Amoclan Dosage

Important Administration Instructions

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 for oral suspension 600 mg/42.9 mg per 5 mL is administered at the start of a meal.

Dosage in Pediatric Patients

Pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg: Based on the amoxicillin component (600 mg/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 Table 1 as a general example guideline for attainment of this dosage). This dose provides 6.4 mg/kg/day of the clavulanic acid component.

Table 1: General Dosage Guidelines for Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL in Pediatric Patients

Pediatric patients weighing greater than 40 kg: Experience with amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL in this group is not available.

Dosage in Adult Patients

Experience with amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL 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 500 mg or 875 mg tablet of amoxicillin and clavulanate potassium.

Dosage in Patients with Hepatic Impairment

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

Preparation of the Oral Suspension

Prepare the suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Measure the total amount of water (see Table 2) 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.

Table 2: Volume of Water for Reconstituting Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL

Each 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 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 600 mg/42.9 mg per 5 mL, 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 600 mg/42.9 mg per 5 mL. The resulting suspension is stable for 10 days under refrigeration. Stability of amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL when mixed with other flavors other than the 5 flavors listed above has not been evaluated.

Switching between Dosage Forms and between Strengths

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 suspensions of amoxicillin and clavulanate potassium for oral suspension.

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 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 600 mg/42.9 mg per 5 mL as they are not interchangeable.