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500mg Naproxen

500mg Naproxen

What Is Naproxen?

Naproxen has been used in the United States since 1980. It is available generically and under many brand names.

After 14 years as a prescription-only medication, in 1994 naproxen was approved by the Food & Drug Administration (FDA) as an over-the-counter (OTC) drug.

The best-known brand name for OTC naproxen is Aleve, which is made by the Bayer Healthcare.

Other brand names for naproxen include Anaprox DS, Naprelan, Anaprox, EC-Naprosyn, and Naprosyn.

As a prescription-strength drug, naproxen comes in the form of tablets or as a liquid.

Tablets may be coated to protect your stomach, or they may be extended-release tablets that you need to take only once a day.

Qualitative and quantitative composition

  • Each tablet contains 500mg naproxen
  • Excipient with known effect: Lactose monohydrate
  • Each tablet contains 144 mg of lactose monohydrate
  • For a full list of excipients.

Contraindications

  • Hypersensitivity to any of the constituents.
  • Since the potential exists for cross-sensitivity reactions, naproxen is contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, nasal polyps, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.Thesereactions
  • have the potential of being fatal. Severe anaphylactic-like reactions to naproxen have been reported in such patients.
  • Severe heart failure, hepatic failure and renal failure (See section 4.4 - Special warnings and precautions for use).
  • Third trimester of pregnancy (See section 4.6 - Pregnancy and lactation)
  • A history of gastrointestinal bleeding or perforation related to previous NSAIDs therapy. Active, or history of peptic ulcer/or active gastrointestinal bleeding (two or more distinct episodes of proven ulceration or bleeding).
  • In principle, naproxen must not be administered to patients with gastrointestinal ulcerations, congestive gastritis or atrophic gastritis, gastrointestinal bleeding or other bleeding such as cerebrovascular bleeding.
  • Hemorrhoids or predisposition to rectal bleeding.

Ocular effects

Studies have not shown changes in the eye attributable to naproxen administration. In rare cases, adverse ocular disorders including papillitis, retrobulbar optic neuritis and papilloedema, have been reported in users of NSAIDs including naproxen, although a cause-and-effect relationship cannot be established; accordingly, patients who develop visual disturbances during treatment with naproxen-containing products should have an ophthalmological examination.

Cardiovascular and cerebrovascular effects

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

Mild peripheral oedema has been observed in a few patients receiving naproxen. Although sodium retention has not been reported in metabolic studies, it is possible that patients with questionable or compromised cardiac function may be at a greater risk when taking Naproxen.

Clinical trial and epidemiological data suggest that use of coxibs and some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

Although data suggest that the use of naproxen (1000mg daily) may be associated with a lower risk, some risk cannot be excluded.

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with naproxen after careful consideration.

Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

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