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Cefuroxime Axetil For Oral Suspension
Overview
What is Cefuroxime Axetil For Oral Suspension?
Cefuroxime axetil for oral suspension, USP contains cefuroxime as cefuroxime axetil. Cefuroxime axetil USP is a semisynthetic, broad-spectrum cephalosporin antibiotic for oral administration.
Chemically, cefuroxime axetil, the 1-(acetyloxy) ethyl ester of cefuroxime, is ()-1- hydroxyethyl (6,7)-7-[2-(2-furyl)glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1- azabicyclo[4.2.0]oct-2-ene-2-carboxylate, 7-()-(-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is CHNOS, and it has a molecular weight of 510.48.
Cefuroxime axetil is in the crystalline form and has the following structural formula:
Cefuroxime axetil for oral suspension USP, when reconstituted with water, provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL of suspension. Cefuroxime axetil USP for oral suspension contains the following inactive ingredients: aspartame, hypromellose phthalate, mannitol, methacrylic acid copolymer, monosodium citrate, peppermint flavor, silicon dioxide, sodium benzoate, sodium chloride, sucrose, tutti frutti flavor, xanthan gum.
What does Cefuroxime Axetil For Oral Suspension look like?
What are the available doses of Cefuroxime Axetil For Oral Suspension?
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What should I talk to my health care provider before I take Cefuroxime Axetil For Oral Suspension?
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How should I use Cefuroxime Axetil For Oral Suspension?
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).
Cefuroxime axetil for oral suspension is indicated for the treatment of pediatric patients 3 months to 12 years of age with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. The safety and effectiveness of cefuroxime axetil for oral suspension in the treatment of infections other than those specifically listed below have not been established either by adequate and well-controlled trials or by pharmacokinetic data with which to determine an effective and safe dosing regimen.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil for oral suspension and other antibacterial drugs, cefuroxime axetil for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
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).
Cefuroxime axetil for oral suspension may be administered to pediatric patients ranging in age from 3 months to 12 years, according to dosages in :
Patients With Renal Failure:
Directions for Mixing
Cefuroxime Axetil For Oral Suspension:
1. Shake the bottle to loosen the powder.
2. Remove the cap.
3. Add the total amount of water for reconstitution (see ) and replace the cap.
4. Vigorously shake in a diagonal direction to form suspension.
NOTE: SHAKE THE ORAL SUSPENSION WELL BEFORE EACH USE.
What interacts with Cefuroxime Axetil For Oral Suspension?
Cefuroxime axetil products are contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
What are the warnings of Cefuroxime Axetil For Oral Suspension?
Convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with metronidazole. The appearance of abnormal neurologic signs demands the prompt discontinuation of metronidazole therapy. Metronidazole should be administered with caution to patients with central nervous system diseases.
CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE THEREFORE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
What are the precautions of Cefuroxime Axetil For Oral Suspension?
General
As with other broad-spectrum antibiotics, prolonged administration of cefuroxime axetil may result in overgrowth of nonsusceptible microorganisms. If superinfection occurs during therapy, appropriate measures should be taken.
Cephalosporins, including cefuroxime axetil, should be given with caution to patients receiving concurrent treatment with potent diuretics because these diuretics are suspected of adversely affecting renal function.
Cefuroxime axetil, as with other broad-spectrum antibiotics, should be prescribed with caution in individuals with a history of colitis. The safety and effectiveness of cefuroxime axetil have not been established in patients with gastrointestinal malabsorption. Patients with gastrointestinal malabsorption were excluded from participating in clinical trials of cefuroxime axetil.
Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.
Prescribing cefuroxime axetil for oral suspension 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.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Information for Patients/Caregivers (Pediatric)
Drug/Laboratory Test Interactions
A false-positive reaction for glucose in the urine may occur with copper reduction tests (Benedict's or Fehling's solution or with CLINITEST tablets), but not with enzyme-based tests for glycosuria (e.g., CLINISTIX). As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood/plasma glucose levels in patients receiving cefuroxime axetil. The presence of cefuroxime does not interfere with the assay of serum and urine creatinine by the alkaline picrate method.
Drug/Drug Interactions
Concomitant administration of probenecid with cefuroxime axetil tablets increases the area under the serum concentration versus time curve by 50%. The peak serum cefuroxime concentration after a 1.5 g single dose is greater when taken with 1 g of probenecid (mean = 14.8 mcg/mL) than without probenecid (mean = 12.2 mcg/mL).
Drugs that reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with that of fasting state and tend to cancel the effect of postprandial absorption.
In common with other antibiotics, cefuroxime axetil may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Although lifetime studies in animals have not been performed to evaluate carcinogenic potential, no mutagenic activity was found for cefuroxime axetil in a battery of bacterial mutation tests. Positive results were obtained in an chromosome aberration assay, however, negative results were found in an micronucleus test at doses up to 1.5 g/kg. Reproduction studies in rats at doses up to 1,000 mg/kg/day (9 times the recommended maximum human dose based on mg/m) have revealed no impairment of fertility.
Pregnancy
inv-a07aee9b-fb53-425d-86cd-6b4f5c863744
Teratogenic Effects:
2
2
Labor and Delivery
Cefuroxime axetil has not been studied for use during labor and delivery.
Nursing Mothers
Because cefuroxime is excreted in human milk, consideration should be given to discontinuing nursing temporarily during treatment with cefuroxime axetil.
Array
Pediatric Use
The safety and effectiveness of cefuroxime axetil have been established for pediatric patients aged 3 months to 12 years for acute bacterial maxillary sinusitis based upon its approval in adults. Use of cefuroxime axetil in pediatric patients is supported by pharmacokinetic and safety data in adults and pediatric patients, and by clinical and microbiological data from adequate and well-controlled studies of the treatment of acute bacterial maxillary sinusitis in adults and of acute otitis media with effusion in pediatric patients. It is also supported by postmarketing adverse events surveillance (see , and).
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.
What are the side effects of Cefuroxime Axetil For Oral Suspension?
In clinical trials using multiple doses of cefuroxime axetil powder for oral suspension, pediatric patients (96.7% of whom were younger than 12 years of age) were treated with the recommended dosages of cefuroxime axetil (20 to 30 mg/kg/day divided twice a day up to a maximum dose of 500 or 1,000 mg/day, respectively). There were no deaths or permanent disabilities in any of the patients in these studies. Eleven U.S. patients (1.2%) discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or vomiting. During clinical trials, discontinuation of therapy due to the taste and/or problems with administering this drug occurred in 13 (1.4%) pediatric patients enrolled at centers in the United States.
The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroxime axetil for oral suspension in multiple-dose clinical trials (n = 931 cefuroxime axetil-treated U.S. patients).
| Incidence ≥ 1% | Diarrhea/loose stools | 8.6% |
| Dislike of taste | 5 % | |
| Diaper rash | 3.4% | |
| Nausea/vomiting | 2.6% | |
| Incidence < 1% but > 0.1% | Abdominal pain | |
| Flatulence | ||
| Gastrointestinal infection | ||
| Candidiasis | ||
| Vaginal irritation | ||
| Rash | ||
| Hyperactivity | ||
| Irritable behavior | ||
| Eosinophilia | ||
| Positive direct Coombs’ test | ||
| Elevated liver enzymes | ||
| Viral illness | ||
| Upper respiratory infection | ||
| Sinusitis | ||
| Cough | ||
| Urinary tract infection | ||
| Joint swelling | ||
| Arthralgia | ||
| Fever | ||
| Ptyalism |
POSTMARKETING EXPERIENCE WITH CEFUROXIME AXETIL PRODUCTS
In addition to adverse events reported during clinical trials, the following events have been identified during clinical practice in patients treated with cefuroxime tablets or with cefuroxime axetil for oral suspension and were reported spontaneously. Data are generally insufficient to allow an estimate of incidence or to establish causation.
General:
WARNINGS
Hematologic:
Hepatic:
Neurologic:
Skin:
Urologic:
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 and). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
What should I look out for while using Cefuroxime Axetil For Oral Suspension?
Cefuroxime axetil products are contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE THEREFORE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
BEFORE THERAPY WITH
CEFUROXIME AXETIL PRODUCTS IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFUROXIME AXETIL PRODUCTS, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF A CLINICALLY SIGNIFICANT ALLERGIC REACTION TO CEFUROXIME AXETIL PRODUCTS OCCURS, DISCONTINUE THE DRUG AND INSTITUTE APPROPRIATE THERAPY. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
Clostridium difficile
C. difficile.
C. difficile
C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
What might happen if I take too much Cefuroxime Axetil For Oral Suspension?
Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.
How should I store and handle Cefuroxime Axetil For Oral Suspension?
Qutenza contains capsaicin capable of producing severe irritation of eyes, skin, respiratory tract and mucous membranes. Do not dispense Qutenza to patients for self-administration. It is critical that health care professionals who administer Qutenza have completely familiarized themselves with proper dosing, handling, and disposal procedures before handling Qutenza to avoid accidental or inadvertent capsaicin exposure to themselves or others []. Cefuroxime Axetil For Oral Suspension USP:The 125 mg/5 mL: NDC 63304-963-03 50 mL bottlesNDC 63304-963-04 100 mL bottlesThe 250 mg/5 mL:NDC 63304-964-03 50 mL bottlesNDC 63304-964-04 100 mL bottlesBefore reconstitution, store dry powder between 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature)After reconstitution, immediately store suspension between 2 - 8C (36 - 46F), in a refrigerator. DISCARD AFTER 10 DAYS.Cefuroxime Axetil For Oral Suspension USP:The 125 mg/5 mL: NDC 63304-963-03 50 mL bottlesNDC 63304-963-04 100 mL bottlesThe 250 mg/5 mL:NDC 63304-964-03 50 mL bottlesNDC 63304-964-04 100 mL bottlesBefore reconstitution, store dry powder between 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature)After reconstitution, immediately store suspension between 2 - 8C (36 - 46F), in a refrigerator. DISCARD AFTER 10 DAYS.Cefuroxime Axetil For Oral Suspension USP:The 125 mg/5 mL: NDC 63304-963-03 50 mL bottlesNDC 63304-963-04 100 mL bottlesThe 250 mg/5 mL:NDC 63304-964-03 50 mL bottlesNDC 63304-964-04 100 mL bottlesBefore reconstitution, store dry powder between 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature)After reconstitution, immediately store suspension between 2 - 8C (36 - 46F), in a refrigerator. DISCARD AFTER 10 DAYS.Cefuroxime Axetil For Oral Suspension USP:The 125 mg/5 mL: NDC 63304-963-03 50 mL bottlesNDC 63304-963-04 100 mL bottlesThe 250 mg/5 mL:NDC 63304-964-03 50 mL bottlesNDC 63304-964-04 100 mL bottlesBefore reconstitution, store dry powder between 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature)After reconstitution, immediately store suspension between 2 - 8C (36 - 46F), in a refrigerator. DISCARD AFTER 10 DAYS.Cefuroxime Axetil For Oral Suspension USP:The 125 mg/5 mL: NDC 63304-963-03 50 mL bottlesNDC 63304-963-04 100 mL bottlesThe 250 mg/5 mL:NDC 63304-964-03 50 mL bottlesNDC 63304-964-04 100 mL bottlesBefore reconstitution, store dry powder between 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature)After reconstitution, immediately store suspension between 2 - 8C (36 - 46F), in a refrigerator. DISCARD AFTER 10 DAYS.Cefuroxime Axetil For Oral Suspension USP:The 125 mg/5 mL: NDC 63304-963-03 50 mL bottlesNDC 63304-963-04 100 mL bottlesThe 250 mg/5 mL:NDC 63304-964-03 50 mL bottlesNDC 63304-964-04 100 mL bottlesBefore reconstitution, store dry powder between 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature)After reconstitution, immediately store suspension between 2 - 8C (36 - 46F), in a refrigerator. DISCARD AFTER 10 DAYS.Cefuroxime Axetil For Oral Suspension USP:The 125 mg/5 mL: NDC 63304-963-03 50 mL bottlesNDC 63304-963-04 100 mL bottlesThe 250 mg/5 mL:NDC 63304-964-03 50 mL bottlesNDC 63304-964-04 100 mL bottlesBefore reconstitution, store dry powder between 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature)After reconstitution, immediately store suspension between 2 - 8C (36 - 46F), in a refrigerator. DISCARD AFTER 10 DAYS.Cefuroxime Axetil For Oral Suspension USP:The 125 mg/5 mL: NDC 63304-963-03 50 mL bottlesNDC 63304-963-04 100 mL bottlesThe 250 mg/5 mL:NDC 63304-964-03 50 mL bottlesNDC 63304-964-04 100 mL bottlesBefore reconstitution, store dry powder between 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature)After reconstitution, immediately store suspension between 2 - 8C (36 - 46F), in a refrigerator. DISCARD AFTER 10 DAYS.Cefuroxime Axetil For Oral Suspension USP:The 125 mg/5 mL: NDC 63304-963-03 50 mL bottlesNDC 63304-963-04 100 mL bottlesThe 250 mg/5 mL:NDC 63304-964-03 50 mL bottlesNDC 63304-964-04 100 mL bottlesBefore reconstitution, store dry powder between 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature)After reconstitution, immediately store suspension between 2 - 8C (36 - 46F), in a refrigerator. DISCARD AFTER 10 DAYS.Cefuroxime Axetil For Oral Suspension USP:The 125 mg/5 mL: NDC 63304-963-03 50 mL bottlesNDC 63304-963-04 100 mL bottlesThe 250 mg/5 mL:NDC 63304-964-03 50 mL bottlesNDC 63304-964-04 100 mL bottlesBefore reconstitution, store dry powder between 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature)After reconstitution, immediately store suspension between 2 - 8C (36 - 46F), in a refrigerator. DISCARD AFTER 10 DAYS.Cefuroxime Axetil For Oral Suspension USP:The 125 mg/5 mL: NDC 63304-963-03 50 mL bottlesNDC 63304-963-04 100 mL bottlesThe 250 mg/5 mL:NDC 63304-964-03 50 mL bottlesNDC 63304-964-04 100 mL bottlesBefore reconstitution, store dry powder between 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature)After reconstitution, immediately store suspension between 2 - 8C (36 - 46F), in a refrigerator. DISCARD AFTER 10 DAYS.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Absorption and Metabolism:
Pharmacokinetics:
*
†
Comparative Pharmacokinetic Properties:
Cefuroxime axetil for oral suspension was not bioequivalent to cefuroxime axetil tablets when tested in healthy adults. The tablet and powder for oral suspension formulations are NOT substitutable on a milligram-per-milligram basis.
*
Food Effect on Pharmacokinetics:
Renal Excretion:
Because cefuroxime is renally excreted, the serum half-life is prolonged in patients with reduced renal function. In a study of 20 elderly patients (mean age = 83.9 years) having a mean creatinine clearance of 34.9 mL/min, the mean serum elimination half-life was 3.5 hours. Despite the lower elimination of cefuroxime in geriatric patients, dosage adjustment based on age is not necessary (see ).
Microbiology:
in vivo
Cefuroxime has bactericidal activity against a wide range of common pathogens, including many beta-lactamase-producing strains. Cefuroxime is stable to many bacterial beta-lactamases, especially plasmid-mediated enzymes that are commonly found in enterobacteriaceae.
Cefuroxime has been demonstrated to be active against most strains of the following microorganisms both and in clinical infections as described in the section (see section).
Aerobic Gram-Positive Microorganisms:
Staphylococcus aureus
Streptococcus pneumoniae
Streptococcus pyogenes
Aerobic Gram-Negative Microorganisms:
Escherichia coli
Haemophilus influenzae
Haemophilus parainfluenzae
Klebsiella pneumoniae
Moraxella catarrhalis
Neisseria gonorrhoeae
Spirochetes:
Borrelia burgdorferi
Cefuroxime has been shown to be active against most strains of the following microorganisms; however, the clinical significance of these findings is unknown.
Cefuroxime exhibits minimum inhibitory concentrations (MICs) of 4 mcg/mL or less (systemic susceptible breakpoint) against most ( 90%) strains of the following microorganisms; however, the safety and effectiveness of cefuroxime in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled trials.
Aerobic Gram-Positive Microorganisms:
Staphylococcus epidermidis
Staphylococcus saprophyticus
Streptococcus agalactiae
NOTE: and certain strains of enterococci, e.g., (formerly ), are resistant to cefuroxime. Methicillin-resistant staphylococci are resistant to cefuroxime.
Aerobic Gram-Negative Microorganisms:
Morganella morganii
Proteus inconstans
Proteus mirabilis
Providencia rettgeri
NOTE: spp., spp.,
, spp., and most strains of spp. and are resistant to most first- and second-generation cephalosporins. Some strains of
,
, and spp. have been shown by tests to be resistant to cefuroxime and other cephalosporins.
Anaerobic Microorganisms:
Peptococcus
niger
NOTE: Most strains of and are resistant to cefuroxime.
Susceptibility
Tests:
A report of "Susceptible" indicates that the pathogen, if in the blood, is likely to be inhibited by usually achievable concentrations of the antimicrobial compound in blood. A report of "Intermediate" indicates that inhibitory concentrations of the antibiotic may be achieved if high dosage is used or if the infection is confined to tissues or fluids in which high antibiotic concentrations are attained. This category also provides a buffer zone that prevents small, uncontrolled technical factors from causing major discrepancies in interpretation. A report of "Resistant" indicates that usually achievable concentrations of the antimicrobial compound in the blood are unlikely to be inhibitory and that other therapy should be selected.
Standardized susceptibility test procedures require the use of laboratory control microorganisms. Standard cefuroxime powder should give the following MIC values:
Reports from the laboratory providing results of the standard single-disk susceptibility test with a 30 mcg cefuroxime disk should be interpreted according to the following criteria:
Interpretation should be as stated above for results using dilution techniques.
As with standard dilution techniques, diffusion methods require the use of laboratory control microorganisms. The 30 mcg cefuroxime disk provides the following zone diameters in these laboratory test quality control strains:
Non-Clinical Toxicology
Cefuroxime axetil products are contraindicated in patients with known allergy to the cephalosporin group of antibiotics.CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE THEREFORE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
BEFORE THERAPY WITH
CEFUROXIME AXETIL PRODUCTS IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFUROXIME AXETIL PRODUCTS, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF A CLINICALLY SIGNIFICANT ALLERGIC REACTION TO CEFUROXIME AXETIL PRODUCTS OCCURS, DISCONTINUE THE DRUG AND INSTITUTE APPROPRIATE THERAPY. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
Clostridium difficile
C. difficile.
C. difficile
C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
Concomitant administration of probenecid with cefuroxime axetil tablets increases the area under the serum concentration versus time curve by 50%. The peak serum cefuroxime concentration after a 1.5 g single dose is greater when taken with 1 g of probenecid (mean = 14.8 mcg/mL) than without probenecid (mean = 12.2 mcg/mL).
Drugs that reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with that of fasting state and tend to cancel the effect of postprandial absorption.
In common with other antibiotics, cefuroxime axetil may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
As with other broad-spectrum antibiotics, prolonged administration of cefuroxime axetil may result in overgrowth of nonsusceptible microorganisms. If superinfection occurs during therapy, appropriate measures should be taken.
Cephalosporins, including cefuroxime axetil, should be given with caution to patients receiving concurrent treatment with potent diuretics because these diuretics are suspected of adversely affecting renal function.
Cefuroxime axetil, as with other broad-spectrum antibiotics, should be prescribed with caution in individuals with a history of colitis. The safety and effectiveness of cefuroxime axetil have not been established in patients with gastrointestinal malabsorption. Patients with gastrointestinal malabsorption were excluded from participating in clinical trials of cefuroxime axetil.
Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.
Prescribing cefuroxime axetil for oral suspension 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.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
In clinical trials using multiple doses of cefuroxime axetil powder for oral suspension, pediatric patients (96.7% of whom were younger than 12 years of age) were treated with the recommended dosages of cefuroxime axetil (20 to 30 mg/kg/day divided twice a day up to a maximum dose of 500 or 1,000 mg/day, respectively). There were no deaths or permanent disabilities in any of the patients in these studies. Eleven U.S. patients (1.2%) discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or vomiting. During clinical trials, discontinuation of therapy due to the taste and/or problems with administering this drug occurred in 13 (1.4%) pediatric patients enrolled at centers in the United States.
The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroxime axetil for oral suspension in multiple-dose clinical trials (n = 931 cefuroxime axetil-treated U.S. patients).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).