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Naproxen

Naproxen is a non-steroidal anti-inflammatory drug (NSAIDs) that is used in the treatment of mild to moderate pain, fever, inflammation and stiffness caused by conditions such as osteoarthritis, psoriatic arthritis, ankylosing spondylitis, tendinitis and bursitis.

Naproxen is taken orally, during or after meals to avoid possible gastrointestinal injuries. It is available as naproxen or as sodium naproxen. Both are different, since one is naproxen base and the other is naproxen salt. Regarding absorption, in the case of sodium naproxen it is faster than in naproxen.

Trade Names: Naprosyn, Anaprox, Anaprox DS

Generic Names: Naproxen, Naproxen Sodium

Prescription Naproxen is available in strengths of 250mg to 500mg per tablet.

Nonprescription Naproxen Sodium is available in a strength of 220mg per tablet and marketed under the brand name Flanax Pain Reliever Tablets in the U.S.

Dosage Forms And Administration

Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Patients With Moderate to Severe Renal Impairment (kidney disease)-Please consult your doctor for the proper dose of naproxen products.

Prescription Naproxen

Prescription Naproxen, Naprosyn, Anaprox, Anaprox DS:

Name Concentration Dose
Naprosyn 250mg, 375mg, 500mg tablets One tablet twice daily, maximum of 1500mg per day.
Anaprox 275mg tablets One tablet twice daily, maximum of 1100mg per day.
Anaprox DS 550mg tablets One tablet twice daily, maximum of 1100mg per day.
EC-Naprosyn 375mg, 500mg tablets One tablet twice daily, maximum of 1500mg per day.

Nonprescription Naproxen

Nonprescription Naproxen Sodium (Flanax Pain Reliever Tablets):

Name Concentration Dose
Flanax Pain Reliever Tablets 220mg One tablet every 8 to 12 hours, maximum of 3 tablets per day(660mg)
Naproxen Sodium Tablets 220mg One tablet every 8 to 12 hours, maximum of 3 tablets per day(660mg)

To maintain the integrity of the enteric coating, the EC-NAPROSYN tablet should not be broken, crushed or chewed during ingestion.

Cardiovascular Risk Warning

Cardiovascular Risk

  • Naproxen products are considered non-steriodal 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 (see WARNINGS).

  • Naproxen as NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS or NAPROSYN

Suspension is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

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 (see WARNINGS).

Side Effects

In patients taking prescription naproxen in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:

Prescription Naproxen

  • Gastrointestinal (GI) Experiences, including: heartburn*, abdominal pain*, nausea*, constipation*, diarrhea, dyspepsia, stomatitis
  • Central Nervous System: headache*, dizziness*, drowsiness*, lightheadedness, vertigo
  • Dermatologic: pruritus (itching)*, skin eruptions*, ecchymoses*, sweating, purpura
  • Special Senses: tinnitus*, visual disturbances, hearing disturbances
  • Cardiovascular: edema*, palpitations
  • General: dyspnea*, thirst

*Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients are unmarked.

In patients taking NSAIDs, the following adverse experiences have also been reported in approximately 1% to 10% of patients.

  • Gastrointestinal (GI) Experiences, including: flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting
  • General: abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashes
  • The following are additional adverse experiences reported in <1% of patients taking naproxen during clinical trials and through postmarketing reports. Those adverse reactions observed through postmarketing reports are italicized.
  • Body as a Whole: anaphylactoid reactions, angioneurotic edema, menstrual disorders, pyrexia (chills and fever)
  • Cardiovascular: congestive heart failure,vasculitis, hypertension, pulmonary edema
  • Gastrointestinal: inflammation, bleeding (sometimes fatal, particularly in the elderly), ulceration, perforation and obstruction of the upper or lower gastrointestinal tract.Esophagitis, stomatitis,hematemesis, pancreatitis, vomiting, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn’s disease).
  • Hepatobiliary: jaundice, abnormal liver function tests, hepatitis (some cases have been fatal)
  • Hemic and Lymphatic: eosinophilia, leucopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia
  • Metabolic and Nutritional: hyperglycemia, hypoglycemia
  • Nervous System: inability to concentrate, depression, dream abnormalities, insomnia, malaise,myalgia, muscle weakness,aseptic meningitis, cognitive dysfunction, convulsions
  • Respiratory:eosinophilic pneumonitis, asthma
  • Dermatologic: alopecia, urticaria, skin rashes, toxic epidermal necrolysis, erythema multiforme,erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematoses, bullous reactions, including Stevens-Johnson syndrome, photosensitive dermatitis,photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa. If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.
  • Special Senses: hearing impairment, corneal opacity, papillitis, retrobulbar optic neuritis, papilledema
  • Urogenital: glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis, raised serum creatinine
  • Reproduction (female): infertility
  • In patients taking NSAIDs, the following adverse experiences have also been reported in <1% of patients.
  • Body as a Whole: fever, infection, sepsis, anaphylactic reactions, appetite changes, death
  • Cardiovascular: hypertension, tachycardia, syncope, arrhythmia, hypotension, myocardial infarction
  • Gastrointestinal: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, glossitis, eructation
  • Hepatobiliary: hepatitis, liver failure
  • Hemic and Lymphatic: rectal bleeding, lymphadenopathy, pancytopenia
  • Metabolic and Nutritional: weight changes
  • Nervous System: anxiety, asthenia, confusion, nervousness, paresthesia, somnolence, tremors, convulsions, coma, hallucinations
  • Respiratory: asthma, respiratory depression, pneumonia
  • Dermatologic: exfoliative dermatitis
  • Special Senses: blurred vision, conjunctivitis
  • Urogenital: cystitis, dysuria, oliguria/polyuria, proteinuria

Non-Prescription Naproxen

In patients taking non- prescription naproxen sodium in clinical trials, the most frequently reported adverse experiences in approximately 3% to 9% of patients are:

The more common side effects that occur with nonprescription naproxen sodium oral tablets include:

  • stomach pain
  • constipation
  • diarrhea
  • gas
  • heartburn
  • nausea and vomiting
  • dizziness

Mild side effects may go away within a few days or a couple of weeks. Talk to your doctor or pharmacist if they’re more severe or don’t go away.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • chest pain
  • shortness of breath or trouble breathing
  • weakness in one part or side of your body
  • difficulty speaking
  • swelling of the face or throat
  • high blood pressure
  • bleeding and ulcers in your stomach and intestines, with symptoms such as:
    • stomach pain
    • bloody vomit
    • blood in your stool
    • black and sticky stool
    • asthma attacks in people who have asthma
    • low red blood cell count, which can cause fatigue, lethargy, and weakness
    • yellowing of your skin or the whites of your eyes
    • unusual weight gain or swelling of your arms, legs, hands, and feet
    • skin rash or blisters with fever

Drug Interactions

Naproxen may interact with several prescription and nonprescription drugs. Drinking alcohol and taking naproxen may increase the risk of gastrointestinal side effects.

Selective serotonin reuptake inhibitors

People taking the antidepressant class of selective serotonin reuptake inhibitors (SSRIs) have an increased risk of gastrointestinal bleeding and ulcers when taking naproxen. SSRIs include:

  • citalopram
  • escitalopram
  • fluoxetine
  • fluvoxamine
  • paroxetine
  • sertraline
  • vortioxetine

Oral steroids

Oral steroids, such as prednisone and antiplatelet drugs, may also increase stomach and intestinal bleeding and ulceration if people combine them with naproxen.

Blood thinners

Naproxen blocks the aggregation of platelets, which is an essential step in blood clotting. Blocking the aggregation of platelets can increase the time it takes for bleeding to stop.

People must talk to a doctor before combining naproxen with blood thinners, such as antiplatelet and anticoagulant medications.

Pregnancy and breastfeeding

Women should avoid taking naproxen in the third trimester of pregnancy.

NSAIDs can prevent the body from producing prostaglandin, which may affect pregnancy. Taking naproxen during the third trimester of pregnancy may cause heart malformations in the fetus.

Also, nursing babies may experience serious side effects if the mother is taking naproxen. Doctors do not recommend naproxen for women who are breastfeeding.

Prescription And Non-prescription Naproxen

Non-prescription naproxen consists of naproxen sodium. Naproxen Sodium has a quicker onset of action versus naproxen due to the addition of the sodium salt to the molecule. For those consumers wanting an alternative to prescription naproxen, nonprescription naproxen sodium, Flanax Pain Reliever Tablets, is the closest option. 

To find Flanax Pain Reliever Tablets closest to you, click here.

References

  1. https://www.healthline.com/health/naproxen-oral-tablet#interactions
  2. https://www.medicalnewstoday.com/articles/324917.php#side-effects
  3. https://www.medicalnewstoday.com/articles/324917.php#interactions
  4. https://www.medicalnewstoday.com/articles/324917.php