Elevated liver enzymes and changes in blood counts have been reported see section 4. Anticoagulants Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation see section 4.

Crystalluria In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria. In patients with bladder catheters, a regular check of patency should be maintained see section 4. Interference with diagnostic tests Elevated serum and urinary levels of amoxicillin are likely to affect certain laboratory tests.

Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods. It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used.

The presence of amoxicillin may distort assay results for oestriol in pregnant women. If superinfections occur, amoxicillin should be discontinued and appropriate therapy instituted. A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin-class antibiotics should not be administered to patients with mononucleosis. Prescribing amoxicillin capsules, amoxicillin for oral suspension, or amoxicillin tablets chewable in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Laboratory Tests As with any potent drug, periodic assessment of renal, hepatic, and hematopoietic function should be made during prolonged therapy. All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with amoxicillin should have a follow-up serologic test for syphilis after 3 months. Drug Interactions Probenecid decreases the renal tubular secretion of amoxicillin.

Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin. Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin.

This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented.

Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted. This effect may also occur with amoxicillin. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4: Amoxicillin and potassium clavulanate was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic-hepatocellular changes.

The hepatic dysfunction, which may be severe, is usually reversible. Interstitial nephritis and hematuria have been reported rarely. 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. Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported rarely. 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.

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.

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. Performance Standards for Antimicrobial Susceptibility Testing: The overall incidence of adverse reactions, and in particular diarrhea, increased with the higher recommended dose.

Abdominal discomfort, flatulence , and headache. A total of patients were enrolled, and only the suspension formulations were used in this trial. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment.

The histologic findings on liver biopsy have consisted of predominantly cholestatic, treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic hepatocellular changes. The hepatic dysfunction, which may be severe, is usually reversible. Deaths have been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

Allow 24 hours or more to elapse between the administration of the last dose of the antibiotic and the live typhoid vaccine.

Moderate The concomitant use of warfarin with many classes of antibiotics, including penicillins, may result in an increased INR thereby potentiating the risk for bleeding. Inhibition of vitamin K synthesis due to alterations in the intestinal flora may be a mechanism; however, concurrent infection is also a potential risk factor for elevated INR. Monitor patients for signs and symptoms of bleeding.

Additionally, increased monitoring of the INR, especially during initiation and upon discontinuation of the antibiotic, may be necessary. However, unless the infant is allergic to penicillins, breast-feeding is generally safe during maternal penicillin therapy. The American Academy of Pediatrics AAP considers amoxicillin a medication that is usually compatible with breast-feeding; however, amoxicillin; clavulanic acid has not been evaluated by the AAP. Amoxicillin; clavulanic acid is excreted in breast milk in small amounts.

Penicillins may cause diarrhea due to disruption of GI flora , candidiasis, and skin rash in breast-feeding infants. In a study assessing adverse events in breast-fed infants of mothers exposed to antibiotics, The adverse events included constipation, rash, diarrhea, irritability, and elevated liver enzymes. The rate of adverse events was positively correlated with the dose of amoxicillin; clavulanic acid..

The infant should be observed for potential effects. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

It inhibits the third and final stage of bacterial cell wall synthesis by preferentially binding to specific penicillin-binding proteins PBPs that are located inside the bacterial cell wall. Like all beta-lactam antibiotics, amoxicillin's ability to interfere with PBP-mediated cell wall synthesis ultimately leads to cell lysis.

Lysis is mediated by bacterial cell wall autolytic enzymes i. The relationship between PBPs and autolysins is unclear, but it is possible that the beta-lactam antibiotic interferes with an autolysin inhibitor. Clavulanic acid is a beta-lactam drug that acts as a competitive "suicide" inhibitor of many plasmid-mediated and chromosomally mediated bacterial beta-lactamases. It will not inhibit chromosomal type I, however, found in some Enterbacteriaceae.

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