Axcel Diclofenac-50: Dosing, Side Effect & Interaction

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

Concise Prescribing Info

Contents

Diclofenac Na

Indications/Uses

Inflammatory, degenerative & non-articular forms of rheumatism & juvenile arthritis; acute gout; post-traumatic & post-op inflammation & swelling. Primary dysmenorrhea.

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Dosage/Direction for Use

Adult 75-150 mg daily in 2-3 divided doses. RA 75 mg once daily. Max: 100-150 mg daily. Primary dysmenorrhea Initially 50-150 mg, may be increased up to max: 200 mg daily.

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Overdosage

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Administration

Should be taken with food.

Contraindications

History of hypersensitivity to ASA & other NSAIDs. Severe cardiac failure, peptic ulcerations, asthma attacks, urticaria, acute rhinitis.

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Warnings

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Special Precautions

Discontinue use if rash occurs. Not recommended in patients w/ established CV disease (CHF, ischemic heart & peripheral arterial disease), uncontrolled HTN. Patients w/ haemorrhagic disorders; peptic ulceration, perforation & bleeding, history of serious adverse events & other risk factors associated w/ PUD (eg, alcoholism, corticosteroid therapy), post GI surgery; asthma; impaired cardiac function, significant risk factors for CV disease (eg, HTN, hyperlipidaemia, DM, smoking), signs & symptoms of serious arteriothrombotic events; fluid retention, oedema. High-dose & long-term use. Closely monitor signs of hypersensitivity reactions; BP during treatment & at regular intervals thereafter. Renal & hepatic impairment. Avoid use in late pregnancy. Not recommended during lactation. Not to be used in childn <1 yr. Elderly or debilitated patients.

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Use In Pregnancy & Lactation

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Adverse Reactions

Epigastric pain, nausea, vomiting, diarrhoea; haemolytic anaemia, thrombocytopenia, neutropenia, agranulocytosis; elevated serum aminotransferase activity, clinical hepatitis eg, fatal fulminant hepatitis; rashes, skin eruptions; renal papillary necrosis, nephrotic syndrome; hypersensitivity reactions, headache, dizziness, vertigo, hearing disturbances eg, tinnitus; photosensitivity.

Drug Interactions

Increased plasma conc of lithium & MTX. Increased side effects w/ other NSAIDs & ASA. Increased cyclosporin nephrotoxicity. Increased risk of convulsions w/ quinolones. Increased serum K levels w/ K-sparing diuretics. Inhibited platelet aggregation w/ anticoagulants. Inhibited metabolism of sulfonylureas. Decreased elimination & increased plasma conc of aminoglycosides. Reduced metabolism & elimination w/ probenecid. Reduced effects of anti-hypertensives, mifepristone. Exacerbated cardiac failure, reduced GFR & increased plasma levels of cardiac glycosides eg, digoxin. Increased risk of GI bleeding w/ corticosteroids.

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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

M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.

Regulatory Classification

Presentation/Packing

Form

Axcel Diclofenac-50 EC tab 50 mg

Packing/Price

100 × 10's;10 × 10's

Axcel Diclofenac-50

diclofenac

Manufacturer:

Kotra Pharma

Distributor:

Kotra Pharma