augmentin xr

Adults and Pediatric Patients weighing greater than or equal to 40 kg who are able to swallow tablets: The recommended dosage of Amoxicillin and Clavulanate Potassium Extended Release Tablets is 4,000 mg/250 mg daily in divided doses at the start of a meal according to the following table. (2) Indication Dose Duration Acute bacterial sinusitis Two (1,000 mg/62.5 mg) tablets every 12 hours 10 days Community-acquired pneumonia Two (1,000 mg/62.5 mg) tablets every 12 hours 7 to 10 days 2.1 Important Administration Instructions Amoxicillin and Clavulanate Potassium Extended Release Tablets should be taken at the start of a meal to enhance the absorption of amoxicillin and to minimize the potential for gastrointestinal intolerance. Amoxicillin and Clavulanate Potassium Extended Release Tablets is not recommended to be taken with a high-fat meal because clavulanate absorption is decreased [see Clinical Pharmacology (12.3) ]. 2.2 Dosage in Adults Patients The recommended dosage of Amoxicillin and Clavulanate Potassium Extended Release Tablets is 4,000 mg/250 mg daily in divided doses according to the following table: Table 1: Recommended Dosage of Amoxicillin and Clavulanate Potassium Extended Release Tablets in Adult Patients Indication Dose Duration Acute bacterial sinusitis Two (1,000 mg/62.5 mg) tablets every 12 hours 10 days Community-acquired pneumonia Two (1,000 mg/62.5 mg)…

The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylactic reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [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) ] Skin Rash in Patients with Mononucleosis [see Warnings and Precautions (5.6) ] The most frequently reported adverse reactions were (incidence >2%) diarrhea, vaginal mycosis, nausea, and loose stools. (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 Trials 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. In clinical trials, 5,643 patients have been treated with Amoxicillin and Clavulanate Potassium Extended Release Tablets. The most frequently reported adverse reactions were diarrhea (15%), vaginal mycosis (3%), nausea (2%), and loose stools (2%). Amoxicillin and Clavulanate Potassium Extended Release…

History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to AUGMENTIN or to other beta‑lactams (e.g., penicillins or cephalosporins). (4.1) History of cholestatic jaundice/hepatic dysfunction associated with AUGMENTIN. (4.2) In patients with severe renal impairment (creatinine clearance less than 30 mL/min) and in hemodialysis patients. (4.3) 4.1 Serious Hypersensitivity Reactions Amoxicillin and Clavulanate Potassium Extended Release Tablets 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 Extended Release Tablets is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with amoxicillin/clavulanate potassium. 4.3 Renal Impairment Amoxicillin and Clavulanate Potassium Extended Release Tablets is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/min) and in hemodialysis patients.

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 Amoxicillin and Clavulanate Potassium Extended Release Tablets, 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 the 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…

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 Amoxicillin and Clavulanate Potassium Extended Release Tablets and 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 Extended Release Tablets 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 Extended Release Tablets 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 substantially increases 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. In controlled clinical trials of Amoxicillin and Clavulanate Potassium Extended Release Tablets, 25 patients received concomitant allopurinol and Amoxicillin and Clavulanate Potassium Extended Release Tablets. No rashes were reported in these patients. However, this sample size is too small to allow for any conclusions to be drawn regarding the risk of rashes with concomitant Amoxicillin and Clavulanate Potassium Extended Release Tablets and allopurinol use. 7.4 Oral Contraceptives Amoxicillin and Clavulanate Potassium Extended Release Tablets 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 Extended Release Tablets, 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.