Drug Information for AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION USP8675 (TEVA PHARMACEUTICALS USA): DOSAGE AND ADMINISTRATION

Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other amoxicillinand clavulanate potassium suspensions. Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL whereas amoxicillin and clavulanate potassium, 200 mg/28.5 mg per 5 mL suspension contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/57 mg per 5 mL suspension contains 57 mgof clavulanic acid per 5 mL.Therefore, the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL and 400 mg/57 mgper5mLsuspensionsshouldnotbe substituted for amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per5 mL, as they are not interchangeable.

Based on the amoxicillin component (600 mg per 5 mL), the recommended dose of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).

Experience with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL formulation in this group is not available.

Experience with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL formulation in adults is not available and adults who have difficulty swallowing should not be given amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL in place of the amoxicillin and clavulanate potassium 500 mg or 875 mg tablet.

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

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.

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.

To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when amoxicillin and clavulanate potassium, 600 mg/42.9 mg per 5 mL is administered at the start of a meal.