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ARRESTIN / ARRESTIN-SR: |
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Abridged Prescribing Information |
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Composition |
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Each tablet of ARRESTIN contains: |
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Aceclofenac. . .100 mg |
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Each sustained release tablet of ARRESTIN SR contains: |
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Aceclofenac. . .200 mg |
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Therapeutic Indications & Usage |
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ARRESTIN is indicated for mild to moderate pain associated with inflammation. |
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ARRESTIN SR is indicated for rheumatic disorders such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis; non-articular rheumatism, soft tissue injuries and various other infla-mmatory disorders. |
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Contraindications |
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ARRESTIN / SR is contraindicated in patients with hypersensitivity to any of the ingredients, in those known to have bronchospasm or acute rhinitis or urticaria with aspirin or similar agents, presence of active or suspected peptic ulcer, gastrointestinal or other active bleeding, bleeding disorders, severe heart or kidney or liver failure. It is not advocated in small children below 18 months of age, and during the last trimester of pregnancy. |
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Precautions |
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ARRESTIN / SR should be administered with caution in patients with acid-peptic disease, infla-mmatory bowel disease, impaired renal or liver functions, blood dyscrasias, SLE, porphyria, hematopoietic and coagulation disorders, and in patients with hypersensitivity to aspirin or other NSAIDs. |
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Warnings |
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ARRESTIN / SR is to be advocated with due caution in those on diuretics, or otherwise at risk of hypovolemia. It should be used in pregnant women and nursing mothers only if absolutely required. Data on safety and efficacy of aceclofenac in children is not adequate. In those receiving long-term ARRESTIN / SR, periodical monitoring of renal and hepatic functions and blood counts is necessary. |
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Adverse Reactions |
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The most common side effects are gastric pain, flatulence, nausea, vomiting, diarrhea & dyspepsia; rarely peptic ulcer and gastrointestinal bleeding occur. Infrequently, hypersensitivity reactions, skin reactions, taste perversion,
malaise, change in appetite and weight, edema, palpitations, flushing, purpura and eye disorders are possible due to aceclofenac (ARRESTIN / SR). Neurological reactions possible include headache, drowsiness, insomnia, irritability and mood disturbances. ARRESTIN / SR can rarely cause hepatitis, renal dysfunction and blood dyscrasias on account of its aceclofenac content |
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Drug Interactions: |
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Aceclofenac (ARRESTIN / SR) could interact with oral thrombolytics, diuretics, cyclosporine, tacrolimus, phenytoin, digoxin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole, sulfaphenazole, methotrexate, lithium, and highly protein-bound drugs. |
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Recommended Dosage & Administration |
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ADULTS: 1 ARRESTIN Tab bid, or 1 ARRESTIN SR Tab od, or as prescribed |
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Presentations |
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ARRESTIN Tablets: Blisters of 10s. |
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ARRESTIN-SR Tablets: Blisters of 10s. |
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