Naprelan

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

Naprelan Generic Name & Formulations

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

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

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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