Naproxen 250 Community Pharm

Naproxen.

Green, hexagon, convex tablet. One side has letter "NPX" and scored and letter "250" and another side is smooth.
Each tablet contains Naproxen 250 mg.

Pharmacology: Pharmacodynamics: Mechanism of action: Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic and antipyretic activities. Naproxen inhibits synthesis of prostaglandins in body tissues by inhibiting cyclooxygenase; at least 2 isoenzymes, cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) have been identified that catalyze the formation of prostaglandins in the arachidonic acid pathway.
Pharmacokinetics: Naproxen is completely absorbed from the gastrointestinal tract. Oral bioavailability of naproxen is 95%. The peak plasma concentration of the drug occurs in 2-4 hours following oral administration. The volume of distribution of naproxen is 0.16 L/kg. Naproxen is more than 99% bound to plasma proteins. The drug crosses the placenta. Naproxen is also distributed into milk in concentrations of about 1% of simultaneous maternal plasma drug concentrations. The plasma half-life of naproxen is about 13 hours. Naproxen is extensively metabolized in the liver by cytochrome P-450 (CYP) isoenzymes 1A2 and 2C9 to 6-desmethylnaproxen. Approximately 95% of the drug is excreted in urine as unchanged naproxen (less than 1%) and 6-desmethylnaproxen (less than 1%) and their glucuronide or other conjugates (66-92%). Elimination of naproxen is reduced in patients with severe renal impairment. A small amount (less than 5%) of the drug is excreted in faces.

Rhumatoid arthritis, ankylosing spondylitis and tendinitis, inflammation of skeletal muscle, gouty arthritis, relief of pain and dysmenorrhea.

Adults: Usual dose: 2 tablets initially followed by 1 tablet 2 times a day, morning and evening. Acute gout: 3 tablets initially, then 1 tablet every 8 hours until the attack has subsided.
Analgesic and dysmenorrhea: 2 tablets initially, then 1 tablet every 8 hours as needed, not more than 5 tablets a day.
Children: 11 mg/kg/day or as prescribed by the physicians.
Mode of Administration: Naproxen is administered orally. To be taken preferably with or after food, with a glass of water.

Symptoms include headache, heartburn, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, drowsiness, dizziness, tinnitus, fainting. In cases of significant poisoning acute renal failure and liver damage are possible.
Respiratory depression and coma may occur after the ingestion of NSAIDs but are rare. In one case of naproxen overdose, transient prolongation of the prothrombin time due to hypothrombinaemia may have been due to selective inhibition of the synthesis of vitamin-K dependent clotting factors.
Treatment: Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Good urine output should be closely monitored. Renal and liver functions should be closely monitored. Patients should be observed for at least four hours after ingestion of potentially toxic amounts. Frequently or prolonged convulsions should be treated with intravenous diazepam. Other measures may be indicated by the patient's clinical condition. Haemodialysis does not decrease the plasma concentration of naproxen because of the high degree of protein binding. However, haemodialysis may still be appropriate in a patient with renal failure who has taken naproxen.

Hypersensitivity to naproxen or to any of the excipients.
Naproxen is contraindicated in patients who have previously shown hypersensitivity reactions (e.g. nasal polyps, asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other non-steroidal anti-inflammatory/analgesic drugs. These reactions have the potential of being fatal. Severe anaphylactic-like reactions to naproxen have been reported in such patients.
Severe heart failure, hepatic failure or renal failure.
During the last trimester of pregnancy.
History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. Patients treated with NSAIDs long-term should undergo regular medical supervision to monitor for adverse events.
The antipyretic and anti-inflammatory activities of Naproxen may reduce fever and inflammation, thereby diminishing their utility as diagnostic signs.
Naproxen decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined.
Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.

Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of closure of the ductus arteriosus), use in the last trimester of pregnancy is contraindicated. NSAIDs should not be used during the first two trimester of the pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus.
Naproxen can appear in the breast milk of lactating women. Naproxen should be avoided when breastfeeding.

Gastro-intestinal: The most commonly-observed adverse events are gastrointestinal in nature. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, heartburn and epigastric distress. More serious reactions which may occur are gastro-intestinal ulceration, which is sometimes fatal, particularly in the elderly, peptic ulceration perforation, non-peptic gastro-intestinal ulceration, melaena, haematemesis, stomatitis, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease and oesophagitis. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.
Immune system disorders: Hypersensitivity reactions have been reported following treatment with NSAIDs in patients with, or without, a history of previous hypersensitivity reaction to NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritis, urticaria, purpura, angioedema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis, erythema multiforme).
Metabolic and nutrition disorders: Hyperkalaemia.
Psychiatric disorders: Insomnia, dream abnormalities, depression, confusion and hallucinations.
Cardiac disorders: Oedema, palpitations, cardiac failure and congestive heart failure have been reported in association with NSAID treatment.
Vascular disorders: Hypertension, vasculitis.
Renal and urinary disorders: Including, but not limited to, glomerular nephritis, interstitial nephritis, nephrotic syndrome, haematuria, raised serum creatinine, renal papillary necrosis and renal failure.
Hepatobiliary disorders: Abnormal liver function, fatal hepatitis and jaundice.

Concomitant use of Naproxen and other non-steroidal anti-inflammatory drugs may increase the risk of renal impairment associated with the use of ACE-inhibitors.
Coadministration of Naproxen and Anti-hypertensives may result in reduced anti-hypertensive effect.
Concurrent use of Naproxen and Cardiac glycosides may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.
Coadministration of Naproxen and Corticosteroids may result in increased risk of gastrointestinal ulceration or bleeding.

Store at a temperature below 30°C.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AE02 - naproxen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.

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