CLAVENEN 600 is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including (beta)-lactamase-producing strains), or M. catarrhalis (including (beta)-lactamase-producing strains) characterized by the following risk factors:
- antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following:
- age ≤ 2 years
- daycare attendance
NOTE: Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. CLAVENEN 600 is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC ≥ 4 mcg/mL.
Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC ≤ 2 mcg/mL) and the (beta)-lactamase-producing organisms listed above.
CLAVENEN 600 is contraindicated in patients with a history of allergic reactions to any penicillin. It is also contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with CLAVENEN.
CLAVENEN 600 is generally well tolerated. The majority of side effects observed in pediatric clinical trials of acute otitis media were either mild or moderate, and transient in nature; 4.4% of patients discontinued therapy because of drug-related side effects. The most commonly reported side effects with probable or suspected relationship to CLAVENEN 600 were contact dermatitis, i.e., diaper rash (3.5%), diarrhea (2.9%), vomiting (2.2%), moniliasis (1.4%), and rash (1.1%). The most common adverse experiences leading to withdrawal that were of probable or suspected relationship to CLAVENEN 600 were diarrhea (2.5%) and vomiting (1.4%).
DOSAGE AND ADMINISTRATION:
CLAVENEN 600, 600 mg/5 mL, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of CLAVENEN. CLAVENEN 600 contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/5 mL suspension of CLAVENEN contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/5 mL and 400 mg/5 mL suspensions of CLAVENEN should not be substituted for CLAVENEN 600, as they are not interchangeable.
Pediatric patients 3 months and older: Based on the amoxicillin component (600 mg/5 mL), the recommended dose of CLAVENEN 600 is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
Body Weight (kg) Volume of CLAVENEN 600
providing 90 mg/kg/day
8 3.0 mL twice daily
12 4.5 mL twice daily
16 6.0 mL twice daily
20 7.5 mL twice daily
24 9.0 mL twice daily
28 10.5 mL twice daily
32 12.0 mL twice daily
36 13.5 mL twice daily
Pediatric patients weighing 40 kg and more: Experience with CLAVENEN 600 (600 mg/5 mL formulation) in this group is not available.
Adults: Experience with CLAVENEN 600 (600 mg/5 mL formulation) in adults is not available and adults who have difficulty swallowing should not be given CLAVENEN 600 (600 mg/5 mL) in place of the 500-mg or 875-mg tablet of CLAVENEN.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.
Directions for Mixing Oral Suspension: Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
CLAVENEN 600: Bottle of 60 mL or 75 mL or 125 mL or 200 mL.