AUGMENTIN ES-600 (Page 5 of 7)

Renal:

Interstitial nephritis and hematuria have been reported rarely. Crystalluria has also been reported (see OVERDOSAGE).

Hemic and Lymphatic Systems:

Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. A slight thrombocytosis was noted in less than 1% of the patients treated with AUGMENTIN. There have been reports of increased prothrombin time in patients receiving AUGMENTIN and anticoagulant therapy concomitantly.

Central Nervous System:

Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported rarely.

Miscellaneous:

Tooth discoloration (brown, yellow, or gray staining) has been rarely reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.

OVERDOSAGE

Following overdosage, patients have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness have also been observed in a small number of patients.

In the case of overdosage, discontinue AUGMENTIN ES-600 Powder for Oral Suspension, treat symptomatically, and institute supportive measures as required. If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed. A prospective study of 51 pediatric patients at a poison control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying.⁴

Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin.

Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria.

Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of both amoxicillin and clavulanate. Both amoxicillin and clavulanate are removed from the circulation by hemodialysis.

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 WaterRequired 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.