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Augmentin ES (Amoxicillin / Clavulanate Potassium) - Indications and Dosage

 
 



INDICATIONS AND USAGE

AUGMENTIN ES-600 Powder for Oral Suspension 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 β-lactamase–producing strains), or
M. catarrhalis (including β-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

[See CLINICAL PHARMACOLOGY, Microbiology.]

NOTE: Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. AUGMENTIN ES-600 Powder for Oral Suspension 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 β-lactamase–producing organisms listed above.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN ES-600 Powder for Oral Suspension and other antibacterial drugs, AUGMENTIN ES-600 Powder for Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

DOSAGE AND ADMINISTRATION

AUGMENTIN ES-600 Powder for Oral Suspension, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of AUGMENTIN. AUGMENTIN ES-600 Powder for Oral Suspension contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/5 mL suspension of AUGMENTIN 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/28.5 mg/5 mL and 400 mg/57 mg/5 mL suspensions of AUGMENTIN should not be substituted for AUGMENTIN ES-600 Powder for Oral Suspension as they are not interchangeable.

Dosage:

Pediatric patients 3 months and older:

Based on the amoxicillin component (600 mg/5 mL), the recommended dose of AUGMENTIN ES-600 Powder for Oral Suspension is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).

Body Weight (kg) Volume of AUGMENTIN ES-600 Powder for Oral Suspension 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 AUGMENTIN ES-600 Powder for Oral Suspension in this group is not available.

Adults:

Experience with AUGMENTIN ES-600 Powder for Oral Suspension in adults is not available and adults who have difficulty swallowing should not be given AUGMENTIN ES-600 Powder for Oral Suspension in place of the 500-mg or 875-mg tablet of AUGMENTIN.

Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)

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 (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.

AUGMENTIN ES-600 Powder for Oral Suspension
Bottle Size Amount of Water
Required for Reconstitution
75 mL 70 mL
125 mL 110 mL
200 mL 180 mL

Each teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.

NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.

Information for the Pharmacist:

For patients who wish to alter the taste of AUGMENTIN ES-600 Powder for Oral Suspension, immediately after reconstitution 1 drop of FLAVORx (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of AUGMENTIN ES-600 Powder for Oral Suspension. The resulting suspension is stable for 10 days under refrigeration. Stability of AUGMENTIN ES-600 Powder for Oral Suspension when mixed with other flavors distributed by FLAVORx has not been evaluated for flavors other than the 5 flavors listed above.

Administration:

To minimize the potential for gastrointestinal intolerance, AUGMENTIN ES-600 Powder for Oral Suspension should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when AUGMENTIN ES-600 Powder for Oral Suspension is administered at the start of a meal.

HOW SUPPLIED

AUGMENTIN ES-600 Powder for Oral Suspension: Each 5 mL of reconstituted strawberry cream-flavored suspension contains 600 mg amoxicillin and 42.9 mg clavulanic acid as the potassium salt.

HOW SUPPLIED

NDC 43598-003-51       75 mL bottle

NDC 43598-003-69     125 mL bottle

NDC 43598-003-54     200 mL bottle

STORAGE

Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Store dry powder for oral suspension at or below 25°C (77°F). Dispense in original container.

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