Naprelan Generic Name & Formulations
Legal Class
Rx
General Description
Naproxen (as sodium) 375mg, 500mg, 750mg; controlled-rel tabs.
Pharmacological Class
NSAID (arylacetic acid deriv.).
How Supplied
Tabs 375mg—100; 500mg—75; 750mg—30
Manufacturer
Generic Availability
YES
Naprelan Indications
Indications
Rheumatoid arthritis. Osteoarthritis. Ankylosing spondylitis. Acute gout. Tendinitis. Bursitis.
Naprelan Dosage and Administration
Adult
Use lowest effective dose for shortest duration. Rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis: 750mg–1g once daily; max 1.5g once daily. Acute tendonitis or bursitis: 1g once daily, or 1.5g once daily for a limited period; max 1g/day thereafter. Gout: 1–1.5g once daily for 1 day then 1g once daily until attack subsides. Renal or hepatic impairment, elderly: consider lower doses.
Children
Not established.
Naprelan Contraindications
Contraindications
Aspirin allergy. Coronary artery bypass graft surgery.
Naprelan Boxed Warnings
Not Applicable
Naprelan 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. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal 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.
Naprelan Pharmacokinetics
See Literature
Naprelan 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.
Naprelan Adverse Reactions
Adverse Reactions
Headache, dyspepsia, flu syndrome; 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.
Naprelan Clinical Trials
See Literature
Naprelan Note
Not Applicable
Naprelan Patient Counseling
See Literature
Naprelan Generic Name & Formulations
Legal Class
Rx
General Description
Naproxen (as sodium) 375mg, 500mg, 750mg; controlled-rel tabs.
Pharmacological Class
NSAID (arylacetic acid deriv.).
How Supplied
Tabs 375mg—100; 500mg—75; 750mg—30
Manufacturer
Generic Availability
YES
Naprelan Indications
Indications
Dysmenorrhea.
Naprelan Dosage and Administration
Adult
Use lowest effective dose for shortest duration. 1g once daily, or 1.5g once daily for a limited period; max 1g/day thereafter. Renal or hepatic impairment, elderly: consider lower doses.
Children
Not established.
Naprelan Contraindications
Contraindications
Aspirin allergy. Coronary artery bypass graft surgery.
Naprelan Boxed Warnings
Not Applicable
Naprelan 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. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal 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.
Naprelan Pharmacokinetics
See Literature
Naprelan 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.
Naprelan Adverse Reactions
Adverse Reactions
Headache, dyspepsia, flu syndrome; 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.
Naprelan Clinical Trials
See Literature
Naprelan Note
Not Applicable
Naprelan Patient Counseling
See Literature
Naprelan Generic Name & Formulations
Legal Class
Rx
General Description
Naproxen (as sodium) 375mg, 500mg, 750mg; controlled-rel tabs.
Pharmacological Class
NSAID (arylacetic acid deriv.).
How Supplied
Tabs 375mg—100; 500mg—75; 750mg—30
Manufacturer
Generic Availability
YES
Naprelan Indications
Indications
Mild to moderate pain.
Naprelan Dosage and Administration
Adult
Use lowest effective dose for shortest duration. 1g once daily, or 1.5g once daily for a limited period; max 1g/day thereafter. Renal or hepatic impairment, elderly: consider lower doses.
Children
Not established.
Naprelan Contraindications
Contraindications
Aspirin allergy. Coronary artery bypass graft surgery.
Naprelan Boxed Warnings
Not Applicable
Naprelan 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. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal 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.
Naprelan Pharmacokinetics
See Literature
Naprelan 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.
Naprelan Adverse Reactions
Adverse Reactions
Headache, dyspepsia, flu syndrome; 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.
Naprelan Clinical Trials
See Literature
Naprelan Note
Not Applicable
Naprelan Patient Counseling
See Literature
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