Amoxicillin and Clavulanate Potassium

AMOXICILLIN AND CLAVULANATE POTASSIUM — amoxicillin and clavulanate potassium powder, for suspension
Aurobindo Pharma Limited

1 INDICATIONS AND USAGE

Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of pediatric patients with

• Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains) characterized by the following risk factors:

– Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology (12.4)].

Limitations of Use

Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and clavulanate potassium for oral suspension is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC greater than or equal to 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 less than or equal to 2 mcg/mL) and the β-lactamase-producing organisms listed above.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, amoxicillin and clavulanate potassium 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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal.

2.2 Dosage in Pediatric Patients

Pediatric patients 3 months and older: Based on the amoxicillin component (600 mg/5 mL), the recommended dose of amoxicillin and clavulanate potassium for oral suspension is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below). This dose provides 6.4 mg/kg/day of the clavulanic acid component.

Body Weight (kg)	Volume of Amoxicillin and Clavulanate Potassium for Oral Suspension providing 90 mg/kg/day
8	3 mL twice daily
12	4.5 mL twice daily
16	6 mL twice daily
20	7.5 mL twice daily
24	9 mL twice daily
28	10.5 mL twice daily
32	12 mL twice daily
36	13.5 mL twice daily

Pediatric patients weighing 40 kg and more: Experience with amoxicillin and clavulanate potassium for oral suspension in this group is not available.

2.3 Dosage in Adult Patients

Experience with amoxicillin and clavulanate potassium for oral suspension in adults is not available and adults who have difficulty swallowing should not be given amoxicillin and clavulanate potassium for oral suspension in place of the 500 mg or 875 mg tablet of amoxicillin and clavulanate potassium.

2.4 Dosage in Patients with Hepatic Impairment

Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals [see Warnings and Precautions (5)].

2.5 Preparation of the Oral Suspension

Directions for Mixing Oral Suspension: Prepare a suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Measure the total amount of water (see chart below) to be added in two parts. Add approximately 2/3 of the total amount of water for reconstitution, replace cap and shake vigorously to suspend powder. Add remainder of the water (that had been measured), replace cap and again shake vigorously.

Amoxicillin and Clavulanate Potassium for Oral Suspension
Bottle Size	Amount of Water Required for Reconstitution
75 mL	71 mL
125 mL	112 mL
200 mL	176 mL

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

Shake oral suspension well before each use. Suspension must be refrigerated. Discard after 10 days. Suspension is white to off-white at time of reconstitution; some color change is normal during the dosing period.

Flavoring Information: For patients who wish to alter the taste of amoxicillin and clavulanate potassium 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 amoxicillin and clavulanate potassium for oral suspension. The resulting suspension is stable for 10 days under refrigeration. Stability of amoxicillin and clavulanate potassium for oral suspension when mixed with other flavors distributed by FLAVORx has not been evaluated for flavors other than the 5 flavors listed above.

2.6 Switching between Dosage Forms and between Strengths

Amoxicillin and clavulanate potassium for oral suspension does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of amoxicillin and clavulanate potassium. Amoxicillin and clavulanate potassium for oral suspension contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/28.5 mg per 5 mL suspension of amoxicillin and clavulanate potassium contains 28.5 mg clavulanic acid per 5 mL and the 400 mg/57 mg per 5 mL suspension of amoxicillin and clavulanate potassium contains 57 mg clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL suspensions of amoxicillin and clavulanate potassium should not be substituted for amoxicillin and clavulanate potassium for oral suspension as they are not interchangeable.

3 DOSAGE FORMS AND STRENGTHS

Amoxicillin and Clavulanate Potassium for Oral Suspension, USP:

• 600 mg/42.9 mg per 5 mL: Strawberry-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 600 mg of amoxicillin USP as the trihydrate, and 42.9 mg of clavulanic acid as the potassium salt).