Colgate Triple Action

Colgate Triple Action Manufacturers

• Mission Hills S.a De C.v
  

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  Colgate Triple Action | Pd-rx Pharmaceuticals, Inc.

  

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  2.1 Important Administration Instructions Cefuroxime axetil tablets and cefuroxime axetil for oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis Administer cefuroxime axetil tablets as described in the appropriate dosage guidelines [see Dosage and Administration (2.2)]. Administer cefuroxime axetil tablets with or without food. Pediatric patients (aged 13 years and older) who cannot swallow the cefuroxime axetil tablets whole should receive cefuroxime axetil for oral suspension because the tablet has a strong, persistent bitter taste when crushed [see Dosage and Administration (2.2)]. 2.2 Dosage for Cefuroxime Axetil Tablets

  Administer cefuroxime axetil tablets as described in the dosage guidelines table below with or without food.

  Table 1. Adult Patients and Pediatric Patients Dosage Guidelines for Cefuroxime Axetil Tablets a The safety and effectiveness of cefuroxime axetil tablets  administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.
  b When crushed, the tablet has a strong, persistent bitter taste. Therefore, patients who cannot swallow the tablet whole should receive the oral suspension.
   
  Infection
  Dosage
  Duration
  (Days)
  Adults and Adolescents (13 years and older)
  Pharyngitis/tonsillitis (mild to moderate)
  250 mg every 12 hours
  10
  Acute bacterial maxillary sinusitis (mild to moderate)
  250 mg every 12 hours
  10
  Acute bacterial exacerbations of chronic bronchitis (mild to moderate)
  250 mg or 500 mg every
  12 hours
  10 a
  Secondary bacterial infections of acute bronchitis
  250 mg or 500 mg every
  12 hours
  5 to 10
  Uncomplicated skin and skin-structure infections
  250 mg or 500 mg every
  12 hours
  10
  Uncomplicated urinary tract infections
  250 mg every 12 hours
  7 to 10
  Uncomplicated gonorrhea
  1,000 mg
  single dose
  Early Lyme disease
  500 mg every 12 hours
  20
  Pediatric Patients younger than 13 years (who can swallow tablets whole) b
  Acute bacterial otitis media
  250 mg every 12 hours
  10
  Acute bacterial maxillary sinusitis
  250 mg every 12 hours
  10
  2.5 Dosage in Patients with Impaired Renal Function

  A dosage interval adjustment is required for patients whose creatinine clearance is <30 mL/min, as listed in Table 4 below, because cefuroxime is eliminated primarily by the kidney [see Clinical Pharmacology (12.3)].

  Table 4. Dosing in Adults with Renal Impairment Creatinine Clearance (mL/min)
  Recommended Dosage
  ≥30
  No dosage adjustment
  10 to <30
  Standard individual dose given every 24 hours
  <10 (without hemodialysis)
  Standard individual dose given every 48 hours
  Hemodialysis
  A single additional standard dose should be given at the end of each dialysis
  

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