Sciele Pharma, Inc.

Sciele Pharma, Inc. Drugs

• Cedax
  

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  Cedax

  

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  The recommended doses of CEDAX Oral Suspension are presented in the table below. CEDAX Oral Suspension must be administered at least 2 hours before or 1 hour after a meal.

  Type of infection (as qualified in the INDICATIONS AND USAGE section of this labeling) Daily Maximum Dose Dose and Frequency Duration ADULTS (12 years of age and older): 400 mg 400 mg QD 10 days Acute Bacterial Exacerbations of Chronic Bronchitis due to H. influenzae (including β-lactamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only). (See INDICATIONS AND USAGE - NOTE.) Pharyngitis and tonsillitis due to S. pyogenes. Acute Bacterial Otitis Media due to H. influenzae (including β-lactamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or S. pyogenes. (See INDICATIONS AND USAGE - NOTE.) PEDIATRIC PATIENTS: 400 mg 9 mg/kg QD 10 days Pharyngitis and tonsillitis due to S. pyogenes. Acute Bacterial Otitis Media due to H. influenzae (including β-lactamase-producing strains), and M. catarrhalis (including β-lactamase-producing strains), or S. pyogenes. (See INDICATIONS AND USAGE - NOTE.) CEFTIBUTEN ORAL SUSPENSION PEDIATRIC DOSAGE CHART CHILD'S WEIGHT 90 mg/5 mL 10 kg 22 lbs 1 tsp QD 20 kg 44 lbs 2 tsp QD 40 kg 88 lbs 4 tsp QD

  Pediatric patients weighing more than 45 kg should receive the maximum daily dose of 400 mg.

  Renal Impairment

  CEDAX Capsules and CEDAX Oral Suspension may be administered at normal doses in the presence of impaired renal function with creatinine clearance of 50 mL/min or greater. The recommendations for dosing in patients with varying degrees of renal insufficiency are presented in the following table.

  Creatinine Clearance (mL/min) Recommended Dosing Schedules >50 9 mg/kg or 400 mg Q24h (normal dosing schedule) 30-49 4.5 mg/kg or 200 mg Q24h 5-29 2.25 mg/kg or 100 mg Q24h

  Hemodialysis Patients

  In patients undergoing hemodialysis two or three times weekly, a single 400-mg dose of ceftibuten capsules or a single dose of 9 mg/kg (maximum of 400 mg of ceftibuten) oral suspension may be administered at the end of each hemodialysis session.

  Directions for Mixing CEDAX Oral Suspension

  DIRECTIONS FOR MIXING CEDAX ORAL SUSPENSION Final Concentration Bottle Size Amount of Water Directions 60 mL Suspend in 53 mL of water First tap the bottle to loosen powder. Then add water in two portions, shaking well after each aliquot. 90 mg per 5 mL 90 mL Suspend in 78 mL of water 120 mL Suspend in 103 mL of water

  After mixing, the suspension may be kept for 14 days and must be stored in the refrigerator. Keep tightly closed. Shake well before each use. Discard any unused portion after 14 days.

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