augmentin es-600

Pediatric Patients less than 40 kg: 90 mg/kg/day divided every 12 hours, administered for 10 days. ( 2 ) 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…

The following are discussed in more detail in other sections of the labeling [see Warnings and Precautions ( 5 )] : Anaphylactic reactions [see Warnings and Precautions ( 5.1 )] Severe Cutaneous Adverse Reactions (SCAR) [see Warnings and Precautions ( 5.2 )] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions ( 5.3 )] Hepatic Dysfunction [see Warnings and Precautions ( 5.4 )] Clostridioides difficile- Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.5 )] The most frequently reported adverse reactions were diaper rash (4%), diarrhea (3%), vomiting (2%), candidiasis (1%), and rash (1%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact USAntibiotics, LLC at 1-844-454-5532 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Two clinical trials evaluated the safety of a 10-day treatment course of Amoxicillin and Clavulanate Potassium for oral suspension 90/6.4 mg/kg/day, divided every 12 hours, in pediatric patients with acute otitis media [ see Clinical Studies ( 14 ) ]. The first trial involved 521 pediatric patients (3 months to 50 months) and the…

History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to Amoxicillin and Clavulanate Potassium for oral suspension or any other beta-lactams (e.g., penicillins or cephalosporins). ( 4.1 ) History of cholestatic jaundice/hepatic dysfunction associated with Amoxicillin and Clavulanate Potassium for oral suspension. ( 4.2 ) 4.1 Serious Hypersensitivity Reactions Amoxicillin and Clavulanate Potassium for oral suspension 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 for oral suspension is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with Amoxicillin and Clavulanate Potassium for oral suspension.

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 case of overdosage, discontinue Amoxicillin and Clavulanate Potassium 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. 1 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…

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

Co-administration with probenecid is not recommended. ( 7.1 ) Concomitant use of Amoxicillin and Clavulanate Potassium for oral suspension with oral anticoagulants may increase the prolongation of prothrombin time. ( 7.2 ) Co-administration with allopurinol increases the risk of rash. ( 7.3 ) Amoxicillin and Clavulanate Potassium for oral suspension may reduce efficacy of oral contraceptives. ( 7.4 ) 7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with Amoxicillin and Clavulanate Potassium for oral suspension may result in increased and prolonged blood levels of amoxicillin. Co-administration of probenecid is not recommended. 7.2 Oral Anticoagulants Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. 7.3 Allopurinol The concurrent administration of allopurinol and amoxicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with Amoxicillin and Clavulanate Potassium for oral suspension and allopurinol administered concurrently. 7.4 Oral Contraceptives Amoxicillin and Clavulanate Potassium for oral suspension may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. 7.5 Effects on Laboratory Tests High urine concentrations of amoxicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST ® , Benedict's Solution, or Fehling's Solution. Since this effect may also occur with Amoxicillin and Clavulanate Potassium for oral suspension, it is recommended that glucose tests based on enzymatic glucose oxidase reactions be used. Following administration of amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.