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NAPRELAN
Arthritis/rheumatic disorders
Dysmenorrhea
Nonnarcotic analgesics
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Drug Name:

NAPRELAN Rx

Generic Name and Formulations:
Naproxen (as sodium) 375mg, 500mg, 750mg; controlled-rel tabs.

Company:
Alvogen

Therapeutic Use:

Indications for NAPRELAN:

Rheumatoid arthritis. Osteoarthritis. Ankylosing spondylitis. Acute gout. Tendinitis. Bursitis.

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.

Contraindications:

Aspirin allergy. Coronary artery bypass graft surgery.

Warnings/Precautions:

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; 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. Advanced renal disease: not recommended. 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. Pregnancy (≥30 weeks gestation; avoid). Nursing mothers.

Interactions:

Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. 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. Concomitant antacids, sucralfate, cholestyramine: not recommended. Serum levels increased by probenecid. May potentiate protein-bound drugs (eg, phenytoin, sulfonylureas, sulfonamides). May interfere with 5HIAA urinary assays or Porter-Silber tests.

Pharmacological Class:

NSAID (arylacetic acid deriv.).

Adverse Reactions:

Headache, dyspepsia, flu syndrome; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, anemia.

How Supplied:

Tabs 375mg—100; 500mg—75; 750mg—30

Indications for NAPRELAN:

Dysmenorrhea.

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.

Contraindications:

Aspirin allergy. Coronary artery bypass graft surgery.

Warnings/Precautions:

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; 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. Advanced renal disease: not recommended. 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. Pregnancy (≥30 weeks gestation; avoid). Nursing mothers.

Interactions:

Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. 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. Concomitant antacids, sucralfate, cholestyramine: not recommended. Serum levels increased by probenecid. May potentiate protein-bound drugs (eg, phenytoin, sulfonylureas, sulfonamides). May interfere with 5HIAA urinary assays or Porter-Silber tests.

Pharmacological Class:

NSAID (arylacetic acid deriv.).

Adverse Reactions:

Headache, dyspepsia, flu syndrome; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, anemia.

How Supplied:

Tabs 375mg—100; 500mg—75; 750mg—30

Indications for NAPRELAN:

Mild-to-moderate pain.

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.

Contraindications:

Aspirin allergy. Coronary artery bypass graft surgery.

Warnings/Precautions:

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; 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. Advanced renal disease: not recommended. 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. Pregnancy (≥30 weeks gestation; avoid). Nursing mothers.

Interactions:

Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. 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. Concomitant antacids, sucralfate, cholestyramine: not recommended. Serum levels increased by probenecid. May potentiate protein-bound drugs (eg, phenytoin, sulfonylureas, sulfonamides). May interfere with 5HIAA urinary assays or Porter-Silber tests.

Pharmacological Class:

NSAID (arylacetic acid deriv.).

Adverse Reactions:

Headache, dyspepsia, flu syndrome; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, anemia.

How Supplied:

Tabs 375mg—100; 500mg—75; 750mg—30

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