Amoxicillin publix

Thus, AUGMENTIN XR should not be administered to patients with mononucleosis.

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy.

If superinfections occur (usually involving Pseudomonas spp. or Candida spp.), the drug should be discontinued and/or appropriate therapy instituted. Prescribing AUGMENTIN XR in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION) Nonclinical

Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility. Long-term studies in animals have not been performed to evaluate carcinogenic potential.

The mutagenic potential of AUGMENTIN was investigated in vitro with an Ames test, a human lymphocyte cytogenetic assay, a yeast test, and a mouse lymphoma forward mutation assay, and in vivo with mouse micronucleus tests and a dominant lethal test. All were negative apart from the in vitro mouse lymphoma assay, where weak activity was found at very high, cytotoxic concentrations.

AUGMENTIN at oral doses of up to 1,200 mg/kg/day (1.9 times the maximum human dose of amoxicillin and 15 times the maximum human dose of clavulanate based on body surface area) was found to have no effect on fertility and reproductive performance in rats dosed with a 2:1 ratio formulation of amoxicillin:clavulanate. Reproduction studies performed in pregnant rats and mice given AUGMENTIN at oral doses up to 1,200 mg/kg/day revealed no evidence of harm to the fetus due to AUGMENTIN.

In terms of body surface area, the doses in rats were 1.6 times the maximum human oral dose of amoxicillin and 13 times the maximum human dose for clavulanate. For mice, these doses were 0.9 and 7.4 times the maximum human oral dose of amoxicillin and clavulanate, respectively. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Studies in guinea pigs have shown that intravenous administration of ampicillin decreased the uterine tone, frequency of contractions, height of contractions, and duration of contractions.

However, it is not known whether the use of AUGMENTIN XR in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.

In a single study in women with premature rupture of fetal membranes, it was reported that prophylactic treatment with AUGMENTIN may be associated with an increased risk of necrotizing enterocolitis in neonates. Amoxicillin has been shown to be excreted in human milk; therefore, caution should be exercised when AUGMENTIN XR is administered to a nursing woman.

The safety and effectiveness of AUGMENTIN XR have been established for pediatric patients weighing ? 40 kg who are able to swallow tablets. Use of AUGMENTIN XR in these pediatric patients is supported by evidence from adequate and well-controlled trials of adults with acute bacterial sinusitis and community-acquired pneumonia with additional data from a pediatric pharmacokinetic study. A pharmacokinetic study in pediatric patients (7 to 15 years of age and weighing ? 40 kg) was conducted [see CLINICAL PHARMACOLOGY ]. The adverse event profile in 44 pediatric patients who received at least one dose of AUGMENTIN XR was consistent with the established adverse event profile for the product in adults.

Of the total number of subjects in clinical studies of AUGMENTIN XR, 18% were 65 years or older and 7% were 75 years or older. No overall differences in safety and effectiveness were observed between these subjects and younger subjects, and other clinical experience has not reported differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney, and the risk of dose dependent toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function. The pharmacokinetics of AUGMENTIN XR have not been studied in patients with renal impairment. AUGMENTIN XR is contraindicated in patients with a creatinine clearance of.

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 XR, 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 5 . 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 clearance of both amoxicillin and clavulanate. Both amoxicillin and clavulanate are removed from the circulation by hemodialysis [see DOSAGE AND ADMINISTRATION ].

AUGMENTIN XR 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). Augmentin XR is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with amoxicillin/clavulanate potassium. AUGMENTIN XR is contraindicated in patients with severe renal impairment (creatinine clearance.

AUGMENTIN XR is an extended-release formulation which provides sustained plasma concentrations of amoxicillin. Amoxicillin systemic exposure achieved with AUGMENTIN XR is similar to that produced by the oral administration of equivalent doses of amoxicillin alone.

Amoxicillin and clavulanate potassium are well absorbed from the gastrointestinal tract after oral administration of AUGMENTIN XR.

In a study of healthy adult volunteers, the pharmacokinetics of AUGMENTIN XR were compared when administered in a fasted state, at the start of a standardized meal (612 kcal, 89.3 g carb, 24.9 g fat, and 14.0 g protein), or 30 minutes after a high-fat meal. When the systemic exposure to both amoxicillin and clavulanate is taken into consideration, AUGMENTIN XR is optimally administered at the start of a standardized meal.

Absorption of amoxicillin is decreased in the fasted state.

AUGMENTIN XR is not recommended to be taken with a high-fat meal, because clavulanate absorption is decreased. The pharmacokinetics of the components of AUGMENTIN XR following administration of two AUGMENTIN XR tablets at the start of a standardized meal are presented in Table 1.

Table 1: Mean (SD) Pharmacokinetic Parameter for Amoxicillin and Clavulanate Following Oral Administration of Two AUGMENTIN XR Tablets (2,000 mg/125 mg) to Healthy Adult Volunteers (n = 55) Fed a Standardized Meal Parameter (units) Amoxicillin Clavulanate AUC(0-inf) (mcg•hr/mL) 71.6 (16.5) 5.29 (1.55) Cmax (mcg/mL) 17.0 (4.0) 2.05 (0.80) Tmax (hours) a 1.50 (1.00 -6.00) 1.03 (0.75 -3.00) T? (hours) 1.27 (0.20) 1.03 (0.17) a Median (range).

The half-life of amoxicillin after the oral administration of AUGMENTIN XR is approximately 1.3 hours, and that of clavulanate is approximately 1.0 hour.

Neither component in AUGMENTIN XR is highly protein-bound; clavulanate has been found to be approximately 25% bound to human serum and amoxicillin approximately 18% bound. Amoxicillin diffuses readily into most body tissues and fluids, with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like amoxicillin, is well distributed in body tissues. Clearance of amoxicillin is predominantly renal, with approximately 60% to 80% of the dose being excreted unchanged in urine, whereas clearance of clavulanate has both a renal (30% to 50%) and a non-renal component.

Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanate. In a study of adults, the pharmacokinetics of amoxicillin and

clavulanate

In a study of pediatric patients with acute bacterial sinusitis, 7 to 15 years of age, and weighing at least 40 kg, the pharmacokinetics of amoxicillin and clavulanate were assessed following administration of AUGMENTIN XR 2000 mg/125 mg (as two 1000 mg/62.5 mg tablets) every 12 hours with food (Table 2). Table 2: Mean (SD) Pharmacokinetic Parameters for Amoxicillin and Clavulanate Following Oral Administration of Two AUGMENTIN XR Tablets (2,000 mg/125 mg) Every 12 Hours With Food to Pediatric Patients (7 to 15 Years of Age and Weighing ? 40kg) With Acute Bacterial Sinusitis Parameter (units) Amoxicillin (n=24) Clavulanate (n=23) AUC(0-?) (mcg•hr/mL) 57.8 (15.6) 3.18 (1.37) Cmax (mcg/mL) 11.0 (3.34) 1.17 (0.67) Tmax (hours) a 2.0 (1.0 -5.0) 2.0 (1.0-4.0) T?(hours) 3.32 (2.21) b 0.94 (0.13) c a Median (range) b n=18. Amoxicillin binds to penicillin-binding proteins within the bacterial cell wall and inhibits bacterial cell wall synthesis. Clavulanic acid is a ?-lactam, structurally related to penicillin, that may inactivate certain ?-lactamase enzymes.

Resistance to penicillins may be mediated by destruction of the beta-lactam ring by a beta-lactamase, altered affinity of penicillin for target, or decreased penetration of the antibiotic to reach the target site. Amoxicillin alone is susceptible to degradation by ?­lactamases, and therefore its spectrum of activity does not include bacteria that produce these enzymes.

Amoxicillin/clavulanic acid has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Haemophilus influenzae Haemophilus parainfluenzae Klebsiella pneumoniae Moraxella catarrhalis.

The following in vitro data are available, but their clinical significance is unknown.

At least 90 percent of the following bacteria exhibit in vitro minimum inhibitory concentrations (MICs) less than or equal to the susceptible breakpoint for amoxicillin/clavulanic acid. 1 However, the safety and effectiveness of amoxicillin/clavulanic acid in treating clinical infections due to these bacteria have not been established in adequate and well-controlled clinical

trials

When available, the clinical microbiology laboratory

should

Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs).

These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test method 1,2 (broth and/or agar). The MIC values should be interpreted according to criteria provided in Table 3.

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility mankind amoxicillin clavulanic acid of bacteria to antimicrobial compounds.

The zone size provides an estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized test method. 1,3 This procedure uses paper disks impregnated with 30 mcg amoxicillin/clavulanate potassium (20 mcg amoxicillin plus 10 mcg clavulanate potassium) to test susceptibility of microorganisms to amoxicillin/clavulanate potassium. Disk diffusion interpretive criteria should be interpreted according to criteria provided in Table 3. Table 3: Susceptibility Interpretive Criteria for Amoxicillin/ Clavulanate Potassium Pathogen Minimum Inhibitory Concentration (mcg/mL) Disk Diffusion Zone Diameter (mm) S I R S I R Streptococcus pneumoniae (nonmeningitis isolates) ? 2/1 4/2 ? 8/4 - - - Haemophilus spp. ? 4/2 - ? 8/4 ? 20 - ? 19 Klebsiella pneumonia ? 8/4 16/8 ? 32/16 ? 18 14 to 17 ? 13 S= Susceptible, I=Intermediate, R=Resistant.

NOTE: Susceptibility of staphylococci to amoxicillin/clavulanate may be deduced from testing only penicillin and either cefoxitin or oxacillin. pneumoniae by disk diffusion should be determined using a 1mcg oxacillin disk.

NOTE: For nonmeningitis isolates, a penicillin MIC of ? 0.06 mcg/ml (or oxacillin zone ? 20 mm) can predict susceptibility to amoxicillin/clavulanate.

NOTE: Beta-lactamase–negative, ampicillin-resistant (BLNAR) H.

influenzae isolates should be considered resistant to amoxicillin/clavulanic acid, despite apparent in vitro susceptibility of some BLNAR isolates to these agents.

A report of Susceptible indicates that the antimicrobial is likely to inhibit growth of the pathogen if

the

A report of

Intermediate

This category implies possible clinical applicability in body sites where the drug is physiologically concentrated.