Naproxen

What is Naproxen?

• Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drug used to treat pain, menstrual cramps, inflammatory diseases such as rheumatoid arthritis, gout and fever.

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Naproxen

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What are the uses of this medicine?

Naproxen as naproxen or naproxen sodium tablets are indicated:

• For the relief of the signs and symptoms of rheumatoid arthritis
• For the relief of the signs and symptoms of osteoarthritis
• For the relief of the signs and symptoms of ankylosing spondylitis
• For the relief of the signs and symptoms of juvenile arthritis

• Naproxen as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight.

Naproxen as naproxen and naproxen sodium tablets are also indicated:

• For relief of the signs and symptoms of tendonitis
• For relief of the signs and symptoms of bursitis
• For relief of the signs and symptoms of acute gout
• For the management of pain
• For the management of primary dysmenorrhea

How does this medicine work?

• Naproxen (na prox' en) belongs to the propionic acid class of NSAIDs similar to fenoprofen, ibuprofen, ketoprofen and oxaprozin. The anti inflammatory and analgesic properties of NSAIDs such as naproxen are mediated by inhibition of tissue cyclo-oxygenases (Cox-1 and -2), which results in a decrease in pro-inflammatory prostaglandins, important mediators in inflammatory and pain pathways.
• Naproxen has analgesic as well as antipyretic and antiinflammatory activity.
• It has a longer half-life than other commonly used NSAIDs, making a twice daily regimen feasible.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known hypersensitivity to naproxen and naproxen sodium.
• asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
• for the treatment of peri-operative pain in the setting of 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 any of the following:

• anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven)
• aspirin
• other NSAIDs such as ibuprofen (Advil, Motrin) and ketoprofen
• oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); salicylate pain relievers such as diflunisal, magnesium salicylate (Doan's, others), and salsalate
• selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); or serotonin norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (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 (Zestril, in Zestoretic), moexipril (Univasc), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka)
• angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi, in Edarbyclor), 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)
• cholestyramine (Prevalite)
• cyclosporine (Gengraf, Neoral, Sandimimune)
• digoxin (Lanoxin)
• diuretics ('water pills')
• lithium (Lithobid), medications for diabetes; methotrexate (Otrexup, Rasuvo, Trexall)
• pemetrexed (Alimta, Pemfexy)
• phenytoin (Dilantin, Phenytek)
• probenecid (Probalan; in Col-Probenecid)
• sulfa medications such as sulfamethoxazole (in Bactrim, in Septra).
• antacids or sucralfate (Carafate)

Is this medicine FDA approved?

• Naproxen was approved for use by prescription in the United States in 1976 and for over-the-counter use in 1994.
• Currently more than 10 million prescriptions for naproxen are filled yearly and these numbers do not capture the wide scale over-the-counter sales.

How should this medicine be used?

Recommended dosage:

• The typical dose is 250 to 500 mg taken orally twice daily.

Administration:

• Prescription naproxen comes as a regular tablet, a delayed-release (a tablet that releases the medication in the intestine to prevent damage to the stomach) tablet, an extended-release (long-acting) tablet, and a suspension (liquid) to take by mouth.
• The extended-release tablets are usually taken once a day.
• The tablets, delayed-release tablets, and suspension are usually taken twice a day for arthritis.
• The tablets and suspension are usually taken every 8 hours for gout, and every 6 to 8 hours as needed for pain.
• If you are taking naproxen on a regular basis, you should take it at the same time(s) every day.
• Nonprescription naproxen comes as tablet, a capsule, and a gel capsule to take by mouth.
• It is usually taken with a full glass of water every 8 to 12 hours as needed.
• Nonprescription naproxen may be taken with food or milk to prevent nausea.
• If you are taking the suspension, gently shake the suspension well before each use to mix the medication evenly.
• Use an oral syringe or measuring cup provided by your pharmacist to measure the correct amount of liquid needed for your dose.
• Swallow the delayed-release tablets and extended release tablets whole; do not split, chew, or crush them.
• If you are taking naproxen to relieve the symptoms of arthritis, your symptoms may begin to improve within 1 week.
• It may take 2 weeks or longer for you to feel the full benefit of the medication.

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

This medicine is available in fallowing doasage form:

• As a tablet, a delayed-release tablet , an extended-release tablet, and a suspension, a capsule, and a gel capsule

This medicine is available in fallowing brand namesː

• Aleve, Anaprox, Naprosyn, Naxen, Naxodol, Neo-Prox, Nu-Naprox, Nycopren, Proxen, Synflex

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• dizziness
• somnolence
• dyspepsia
• nausea
• abdominal discomfort
• heartburn
• peripheral edema
• hypersensitivity reactions
• lightheadedness
• drowsiness
• difficulty falling asleep or staying asleep
• burning or tingling in the arms or legs
• cold symptoms
• ringing in the ears
• hearing problems

Serious side effects include:

• heart attack
• stomach pain
• stroke
• constipation
• high blood pressure
• diarrhea
• heart failure from body swelling (fluid retention)
• gas
• kidney problems including kidney failure
• heartburn
• bleeding and ulcers in the stomach and intestine
• nausea
• low red blood cells (anemia)
• vomiting
• life-threatening skin reactions
• dizziness
• life-threatening allergic reactions
• liver problems including liver failure
• asthma attacks in people who have asthma

What special precautions should I follow?

• Several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal.
• NSAIDs, including naproxen and naproxen sodium, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.
• Fluid retention, edema, and peripheral edema have been observed in some patients taking NSAIDs. Naproxen and naproxen sodium should be used with caution in patients with fluid retention, hypertension, or heart failure.
• NSAIDs, including naproxen and naproxen sodium, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. NSAIDs should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated.
• Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Patients at greatest risk of this reaction are those with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, those taking diuretics and ACE inhibitors, and the elderly.
• No information is available from controlled clinical studies regarding the use of naproxen or naproxen sodium in patients with advanced renal disease. Therefore, treatment with naproxen and naproxen sodium is not recommended in these patients with advanced renal disease.
• As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to naproxen or naproxen sodium. Emergency help should be sought in cases where an anaphylactoid reaction occurs. Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome.
• NSAIDs, including naproxen and naproxen sodium, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
• In late pregnancy, as with other NSAIDs, naproxen and naproxen sodium should be avoided because it may cause premature closure of the ductus arteriosus.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• lethargy
• dizziness
• drowsiness
• epigastric pain
• abdominal discomfort
• heartburn
• indigestion
• nausea
• transient alterations in liver function
• hypoprothrombinemia
• renal dysfunction
• metabolic acidosis
• apnea
• disorientation or vomiting
• Gastrointestinal bleeding
• Hypertension
• acute renal failure
• respiratory depression
• coma

Management of overdosage:

• Patients should be managed by symptomatic and supportive care following a NSAID overdose.
• There are no specific antidotes.
• Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding.
• Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose.
• Forced diuresis, alkalinization of urine or hemoperfusion may not be useful due to high protein binding.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are no adequate and well-controlled studies in pregnant women.
• Naproxen and naproxen sodium 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 in pediatric patients below the age of 2 years have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• NAPROXEN

Inactive Ingredients:

• CELLULOSE, MICROCRYSTALLINE
• CROSCARMELLOSE SODIUM
• POVIDONE
• MAGNESIUM STEARATE

Who manufactures and distributes this medicine?

Manufactured by:

• Glenmark Generics Ltd
• Colvale-Bardez, Goa
• India

Manufactured for:

• Glenmark Logo
• Glenmark Generics Inc., USA
• Mahwah, NJ

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

• Store at 15° to 30°C (59° to 86°F) in well-closed containers; dispense in light-resistant containers.

• Dailymed label info on Naproxen
• FDA Naproxen

Naproxen Resources
Latest articles Most recent articles Ongoing trials	Wikipedia

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 Naproxen
• FDA Naproxen

Naproxen Resources
Latest articles Most recent articles Ongoing trials	Wikipedia