CEFUROXIME AXETIL (Page 4 of 6)

Geriatric Use

Of the total number of subjects who received cefuroxime axetil in 20 clinical studies of cefuroxime axetil, 375 were 65 and over while 151 were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger adult subjects. The geriatric patients reported somewhat fewer gastrointestinal events and less frequent vaginal candidiasis compared with patients aged 12 to 64 years old; however, no clinically significant differences were reported between the elderly and younger adult patients. Other reported clinical experience has not identified differences in responses between the elderly and younger adult patients.

ADVERSE REACTIONS

CEFUROXIME AXETIL TABLETS IN CLINICAL TRIALS: Multiple-Dose Dosing Regimens: 7 to 10 Days Dosing: Using multiple doses of cefuroxime axetil tablets, 912 patients were treated with cefuroxime axetil (125 to 500 mg twice daily). There were no deaths or permanent disabilities thought related to drug toxicity. Twenty (2.2%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. Seventeen (85%) of the 20 patients who discontinued therapy did so because of gastrointestinal disturbances, including diarrhea, nausea, vomiting, and abdominal pain. The percentage of cefuroxime axetil tablet-treated patients who discontinued study drug because of adverse events was very similar at daily doses of 1,000, 500, and 250 mg (2.3%, 2.1%, and 2.2%, respectively). However, the incidence of gastrointestinal adverse events increased with the higher recommended doses.

The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroxime axetil tablets in multiple-dose clinical trials (n = 912 cefuroxime axetil-treated patients).

Table 2. Adverse Reactions-Cefuroxime Axetil TabletsMultiple-Dose Dosing Regimens-Clinical Trials
Incidence ≥ 1% Diarrhea/loose stools Nausea/vomiting Transient elevation in AST Transient elevation in ALT Eosinophilia Transient elevation in LDH 3.7%3%2%1.6%1.1%1%
Incidence < 1% but > 0.1% Abdominal painAbdominal crampsFlatulenceIndigestionHeadacheVaginitisVulvar itchRashHivesItchDysuriaChillsChest PainShortness of breathMouth ulcersSwollen tongueSleepinessThirstAnorexiaPositive Coombs test

5-Day Experience (see CLINICAL STUDIESsection): In clinical trials using Cefuroxime Axetil Tablets in a dose of 250 mg twice daily in the treatment of secondary bacterial infections of acute bronchitis, 399 patients were treated for 5 days and 402 patients were treated for 10 days. No difference in the occurrence of adverse events was found between the 2 regimens.

In Clinical Trials for Early Lyme Disease With 20 Days Dosing: Two multicenter trials assessed cefuroxime axetil tablets 500 mg twice a day for 20 days. The most common drug-related adverse experiences were diarrhea (10.6% of patients), Jarisch-Herxheimer reaction (5.6%), and vaginitis (5.4%). Other adverse experiences occurred with frequencies comparable to those reported with 7 to 10 days dosing.

Single-Dose Regimen for Uncomplicated Gonorrhea: In clinical trials using a single dose of cefuroxime axetil tablets, 1061 patients were treated with the recommended dosage of cefuroxime axetil (1,000 mg) for the treatment of uncomplicated gonorrhea. There were no deaths or permanent disabilities thought related to drug toxicity in these studies.

The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroxime axetil in 1,000-mg single-dose clinical trials of cefuroxime axetil tablets in the treatment of uncomplicated gonorrhea conducted in the United States.

Table 3. Adverse Reactions-Cefuroxime Axetil Tablets1-g Single-Dose Regimen for Uncomplicated-Gonorrhea Clinical Trials
Incidence ≥ 1% Nausea/vomiting Diarrhea 6.8%4.2%
Incidence < 1% but > 0.1% Abdominal painDyspepsiaErythemaRashPruritusVaginal candidiasisVaginal itchVaginal dischargeHeadacheDizzinessSomnolenceMuscle crampsMuscle stiffnessMuscle spasm of neckTightness/pain in chestBleeding/pain in urethraKidney painTachycardiaLockjaw-type reaction

Postmarketing Experience With Cefuroxime Axetil Products

In addition to adverse event reported during clinical trials, the following events have been identified during clinical practice in patients treated with cefuroxime axetil tablets and were reported spontaneously. Data are generally insufficient to allow an estimate of incidence or to establish causation.

General: The following hypersensitivity reactions have been reported: anaphylaxis, angioedema, pruritus, rash, serum sickness-like reaction, urticaria.

Gastrointestinal: Pseudomembranous colitis (see WARNINGS).

Hematologic: Hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia, and increased prothrombin time.

Hepatic: Hepatic impairment including hepatitis and cholestasis, jaundice.

Neurologic: Seizure.

Skin: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Urologic: Renal dysfunction.

CEPHALOSPORIN-CLASS ADVERSE REACTIONS

In addition to the adverse reactions listed above that have been observed in patients treated with cefuroxime axetil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: toxic nephropathy, aplastic anemia, hemorrhage, increased BUN, increased creatinine, false-positive test for urinary glucose, increased alkaline phosphatase, neutropenia, elevated bilirubin and agranulocytosis.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see DOSAGE AND ADMINISTRATION and OVERDOSAGE). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

OVERDOSAGE

Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.

DOSAGE AND ADMINISTRATION

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).

Table 4. Cefuroxime Axetil Tablets(May be administered without regard to meals.)

*The safety and effectiveness of Cefuroxime Axetil Tablets administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.

Population/Infection Dosage Duration (days)
Adolescents and Adults ( 13 years and older )
Pharyngitis/tonsillitisAcute bacterial maxillary sinusitisAcute bacterial exacerbations of chronic bronchitis Secondary bacterial infections of acute bronchitis Uncomplicated skin and skin-structure infections Uncomplicated urinary tract infectionsUncomplicated gonorrhea Early Lyme disease 250 mg b.i.d.250 mg b.i.d.250 or 500 mg b.i.d.250 or 500 mg b.i.d.250 or 500 mg b.i.d.125 or 250 mg b.i.d.1,000 mg once500 mg b.i.d. 101010*5-10107-10single dose20
Pediatric Patients ( who can swallow tablets whole )
Acute otitis media Acute bacterial maxillary sinusitis 250 mg b.i.d.250 mg b.i.d. 1010

Patients with Renal Failure

The safety and efficacy of cefuroxime axetil in patients with renal failure have not been established. Since cefuroxime is renally eliminated, its half-life will be prolonged in patients with renal failure.

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