Naprosyn Suspension Generic Name & Formulations
Legal Class
Rx
General Description
Naproxen 125mg/5mL; pineapple-orange flavor.
Pharmacological Class
NSAID (propionic acid deriv.).
See Also
How Supplied
Tabs—100; Susp—473mL; EC—100
Manufacturer
Generic Availability
YES
Naprosyn Suspension Indications
Indications
Rheumatoid arthritis. Osteoarthritis. Ankylosing spondylitis. Polyarticular juvenile idiopathic arthritis (JIA). Tendinitis. Bursitis. Acute gout.
Naprosyn Suspension 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 Suspension Contraindications
Contraindications
Aspirin allergy. Coronary artery bypass graft surgery.
Naprosyn Suspension Boxed Warnings
Boxed Warning
Risk of serious cardiovascular and gastrointestinal events.
Naprosyn Suspension 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 Suspension Pharmacokinetics
See Literature
Naprosyn Suspension 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 Suspension 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 Suspension Clinical Trials
See Literature
Naprosyn Suspension Note
Not Applicable
Naprosyn Suspension Patient Counseling
See Literature
Naprosyn Suspension Generic Name & Formulations
Legal Class
Rx
General Description
Naproxen 125mg/5mL; pineapple-orange flavor.
Pharmacological Class
NSAID (propionic acid deriv.).
See Also
How Supplied
Tabs—100; Susp—473mL
Manufacturer
Generic Availability
YES
Naprosyn Suspension Indications
Indications
Dysmenorrhea.
Naprosyn Suspension 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 Suspension Contraindications
Contraindications
Aspirin allergy. Coronary artery bypass graft surgery.
Naprosyn Suspension Boxed Warnings
Boxed Warning
Risk of serious cardiovascular and gastrointestinal events.
Naprosyn Suspension 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 Suspension Pharmacokinetics
See Literature
Naprosyn Suspension 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 Suspension 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 Suspension Clinical Trials
See Literature
Naprosyn Suspension Note
Not Applicable
Naprosyn Suspension Patient Counseling
See Literature
Naprosyn Suspension Generic Name & Formulations
Legal Class
Rx
General Description
Naproxen 125mg/5mL; pineapple-orange flavor.
Pharmacological Class
NSAID (propionic acid deriv.).
See Also
How Supplied
Tabs—100; Susp—473mL
Manufacturer
Generic Availability
YES
Naprosyn Suspension Indications
Indications
Pain.
Naprosyn Suspension 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 Suspension Contraindications
Contraindications
Aspirin allergy. Coronary artery bypass graft surgery.
Naprosyn Suspension Boxed Warnings
Boxed Warning
Risk of serious cardiovascular and gastrointestinal events.
Naprosyn Suspension 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 Suspension Pharmacokinetics
See Literature
Naprosyn Suspension 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 Suspension 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 Suspension Clinical Trials
See Literature
Naprosyn Suspension Note
Not Applicable
Naprosyn Suspension Patient Counseling
See Literature