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Naprosyn, Anaprox, Anaprox DS
(naproxen) Delayed Release Tablets
(naproxen sodium) Tablets
- 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).
- 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).
Naproxen is a proprionic 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)-6-methoxy-α-methyl-2- naphthaleneacetic acid, sodium salt, respectively. Naproxen and naproxen sodium have the following structures, respectively:
naproxen (R=-COOH) C14H14O3 mol wt 230.26
naproxen sodium (R=-COONa) C14H13NaO3 mol wt 252.23
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 is an odorless, white to off-white crystalline substance. It is lipidsoluble, 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.
NAPROSYN (naproxen tablets) is available as yellow tablets containing 250 mg of naproxen, pink tablets containing 375 mg of naproxen and yellow tablets containing 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, iron oxides, povidone and magnesium stearate.
EC-NAPROSYN (naproxen delayed-release tablets) is available as entericcoated white tablets containing 375 mg of naproxen and 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4.
ANAPROX (naproxen sodium tablets) is available as blue tablets containing 275 mg of naproxen sodium and ANAPROX DS (naproxen sodium tablets) is available as dark blue tablets containing 550 mg of naproxen sodium for oral administration. The inactive ingredients are magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the ANAPROX 275 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4210A, polyethylene glycol 8000 or Opadry YS-1-4215. The coating suspension for the ANAPROX DS 550 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216.
NAPROSYN (naproxen suspension) is available as a light orange-colored opaque oral suspension containing 125 mg/5 mL of naproxen in a vehicle containing sucrose, magnesium aluminum silicate, sorbitol solution and sodium chloride (39 mg/5 mL, 1.5 mEq), methylparaben, fumaric acid, FD&C Yellow No. 6, imitation pineapple flavor, imitation orange flavor and purified water. The pH of the suspension ranges from 2.2 to 3.7.
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;
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).
Prescribing Document Revised: March 2013This monograph has been modified to include the generic and brand name in many instances.
Additional Naprosyn, Anaprox, Anaprox DS Information
- Naprosyn, Anaprox, Anaprox DS Drug Interactions Center: naproxen oral
- Naprosyn, Anaprox, Anaprox DS Side Effects Center
- Naprosyn, Anaprox, Anaprox DS in detail including Side Effects and Drug Images
- Naprosyn, Anaprox, Anaprox DS Overview including Precautions
- Naprosyn, Anaprox, Anaprox DS FDA Approved Prescribing Information including Dosage
Naprosyn, Anaprox, Anaprox DS - User Reviews
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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.