation.

This medication comes in tablet form and is taken up to 4 times a day with or without food.

It is also available as an eye drop, and is usually instilled every 30 minutes beginning 2 hours before surgery, for a total of 4 doses.

Common side effects of flurbiprofen tablets include stomach pain, heartburn, and nausea/vomiting. Flurbiprofen can also cause dizziness. Do not drive or operate heavy machinery until you know how flurbiprofen affects you.

Common side effects of flurbiprofen eye drops include burning and stinging after instilling drops. 

Flurbiprofen is part of the drug class:

• Propionic acid derivatives

Flurbiprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Flurbiprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using flurbiprofen, especially in older adults.

Contraindications

• Known hypersensitivity to flurbiprofen or any ingredient in the formulation.1 15 f

• History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.1 f

• In the setting of CABG surgery.508

Warnings/Precautions

Warnings

NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) increase the risk of serious adverse cardiovascular thrombotic events (e.g., MI, stroke) in patients with or without cardiovascular disease or risk factors for cardiovascular disease.500 502 508

Findings of FDA review of observational studies, meta-analysis of randomized controlled trials, and other published information500 501 502 indicate that NSAIAs may increase the risk of such events by 10–50% or more, depending on the drugs and dosages studied.500

Relative increase in risk appears to be similar in patients with or without known underlying cardiovascular disease or risk factors for cardiovascular disease, but the absolute incidence of serious NSAIA-associated cardiovascular thrombotic events is higher in those with cardiovascular disease or risk factors for cardiovascular disease because of their elevated baseline risk.500 502 506 508

Increased risk may occur early (within the first weeks) following initiation of therapy and may increase with higher dosages and longer durations of use.500 502 505 506 508

In controlled studies, increased risk of MI and stroke observed in patients receiving a selective COX-2 inhibitor for analgesia in first 10–14 days following CABG surgery.508

In patients receiving NSAIAs following MI, increased risk of reinfarction and death observed beginning in the first week of treatment.505 508

Increased 1-year mortality rate observed in patients receiving NSAIAs following MI;500 508 511 absolute mortality rate declined somewhat after the first post-MI year, but the increased relative risk of death persisted over at least the next 4 years.508 511

Some systematic reviews of controlled observational studies and meta-analyses of randomized studies suggest naproxen may be associated with lower risk of cardiovascular thrombotic events compared with other NSAIAs.19 20 21 23 500 501 502 503 506 FDA states that limitations of these studies and indirect comparisons preclude definitive conclusions regarding relative risks of NSAIAs.500

Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events throughout therapy, even in those without prior cardiovascular symptoms) and at the lowest effective dosage for the shortest duration necessary.1 500 508 f

Some clinicians suggest that it may be prudent to avoid NSAIA use, whenever possible, in patients with cardiovascular disease.505 511 512 516 Avoid use in patients with recent MI unless benefits of therapy are expected to outweigh risk of recurrent cardiovascular thrombotic events; if used, monitor for cardiac ischemia.508 Contraindicated in the setting of CABG surgery.508

No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.1 16 502 508 f (See Specific Drugs under Interactions.)

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms; increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.1 15 f h i

For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol;h j k l alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole)h j k or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).k

Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events.1 f Use with caution in patients with hypertension; monitor BP.1 f

Impaired response to ACE inhibitors, angiotensin II receptor antagonists, β-blockers, and certain diuretics may occur.1 508 f (See Specific Drugs under Interactions.)

Fluid retention and edema reported.1 508 f

NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) may increase morbidity and mortality in patients with heart failure.500 501 504 507 508

NSAIAs may diminish cardiovascular effects of diuretics, ACE inhibitors, or angiotensin II receptor antagonists used to treat heart failure or edema.508 (See Specific Drugs under Interactions.)

Manufacturer recommends avoiding use in patients with severe heart failure unless benefits of therapy are expected to outweigh risk of worsening heart failure; if used, monitor for worsening heart failure.508

Some experts recommend avoiding use, whenever possible, in patients with reduced left ventricular ejection fraction and current or prior symptoms of heart failure.507

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.1 f

Potential for overt renal decompensation.1 f Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in geriatric patients, in patients with volume depletion, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist.1 18 f (See Renal Impairment under Cautions.)

Sensitivity Reactions

Anaphylactoid reactions reported.1 f

Immediate medical intervention and discontinuance for anaphylaxis.1 f

Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps);1 f caution in patients with asthma.1 f

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning.1 f Discontinue at first appearance of rash or any other sign of hypersensitivity (e.g., blisters, fever, pruritus).1 f

General Precautions

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.1 f

Elevations of serum ALT or AST reported.1 f

Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results.1 Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur.1

Anemia reported rarely.1 Determine hemoglobin concentration or hematocrit periodically in patients receiving long-term therapy even if signs or symptoms of anemia do not occur.1

May inhibit platelet aggregation and prolong bleeding time.1

Visual disturbances reported; ophthalmic evaluation recommended if visual changes occur.1

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.1 f

May mask certain signs of infection.1 f

Obtain CBC and chemistry profile periodically during long-term use.1 f

Specific Populations

Category C.1 Avoid use in third trimester because of possible premature closure of the ductus arteriosus.1

Distributed into milk.1 13 15 c d Discontinue nursing or the drug.1

Safety and efficacy not established.1

Use with caution in patients ≥65 years of age.1 f Geriatric patients appear to tolerate NSAIA therapy less well (e.g., possible higher incidence of adverse GI effects, greater risk of developing renal decompensation) than younger individuals.1 f Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.1 f

Metabolites eliminated principally via the kidney.1 3 Use not recommended in patients with advanced renal disease.1 If flurbiprofen must be used, closely monitor renal function.1

Common Adverse Effects

Edema, abdominal pain, constipation, diarrhea, dyspepsia/heartburn, flatulence, GI bleeding, nausea, vomiting, elevated liver enzymes, body weight changes, headache, nervousness, CNS stimulation (e.g., anxiety, insomnia, increased reflexes, tremor), CNS inhibition (e.g., amnesia, asthenia, depression, malaise, somnolence), rhinitis, vision changes, dizziness/vertigo, tinnitus, urinary tract infection, rash.1 f

Applies to flurbiprofen: oral capsule extended release, oral tablet

Along with its needed effects, flurbiprofen may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking flurbiprofen:

• Abdominal or stomach pain
• bladder pain
• bloody or black, tarry stools
• bloody or cloudy urine
• constipation
• difficult, burning, or painful urination
• frequent urge to urinate
• lower back or side pain
• rash
• severe stomach pain
• swelling
• vomiting of blood or material that looks like coffee grounds

• Back or leg pains
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloody diarrhea
• bloody nose
• blurred vision
• burning feeling in the chest or stomach
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• chills
• clay-colored stools
• cough
• cracks in the skin
• dark urine
• decreased urine output
• difficulty breathing
• difficulty swallowing
• dilated neck veins
• dizziness
• extreme fatigue
• fast heartbeat
• feeling faint, dizzy, or lightheaded
• feeling of warmth or heat
• fever with or without chills
• flushing or redness of the skin, especially on the face and neck
• general feeling of tiredness or weakness
• greatly decreased frequency of urination
• headache
• high fever
• hives or itching
• hoarseness
• increased blood pressure
• increased sensitivity of the skin to sunlight
• increased thirst
• indigestion
• irregular breathing
• irregular heartbeat
• joint pain, stiffness, or swelling
• large, flat, blue, or purplish patches in the skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• loss of appetite
• loss of heat from the body
• muscle pain
• nausea
• nervousness
• noisy breathing
• nosebleeds
• pale skin
• pinpoint red or purple spots on the skin
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• red, swollen skin
• redness or other discoloration of the skin
• redness, swelling, or soreness of the tongue
• scaly skin
• severe or continuing stomach pain
• severe sunburn
• shakiness and unsteady walk
• skin rash, encrusted, scaly and oozing
• slow or fast heartbeat
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach bloating or cramping
• stomach upset
• sweating
• swelling of the face, fingers, feet, or lower legs
• swelling or inflammation of the mouth
• swollen or painful glands
• tenderness in the stomach area
• tightness in the chest
• troubled breathing
• unpleasant breath odor
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• vomiting
• weight gain
• weight loss
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking flurbiprofen:

• Change in consciousness
• fast or slow, or shallow breathing
• heartburn
• loss of consciousness
• pain or discomfort in the chest, upper stomach, or throat
• pale or blue lips, fingernails, or skin
• unusual drowsiness, dullness, or feeling of sluggishness

Some side effects of flurbiprofen may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• changes in vision
• continuing ringing or buzzing or other unexplained noise in the ear
• diarrhea
• discouragement
• excess air or gas in the stomach or intestines
• fear
• feeling of constant movement of self or surroundings
• feeling sad or empty
• full feeling
• general feeling of discomfort or illness
• hearing loss
• irritability
• lack of appetite
• lack or loss of strength
• lightheadedness
• loss of interest or pleasure
• loss of memory
• passing gas
• problems with memory
• runny nose
• sensation of spinning
• sleepiness
• sneezing
• stomach discomfort
• stuffy nose
• tremor
• trouble concentrating
• trouble sleeping

• Burning, dry, or itching eyes
• confusion
• discharge or excessive tearing
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• transient, mild, pleasant aromatic odor
• twitching

200 mg to 300 mg orally per day in 2 to 4 divided doses
Maximum single dose: 100 mg

Comments:
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit individual patient treatment goals.

Uses: For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis

Administration advice:
-Take with food

General:
-Prior to initiating treatment, the potential benefits and risks of this drug should be weighed against other treatment options.
-The lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
-There is an increased risk of heart attack, heart failure, and stroke when taking nonsteroidal anti-inflammatory drugs (NSAIDs); these events may occur at any time during treatment and risk increases with long term use, a history of cardiovascular (CV) disease or risk factors for CV disease, and higher doses.

Monitoring:
-Cardiovascular: Monitor blood pressure closely during initiation and throughout course of therapy.
-Gastrointestinal: Monitor for signs/symptoms of gastrointestinal bleeding.
-Renal function: Monitor renal status, especially in patients with conditions where renal prostaglandins have a supportive role in the maintenance of renal perfusion.
-Monitor blood counts, renal, and hepatic function periodically for patients receiving long-term therapy.

Patient advice:
-Patients should seek medical advice for signs and symptoms of gastrointestinal events, adverse skin reactions, allergic reactions, hepatotoxicity, or unexplained weight gain or edema.
-Patients should seek medical attention immediately if signs/symptoms of cardiovascular events occur including, shortness of breath, slurred speech, chest pain, or weakness on one side of the body.
-Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding; this drug is not recommended for use during pregnancy.