Skelan Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Naproxen Na

Indications/Uses

Symptomatic relief of RA, OA, ankylosing spondylitis, tendinitis, bursitis, acute gout. Pain including headache, migraine; post-op, post-partum pain & primary dysmenorrhea.

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Dosage/Direction for Use

220 mg tab Adult & childn ≥12 yr 1 tab 8-12 hrly. Adult >65 yr 1 tab 12 hrly. 550 mg tab 1 tab bid. Max: 2 tab once daily.

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Overdosage

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Administration

Should be taken with food.

Contraindications

Hypersensitivity to naproxen Na, aspirin or other NSAIDs. History of peptic/GI ulcers, chronic dyspepsia, bleeding or perforation related to previous NSAID therapy; recurrent peptic ulcer/hemorrhage unrelated to previous NSAID therapy. Severe renal, hepatic or cardiac failure. Perioperative pain in CABG surgery. Pregnancy (last trimester).

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Special Precautions

Increased risk of serious CV thrombotic events. MI & stroke. HTN or worsening of pre-existing HTN. Fluid retention & edema. History of ulcer disease or GI bleeding. Impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion. Advanced renal disease. Preexisting asthma. Skin rash or any sign of hypersensitivity. Liver dysfunction. Anemia. Lactation. Elderly. Childn.

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Use In Pregnancy & Lactation

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Adverse Reactions

Angioneurotic edema, thirst, menstrual disorders, pyrexia, infection, sepsis, anaphylactic/anaphylactoid reactions, death.

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Drug Interactions

Hydantoins, sulfonamides & sulfonylureas. May diminish antihypertensive effect & BP response to ACE inhibitor or AIIA. May delay absorption w/ antacids & sucralfate. Synergistic effect w/ anticoagulants/thrombolytics. Increased risk of bleeding w/ antiplatelets. Increased risk of serious GI events w/ aspirin & other NSAIDs. May interfere w/ antihypertensive effects of propranolol. Exacerbate cardiac failure, reduce GFR, increase plasma cardiac glycoside levels. May delay absorption w/ cholestyramine. Increased risk of nephrotoxicity w/ ciclosporin, tacrolimus. Increased risk of GI ulceration or bleeding w/ corticosteroids. Increased risk of lithium toxicity. Enhanced toxicity of MTX. Reduced effects of mifepristone. Increased risk of convulsions w/ quinolones. Increased plasma levels w/ probenecid. Increased risk of bleeding w/ SSRIs.

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Storage

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Description

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Action

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MIMS Class

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

ATC Classification

M01AE02 - naproxen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.

Regulatory Classification

220 mg: Non-Rx; 550 mg: Rx

Presentation/Packing

Form

Skelan tab 220 mg

Packing/Price

100's (P9.5/tab, P950/box)

Form

Skelan tab 550 mg

Packing/Price

100's (P1,900/box, P20.25/tab)

Skelan

naproxen

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc