Call 1-866-335-8064 for pricing
| Medication |
Strength |
Quantity |
| Anaprox 275mg-brand name |
100 |
1 |
| Anaprox DS 550mg |
100 |
1 |
Anaprox
Naproxen Sodium
Anaprox - Anaprox Side Effects - Anaprox Information
Pharmacology: Naproxen sodium, has demonstrated analgesic, anti-inflammatory and antipyretic properties in human clinical studies and in classical animal test systems. It exhibits an anti-inflammatory effect even in adrenalectomized animals and therefore its action is not mediated through the pituitary-adrenal axis. It is not a corticosteroid. It inhibits prostaglandin synthetase, as do certain other nonsteroidal analgesic/anti-inflammatory agents. As with other agents, however, the exact mechanism of its anti-inflammatory and analgesic actions is not known.
Blood loss and gastroscopy studies with normal volunteers showed that daily administration of 1 100 mg of naproxen sodium caused significantly less gastric bleeding and erosion than 3 250 mg of ASA.
At the recommended dosage, the analgesic effect was shown to be comparable to that observed using 650 mg of ASA. The analgesic effect is obtained within 1 hour and can last at least 7 hours.
Pharmacokinetics: Naproxen sodium is freely soluble in water and is completely absorbed from the gastrointestinal tract. Plasma levels are obtained in patients within 20 minutes and peak levels in approximately 1 hour. It is extensively bound to plasma protein and has a plasma half-life of approximately 13 hours. The preferred route of excretion is via the urine with only 1% of the dose excreted in the feces.
Indications: In the relief of mild to moderately severe pain, accompanied by inflammation in conditions such as musculoskeletal trauma and postdental extraction. It is also indicated for the relief of pain associated with postpartum cramping and dysmenorrhea.
Contraindications: In patients with active peptic ulcers, a history of recurrent ulceration, or active inflammatory diseases of the gastro-intestinal tract. Anaprox and Anaprox DS are also contraindicated in patients who have known or suspected hypersensitivity to it or to naproxen or to other NSAIDs. The potential for cross-reactivity between different NSAIDs must be kept in mind. Naproxen sodium should not be given to patients with the complete or partial syndrome of nasal polyps, or in whom asthma, anaphylaxis, rhinitis, urticaria, or other allergic manifestations are precipitated by ASA or other NSAIDs. Fatal anaphylactoid reactions have occurred in such individuals. As well, individuals with the above medical problems are at risk of a severe reaction even if they have taken NSAIDs in the past without any adverse effects.
Naproxen sodium is contraindicated in patients with significant hepatic impairment or active liver disease and in patients with severely impaired or deteriorating renal function (creatinine clearance <30 mL/min or 0.5 mL/s). Individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored. Naproxen sodium is not recommended for use with other NSAIDs because of the absence of any evidence demonstrating synergistic benefits and the potential for additive side effects.
Warnings: Serious gastrointestinal toxicity, such as peptic ulceration, perforation and gastrointestinal bleeding, sometimes severe and occasionally fatal can occur at any time, with or without symptoms in patients treated with NSAID's including naproxen sodium.
Minor upper gastrointestinal problems, such as dyspepsia, are common, usually developing early in therapy. Physicians should remain alert for ulceration and bleeding in patients treated with NSAIDs, even in the absence of previous gastrointestinal tract symptoms.
In patients observed in clinical trials of such agents, symptomatic upper gastrointestinal ulcers, gross bleeding, or perforation appear to occur in approximately 1% of patients treated for 3 to 6 months and in about 2 to 4% of patients treated for 1 year. The risk continues beyond 1 year and possibly increases. The incidence of these complications increases with increasing dose.
Naproxen sodium should be given under close medical supervision to patients prone to gastrointestinal tract irritation, particularly those with a history of peptic ulcer, diverticulosis or other inflammatory disease of the gastrointestinal tract such as ulcerative colitis and Crohn's disease. In these cases the physician must weigh the benefits of treatment against the possible hazards.
Physicians should inform patients about the signs and/or symptoms of serious gastrointestinal toxicity and instruct them to contact a physician immediately if they experience persistent dyspepsia or other symptoms or signs suggestive of gastrointestinal ulceration or bleeding.
Because serious gastrointestinal tract ulceration and bleeding can occur without warning symptoms, physicians should follow chronically treated patients by checking their hemoglobin periodically and by being vigilant for the signs and symptoms of ulceration and bleeding and should inform the patients of the importance of this followup.
If ulceration is suspected or confirmed, or if gastrointestinal bleeding occurs, naproxen sodium should be discontinued immediately, appropriate treatment instituted and the patient monitored closely.
No studies, to date, have identified any group of patients not at risk of developing ulceration and bleeding. A prior history of serious gastrointestinal events and other factors such as excess alcohol intake, smoking, age, female gender and concomitant oral steroid and anticoagulant use have been associated with increased risk.
Geriatrics: Patients older than 65 years and frail or debilitated patients are more susceptible to a variety of adverse reactions from NSAIDs: the incidence of these adverse reactions increases with dose and duration of treatment. In addition, these patients are less tolerant to the effects of ulceration and bleeding. Most reports of fatal gastrointestinal events are in this population. Older patients are also at risk of lower esophageal ulceration and bleeding.
For such patients, consideration should be given to a starting dose lower than the one usually recommended, with individual adjustment when necessary and under close supervision. See Precautions for further advice.
Cross-sensitivity: Patients sensitive to any one of the NSAIDs may be sensitive to any of the other NSAIDs also.
Aseptic Meningitis: In occasional cases, with some NSAIDs, the symptoms of aseptic meningitis (stiff neck, severe headaches, nausea and vomiting, fever or clouding of consciousness) have been observed. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissues diseases, etc.) seem to be predisposed. Therefore, in such patients, the physician must be vigilant to the development of this complication.
Pregnancy , Labor and Lactation: Safety in pregnancy and lactation has not been established and its use during these events is therefore not recommended. Reproduction studies have been performed in rats, rabbits and mice. In rats, pregnancy was prolonged when naproxen sodium was given before the onset of labor; when it was given after the delivery process had begun, labor was protracted. Similar results have been found with other NSAIDs and the evidence suggests that this may be due to decreased uterine contractility resulting from the inhibition of prostaglandin synthesis. This may also increase the risk of uterine hemorrhage. Moreover, because of the known effect of drugs of this class on the human fetal cardiovascular system (closure of ductus arteriosus), use during late pregnancy should be avoided. The naproxen anion readily crosses the placental barrier. It has been found in the milk of lactating women at a concentration approximately 1% of that found in the plasma.
Precautions: Naproxen sodium should not be used concomitantly with the related drug naproxen since they circulate in plasma as the naproxen anion.
Gastrointestinal: There is no definitive evidence that the concomitant administration of histamine H 2-receptor antagonists and/or antacids will either prevent the occurrence of gastrointestinal side effects or allow continuation of naproxen sodium therapy when and if these adverse reactions appear.
Renal Effects: Long-term administration of naproxen sodium to animals has resulted in renal papillary necrosis and other abnormal renal pathology. In humans, there have been reports of acute interstitial nephritis with hematuria, proteinuria and occasionally nephrotic syndrome.
A second form of renal toxicity has been seen in patients with prerenal conditions leading to the reduction in renal blood flow or blood volume, where the renal prostaglandins have a supportive role in the maintenance of renal perfusion. In these patients, administration of a NSAID may cause a dose-dependent reduction in prostaglandin formation and may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, extracellular volume depletion, sodium restrictions, heart failure, liver dysfunction, those taking diuretics and the elderly. Assessment of renal function in these patients before and during therapy with naproxen sodium is recommended. Discontinuation of nonsteroidal anti-inflammatory therapy is typically followed by recovery to the pretreatment state.
Naproxen sodium and its metabolites are eliminated primarily by the kidneys, therefore, the drug should be used with great caution in patients with significantly impaired renal function or a history of kidney disease because naproxen, the active moiety of naproxen sodium, is an inhibitor of prostaglandin synthesis. In these cases utilization of lower doses of naproxen sodium should be considered and patients carefully monitored.
Naproxen sodium should not be used chronically in patients having baseline creatinine clearance less than 20 mL/min. During long-term therapy, kidney function should be monitored periodically.
Genitourinary Tract: Some NSAIDs are known to cause persistent urinary symptoms (bladder pain, dysuria, urinary frequency), hematuria or cystitis. The onset of these symptoms may occur at any time after the initiation of therapy with an NSAID. Some cases have become severe on continued treatment. Should urinary symptoms occur, treatment with naproxen sodium must be stopped immediately to obtain recovery. This should be done before any urological investigations or treatments are carried out.
Hepatic Function: As with other NSAIDs, borderline elevations of one or more liver function tests may occur in up to 15% of patients (less than 1% for naproxen sodium). These abnormalities may progress, may remain essentially unchanged, or may be transient with continued therapy. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of more severe hepatic reaction while on therapy with this drug. Severe hepatic reactions including jaundice and cases of fatal hepatitis have been reported with NSAIDs.
Although such reactions are rare, if abnormal liver tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), this drug should be discontinued.
During long-term therapy, liver function tests should be monitored periodically. If there is a need to prescribe this drug in the presence of impaired liver function, it must be done under strict observation.
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 sodium dosing is unknown, but caution is advised when high doses are required. It is prudent to use the lowest effective dose.
Steroids: 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.
Fluid and Electrolyte Balance: Fluid retention and edema have been observed in some patients receiving naproxen sodium. Therefore, as with many other NSAIDs, the possibility of precipitating congestive heart failure in elderly patients or those with compromised cardiac function should be borne in mind. Although sodium retention has not been reported in metabolic studies, the drug should be used with caution in patients with heart failure, hypertension, or other conditions predisposing to fluid retention.
With NSAID treatment there is a potential risk of hyperkalemia, particularly in patients with conditions such as diabetes mellitus or renal failure; elderly patients; or in patients receiving concomitant therapy with b-andrenergic blockers, angiotensin converting enzyme inhibitors or some diuretics. Serum electrolytes should be monitored periodically during long-term therapy, especially in those patients who are at risk.
Each Anaprox tablet contains approximately 25 mg of sodium and each Anaprox DS tablet contains approximately 50 mg of sodium. This should be considered in patients whose overall intake of sodium must be markedly restricted.
It is possible that patients with questionable or compromised cardiac function may be at greater risk when taking naproxen sodium.
Hematology: Drugs inhibiting prostaglandin biosynthesis do interfere with platelet function to varying degrees; therefore, patients who may be adversely affected by such an action should be carefully observed when naproxen sodium is administered.
Blood dyscrasias (such as neutropenia, leukopenia, thrombocytopenia, aplastic anemia and agranulocytosis; all less than 1% with naproxen sodium) associated with the use of NSAIDs are rare, but could be associated with severe consequences.
Patients with initial hemoglobin values of 10 g or less who are to receive long-term therapy should have hemoglobin values determined frequently.
Infection: The anti-inflammatory, antipyretic and analgesic effects of naproxen sodium may mask the usual signs of infection.
Ophthalmology: Blurred and/or diminished vision has been reported with the use of naproxen sodium and other NSAIDs. In rare cases, adverse ocular disorders including papillitis, retrobulbar optic neuritis and papilledema have been reported in users of NSAIDs including naproxen, although a cause and effect relationship cannot be established. If such symptoms develop, this drug should be discontinued and an ophthalmologic examination performed; ophthalmic examination should be carried out at periodic intervals in any patient receiving this drug for an extended period of time.
Occupational Hazards: CNS: Some patients may experience drowsiness, dizziness, vertigo, insomnia or depression with the use of naproxen sodium. If patients experience these side effects, they should exercise caution in carrying out activities that require alertness.
Hypersensitivity Reactions: Anaphylactoid reactions to naproxen or naproxen sodium, whether of the true allergic type or the pharmacologic idiosyncratic (e.g., syndrome associated with the use of ASA) type, usually but not always occur in patients with a known history of such reactions.
Therefore, careful questioning of patients for such things as asthma, nasal polyps, urticaria, and hypotension associated NSAIDs before starting therapy is important. In addition, if such symptoms occur during therapy, treatment should be discontinued.
Dermatology: If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.
Geriatrics: One study indicates that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. The implication of this finding for naproxen sodium dosing is unknown, but caution is advised when high doses are required. As with other drugs used in the elderly, it is prudent to use the lowest effective dose.
Drug Interactions : ASA or other NSAIDs: The use of naproxen sodium in addition to any other NSAID, including those over-the-counter ones (such as ASA and ibuprofen) is not recommended due to the possibility of additive side effects.
Anticoagulants: Numerous studies have shown that the concomitant use of NSAIDs and anticoagulants increases the risk of gastrointestinal adverse events such as ulceration and bleeding.
Because prostaglandins play an important role in hemostasis, and NSAIDs affect platelet function, concurrent therapy of naproxen sodium with warfarin requires close monitoring to be certain that no change in anticoagulant dosage is necessary.
Albumin Bound Drugs: The naproxen anion may displace from their binding sites other drugs which are also albumin-bound and may lead to drug interactions. For example, in patients receiving bishydroxycoumarin or warfarin, the addition of naproxen sodium could prolong the prothrombin time. These patients should, therefore, be under careful observation. Similarly, patients receiving naproxen sodium and a hydantoin, sulfonamide or sulfonylurea should be observed for adjustment of dose if required.
Diuretics: The natriuretic effect of furosemide has been reported to be inhibited by some drugs of this class.
Lithium: Inhibition of renal lithium clearance leading to increases in plasma lithium concentrations have also been reported.
Antihypertensive Agents: Naproxen sodium and other NSAIDs can reduce the antihypertensive effect of propranolol and other beta blockers as well as other antihypertensive agents.
Antacids: The rate of absorption of naproxen sodium is altered by concomitant administration of antacids but is not adversely influenced by the presence of food.
Probenecid: Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly.
Cholestyramine: Concomitant administration of cholestyramine can delay the absorption of naproxen, but does not affect its extent.
Methotrexate: Caution is advised in the concomitant administration of naproxen sodium and methotrexate since naproxen and other NSAIDs have been reported to reduce the tubular secretion of methotrexate in an animal model, thereby possibly enhancing its toxicity.
Glucocorticoids: Numerous studies have shown that the concomitant use of NSAIDs and oral glucocorticoids increases the risk of gastrointestinal side effects such as ulceration and bleeding. This is especially the case in older (>65 years of age) individuals.
Acetaminophen: Prolonged concurrent use of acetaminophen with an NSAID may increase the risk of adverse renal effects. Therefore it is recommended that patients be under close medical supervision while receiving such combined therapy.
Alcohol/Potassium Supplements: Concurrent use of alcohol or potassium supplements with an NSAID may increase the risk of gastrointestinal side effects including ulceration and hemorrhage.
Cyclosporine: Inhibition of renal prostaglandin activity by NSAIDs may increase the plasma concentration of cyclosporine and/or the risk of cyclosporine induced nephrotoxicity. Patients should be carefully monitored during concurrent use.
Digoxin: Concomitant administration of an NSAID with digoxin can result in an increase in digoxin concentrations which may result in digitalis toxicity. Increased monitoring and dosage adjustments of digitalis glycosides may be necessary during and following concurrent NSAID therapy.
Laboratory Tests: Naproxen sodium decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined.
The administration of naproxen sodium may result in increased urinary values for 17-ketogenic steroids because of an interaction between the drug and/or its metabolites with m-dinitrobenzene used in this assay. Although 17-hydroxy corticosteroid measurements (Porter-Silber test) do not appear to be artifactually altered, it is suggested that naproxen sodium therapy be temporarily discontinued 48 hours before adrenal function tests are performed.
The drug may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA).
Children: The safety and efficacy of this drug in children has not been established and its use in children is therefore not recommended.
Adverse Effects: The most common adverse reactions encountered with NSAIDs are gastrointestinal, of which peptic ulcer, with or without bleeding is the most severe. Fatalities have occurred on occasion, particularly in the elderly.
Adverse reactions reported in controlled clinical trials are listed below. (1) Denotes incidence of reported reaction between 3% and 9%. (2) Denotes incidence of reported reactions between 1% and 3%. Reactions occurring in less than 1% of the patients during controlled clinical trials and through voluntary reports since marketing are unmarked.
Gastrointestinal: heartburn (1), constipation (1), abdominal pain (1), nausea (1), diarrhea (2), dyspepsia (2), stomatitis (2), diverticulitis (2), gastrointestinal bleeding, hematemesis, melena, peptic ulceration with or without bleeding and/or perforation, vomiting, ulcerative stomatitis.
CNS: headache (1), dizziness (1), drowsiness (1), lightheadedness (2), vertigo (2), depression (2) and fatigue (2). Occasionally patients had to discontinue treatment because of the severity of some of these complaints (headache and dizziness). Other adverse effects were inability to concentrate, malaise, myalgia, insomnia and cognitive dysfunction (i.e., decreased attention span, loss of short-term memory, difficulty with calculations).
Skin: pruritus (1), ecchymoses (1), skin eruptions (1), sweating (2), purpura (2), alopecia, urticaria, skin rash, erythema multiforme, Stevens-Johnson syndrome, epidermal necrolysis, photosensitive dermatitis, exfoliative dermatitis and erythema nodosum.
Hepatic Changes: abnormal liver function tests, jaundice, cholestasis and hepatitis.
Cardiovascular Reactions: dyspnea (1), peripheral edema (1), palpitations (2), congestive heart failure and vasculitis.
Renal: glomerular nephritis, hematuria, interstitial nephritis, nephrotic syndrome, nephropathy and tubular necrosis.
Hematologic: eosinophilia, granulocytopenia, leukopenia, thrombocytopenia, agranulocytosis, aplastic anemia and hemolytic anemia.
Special Senses: tinnitus (1), hearing disturbances (2), hearing impairment and visual disturbances.
Others: thirst (2), muscle weakness, anaphylactoid reactions, menstrual disorders, pyrexia (chills and fever), angioneurotic edema, hyperglycemia, hypoglycemia, hematuria and eosinophilic pneumonitis.
The following adverse events have also been reported in the literature in association with either naproxen or naproxen sodium: Gastrointestinal: nonpeptic gastrointestinal ulceration, pancreatitis, colitis, esophagitis.
Renal: hyperkalemia, renal disease, renal failure, renal papillary necrosis, raised serum creatinine.
CNS: aseptic meningitis, convulsions, dream abnormalities.
Dermatologic: fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythmatosus, photosensitivity reactions including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa.
Cardiovasvular: hypertension, pulmonary edema.
Respiratory: asthma.
Special Senses: corneal opacity, papillitis, retrobulbar, optic neuritis and papilledema.
Overdose: Symptoms and Treatment: Significant overdosage may be characterized by drowsiness, dizziness, disorientation, heartburn, indigestion, epigastric pain, abdominal discomfort, nausea, vomiting, transient alterations in liver function, hypoprothombinemia, renal dysfunction, metabolic acidosis, apnea. A few patients have experienced convulsions, but it is not clear whether or not these were naproxen related. No evidence of toxicity or late sequela have been reported 5 to 15 months after ingestion for 3 to 7 days of doses up to 3 000 mg of naproxen. One patient ingested a single dose of 25 g of naproxen and experienced mild nausea and indigestion. It is not known what dose of the drug would be life threatening. The oral LD 50 of the drug is 543 mg/kg in rats, 1 234 mg/kg in mice, 4 110 mg/kg in hamsters and greater than 1 000 mg/kg in dogs.
Should a patient ingest a large number of naproxen tablets, the stomach may be emptied and usual supportive measures employed. Animal studies suggest that the prompt administration of 50 to 100 g of activated charcoal as an aqueous slurry over 15 minutes within 2 hours of the overdose would tend to reduce markedly the absorption of the drug. In dogs, 0.5 g/kg of charcoal was effective in reducing the plasma levels of naproxen. Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding. However, hemodialysis may still be appropriate in the management of renal failure.
Dosage: The recommended starting dose of Anaprox for adults is two 275 mg tablets, followed by one 275 mg tablet every 6 to 8 hours, as required. The total daily dose should not exceed 1 375 mg (5 tablets). Alternatively, one Anaprox DS tablet (550 mg) given twice daily may be used.
Information for the Patient: See Blue Section--Information for the Patient Anaprox/Anaprox DS.
Supplied: Anaprox: Each oval-shaped, light blue, film-coated tablet, NPS-275 engraved on one side, contains: naproxen sodium 275 mg. Nonmedicinal ingredients: indigotine aluminum lake, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide. Bisulfite-, erythrosine-, gluten-, lactose-, sorbitol-, tartrazine- and xylitol-free. Bottles of 100.
Anaprox DS: Each oblong, blue, film-coated tablet, NPS 550 engraved on one side, break scored on both sides, contains: naproxen sodium 550 mg. Nonmedicinal ingredients: hydroxypropyl methylcellulose, indigotine aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide. Bisulfite-, erythrosine-, gluten-, lactose-, sorbitol-, tartrazine- and xylitol-free. Bottles of 100.
Store at room temperature (15 to 30°C) in a well-closed container, protected from light.
IMPORTANT NOTE: THE FOLLOWING INFORMATION IS INTENDED TO SUPPLEMENT, NOT SUBSTITUTE FOR, THE EXPERTISE AND JUDGMENT OF YOUR PHYSICIAN, PHARMACIST OR OTHER HEALTHCARE PROFESSIONAL. IT SHOULD NOT BE CONSTRUED TO INDICATE THAT USE OF THE DRUG IS SAFE, APPROPRIATE, OR EFFECTIVE FOR YOU. CONSULT YOUR HEALTHCARE PROFESSIONAL BEFORE USING THIS DRUG.
|
