Naproflam 250

OTC

Indications

• Adults: Treatment of rheumatoid arthritis, osteoarthrosis (degenerative arthritis), ankylosing spondylitis, acute gout, acute musculoskeletal disorders and dysmenorrhoea.
• Children: Juvenile rheumatoid arthritis.

Dosage

Adults

• Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis
  500 mg to 1 g taken in 2 doses at 12-hour intervals or alternatively, as a single administration.
  In the following cases a loading dose of 750 mg or 1 g per day for the acute phase is recommended:
  – In patients reporting severe night-time pain/or morning stiffness.
  – In patients being switched to naproxen from a high dose of another anti-rheumatic compound.
  – In osteoarthrosis where pain is the predominant symptom.
• Acute gout
  750 mg at once then 250 mg every 8 hours until the attack has passed.
• Acute musculoskeletal disorders and dysmenorrhoea
  500 mg initially followed by 250 mg at 6 – 8 hour intervals as needed, with a maximum daily dose after the first day of 1250 mg.
• Older people
  It is prudent to use the lowest effective dose and for the shortest duration possible as older people are more prone to adverse events. The patient should be monitored regularly for GI bleeding during NSAID therapy.
• Paediatric population (over 5 years)
  For juvenile rheumatoid arthritis: 10 mg/kg/day taken in 2 doses at 12-hour intervals.
  Naproxen is not recommended for use in any other indication in children under 16 years of age.
• Renal/hepatic impairment
  A lower dose should be considered in patients with renal or hepatic impairment. Naproxen is contraindicated in patients with baseline creatinine clearance less than 30 ml/minute.
  Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs.

Usage

• Oral administration, preferably with or after food

• Active or history of peptic ulceration or active gastrointestinal bleeding (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
• Hypersensitivity to naproxen, naproxen sodium, or any of the excipients. Since the potential exists for cross-sensitivity reactions, naproxen should not be given to patients in whom aspirin or other non-steroidal anti-inflammatory/analgesic drugs induce the syndrome of asthma, rhinitis, nasal polyps or urticaria. These reactions have the potential of being fatal. Severe anaphylactic-like reactions to naproxen have been reported in such patients.
• Severe renal, hepatic or heart failure.
• Naproxen is contraindicated during the last trimester of pregnancy.

• Risk of cardiovascular thrombotic events;

Common

• Heartburn, nausea, vomiting, constipation, diarrhoea, flatulence, dyspepsia, abdominal discomfort and epigastric distress;
• Headache, tinnitus, dizziness, insomnia or drowsiness;
• Itching, skin rashes, sweating, purpura;
• Hearing disturbances, visual disturbances;
• Oedema, palpitations, dyspnoea.

• The antipyretic and anti-inflammatory activities of naproxen may reduce fever and inflammation, thereby diminishing their utility as diagnostic signs.
• Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease.
• Elevations of one or more liver function tests may occur. Hepatic abnormalities may be the result of hypersensitivity rather than direct toxicity. Severe hepatic reactions, including jaundice and hepatitis (some cases of hepatitis have been fatal) have been reported with this drug as with other non-steroidal anti-inflammatory drugs. Cross reactivity has been reported.
• 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.
• Because the drug has harmful effects on the digestive tract, it is necessary to monitor for abnormal symptoms in the digestive tract during treatment, especially in people taking anticoagulants. If there are symptoms of gastrointestinal bleeding, the drug must be stopped immediately. When using the drug in people with kidney damage, extreme caution is required because 95% of naproxen and naproxen metabolites are filtered and excreted by the kidneys. Blood creatinine must be checked regularly to choose the lowest effective dose.
• Chronic alcoholic liver disease and probably also other forms of cirrhosis reduce the total plasma concentration of naproxen, but the plasma concentration of unbound naproxen is increased. The implication of this finding for naproxen dosing is unknown but it is prudent to use the lowest effective dose.
• Patients who have coagulation disorders or are receiving drug therapy that interferes with haemostasis should be carefully observed if naproxen-containing products are administered. Patients at high risk of bleeding or those on full anti-coagulation therapy (e.g. dicoumarol derivatives) may be at increased risk of bleeding if given naproxen-containing products concurrently.
• Hypersensitivity reactions may occur in susceptible individuals. Anaphylactic (anaphylactoid) reactions may occur both in patients with and without a history of hypersensitivity or exposure to aspirin, other non-steroidal anti-inflammatory drugs or naproxen-containing products. They may also occur in individuals with a history of angio-oedema, bronchospastic reactivity (e.g. asthma), rhinitis and nasal polyps. Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome.
• If steroid dosage is reduced or eliminated during therapy, the steroid dosage should be reduced slowly and the patients must be observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of arthritis.
• 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.
• 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).
• In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.
• Naproxen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
• The combination of naproxen-containing products and other NSAIDs, includingcyclooxygenase-2 selective inhibitors, is not recommended, because of the cumulative risks of inducing serious NSAID-related adverse events.
• To minimize the risk for an adverse cardiovascular event in patients treated with naproxen, prescribe the lowest effective daily dose for the shortest duration possible.
• Use of naproxen in the last trimester of pregnancy is contraindicated. NSAIDs should not be used during the first two trimesters of pregnancy, unless the potential benefit to the patient outweighs the potential risk to the foetus.
• The use of naproxen should be avoided in patients who are breast-feeding.
• Some patients may experience drowsiness, dizziness, vertigo, insomnia, fatigue, visual disturbances or depression with the use of naproxen. If patients experience these or similar undesirable effects, they should not drive or operate machinery.