May 25, 2017
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Naprosyn

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Naprosyn, Anaprox, Anaprox DS

NAPROSYN®
(naproxen) Tablets




WARNING

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see WARNINGS AND PRECAUTIONS].
  • NAPROSYN Tablets, EC-NAPROSYN and ANAPROX DS are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

NAPROSYN (naproxen) tablets, EC-NAPROSYN (naproxen) delayed-release tablets and ANAPROX DS (naproxen sodium) tablets are nonsteroidal anti-inflammatory drugs available as follows: NAPROSYN tablets are available as yellow tablets containing 500 mg of naproxen for oral administration.

EC-NAPROSYN delayed-release tablets are available as enteric-coated white tablets containing 375 mg of naproxen or 500 mg of naproxen for oral administration.

ANAPROX DS tablets are available as dark blue tablets containing 550 mg of naproxen sodium for oral administration.

Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen and naproxen sodium are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen and naproxen sodium have the following structures, respectively:

NAPROSYN® (naproxen) Structural Formula Illustration

Naproxen is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH.

The inactive ingredients in NAPROSYN tablets include: croscarmellose sodium, iron oxides, povidone and magnesium stearate.

The inactive ingredients in EC-NAPROSYN delayed release tablets include: croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The imprinting on the tablets is black ink. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4.

The inactive ingredients in ANAPROX DS tablets include: magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216.

What are the possible side effects of naproxen?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking naproxen and seek medical attention or call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • swelling or rapid weight gain;
  • urinating less than usual or not at all;
  • nausea,...

Read All Potential Side Effects and See Pictures of Naprosyn, Anaprox, Anaprox DS »

What are the precautions when taking naproxen (Naprosyn, Anaprox, Anaprox DS)?

Before taking naproxen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), blood disorders (such as anemia, bleeding/clotting problems), growths in the nose (nasal polyps), heart disease (such as previous heart attack), high blood pressure, liver disease, stroke, throat/stomach/intestinal problems (such as bleeding, heartburn, ulcers).

Kidney...

Read All Potential Precautions of Naprosyn, Anaprox, Anaprox DS »

Last reviewed on RxList: 3/24/2017
This monograph has been modified to include the generic and brand name in many instances.

Naprosyn, Anaprox, Anaprox DS - User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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