Drug Detail:Ec-naprosyn (Naproxen [ na-prox-en ])
Drug Class: Nonsteroidal anti-inflammatory drugs
Usual Adult Dose for Ankylosing Spondylitis
Immediate Release Tablets and Suspension:
250 mg to 500 mg (naproxen) or 275 mg to 550 mg (naproxen sodium) orally twice a day
Controlled Release:
750 mg to 1000 mg orally once a day
Delayed Release:
375 mg to 500 mg orally twice a day
Comments:
- May increase to 1500 mg orally once a day for a limited time up to 6 months in patients requiring higher levels of anti-inflammatory/analgesic activity.
- When treating patients, especially at higher doses, sufficient increased clinical benefit should be observed to offset the potential for increased risk of adverse events.
- Symptomatic improvement of arthritis is usually observed within 1 week; however, treatment for 2 weeks may be required to achieve therapeutic benefit.
Uses: For the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis
Usual Adult Dose for Osteoarthritis
Immediate Release Tablets and Suspension:
250 mg to 500 mg (naproxen) or 275 mg to 550 mg (naproxen sodium) orally twice a day
Controlled Release:
750 mg to 1000 mg orally once a day
Delayed Release:
375 mg to 500 mg orally twice a day
Comments:
- May increase to 1500 mg orally once a day for a limited time up to 6 months in patients requiring higher levels of anti-inflammatory/analgesic activity.
- When treating patients, especially at higher doses, sufficient increased clinical benefit should be observed to offset the potential for increased risk of adverse events.
- Symptomatic improvement of arthritis is usually observed within 1 week; however, treatment for 2 weeks may be required to achieve therapeutic benefit.
Uses: For the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis
Usual Adult Dose for Rheumatoid Arthritis
Immediate Release Tablets and Suspension:
250 mg to 500 mg (naproxen) or 275 mg to 550 mg (naproxen sodium) orally twice a day
Controlled Release:
750 mg to 1000 mg orally once a day
Delayed Release:
375 mg to 500 mg orally twice a day
Comments:
- May increase to 1500 mg orally once a day for a limited time up to 6 months in patients requiring higher levels of anti-inflammatory/analgesic activity.
- When treating patients, especially at higher doses, sufficient increased clinical benefit should be observed to offset the potential for increased risk of adverse events.
- Symptomatic improvement of arthritis is usually observed within 1 week; however, treatment for 2 weeks may be required to achieve therapeutic benefit.
Uses: For the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis
Usual Adult Dose for Acute Gout
Immediate Release Tablets and Suspension:
- Initial dose: 750 mg (naproxen) or 825 mg (naproxen sodium) orally once on first day of attack
- Following initial dose: 250 mg (naproxen) or 275 mg (naproxen sodium) orally every 8 hours until attack subsides
Controlled Release:
1000 mg to 1500 mg orally once on first day of attack, followed by 1000 mg orally once a day until attack subsides
Comments:
- The delayed release tablets (EC-Naprosyn[R]) are not recommended due to delayed absorption.
Use: For the relief of an acute gout attack
Usual Adult Dose for Bursitis
Immediate Release (naproxen sodium):
550 mg orally once, followed by 275 mg orally every 6 to 8 hours or 550 mg orally every 12 hours as needed
- Maximum dose: Initial total daily dose not to exceed 1375 mg; thereafter, not to exceed 1100 mg/day
Comments:
- Naproxen (Naprosyn[R]) may also but used, however, the delayed release tablets (EC-Naprosyn[R]) are not recommended for initial treatment of acute pain due to delayed absorption.
Controlled Release:
1000 mg orally once a day
- For patients requiring additional analgesia, may increase to 1500 mg orally once a day for a limited time; thereafter, total daily dose should not exceed 1000 mg/day
Uses: For the relief of signs and symptoms of bursitis and tendinitis
Usual Adult Dose for Tendonitis
Immediate Release (naproxen sodium):
550 mg orally once, followed by 275 mg orally every 6 to 8 hours or 550 mg orally every 12 hours as needed
- Maximum dose: Initial total daily dose not to exceed 1375 mg; thereafter, not to exceed 1100 mg/day
Comments:
- Naproxen (Naprosyn[R]) may also but used, however, the delayed release tablets (EC-Naprosyn[R]) are not recommended for initial treatment of acute pain due to delayed absorption.
Controlled Release:
1000 mg orally once a day
- For patients requiring additional analgesia, may increase to 1500 mg orally once a day for a limited time; thereafter, total daily dose should not exceed 1000 mg/day
Uses: For the relief of signs and symptoms of bursitis and tendinitis
Usual Adult Dose for Dysmenorrhea
Immediate Release (naproxen sodium):
550 mg orally once, followed by 275 mg orally every 6 to 8 hours or 550 mg orally every 12 hours as needed
- Maximum dose: 1375 mg/day initial total daily dose; thereafter, not to exceed 1100 mg/day
Comments:
- Naproxen (Naprosyn[R]) may also but used, however, the delayed release tablets (EC-Naprosyn[R]) are not recommended for initial treatment of acute pain due to delayed absorption.
Controlled Release:
1000 mg orally once a day
- For patients requiring additional analgesia, may increase to 1500 mg orally once a day for a limited time; thereafter, total daily dose should not exceed 1000 mg/day
Over the Counter:
220 mg orally every 8 to 12 hours while symptoms persist
- May take 440 mg orally once in the first hour if needed
Uses: For the management of primary dysmenorrhea
Usual Adult Dose for Pain
Immediate Release (naproxen sodium):
550 mg orally once, followed by 275 mg orally every 6 to 8 hours or 550 mg orally every 12 hours as needed
- Maximum dose: 1375 mg/day initial total daily dose; thereafter, not to exceed 1100 mg/day
Comments:
- Naproxen (Naprosyn[R]) may also but used, however, the delayed release tablets (EC-Naprosyn[R]) are not recommended for initial treatment of acute pain due to delayed absorption.
Controlled Release:
1000 mg orally once a day
- For patients requiring additional analgesia, may increase to 1500 mg orally once a day for a limited time; thereafter, total daily dose should not exceed 1000 mg/day
Over the Counter:
220 mg orally every 8 to 12 hours while symptoms persist
- May take 440 mg orally once in the first hour if needed
Uses: For the relief of mild to moderate pain
Usual Adult Dose for Fever
Over the Counter:
220 mg orally every 8 to 12 hours while symptoms persist
- May take 440 mg orally once in the first hour if needed
Use: For the temporary reduction of fever
Usual Pediatric Dose for Fever
Over the Counter:
12 years or older: 220 mg orally every 8 to 12 hours while symptoms persist
- May take 440 mg orally once in the first hour if needed
Uses: For the relief of minor aches and pains and for the temporary reduction of fever
Usual Pediatric Dose for Pain
Over the Counter:
12 years or older: 220 mg orally every 8 to 12 hours while symptoms persist
- May take 440 mg orally once in the first hour if needed
Uses: For the relief of minor aches and pains and for the temporary reduction of fever
Usual Pediatric Dose for Juvenile Rheumatoid Arthritis
Immediate Release Tablets and Suspension:
2 years or older: 5 mg/kg orally twice a day
Comments:
- The oral suspension is recommended due to flexible dose titration based on patient's weight.
- The delayed release formulation has not been studied in patients less than 18 years.
Use: For the relief of signs and symptoms of juvenile rheumatoid arthritis
Renal Dose Adjustments
Mild renal dysfunction: Caution is recommended; lower doses should be considered
Moderate to severe renal dysfunction: Not recommended.
Liver Dose Adjustments
- Dose adjustments may be required in patients with liver dysfunction, however, no specific guidelines have been suggested. Caution recommended.
- Patients who have an abnormal liver test or who develop signs or symptoms of liver dysfunction should be evaluated for hepatic dysfunction.
- If liver disease develops or if systemic manifestations such as eosinophilia or rash occur, this drug should be discontinued.
Dose Adjustments
Elderly patients may require lower doses due to increased risk for adverse effects and risk for concurrent hepatic and/or renal impairment.
Precautions
US BOXED WARNINGS: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS:
- Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
- This drug is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
- NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.
Immediate Release:
Safety and efficacy have not been established in patients younger than 2 years.
Over the Counter:
Safety and efficacy have not been established in patients younger than 12 years.
Controlled and Delayed Release Tablets:
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Take orally with a full glass of water; take with food or milk if stomach upset occurs.
- Oral Suspension: Shake gently before use; use with dosing device provided.
- Controlled and delayed release tablets: Do not break, crush, or chew.
Storage requirements:
- Dispense in light resistant containers.
- Oral Suspension: Avoid excessive heat above 40C (104F).
General:
- When treating acute painful conditions, the delayed release form is not recommended due to delay in absorption.
- Different dose strengths and dosage forms are not necessarily bioequivalent; differences should be taken into consideration when changing formulations.
- Prior to initiating treatment, the potential benefits and risks of this drug should be weighed against other treatment options.
- The lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
- There is an increased risk of heart attack, heart failure, and stroke when taking nonsteroidal anti-inflammatory drugs (NSAIDs); these events may occur at any time during treatment and risk increases with long term use, a history of cardiovascular (CV) disease or risk factors for CV disease, and higher doses.
Monitoring:
- Cardiovascular: Monitor blood pressure closely during initiation and throughout course of therapy.
- Gastrointestinal: Monitor for signs/symptoms of gastrointestinal bleeding.
- Renal function: Monitor renal status, especially in patients with conditions where renal prostaglandins have a supportive role in the maintenance of renal perfusion.
- Monitor blood counts, renal, and hepatic function periodically for patients receiving long-term therapy.
Patient advice:
- Patients should seek medical advice for signs and symptoms of gastrointestinal events, adverse skin reactions, allergic reactions, hepatotoxicity, or unexplained weight gain or edema.
- Patients should seek medical attention immediately if signs/symptoms of cardiovascular events occur including, shortness of breath, slurred speech, chest pain, or weakness on one side of the body.
- Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding; NSAIDs should not be used at 20 weeks or later in pregnancy unless specifically advised to do so by their health care professional.
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