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NAPROXEN SODIUM
Overview
What is NAPRELAN?
NAPRELAN
Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN Tablets use the proprietary IPDAS
(Intestinal Protective Drug Absorption System) technology. It is a rapidly disintegrating tablet system combining an immediate release component and a sustained release component of microparticles that are widely dispersed, allowing absorption of the active ingredient throughout the gastrointestinal (GI) tract, maintaining blood levels over 24 hours. The chemical name for naproxen sodium is 2-naphthaleneacetic acid, 6-methoxy-a-methyl-sodium salt, (S)- with the following structural formula:
Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen and 37.5, mg 50 mg, and 75 mg sodium respectively. Each NAPRELAN Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.
What does NAPRELAN look like?
What are the available doses of NAPRELAN?
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What should I talk to my health care provider before I take NAPRELAN?
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How should I use NAPRELAN?
Carefully consider the potential benefits and risks of NAPRELAN Tablets and other treatment options before deciding to use NAPRELAN Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
NAPRELAN Tablets are indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis and acute gout. It is also indicated in the relief of mild to moderate pain and the treatment of primary dysmenorrhea.
Carefully consider the potential benefits and risks of NAPRELAN and other treatment options before deciding to use NAPRELAN. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
After observing the response to initial therapy with NAPRELAN, the dose and frequency should be adjusted to suit an individual patient's needs.
For the relief of:
Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis
The recommended starting dose of NAPRELAN Tablets in adults is two NAPRELAN 375 mg tablets (750 mg) once daily, one NAPRELAN 750 mg (750 mg) once daily, or two NAPRELAN 500 mg tablets (1000 mg) once a daily. Patients already taking naproxen 250 mg, 375 mg, or 500mg twice daily (morning and evening) may have their total daily dose replaced with NAPRELAN Tablets as a single daily dose.
During long-term administration, the dose of NAPRELAN Tablets may be adjusted up or down depending on the clinical response of the patient. In patients who tolerate lower doses of NAPRELAN Tablets well, the dose may be increased to two NAPRELAN 750 mg tablets (1500 mg), or three NAPRELAN 500 mg tablets (1500 mg) once daily for limited periods when a higher level of anti-inflammatory/analgesic activity is required. When treating patients, especially at the higher dose levels, the physician should observe sufficient increased clinical benefit to offset the potential increased risk (see ). The lowest effective dose should be sought and used in every patient. Symptomatic improvement in arthritis usually begins within one week; however, treatment for two weeks may be required to achieve a therapeutic benefit.
A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see ). Studies indicate that although total plasma contcentration 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.
What interacts with NAPRELAN?
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What are the warnings of NAPRELAN?
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What are the precautions of NAPRELAN?
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What are the side effects of NAPRELAN?
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What should I look out for while using NAPRELAN?
NAPRELAN is contraindicated in patients with known hypersensitivity to naproxen.
NAPRELAN should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see , and ).
NAPRELAN is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see ).
What might happen if I take too much NAPRELAN?
Significant naproxen overdosage may be characterized by drowsiness, heartburn, indigestion, nausea or vomiting. Because naproxen sodium may be rapidly absorbed, high and early blood levels should be anticipated. A few patients have experienced seizures, but it is not clear whether or not these were drug-related. It is not known what dose of the drug would be life threatening. The oral LD of the drug is 500 mg/kg in rats, 1200 mg/kg in mice, 4000 mg/kg in hamsters and greater than 1000 mg/kg in dogs. In animals 0.5 g/kg of activated charcoal was effective in reducing plasma levels of naproxen.
Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic carthartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine or hemoperfusion may not be useful due to high protein binding.
How should I store and handle NAPRELAN?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].NAPRELAN (naproxen sodium) Controlled-Release Tablets are available as follows: Rx Only US Patent 5,637,320 Store at controlled room temperature, 20° - 25° C (68° - 77° F).Dispense in a well-closed container.______________________________________________________________ Registered Trademark of Elan Corporation plcRegistered Trademark of Elan Pharma Int. Ltd.Naprosynis a registered trademark of Syntex Puerto Rico, Inc.Manufactured for: Victory Pharma, Inc., San Diego, CA 92130 Manufactured by: Elan Pharma International Ltd., Athlone, Ireland PI3750107 Rev 8/09 NAPRELAN (naproxen sodium) Controlled-Release Tablets are available as follows: Rx Only US Patent 5,637,320 Store at controlled room temperature, 20° - 25° C (68° - 77° F).Dispense in a well-closed container.______________________________________________________________ Registered Trademark of Elan Corporation plcRegistered Trademark of Elan Pharma Int. Ltd.Naprosynis a registered trademark of Syntex Puerto Rico, Inc.Manufactured for: Victory Pharma, Inc., San Diego, CA 92130 Manufactured by: Elan Pharma International Ltd., Athlone, Ireland PI3750107 Rev 8/09 NAPRELAN (naproxen sodium) Controlled-Release Tablets are available as follows: Rx Only US Patent 5,637,320 Store at controlled room temperature, 20° - 25° C (68° - 77° F).Dispense in a well-closed container.______________________________________________________________ Registered Trademark of Elan Corporation plcRegistered Trademark of Elan Pharma Int. Ltd.Naprosynis a registered trademark of Syntex Puerto Rico, Inc.Manufactured for: Victory Pharma, Inc., San Diego, CA 92130 Manufactured by: Elan Pharma International Ltd., Athlone, Ireland PI3750107 Rev 8/09 NAPRELAN (naproxen sodium) Controlled-Release Tablets are available as follows: Rx Only US Patent 5,637,320 Store at controlled room temperature, 20° - 25° C (68° - 77° F).Dispense in a well-closed container.______________________________________________________________ Registered Trademark of Elan Corporation plcRegistered Trademark of Elan Pharma Int. Ltd.Naprosynis a registered trademark of Syntex Puerto Rico, Inc.Manufactured for: Victory Pharma, Inc., San Diego, CA 92130 Manufactured by: Elan Pharma International Ltd., Athlone, Ireland PI3750107 Rev 8/09 NAPRELAN (naproxen sodium) Controlled-Release Tablets are available as follows: Rx Only US Patent 5,637,320 Store at controlled room temperature, 20° - 25° C (68° - 77° F).Dispense in a well-closed container.______________________________________________________________ Registered Trademark of Elan Corporation plcRegistered Trademark of Elan Pharma Int. Ltd.Naprosynis a registered trademark of Syntex Puerto Rico, Inc.Manufactured for: Victory Pharma, Inc., San Diego, CA 92130 Manufactured by: Elan Pharma International Ltd., Athlone, Ireland PI3750107 Rev 8/09 NAPRELAN (naproxen sodium) Controlled-Release Tablets are available as follows: Rx Only US Patent 5,637,320 Store at controlled room temperature, 20° - 25° C (68° - 77° F).Dispense in a well-closed container.______________________________________________________________ Registered Trademark of Elan Corporation plcRegistered Trademark of Elan Pharma Int. Ltd.Naprosynis a registered trademark of Syntex Puerto Rico, Inc.Manufactured for: Victory Pharma, Inc., San Diego, CA 92130 Manufactured by: Elan Pharma International Ltd., Athlone, Ireland PI3750107 Rev 8/09 NAPRELAN (naproxen sodium) Controlled-Release Tablets are available as follows: Rx Only US Patent 5,637,320 Store at controlled room temperature, 20° - 25° C (68° - 77° F).Dispense in a well-closed container.______________________________________________________________ Registered Trademark of Elan Corporation plcRegistered Trademark of Elan Pharma Int. Ltd.Naprosynis a registered trademark of Syntex Puerto Rico, Inc.Manufactured for: Victory Pharma, Inc., San Diego, CA 92130 Manufactured by: Elan Pharma International Ltd., Athlone, Ireland PI3750107 Rev 8/09 NAPRELAN (naproxen sodium) Controlled-Release Tablets are available as follows: Rx Only US Patent 5,637,320 Store at controlled room temperature, 20° - 25° C (68° - 77° F).Dispense in a well-closed container.______________________________________________________________ Registered Trademark of Elan Corporation plcRegistered Trademark of Elan Pharma Int. Ltd.Naprosynis a registered trademark of Syntex Puerto Rico, Inc.Manufactured for: Victory Pharma, Inc., San Diego, CA 92130 Manufactured by: Elan Pharma International Ltd., Athlone, Ireland PI3750107 Rev 8/09 NAPRELAN (naproxen sodium) Controlled-Release Tablets are available as follows: Rx Only US Patent 5,637,320 Store at controlled room temperature, 20° - 25° C (68° - 77° F).Dispense in a well-closed container.______________________________________________________________ Registered Trademark of Elan Corporation plcRegistered Trademark of Elan Pharma Int. Ltd.Naprosynis a registered trademark of Syntex Puerto Rico, Inc.Manufactured for: Victory Pharma, Inc., San Diego, CA 92130 Manufactured by: Elan Pharma International Ltd., Athlone, Ireland PI3750107 Rev 8/09 NAPRELAN (naproxen sodium) Controlled-Release Tablets are available as follows: Rx Only US Patent 5,637,320 Store at controlled room temperature, 20° - 25° C (68° - 77° F).Dispense in a well-closed container.______________________________________________________________ Registered Trademark of Elan Corporation plcRegistered Trademark of Elan Pharma Int. Ltd.Naprosynis a registered trademark of Syntex Puerto Rico, Inc.Manufactured for: Victory Pharma, Inc., San Diego, CA 92130 Manufactured by: Elan Pharma International Ltd., Athlone, Ireland PI3750107 Rev 8/09 NAPRELAN (naproxen sodium) Controlled-Release Tablets are available as follows: Rx Only US Patent 5,637,320 Store at controlled room temperature, 20° - 25° C (68° - 77° F).Dispense in a well-closed container.______________________________________________________________ Registered Trademark of Elan Corporation plcRegistered Trademark of Elan Pharma Int. Ltd.Naprosynis a registered trademark of Syntex Puerto Rico, Inc.Manufactured for: Victory Pharma, Inc., San Diego, CA 92130 Manufactured by: Elan Pharma International Ltd., Athlone, Ireland PI3750107 Rev 8/09 NAPRELAN (naproxen sodium) Controlled-Release Tablets are available as follows: Rx Only US Patent 5,637,320 Store at controlled room temperature, 20° - 25° C (68° - 77° F).Dispense in a well-closed container.______________________________________________________________ Registered Trademark of Elan Corporation plcRegistered Trademark of Elan Pharma Int. Ltd.Naprosynis a registered trademark of Syntex Puerto Rico, Inc.Manufactured for: Victory Pharma, Inc., San Diego, CA 92130 Manufactured by: Elan Pharma International Ltd., Athlone, Ireland PI3750107 Rev 8/09 NAPRELAN (naproxen sodium) Controlled-Release Tablets are available as follows: Rx Only US Patent 5,637,320 Store at controlled room temperature, 20° - 25° C (68° - 77° F).Dispense in a well-closed container.______________________________________________________________ Registered Trademark of Elan Corporation plcRegistered Trademark of Elan Pharma Int. Ltd.Naprosynis a registered trademark of Syntex Puerto Rico, Inc.Manufactured for: Victory Pharma, Inc., San Diego, CA 92130 Manufactured by: Elan Pharma International Ltd., Athlone, Ireland PI3750107 Rev 8/09 NAPRELAN (naproxen sodium) Controlled-Release Tablets are available as follows: Rx Only US Patent 5,637,320 Store at controlled room temperature, 20° - 25° C (68° - 77° F).Dispense in a well-closed container.______________________________________________________________ Registered Trademark of Elan Corporation plcRegistered Trademark of Elan Pharma Int. Ltd.Naprosynis a registered trademark of Syntex Puerto Rico, Inc.Manufactured for: Victory Pharma, Inc., San Diego, CA 92130 Manufactured by: Elan Pharma International Ltd., Athlone, Ireland PI3750107 Rev 8/09
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID), with analgesic and antipyretic properties. As with other NSAIDs, its mode of action is not fully understood; however, its ability to inhibit prostaglandin synthesis may be involved in the anti-inflammatory effect.
Non-Clinical Toxicology
NAPRELAN is contraindicated in patients with known hypersensitivity to naproxen.NAPRELAN should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see , and ).
NAPRELAN is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see ).
Alcohol, ethyl: Hepatotoxicity has occurred in chronic alcoholics following various dose levels (moderate to excessive) of acetaminophen.
Anticholinergics: The onset of acetaminophen effect may be delayed or decreased slightly, but the ultimate pharmacological effect is not significantly affected by anticholinergics.
Oral Contraceptives: Increase in glucuronidation resulting in increased plasma clearance and a decreased half-life of acetaminophen.
Charcoal (activated): Reduces acetaminophen absorption when administered as soon as possible after overdose.
Beta Blockers (Propanolol): Propanolol appears to inhibit the enzyme systems responsible for the glucuronidation and oxidation of acetaminophen Therefore, the pharmacologic effects of acetaminophen may be increased.
Loop diuretics: The effects of the loop diuretic may be decreased because acetaminophen may decrease renal prostaglandin excretion and decrease plasma renin activity.
Lamotrigine: Serum lamotrigine concentrations may be reduced, producing a decrease in therapeutic effects.
Probenecid: Probenecid may increase the therapeutic effectiveness of acetaminophen slightly.
Zidovudine: The pharmacologic effects of zidovudine may be decreased because of enhanced non-hepatic or renal clearance of zidovudine.
NAPRELAN cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. The pharmacological activity of NAPRELAN in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
As with all drugs in this class, the frequency and severity of adverse events depends on several factors: the dose of the drug and duration of treatment; the age, the sex, physical condition of the patient; any concurrent medical diagnoses or individual risk factors. The following adverse reactions are divided into three parts based on frequency and whether or not the possibility exists of a causal relationship between drug usage and these adverse events. In those reactions listed as “Probable Causal Relationship” there is at least one case for each adverse reaction where there is evidence to suggest that there is a causal relationship between drug usage and the reported event. The adverse reactions reported were based on the results from two double-blind controlled clinical trials of three months duration with an additional nine month open-label extension. A total of 542 patients received NAPRELAN Tablets either in the double-blind period or in the nine month open-label extension. Of these 542 patients, 232 received NAPRELAN Tablets, 167 were initially treated with Naprosyn and 143 were initially treated with placebo. Adverse reactions reported by patients who received NAPRELAN Tablets are shown by body system. Those adverse reactions observed with naproxen but not reported in controlled trials with NAPRELAN Tablets are .
The most frequent adverse events from the double-blind and open-label clinical trials were headache (15%), followed by dyspepsia (14%), and flu syndrome (10%). The incidence of other adverse events occurring in 3% - 9% of the patients are marked with an asterisk.
Those reactions occurring in less than 3% of the patients are unmarked.
INCIDENCE GREATER THAN 1% (PROBABLE CAUSAL RELATIONSHIP)
INCIDENCE LESS THAN 1% (PROBABLE CAUSAL RELATIONSHIP)
INCIDENCE LESS THAN 1% (CAUSAL RELATIONSHIP UNKNOWN)
Other adverse reactions listed in the naproxen package label, but not reported by those who received NAPRELAN Tablets are shown in italics. These observations are being listed as alerting information to the physician.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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