Naproxen Kit
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Questions & Answers
Side Effects & Adverse Reactions
CARDIOVASCULAR EFFECTS
Cardiovascular Thrombotic Events
Cardiovascular Thrombotic EventsClinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events,myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factorsfor CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for theshortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should beinformed about the signs and/or symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use ofaspirin and an NSAID does increase the risk of serious GI events (see Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation).
Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence ofmyocardial infarction and stroke (see CONTRAINDICATIONS).
Hypertension
NSAIDs, including Naproxen Tablets, USP, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidenceof CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Naproxen Tablets, USP, should beused with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.
Congestive Heart Failure and Edema
Fluid retention, edema, and peripheral edema have been observed in some patients taking NSAIDs. Naproxen Tablets, USP should be used with caution in patients with fluidretention, hypertension, or heart failure.
Gastrointestinal Effects – Risk of Ulceration, Bleeding, and Perforation
NSAIDs, including Naproxen Tablets, USP, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach,small intestine, or large intestine, which can be fatal.
These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upperGI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for3-6 months, and in about 2-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event atsome time during the course of therapy. However, even short-term therapy is not without risk. The utility of periodic laboratory monitoring has not been demonstrated, nor hasit been adequately assessed. Only 1 in 5 patients who develop a serious GI adverse event on NSAID therapy is symptomatic.
NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer diseaseand/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors.Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAIDtherapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, specialcare should be taken in treating this population. To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should beused for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptlyinitiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruledout. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.
Epidemiological studies, both of the case-control and cohort design, have demonstrated an association between use of psychotropic drugs that interfere with seotonin reuptake and the occurence of upper gastrointestinal bleeding. In two-studies concurrent use of NSAID or aspirin in potentiated the risk of bleeding (see PRECAUTIONS - Drug Interactions). Although these studies focused on upper gastrointestinal bleeding there is reason to believe that bleeding at other sites may be similarly potentiated.
NSAIDs should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease) as their conditions may be exacerbated.
Renal Effects
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandinshave a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependentreduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are thosewith impaired renal function, hypovolemia, heart failure, liver disfunction, salt depletion, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of nonsteroidalanti-inflammatory drug therapy is usually followed by recovery to the pretreatment state (see WARNINGS: Advanced Renal Disease).
Advanced Renal Disease
No information is available from controlled clinical studies regarding the use of Naproxen Tablets, USP in patients with advanced renal disease. Therefore, treatment withNaproxen Tablets, USP is not recommended in these patients with advanced renal disease. If Naproxen Tablets, USP therapy must be initiated, close monitoring of the patient’srenal function is advisable.
Anaphylactoid Reactions
As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to Naproxen Tablets, USP. Naproxen Tablets, USP should not be given topatients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentiallyfatal bronchospasm after taking aspirin or other NSAIDs (see CONTRAINDICATIONS and PRECAUTIONS: Preexisting Asthma). Emergency help should be sought in cases wherean anaphylactoid reaction occurs.
Skin Reactions
NSAIDs, including Naproxen Tablets, USP, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermalnecrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestationsand use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Pregnancy
In late pregnancy, as with other NSAIDs, Naproxen Tablets, USP should be avoided because it may cause premature closure of the ductus arteriosus.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Carefully consider the potential benefits and risks of Naproxen Tablets, USP and other treatment options before deciding to use Naproxen Tablets, USP. Use the lowest effectivedose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Naproxen Tablets are indicated:
- For the relief of the signs and symptoms of rheumatoid arthritis
- For the relief of the signs and symptoms of osteoarthritis
- For the relief of the signs and symptoms of ankylosing spondylitis
- For the relief of the signs and symptoms of juvenile arthritis
- For the relief of the signs and symptoms of rheumatoid arthritis
- For the relief of the signs and symptoms of osteoarthritis
- For the relief of the signs and symptoms of ankylosing spondylitis
- For the relief of the signs and symptoms of juvenile arthritis
Naproxen Tablets are also indicated:
- For relief of the signs and symptoms of tendonitis
- For relief of the signs and symptoms of bursitis
- For relief of the signs and symptoms of acute gout
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For the management of pain
- For the management of primary dysmenorrhea
History
There is currently no drug history available for this drug.
Other Information
Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure:
Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3.Naproxen is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. Theoctanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.
Naproxen Tablets, USP are available as white tablets containing 250 mg of naproxen, white tablets containing 375 mg of naproxen and white tablets containing 500 mg ofnaproxen for oral administration. The inactive ingredients are Croscarmellose Sodium, Povidone and Magnesium Stearate.
Sources
Naproxen Kit Manufacturers
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Pharmaceutica North America, Inc
![Naproxen Kit (Naproxen) Kit [Pharmaceutica North America, Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Naproxen Kit | Pharmaceutica North America, Inc
Carefully consider the potential benefits and risks of Naproxen Tablets, USP and other treatment options before deciding to use Naproxen Tablets, USP. Use the lowest effectivedose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with Naproxen Tablets, USP, the dose and frequency should be adjusted to suit an individual patient’s needs.
Different dose strengths and formulations (i.e., tablets, suspension) of the drug are not necessarily bioequivalent. This difference should be taken into consideration whenchanging formulation.
Although naproxen tablets, naproxen suspension, naproxen delayed-release tablets, and naproxen sodium tablets all circulate in the plasma as naproxen, they havepharmacokinetic differences that may affect onset of action. Onset of pain relief can begin within 1 hour in patients taking naproxen.The recommended strategy for initiating therapy is to choose a formulation and a starting dose likely to be effective for the patient and then adjust the dosage based onobservation of benefit and/or adverse events. A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see WARNINGS and PRECAUTIONS).
Geriatric PatientsStudies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised whenhigh doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose.
Patients With Moderate to Severe Renal ImpairmentNaproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance less than 30 mL/min) (seeWARNINGS: Renal Effects).
Naproxen Tablets 250 mg
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis
or 375 mg
or 500 mg twice daily
twice daily
twice daily
During long-term administration, the dose of naproxen may be adjusted up or down depending on the clinical response of the patient. A lower daily dose may suffice for longtermadministration. The morning and evening doses do not have to be equal in size and the administration of the drug more frequently than twice daily is not necessary.
In patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/day for limited periods of up to 6 months when a higher level of anti-inflammatory/analgesic activity is required. When treating such patients with naproxen 1500 mg/day, the physician should observe sufficient increased clinical benefits to off sett he potential increased risk. The morning and evening doses do not have to be equal in size and administration of the drug more frequently than twice daily does not generally make a difference in response (see CLINICAL PHARMACOLOGY).
Juvenile Arthritis
The recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses (i.e. 5 mg/kg given twice a day). Naproxen tablets are not well suited to this dosage so use of naproxen oral suspension is recommended for this indication.
Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis
Because the sodium salt of naproxen is more rapidly absorbed, naproxen sodium is recommended for the management of acute painful conditions when prompt onset of pain relief is desired. Naproxen may also be used. The recommended starting dose of Naproxen is 500 mg, followed by 500 mg every 12 hours or 250 mg every 6 to 8 hours as required. The initial total daily dose should not exceed 1250 mg of naproxen. Thereafter, the total daily dose should not exceed 1000 mg of naproxen.
Acute Gout
The recommended starting dose is 750 mg of naproxen tablets, USP followed by 250 mg every 8 hours until the attack has subsided.
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