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NAPROSYN SUSPENSION
Arthritis/rheumatic disorders
Dysmenorrhea
Nonnarcotic analgesics
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Drug Name:

NAPROSYN SUSPENSION Rx

Generic Name and Formulations:
Naproxen 125mg/5mL; pineapple-orange flavor.

Company:
Atnahs Pharma

Therapeutic Use:

Indications for NAPROSYN SUSPENSION:

Rheumatoid arthritis. Osteoarthritis. Ankylosing spondylitis. Juvenile rheumatoid arthritis (JRA). Tendinitis. Bursitis. Acute gout.

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 6–8 hrs; max (first day) 1.25g, then max 1g/day. Acute gout: 750mg once, then 250mg every 8 hrs. Renal or hepatic impairment, elderly: consider lower doses.

Children:

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

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. 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. 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.

See Also:

NAPROSYN

EC-NAPROSYN

Pharmacological Class:

NSAID (propionic acid deriv.).

Adverse Reactions:

GI upset, headache, dizziness, drowsiness, pruritus, tinnitus, edema, dyspnea; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, anemia.

How Supplied:

Tabs—100; Susp—473mL; EC—100

Indications for NAPROSYN SUSPENSION:

Dysmenorrhea.

Adult:

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

Children:

Not applicable.

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. 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. 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.

See Also:

NAPROSYN

Pharmacological Class:

NSAID (propionic acid deriv.).

Adverse Reactions:

GI upset, headache, dizziness, drowsiness, pruritus, tinnitus, edema, dyspnea; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, anemia.

How Supplied:

Tabs—100; Susp—473mL

Indications for NAPROSYN SUSPENSION:

Mild to moderate pain.

Adult:

Use lowest effective dose for shortest duration. Initially 500mg, then 500mg every 12 hrs or 250mg every 6–8 hrs; 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.

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. 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. 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.

See Also:

NAPROSYN

Pharmacological Class:

NSAID (propionic acid deriv.).

Adverse Reactions:

GI upset, headache, dizziness, drowsiness, pruritus, tinnitus, edema, dyspnea; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, anemia.

How Supplied:

Tabs—100; Susp—473mL

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