Ibuprofen

What is Ibuprofen?

• Ibuprofen a nonsteroidal anti-inflammatory drug (NSAID) used to treat fever, swelling, pain, and redness by preventing the body from making a substance that causes inflammation.

• Ibuprofen is a commonly used nonsteroidal anti inflammatory (NSAID) drug which is available both by prescription and over-the-counter.

Ibuprofen

Ibuprofen2

What are the uses of this medicine?

Ibuprofen is used for:

• relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
• relief of mild to moderate pain.
• the treatment of primary dysmenorrhea (pain that happens before or during a menstrual period).

How does this medicine work?

• Ibuprofen (eye" bue proe' fen) is a propionic acid NSAID similar to ketoprofen and naproxen.
• Like other NSAIDs, ibuprofen is a potent inhibitor of cellular cyclooxygenases (Cox-1 and Cox-2) which blocks the formation of prostaglandin, prostacyclin and thromboxane products, important mediators of inflammation and pain.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known hypersensitivity to ibuprofen
• asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
• coronary artery bypass graft (CABG) surgery.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention if you are taking any of the following:

• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• aspirin
• other NSAIDs such as ketoprofen and 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)
• serotonin norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor XR).
• angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc), 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)
• 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); diuretics ('water pills')
• lithium (Lithobid)
• methotrexate (Otrexup, Rasuvo, Trexall)

Is this medicine FDA approved?

• Ibuprofen has analgesic as well as antipyretic and anti inflammatory activities.
• Ibuprofen was approved for use by prescription in the United States in 1974 and was made available over-the-counter in 1984.
• Currently, more than 20 million prescriptions for ibuprofen are filled yearly, a number that does not include its vast over-the-counter use.
• Ibuprofen is used for treatment of mild-to-moderate forms of joint pain and arthritis from trauma, osteoarthritis or rheumatoid arthritis.
• Ibuprofen is also active against other forms of pain including headache and dysmenorrhea.

How should this medicine be used?

• Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals.

Recommended dosage: Rheumatoid arthritis and osteoarthritis, including flare-ups ofchronic disease:

• 1200 mg-3200 mg daily (400 mg, 600 mg or800 mg tid or qid).
• Do not exceed 3200 mg total daily dose.

Mild to moderate pain:

• 400 mg every 4 to 6 hours as necessary for relief of pain.
• In controlled analgesic clinical trials, doses of Ibuprofen tabletsgreater than 400 mg were no more effective than the 400 mg dose.

Dysmenorrhea:

• For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, IBU tablets should be given in adose of 400 mg every 4 hours as necessary for the relief of pain.

Administration:

• Prescription ibuprofen comes as a tablet to take by mouth.
• It is usually taken three or four times a day for arthritis or every 4 to 6 hours as needed for pain.
• Nonprescription ibuprofen comes as a tablet, chewable tablet, suspension (liquid), and drops (concentrated liquid).
• Adults and children older than 12 years of age may usually take nonprescription ibuprofen every 4 to 6 hours as needed for pain or fever.
• Children and infants may usually be given nonprescription ibuprofen every 6 to 8 hours as needed for pain or fever, but should not be given more than 4 doses in 24 hours.
• Ibuprofen may be taken with food or milk to prevent stomach upset.
• Swallow the tablet whole; do not chew or crush it.
• Shake the suspension and drops well before each use to mix the medication evenly. Use the measuring cup provided to measure each dose of the suspension, and use the dosing device provided to measure each dose of the drops.
• The chewable tablets may cause a burning feeling in the mouth or throat. Take the chewable tablets with food or water.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Prescription ibuprofen comes as a tablet to take by mouth.
• Nonprescription ibuprofen comes as a tablet, chewable tablet, suspension (liquid), and drops (concentrated liquid).

This medicine is available in fallowing brand namesː

• Addaprin
• Advil
• Cedaprin
• I-Prin
• Midol
• Motrin
• Motrin IB
• NeoProfen
• Profen IB
• Proprinal
• Ultraprin

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• dizziness
• somnolence
• dyspepsia
• nausea
• abdominal discomfort
• heartburn
• diarrhea
• peripheral edema
• hypersensitivity reactions

Ibuprofen may cause serious side effects which may include:

• Increased risk of a heart attack or stroke
• Increased risk of bleeding, [[ulcers], and tears (perforation) of the esophagus
• new or worse high blood pressure
• low red blood cells (anemia)
• heart failure
• life-threatening skin reactions
• liver problems including liver failure
• life-threatening allergic reactions
• kidney problems including kidney failure

Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

What special precautions should I follow?

• Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately.
• IBU tablets, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative signs or symptoms including epigastric pain, dyspepsia, melena, and hematemesis.
• IBU tablets, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, Stevens-Johnson Syndrome(SJS), and toxic epidermal necrolysis (TEN), which may result in hospitalization and even death. Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible.
• Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur
• Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness and “flu-like” symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.
• Patients should be informed of the signs of an anaphylactoid reaction(e.g. difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help.
• In late pregnancy, as with other NSAIDs, IBU tablets should beavoided because it may cause premature closure of the ductus arteriosus.
• It is not known whether this drug is excreted in human milk.
• Ibuprofen is considered to be among the safest NSAIDs and is generally well tolerated but can, nevertheless, rarely cause clinically apparent and serious acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• dizziness
• fast eye movements that you cannot control
• slow breathing or short periods of time without breathing
• blue color around the lips, mouth, and nose

Management of overdosage:

• In cases of acute overdosage, the stomach should be emptied by vomiting or lavage, though little drug will likely be recovered if moret han an hour has elapsed since ingestion.
• Because the drug is acidic and is excreted in the urine, it is theoretically beneficial to administer alkali and induce diuresis.
• In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption and reabsorption of Ibuprofen tablets.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies in pregnant women.
• Ibuprofen should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness of IBU tablets in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• IBUPROFEN

Inactive Ingredients:

• MICROCRYSTALLINE CELLULOSE
• COPOVIDONE K25-31
• SODIUM STARCH GLYCOLATE TYPE A POTATO
• SILICON DIOXIDE
• MAGNESIUM STEARATE
• POLYSORBATE 80

Who manufactures and distributes this medicine?

Manufacturing facility:

• Dr. Reddy's Laboratories Louisiana, LLC - Shreveport, LA USA

Distributed by:

• Dr. Reddy's Laboratories, Inc.

Distributed By:

• MAJOR® PHARMACEUTICALS
• N Laurel Park Dr., Suite 233
• Livonia, MI

Distributed by:

• Cardinal Health
• Dublin, OH

What should I know about storage and disposal of this medication?

• Store at room temperature.
• Avoid excessive heat 40°C (104°F).

Nonsteroidal Antiinflammatory Drugs (NSAIDs)

Acetaminophen, Celecoxib, Diclofenac, Diflunisal, Etodolac, Fenoprofen, Flurbiprofen, Ibuprofen, Indomethacin, Ketoprofen, Ketorolac, Mefenamic Acid, Meloxicam, Nabumetone, Naproxen, Nimesulide, Oxaprozin, Phenylbutazone, Piroxicam, Rofecoxib, Sulindac, Tolmetin

• Dailymed label info on Ibuprofen
• FDA Ibuprofen

Ibuprofen Resources
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