Naprosyn

— THERAPEUTIC CATEGORIES —
  • Arthritis/rheumatic disorders
  • Dysmenorrhea
  • Nonnarcotic analgesics

Naprosyn Generic Name & Formulations

General Description

Naproxen 500mg; scored tabs.

Pharmacological Class

NSAID (propionic acid deriv.).

How Supplied

Tabs—100; Susp—473mL; EC—100

Manufacturer

Generic Availability

YES

Naprosyn Indications

Indications

Rheumatoid arthritis. Osteoarthritis. Ankylosing spondylitis. Polyarticular juvenile idiopathic arthritis (JIA). Tendinitis. Bursitis. Acute gout.

Naprosyn Dosage and Administration

Adult

Use lowest effective dose for shortest duration. Arthritis, spondylitis: 250–500mg twice daily; max 1.5g/day (up to 6 months). Tendinitis, bursitis: 500mg once, then 500mg twice daily or 250mg every 6–8hrs; max (first day) 1.25g, then max 1g/day. Acute gout: 750mg once, then 250mg every 8hrs. Renal or hepatic impairment, elderly: consider lower doses.

Children

Use lowest effective dose for shortest duration. <2yrs: not established. ≥2yrs: JIA: 5mg/kg twice daily. Other uses: Doses of 2.5–5mg/kg/dose, max 15mg/kg/day have been used.

Naprosyn Contraindications

Contraindications

Aspirin allergy. Coronary artery bypass graft surgery.

Naprosyn Boxed Warnings

Boxed Warning

Risk of serious cardiovascular and gastrointestinal events.

Naprosyn Warnings/Precautions

Warnings/Precautions

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure, advanced renal disease; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Moderate to severe renal impairment (CrCl <30mL/min): not recommended. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, renal, and ocular function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Elderly. Debilitated. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers.

Naprosyn Pharmacokinetics

See Literature

Naprosyn Interactions

Interactions

Concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs: not recommended. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Avoid antacids, sucralfate, cholestyramine. Serum levels increased by probenecid. May potentiate protein-bound drugs (eg, phenytoin, sulfonylureas, sulfonamides). May interfere with 5HIAA urinary assays or Porter-Silber tests.

Naprosyn Adverse Reactions

Adverse Reactions

Dyspepsia, abdominal pain, nausea, headache, rash, ecchymosis, and edema; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, serious skin reactions (eg, Stevens-Johnson Syndrome, toxic epidermal necrolysis), Drug Reaction with Eosinophilia and Systemic Symptoms (discontinue if occurs), anemia.

Naprosyn Clinical Trials

See Literature

Naprosyn Note

Not Applicable

Naprosyn Patient Counseling

See Literature

Naprosyn Generic Name & Formulations

General Description

Naproxen 500mg; scored tabs.

Pharmacological Class

NSAID (propionic acid deriv.).

How Supplied

Tabs—100; Susp—473mL

Manufacturer

Generic Availability

YES

Naprosyn Indications

Indications

Dysmenorrhea.

Naprosyn Dosage and Administration

Adult

Use lowest effective dose for shortest duration. Initially 500mg, then 500mg every 12hrs or 250mg every 6–8hrs; max 1.25g (first day), then max 1g/day. Renal or hepatic impairment, elderly: consider lower doses.

Children

Not applicable.

Naprosyn Contraindications

Contraindications

Aspirin allergy. Coronary artery bypass graft surgery.

Naprosyn Boxed Warnings

Boxed Warning

Risk of serious cardiovascular and gastrointestinal events.

Naprosyn Warnings/Precautions

Warnings/Precautions

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure, advanced renal disease; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Moderate to severe renal impairment (CrCl <30mL/min): not recommended. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, renal, and ocular function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Elderly. Debilitated. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers.

Naprosyn Pharmacokinetics

See Literature

Naprosyn Interactions

Interactions

Concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs: not recommended. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Avoid antacids, sucralfate, cholestyramine. Serum levels increased by probenecid. May potentiate protein-bound drugs (eg, phenytoin, sulfonylureas, sulfonamides). May interfere with 5HIAA urinary assays or Porter-Silber tests.

Naprosyn Adverse Reactions

Adverse Reactions

Dyspepsia, abdominal pain, nausea, headache, rash, ecchymosis, and edema; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, serious skin reactions (eg, Stevens-Johnson Syndrome, toxic epidermal necrolysis), Drug Reaction with Eosinophilia and Systemic Symptoms (discontinue if occurs), anemia.

Naprosyn Clinical Trials

See Literature

Naprosyn Note

Not Applicable

Naprosyn Patient Counseling

See Literature

Naprosyn Generic Name & Formulations

General Description

Naproxen 500mg; scored tabs.

Pharmacological Class

NSAID (propionic acid deriv.).

How Supplied

Tabs—100; Susp—473mL

Manufacturer

Generic Availability

YES

Naprosyn Indications

Indications

Pain.

Naprosyn Dosage and Administration

Adult

Use lowest effective dose for shortest duration. Initially 500mg, then 500mg every 12hrs or 250mg every 6–8hrs; max 1.25g (first day), then max 1g/day. Renal or hepatic impairment, elderly: consider lower doses.

Children

<2yrs: not established. ≥2yrs: use susp forms of naproxen.

Naprosyn Contraindications

Contraindications

Aspirin allergy. Coronary artery bypass graft surgery.

Naprosyn Boxed Warnings

Boxed Warning

Risk of serious cardiovascular and gastrointestinal events.

Naprosyn Warnings/Precautions

Warnings/Precautions

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure, advanced renal disease; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Moderate to severe renal impairment (CrCl <30mL/min): not recommended. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, renal, and ocular function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Elderly. Debilitated. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers.

Naprosyn Pharmacokinetics

See Literature

Naprosyn Interactions

Interactions

Concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs: not recommended. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Avoid antacids, sucralfate, cholestyramine. Serum levels increased by probenecid. May potentiate protein-bound drugs (eg, phenytoin, sulfonylureas, sulfonamides). May interfere with 5HIAA urinary assays or Porter-Silber tests.

Naprosyn Adverse Reactions

Adverse Reactions

Dyspepsia, abdominal pain, nausea, headache, rash, ecchymosis, and edema; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, serious skin reactions (eg, Stevens-Johnson Syndrome, toxic epidermal necrolysis), Drug Reaction with Eosinophilia and Systemic Symptoms (discontinue if occurs), anemia.

Naprosyn Clinical Trials

See Literature

Naprosyn Note

Not Applicable

Naprosyn Patient Counseling

See Literature

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