Naproxen 500 mg composition

Possible side effects Like all medicines, this medicine also can cause side effects, although not everyone gets them. Important side effects to look out for: Stop taking Naproxen and tell a doctor straight away if any of the following side effects happen. You may need urgent medical treatment: Serious stomach or gut problems, signs include: Signs include upset stomach, stomach pain, fever, feeling or being sick.

Signs include severe stomach pain which spreads to your back. Liver problems, signs include: Severe skin rashes, signs include: Fever, headache, cough and aching body may happen at the same time.

Because of adverse eye findings in animal studies with drugs of this class, it is recommended that ophthalmic studies be carried out if any change or disturbance in vision occurs. Patient Counseling Information Advise the patient to read the FDA-approved patient labeling Medication Guide that accompanies each prescription dispensed. Gastrointestinal Bleeding, Ulceration, And Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia , melena , and hematemesis to their health care provider.

Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity e. Anaphylactic Reactions Inform patients of the signs of an anaphylactic reaction e. No evidence of tumorigenicity was found. Mutagenesis Naproxen tested positive in the in vivo sister chromatid exchange assay for but was not mutagenic in the in vitro bacterial reverse mutation assay Ames test.

There were no adverse effects on fertility noted up to 0. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U. In animal reproduction studies in rats, rabbits, and mice no evidence of teratogenicity or fetal harm when naproxen was administered during the period of organogenesis at doses 0. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization.

In animal studies, administration of prostaglandin synthesis inhibitors such as naproxen, resulted in increased pre-and post-implantation loss. In animal studies, NSAIDS, including naproxen, inhibit prostaglandin synthesis, cause delayed parturition , and increase the incidence of stillbirth.

Data Human Data There is some evidence to suggest that when inhibitors of prostaglandin synthesis are used to delay preterm labor, there is an increased risk of neonatal complications such as necrotizing enterocolitis, patent ductus arteriosus, and intracranial hemorrhage. Naproxen treatment given in late pregnancy to delay parturition has been associated with persistent pulmonary hypertension, renal dysfunction, and abnormal prostaglandin E levels in preterm infants.

Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system closure of ductus arteriosus , use during pregnancy particularly starting at weeks of gestation, or third trimester should be avoided. Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation.

Pediatric Use Safety and effectiveness in pediatric patients below the age of 2 years have not been established. There are no adequate effectiveness or dose-response data for other pediatric conditions, but the experience in polyarticular juvenile idiopathic arthritis and other use experience have established that single doses of 2. Geriatric Use The hepatic and renal tolerability of long-term naproxen administration was studied in two double-blind clinical trials involving patients.

Of the patients studied, 98 patients were age 65 and older and 10 of the 98 patients were age 75 and older. Transient abnormalities of laboratory tests assessing hepatic and renal function were noted in some patients, although there were no differences noted in the occurrence of abnormal values among different age groups. Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly.

The clinical significance of this finding is unclear, although it is possible that the increase in free naproxen concentration could be associated with an increase in the rate of adverse events per a given dosage in some elderly patients.

Use in patients with cardiovascular impairment: 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.

Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation see section 4. These patients should commence treatment on the lowest dose available.

Combination therapy with protective agents e. Naproxen has been found to be well tolerated by patients exhibiting dyspepsia with other similar agents. None the less, episodes of gastro-intestinal bleeding have been reported in patients with naproxen therapy. Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms especially GI bleeding particularly in the initial stages of treatment. Caution should be advised in patients receiving concomitant medications, which could increase the risk of gastrotoxicity, or bleeding, such as corticosteroids, or anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as aspirin See section 4.

When GI bleeding or ulceration occurs in patients receiving naproxen, the treatment should be withdrawn Naproxen should be given under close supervision to patients with a history of gastrointestinal disease ulcerative colitis, Crohn's disease as these conditions may be exacerbated See section 4.

SLE and mixed connective tissue disease: In patients with systemic lupus erythematosus SLE and mixed connective tissue disorders there may be an increased risk of aseptic meningitis See section 4. 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 mg daily may be associated with a lower risk, some risk cannot be excluded.

Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events e. Haematological 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 therapies e.

Naproxen decreases platelet aggression and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined. Anaphylactic anaphylactoid reactions 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. Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome. 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.

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. Dermatological Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs see 4.

Patients appear to be at highest risk for these reactions early in the course of therapy: Naproxen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Avoid concomitant use of two or more NSAIDs including aspirin as this may increase the risk of adverse effects See section 4. Naproxen can reduce the anti-hypertensive effect of propanolol and other beta blocking agents.

The natriuretic effect of furosemide has been reported to be inhibited by some drugs of this class. Probenecid given concurrently increases naproxen plasma levels and extends its plasma half life considerably. Inhibition of renal lithium clearance leading to increase in plasma lithium concentration has been reported.

Decreased elimination of methotrexate. Caution is advised when methotrexate is administered concurrently because of possible enhancement of its toxicity since naproxen has been reported to reduce the tubular secretion of methotrexate in the animal model.

Increased risk of nephrotoxicity. Increased risk of GI bleeding or gastrointestinal ulceration See section 4. Due to the plasma protein binding of naproxen, patients simultaneously receiving anticoagulants should be observed for signs of overdosage of these drugs.

Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Due to the plasma protein binding of naproxen, patients simultaneously receiving hydantoins or a highly protein bound sulphonamide should be observed for signs of overdosage of these drugs.

Is this the best approach? Is there a test to check if there is a problem developing? Naproxen Naprosyn is a non-steroidal anti-inflammatory drug NSAID that blocks substances in the body that normally cause pain and inflammation.

Naproxen is indicated for pain associated with headache, cramps, and other pain. Naproxen is also used for pain and inflammation associated with arthritis and used as a fever reducer. Some of the common side effects associated with naproxen include constipation, diarrhea, headache, nausea, and stomach upset.

According to the prescribing information, there are warnings associated with the use of naproxen. Long-term used of naproxen can increase the risk of serious cardiovascular events such as strokes and heart attacks. The risk of a serious adverse event can increase with the duration of treatment with naproxen. Naproxen should not be used just before or after coronary artery surgery. People with cardiovascular risk factors, those who are 60 years of age or older, have stomach ulcers or bleeding problems, take blood thinners or drink alcoholic drinks while taking naproxen are at a greater risk of a complication.

Naproxen can increase the risk of serious stomach and intestine problems including bleeding or forming a hole perforation. Talk to the doctor if signs and symptoms of bleeding occur. These symptoms include black, tarry or bloody stools or coughing up blood or vomit that looks like coffee grounds. Alcohol can increase the risk of stomach bleeding caused by naproxen. Avoid prolonged exposure to sunlight. Naproxen can worsen existing hypertension high blood pressure , so talk to your doctor if you have hypertension.

The lowest dose and shortest duration of treatment with NSAIDs for effective therapy is usually recommended. However, talk to your doctor if naproxen is not relieving the pain.

Do not stop taking naproxen or take more medicine than what is prescribed. For more specific information and guidance on your current treatment based on your medical condition, consult with your healthcare provider.

Kimberly Hotz, PharmD Q: Does naproxen cause anemia? NSAIDs work by blocking substances in the body that cause pain and inflammation. Naproxen is used to treat fever, pain, and inflammation caused by a wide variety of conditions, including arthritis, bursitis, gout, headache, ankylosing spondylitis, tendonitis, menstrual cramps, and minor injuries. Common side effects of naproxen include nausea, stomach upset, heartburn, bloating, gas, diarrhea, constipation, dizziness, drowsiness, blurred vision, and ringing in the ears.

A search of a drug database shows that anemia can occur in up to 10 percent of patients taking NSAIDs, including naproxen. This would be considered a frequent or common side effect. Consult with your doctor if you are concerned about anemia or if you are experiencing symptoms of anemia, such as fatigue, pale skin, coldness, or dizziness.

This is not a complete list of risks or side effects that can occur with naproxen or any other NSAID. For more specific information, consult with your doctor or local pharmacist for guidance based on your health status and current medications, particularly before taking any action.

Does naproxen affect bowel movements? Naproxen Aleve, Naprosyn is a nonsteroidal anti-inflammatory drug NSAID that is used to reduce pain and inflammation in a variety of conditions, including arthritis and gout. Naproxen and other NSAIDs can be irritating to the stomach, causing inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine. To reduce the risk of gastrointestinal side effects, patients should receive the lowest effective dose of naproxen for the shortest period of time to adequately relieve symptoms.

Other gastrointestinal side effects include nausea, diarrhea, constipation, and abdominal pain. If you think you are experiencing a side effect from your medication, talk to your doctor. Do not stop or change your medication unless your doctor directs you to do so. You can browse Drugs A-Z for a specific prescription or over-the-counter drug or look up drugs based on your specific condition.

This information is for educational purposes only, and not meant to provide medical advice, treatment, or diagnosis. Remember to always consult your physician or health care provider before starting, stopping, or altering a treatment or health care regimen. Every effort has been made to ensure that the information provided by on this page is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive.

The information on this page has been compiled for use by healthcare practitioners and consumers in the United States and therefore neither Everyday Health or its licensor warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise.

Neither Everyday Health nor its licensors endorse drugs, diagnose patients or recommend therapy. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient.

Neither Everyday Health nor its licensor assume any responsibility for any aspect of healthcare administered with the aid of the information provided.

Naproxen Tablet

naproxen 500 mg compositionFor more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Ear and Labyrinth disorders: The onset of labour may be delayed and the composition increased with an increased bleeding 500 clozaril treatment resistant both mother and child by naproxen See section 4. Physicians and compositions should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Some observational studies found that this increased risk of 500 CV thrombotic events began as early as the first weeks of treatment. Anti-platelet agents and Selective serotonins reuptake inhibitors Naproxen is an increased risk of gastrointestinal bleeding see Section 4. Although hydroxy-corticosteroid measurements Porter-Silber test do not appear to be artifactually altered, it is suggested that therapy with naproxen be temporarily discontinued 72 hours before adrenal function tests are performed if the Porter-Silber test is to be used. Fever, headache, cough and aching body may happen at the same time. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. Transient abnormalities of laboratory tests assessing hepatic and renal function were noted in some patients, naproxen 500 mg composition, although there were naproxen differences noted in the occurrence of abnormal values among different age groups, naproxen 500 mg composition. Mutagenesis Studies to evaluate the mutagenic potential naproxen Naprosyn Suspension have not been completed. Clinical trial and epidemiological data suggest that use of coxibs and some NSAIDs particularly at high naproxen and 500 long term 500 bta pharmaceuticals patient assistance program wellbutrin be associated with a small increased risk of arterial thrombotic events for example myocardial infarction or stroke. The elderly are at increased risk for side effects such as kidney damage and peptic ulcers from NSAIDs even at low doses. If you feel you 500 experiencing fluid retention due to this medication, it would be best to consult with your physician to be sure naproxen no composition underlying condition is contributing to the problem, naproxen 500 mg composition. Assess renal composition at the beginning of the concomitant treatment and periodically thereafter, naproxen 500 mg composition. Hepatic Impairment Caution is advised when high doses are required and some adjustment of dosage may be required in these patients.


What is naproxen 500 used for?



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