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SI-FIXIM:

 
       
     
       
      Composition
       
      Each dispersible tablet of                 Each dispersible tablet of SI-FIXIM 400 DT
      SI-FIXIM 50 / 100 DT contains:        contains:
      Cefixime trihydrate                         Cefixime trihydrate    
      Equivalent to anhydrous cefixime                                
      … 50 / 100 mg                                Equivalent to anhydrous cefixime … 400 mg
       
      Each tablet of SI-FIXIM                    Each 5 ml of reconstituted SI-FIXIM Dry
      200 DT contains:                            Syrup contains:
      Cefixime trihydrate                         Cefixime trihydrate
      Equivalent to anhydrous                  Equivalent to anhydrous cefixime … 50 mg
      cefixime … 200 mg                           
                                                         
       
      Therapeutic Indications & Usage
       
      SI-FIXIM is indicated for the treatment of infections caused by susceptible bacteria:
     
  • Upper respiratory tract infections, such as pharyngitis, sinusitis, otitis media, tonsillitis.
     
  • Lower respiratory tract infections, such as acute bronchitis and acute exacerbation of chronic bronchitis.
     
  • Uncomplicated urinary tract infections.
     
  • Uncomplicated gonorrhea.
       
       
      Contraindications
       
     
SI-FIXIM is not advocated for those with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins.
       
       
      Precautions & Warnings
       
     
SI-FIXIM should be advocated with caution in presence of renal impairment or GI disease, particularly colitis. Prolonged use of SI-FIXIM could result in overgrowth of non-susceptible organisms. If superinfections occur (usually involving Aerobacter, Pseudomonas or Candida spp), SI-FIXIM should be discontinued and/or appropriate therapy instituted.
       
     
Periodic assessment of hematopoietic function is advisable during prolonged SI-FIXIM therapy. SI-FIXIM is not ideally meant for pregnant lady or lactating mother; however, it could be only if strictly necessary. Nursing discontinuation temporarily must be considered whilst taking SI-FIXIM. Safety and efficacy of cefixime (SI-FIXIM) in children less than 6 months old have not been established.
       
     
SI-FIXIM must be coadministered with carbamazepine, warfarin and other anticoagulants.
       
       
      Adverse Reactions
       
     
The most frequent adverse effect is gastrointestinal (GI) complaints, and diarrhea incidence is 16%. Other side effects include hypersensitivity reactions, liver / renal dysfunction, headaches, dizziness, seizures, hematopoietic changes, genital pruritus, vaginitis, candidiasis.
       
       
      Drug Interaction:
      Elevated carbamazepine levels occur when cefixime (SI-FIXIM) is coadministered. When given with warfarin / anticoagulants, the prothrombin time is elevated.
       
       
      Recommended Dosage & Administration
       
      Adults
      Susceptible infections: 1 SI-FIXIM 200 Tab / 2 SI-FIXIM 100 DT bid, or 2 SI-FIXIM Tabs od, or as prescribed.
      Uncomplicated cervical / urethral gonococcal infections: 2 SI-FIXIM Tabs stat, or as prescribed.
       
      Children
      <50 kg: 8 mg/kg/day of SI-FIXIM Suspension / SI-FIXIM 50 / 100 DT either as single dose or in two divided doses.
      >50 kg: As per adult recommendations of 400 mg/day as single, or in two divided doses.
       
       
      Presentation
     

SI-FIXIM 50 / 100 DT: Blister strips of 10s.
SI-FIXIM 200 DT: Blister strips of 10s.
SI-FIXIM 400 DT : Blister Strip of 10’s
SI-FIXIM Dry Syrup: Bottles of 30 ml.

       
     
     
       
       
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