Naproxen Suspension
Loading...Naproxen Suspension Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
Clinical 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 factors for 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 the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed 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 of aspirin and an NSAID does increase the risk of serious GI events (see WARNINGS: Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation)
NSAIDs, including Naproxen Oral Suspension, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Naproxen Oral Suspension, should be used 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.
Fluid retention, edema, and peripheral edema have been observed in some patients taking NSAIDs. Naproxen Oral Suspension should be used with caution in patients with fluid retention, hypertension, or heart failure. Since each teaspoonful of Naproxen Oral Suspension contains 39.3 mg (1.71 mEq per each 125 mg of naproxen) of sodium, this should be considered in patients whose overall intake of sodium must be severely restricted.
NSAIDs, including Naproxen Oral Suspension, 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 upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3 to 6 months, and in about 2^ to 4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some 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 has it been adequately assessed. Only 1 in 5 patients who develop a serious upper 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 disease and/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 NSAID therapy, 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, special care 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 be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate 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 ruled out. 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 serotonin reuptake and the occurrence of upper gastrointestinal bleeding. In two studies, concurrent use of an NSAID or aspirin 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 condition may be exacerbated.
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 prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, those taking diuretics and angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), and the elderly. Discontinuation of nonsteroidal anti-inflammatory drug therapy is usually followed by recovery to the pretreatment state (see WARNINGS:Advanced Renal Disease).
No information is available from controlled clinical studies regarding the use of Naproxen Oral Suspension in patients with advanced renal disease. Therefore, treatment with Naproxen Oral Suspension is not recommended in these patients with advanced renal disease. If Naproxen Oral Suspension therapy must be initiated, close monitoring of the patient's renal function is advisable and patients should be adequately hydrated.
As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to Naproxen Oral Suspension. Naproxen Oral Suspension should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see CONTRAINDICATIONS and PRECAUTIONS: Preexisting Asthma). Emergency help should be sought in cases where an anaphylactoid reaction occurs. Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome.
NSAIDs, including Naproxen Oral Suspension, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
In late pregnancy, as with other NSAIDs, Naproxen Oral Suspension 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 Oral Suspension and other treatment options before deciding to use Naproxen Oral Suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Naproxen Oral Suspension is 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
Naproxen Oral Suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight.
Naproxen Oral Suspension is 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
- •
- 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 2-naphthaleneacetic acid (s) 6-methoxy-a-methyl. It has the following structure:
C14H14O3 M.W. 230.26
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. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.
Naproxen Oral Suspension for oral administration contains 125 mg naproxen per 5 mL. In addition, the following inactive ingredients are present: FD&C Yellow #6, fumaric acid, imitation orange flavor, imitation pineapple flavor, magnesium aluminum silicate, methylparaben, purified water, sodium chloride, sorbitol solution and sucrose. It has a sodium content of 39.3 mg/5 mL, 1.71 mEq/5 mL, with a pH range of 2.2 to 3.7
Sources
Naproxen Suspension Manufacturers
-
Palmetto Pharmaceuticals
![Naproxen Suspension [Palmetto Pharmaceuticals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Naproxen Suspension | Palmetto Pharmaceuticals
Carefully consider the potential benefits and risks of Naproxen Oral Suspension and other treatment options before deciding to use Naproxen Oral Suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with Naproxen Oral Suspension, 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 when changing formulation.
Although Naproxen Oral Suspension and other formulations of naproxen and naproxen sodium circulate in the plasma as naproxen, they have pharmacokinetic differences that may affect onset of action. Onset of pain relief can begin within 30 minutes in patients taking naproxen sodium and within 1 hour in patients taking naproxen.
The recommended strategy for initiating therapy is to choose a starting dose likely to be effective for the patient and then adjust the dosage based on observation 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 when high 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 <30 mL/min) (see WARNINGS: Renal Effects).
Rheumatoid Arthritis, Osteoarthritis and Ankylosing SpondylitisNaproxen Oral Suspension
250 mg (10 mL/2 tsp)
twice daily
or 375 mg (15 mL/3 tsp)
twice daily
or 500 mg (20 mL/4 tsp)
twice daily
Naproxen Oral Suspension should be shaken gently before use.
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 long-term administration. 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 offset the 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 ArthritisThe use of Naproxen Oral Suspension is recommended for juvenile arthritis in children 2 years or older because it allows for more flexible dose titration based on the child’s weight. In pediatric patients, doses of 5 mg/kg/day produced plasma levels of naproxen similar to those seen in adults taking 500 mg of naproxen (see CLINICAL PHARMACOLOGY).
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). The following table may be used as a guide for dosing of Naproxen Oral Suspension:
Patient's Weight Dose Administered as13 kg (29 lb)
62.5 mg bid
2.5 mL (1/2 tsp) twice daily
25 kg (55 lb)
125 mg bid
5.0 mL (1 tsp) twice daily
38 kg (84 lb)
187.5 mg bid
7.5 mL (1 1/2 tsp) twice daily
Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and BursitisThe recommended starting dose is 500 mg (20 mL or 4 teaspoonfuls) of Naproxen Oral Suspension, followed by 500 mg every 12 hours, or 250 mg (10 mL or 2 teaspoonfuls) every 6 to 8 hours as required. The initial total daily dose should not exceed 1250 mg (50 mL or 10 teaspoonfuls). Thereafter, the total daily dose should not exceed 1000 mg (40 mL or 8 teaspoonfuls).
Acute GoutThe recommended starting dose of naproxen is 750 mg (30 mL or 6 teaspoonfuls), followed by 250 mg (10 mL or 2 teaspoonfuls) every 8 hours until the attack has subsided.
Login To Your Free Account