EC-Naprosyn

Naproxen is both an over-the-counter and a prescription medication. The over-the-counter form is used to treat minor aches and pains, and to reduce fever. The prescription form is used to reduce pain, redness, swelling, and heat (inflammation) from conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Naproxen belongs to a class of drugs called non-steroidal anti-inflammatory drugs, or NSAIDs. These work by stopping substances in your body that cause inflammation and pain.

Prescription

Naproxen comes as a regular tablet, an enteric coated tablet (delayed-release 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, enteric coated 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.

Over-the-counter

Naproxen is available as tablets, caplets, gelcaps, and liquid gels to take by mouth. It is usually taken every 8 to 12 hours. 

Common side effects of naproxen include stomach pain, heartburn, nausea, and gas. Naproxen can aslo cause dizziness or drowsiness. Do not drive or operate heavy machinery until you know how this medication will affect you.

Prescription

Naproxen is used to treat the following:

• pain and redness
• swelling and inflammation from conditions such as different types of arthritis and gout 
• menstrual cramps
• other types of short-term pain

Over-the-counter

Naproxen is used to temporarily reduce fever, as well as treat minor aches and pains due to:

• minor pain of arthritis
• menstrual cramps
• the common cold
• muscular aches
• headache
• backache
• toothache

This medication may be prescribed for other uses.  Ask your doctor or pharmacist for more information.

Serious side effects have been reported with naproxen.  See "Drug Precautions" section.

Common side effects of naproxen include:

• heartburn
• stomach pain
• nausea
• constipation
• headache
• dizziness
• swelling of arms or legs
• rash

This is not a complete list of naproxen side effects.  Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects.  You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.  Especially tell your doctor if you take:

• ACE inhibitors such as lisinopril (Zestril, Prinivil), ramipril (Altace), quinapril (Accupril), captopril (Capoten), benazepril (Lotensin), and enalapril (Vasotec)
• angiotensin receptor blockers (ARBs) such as losartan (Cozaar), irbesartan (Avapro), olmesartan (Benicar), candesartan (Atacand), and valsartan (Diovan)
• beta-blockers such as propranolol (Inderal), timolol (Timoptic), atenolol (Tenormin), and metoprolol (Lopressor, Toprol)
• antacids such as Tums, Citrical, or Rolaids
• sucralfate (Carafate)
• aspirin (Ecotrin)
• diuretics such as furosemide (Lasix), hydrochlorothiazide (Microzide), and chlorthalidone (Thalitone)
• cholestyramine (Questran)
• lithium
• methotrexate (Trexall)
• warfarin (Coumadin, Jantoven)
• selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac), sertraline (Zoloft), and escitalopram (Lexapro)

This is not a complete list of naproxen interactions.  Ask your doctor or pharmacist for more information.

Serious side effects have been reported with naproxen including:

• Heart attack or stroke: Tell your healthcare provider right away if you have some or all of the following symptoms…
  • shortness of breath
  • chest pain
  • weakness
  • slurring of speech

• New hypertension or worsening of preexisting hypertension: Have your blood pressure watched by your doctor closely if taking naproxen, especially if you have a history of hypertension or are taking medications to treat hypertension.

• Congestive heart failure: Tell your healthcare provider right away if you have some or all of the following symptoms…
  • swelling in the arms or legs
  • shortness of breath
  • unexplained weight gain
  • fatigue

• Serious and sometimes fatal skin reaction: Tell your healthcare provider right away if you have some or all of the following symptoms…
  • rash
  • blistering
  • itching
  • fever

• Stomach bleeding and ulceration (holes or sores of your stomach or intestines): Tell your healthcare provider right away if you have some or all of the following symptoms…
  • pain
  • blood in stools (black or tarry stools)
  • coughing up of blood
  • indigestion or general stomach discomfort
• Liver toxicity: Tell your healthcare provider right away if you have some or all of the following symptoms…
  • flu-like symptoms
  • itchiness
  • fatigue
  • nausea
  • yellow tinting of the skin or eyes
• Kidney injury: Patients at greatest risk of this are those who already have renal dysfunction, heart failure, liver injury, those taking diuretics or ACE inhibitors, and the elderly.
• Anaphylactoid reaction: Tell your healthcare provider right away if you have some or all of the following symptoms…
  • swelling of the face or throat or trouble swallowing
  • difficulty breathing, coughing, chest tightness, wheezing
  • dizziness, fainting, rapid or weak heartbeat
  • flushing, itching, hives or a feeling of warmth
• Pregnancy: In late pregnancy, naproxen should be avoided since it may cause premature closure of the ductus arteriosus.
• Pre-existing asthma: Naproxen should not be taken in patients with aspirin-sensitive asthma and should be used with caution in patients with preexisting asthma.
• Anemia: Tell your healthcare provider right away if you have some or all of the following symptoms…
  • Shortness of breath
  • Dizziness
  • Headache
  • Coldness in the hands and feet
  • Pale skin
  • Chest pain

Naproxen can cause dizziness or drowsiness.  Do not drive or operate heavy machinery until you know how naproxen affects you.

Do not take naproxen if the following has occurred:

• have had a hypersensitivity (allergic) reaction to naproxen
• asthma, hives, or other allergic-type reactions after taking NSAIDs (including naproxen) other aspirin
• coronary artery bypass graft (CABG) surgery; naproxen is not to be used for treating pain before or after this surgery

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of naproxen, there are no specific foods that you must exclude from your diet when receiving naproxen.

Before taking naproxen, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have kidney problems
• have liver problems
• have heart problems
• have clotting problems or are taking anticoagulation medications
• have had a stomach bleed or ulcer (hole in the lining of the stomach) in the past
• have asthma
• are pregnant or are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy.  Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Naproxen falls into category C. This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

In addition, naproxen is known to cause heart defects on the developing fetus. Use during pregnancy, especially during late pregnancy, should be avoided.

Tell your doctor if you are breastfeeding or plan to breastfeed. 

You should not take naproxen if you are breastfeeding. It may be excreted in your breast milk and may harm your nursing child.

Take naproxen exactly as prescribed.

Prescription naproxen comes as a regular tablet, an enteric coated tablet (delayed-release 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, enteric coated 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.

Tn enteric-coated tablet and extended release tablets should not be crushed or chewed.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of naproxen at the same time.

Take naproxen exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Dosing may vary according to age and severity of symptoms and pain. In addition, different forms may not be equivalent; a change in dose may be needed if changing from a tablet to a suspension.

The typical dosing range with naproxen is 250 to 500 twice daily. The maximum daily dose of naproxen recommended is 1500 mg in adults.

The recommended total daily dose of naproxen for children 2 years and older is approximately 10 mg/kg given in 2 divided doses.

In all cases, treatment should be adjusted to give the lowest effective dose for the shortest duration possible in order to reduce the chance of side effects.

If you take too much naproxen, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store naproxen tablets and suspension at room temperature and protect from light.

Keep this and all medicines out of the reach of children.

Cardiovascular Risk

• 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.
• 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.

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.