Amoxicillin and Clavulanate Potassium

AMOXICILLIN AND CLAVULANATE POTASSIUM- amoxicillin and clavulanate potassium suspension
Aidarex Pharmaceuticals LLC

1 INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, USP should be used only to treat 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.

Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 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 or younger
  • - daycare attendance

[see CLINICAL PHARMACOLOGY, Microbiology (12.4)].

NOTE: Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and clavulanate potassium for oral suspension, USP 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.

2 DOSAGE AND ADMINISTRATION

Amoxicillin and clavulanate potassium for oral suspension, USP 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, USP contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/5 mL suspension of amoxicillin and clavulanate potassium 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 per 5 mL and 400 mg/57 mg per 5 mL suspensions of amoxicillin and clavulanate potassium should notbe substituted for amoxicillin and clavulanate potassium for oral suspension, USP as they are not interchangeable.

Dosage

Pediatric Patients 3 Months and Older

Based on the amoxicillin component (600 mg per 5 mL), the recommended dose of amoxicillin and clavulanate potassium for oral suspension, USP 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, USP 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, USP in this group is not available.

Adults

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

Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGSAND PRECAUTIONS (5).

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.

Amoxicillin and Clavulanate Potassium for Oral Suspension

Amoxicillin and Clavulanate Potassium for Oral Suspension

Bottle Size

Amount of Water Required for Reconstitution

75 mL

62 mL

125 mL

103 mL

200 mL

165 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.

Administration

To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium for Oral Suspension, USP should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when Amoxicillin and Clavulanate Potassium for Oral Suspension, USP is administered at the start of a meal.

3 DOSAGE FORMS AND STRENGTHS

Oral Suspension

600 mg/42.9 mg per 5 mL

Caramel-orange-raspberry-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 600 mg amoxicillin and 42.9 mg of clavulanic acid as the potassium salt).

4 CONTRAINDICATIONS

4.1 Serious Hypersensitivity Reactions

Amoxicillin and clavulanate potassium is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).

4.2 Cholestatic Jaundice/Hepatic Dysfunction

Amoxicillin and clavulanate potassium is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with amoxicillin/clavulanate potassium.

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