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ARRESTIN / ARRESTIN-SR:

 
 
 
   
   
   
 
 


 
   
 
             Abridged Prescribing Information
     
     
    Composition
   
    Each tablet of ARRESTIN contains:
    Aceclofenac. . .100 mg
   
    Each sustained release tablet of ARRESTIN SR contains:
    Aceclofenac. . .200 mg
   
   
    Therapeutic Indications & Usage
   
    ARRESTIN is indicated for mild to moderate pain associated with inflammation.
 
  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.
   
   
    Contraindications
   
    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.
   
   
    Precautions
   
 
  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.
   
   
    Warnings
   
 
  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.
   
   
    Adverse Reactions
   
    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
   
   
    Drug Interactions:
   
    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.
   
   
    Recommended Dosage & Administration
   
    ADULTS: 1 ARRESTIN Tab bid, or 1 ARRESTIN SR Tab od, or as prescribed
   
   
    Presentations
   
    ARRESTIN Tablets: Blisters of 10s.
    ARRESTIN-SR Tablets: Blisters of 10s.
   
 
 
 
   
 
         
 
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