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CEFUROXIME AXETIL
Overview
What is CEFUROXIME AXETIL?
Cefuroxime axetil tablets, USP contain Cefuroxime as cefuroxime axetil, USP (amorphous). Cefuroxime axetil 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 amorphous form and has the following structural formula:
Cefuroxime are blue colored, uncoated caplets (capsule-shaped tablets) and contain the equivalent of 125, 250, or 500 mg of cefuroxime as cefuroxime axetil (amorphous). Cefuroxime axetil tablets contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 1 aluminum lake, microcrystalline cellulose, sodium lauryl sulfate, and stearic acid.
What does CEFUROXIME AXETIL look like?
What are the available doses of CEFUROXIME AXETIL?
Sorry No records found.
What should I talk to my health care provider before I take CEFUROXIME AXETIL?
Sorry No records found
How should I use CEFUROXIME AXETIL?
Sorry No records found
What interacts with CEFUROXIME AXETIL?
Cefuroxime axetil products are contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
What are the warnings of CEFUROXIME AXETIL?
Array
CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE THEREFORE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE ).
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.
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?
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 tablets 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)
1. During clinical trials, the tablet was tolerated by pediatric patients old enough to swallow the cefuroxime axetil tablet whole. The crushed tablet has a strong, persistent, bitter taste and should not be administered to pediatric patients in this manner. Pediatric patients who cannot swallow the tablet whole should receive the oral suspension.
2. Discontinuation of therapy due to taste and/or problems of administering this drug occurred in 1.4% of pediatric patients given the oral suspension. Complaints about taste (which may impair compliance) occurred in 5% of pediatric patients.
3. Patients should be counseled that antibacterial drugs, including cefuroxime axetil tablets, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefuroxime axetil tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cefuroxime axetil tablets or other antibacterial drugs in the future.
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, 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
Pregnancy Category B. Reproduction studies have been performed in mice at doses up to 3,200 mg/kg/day (14 times the recommended maximum human dose based on mg/m ) and in rats at doses up to 1,000 mg/kg/day (9 times the recommended maximum human dose based on mg/m) and have revealed no evidence of impaired fertility or harm to the fetus due to cefuroxime axetil. 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.
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.
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 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?
Sorry No records found
What should I look out for while using CEFUROXIME AXETIL?
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 ).
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?
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?
Store the kit at 2°-8°C (36°-46°F) and protect from light.ArrayStore the kit at 2°-8°C (36°-46°F) and protect from light.ArrayCefuroxime axetil tablets, USP, 125 mg, 250 mg and 500 mg containing cefuroxime (as cefuroxime axetil, USP amorphous), are blue colored, uncoated caplets (capsule-shaped tablets) debossed with and ” on one side and plain on the other side, respectively. They are supplied as follows:The 125 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX831”NDCNDCNDC The 250 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX832”NDCNDCNDC The 500 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX833”NDCNDCNDCNDC Store at 20 25°C (68 77°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.Cefuroxime axetil tablets, USP, 125 mg, 250 mg and 500 mg containing cefuroxime (as cefuroxime axetil, USP amorphous), are blue colored, uncoated caplets (capsule-shaped tablets) debossed with and ” on one side and plain on the other side, respectively. They are supplied as follows:The 125 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX831”NDCNDCNDC The 250 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX832”NDCNDCNDC The 500 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX833”NDCNDCNDCNDC Store at 20 25°C (68 77°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.Cefuroxime axetil tablets, USP, 125 mg, 250 mg and 500 mg containing cefuroxime (as cefuroxime axetil, USP amorphous), are blue colored, uncoated caplets (capsule-shaped tablets) debossed with and ” on one side and plain on the other side, respectively. They are supplied as follows:The 125 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX831”NDCNDCNDC The 250 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX832”NDCNDCNDC The 500 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX833”NDCNDCNDCNDC Store at 20 25°C (68 77°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.Cefuroxime axetil tablets, USP, 125 mg, 250 mg and 500 mg containing cefuroxime (as cefuroxime axetil, USP amorphous), are blue colored, uncoated caplets (capsule-shaped tablets) debossed with and ” on one side and plain on the other side, respectively. They are supplied as follows:The 125 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX831”NDCNDCNDC The 250 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX832”NDCNDCNDC The 500 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX833”NDCNDCNDCNDC Store at 20 25°C (68 77°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.Cefuroxime axetil tablets, USP, 125 mg, 250 mg and 500 mg containing cefuroxime (as cefuroxime axetil, USP amorphous), are blue colored, uncoated caplets (capsule-shaped tablets) debossed with and ” on one side and plain on the other side, respectively. They are supplied as follows:The 125 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX831”NDCNDCNDC The 250 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX832”NDCNDCNDC The 500 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX833”NDCNDCNDCNDC Store at 20 25°C (68 77°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.Cefuroxime axetil tablets, USP, 125 mg, 250 mg and 500 mg containing cefuroxime (as cefuroxime axetil, USP amorphous), are blue colored, uncoated caplets (capsule-shaped tablets) debossed with and ” on one side and plain on the other side, respectively. They are supplied as follows:The 125 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX831”NDCNDCNDC The 250 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX832”NDCNDCNDC The 500 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX833”NDCNDCNDCNDC Store at 20 25°C (68 77°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.Cefuroxime axetil tablets, USP, 125 mg, 250 mg and 500 mg containing cefuroxime (as cefuroxime axetil, USP amorphous), are blue colored, uncoated caplets (capsule-shaped tablets) debossed with and ” on one side and plain on the other side, respectively. They are supplied as follows:The 125 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX831”NDCNDCNDC The 250 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX832”NDCNDCNDC The 500 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX833”NDCNDCNDCNDC Store at 20 25°C (68 77°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.Cefuroxime axetil tablets, USP, 125 mg, 250 mg and 500 mg containing cefuroxime (as cefuroxime axetil, USP amorphous), are blue colored, uncoated caplets (capsule-shaped tablets) debossed with and ” on one side and plain on the other side, respectively. They are supplied as follows:The 125 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX831”NDCNDCNDC The 250 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX832”NDCNDCNDC The 500 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX833”NDCNDCNDCNDC Store at 20 25°C (68 77°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.Cefuroxime axetil tablets, USP, 125 mg, 250 mg and 500 mg containing cefuroxime (as cefuroxime axetil, USP amorphous), are blue colored, uncoated caplets (capsule-shaped tablets) debossed with and ” on one side and plain on the other side, respectively. They are supplied as follows:The 125 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX831”NDCNDCNDC The 250 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX832”NDCNDCNDC The 500 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX833”NDCNDCNDCNDC Store at 20 25°C (68 77°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.Cefuroxime axetil tablets, USP, 125 mg, 250 mg and 500 mg containing cefuroxime (as cefuroxime axetil, USP amorphous), are blue colored, uncoated caplets (capsule-shaped tablets) debossed with and ” on one side and plain on the other side, respectively. They are supplied as follows:The 125 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX831”NDCNDCNDC The 250 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX832”NDCNDCNDC The 500 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX833”NDCNDCNDCNDC Store at 20 25°C (68 77°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.Cefuroxime axetil tablets, USP, 125 mg, 250 mg and 500 mg containing cefuroxime (as cefuroxime axetil, USP amorphous), are blue colored, uncoated caplets (capsule-shaped tablets) debossed with and ” on one side and plain on the other side, respectively. They are supplied as follows:The 125 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX831”NDCNDCNDC The 250 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX832”NDCNDCNDC The 500 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX833”NDCNDCNDCNDC Store at 20 25°C (68 77°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.Cefuroxime axetil tablets, USP, 125 mg, 250 mg and 500 mg containing cefuroxime (as cefuroxime axetil, USP amorphous), are blue colored, uncoated caplets (capsule-shaped tablets) debossed with and ” on one side and plain on the other side, respectively. They are supplied as follows:The 125 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX831”NDCNDCNDC The 250 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX832”NDCNDCNDC The 500 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX833”NDCNDCNDCNDC Store at 20 25°C (68 77°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.Cefuroxime axetil tablets, USP, 125 mg, 250 mg and 500 mg containing cefuroxime (as cefuroxime axetil, USP amorphous), are blue colored, uncoated caplets (capsule-shaped tablets) debossed with and ” on one side and plain on the other side, respectively. They are supplied as follows:The 125 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX831”NDCNDCNDC The 250 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX832”NDCNDCNDC The 500 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX833”NDCNDCNDCNDC Store at 20 25°C (68 77°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.Cefuroxime axetil tablets, USP, 125 mg, 250 mg and 500 mg containing cefuroxime (as cefuroxime axetil, USP amorphous), are blue colored, uncoated caplets (capsule-shaped tablets) debossed with and ” on one side and plain on the other side, respectively. They are supplied as follows:The 125 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX831”NDCNDCNDC The 250 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX832”NDCNDCNDC The 500 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX833”NDCNDCNDCNDC Store at 20 25°C (68 77°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.Cefuroxime axetil tablets, USP, 125 mg, 250 mg and 500 mg containing cefuroxime (as cefuroxime axetil, USP amorphous), are blue colored, uncoated caplets (capsule-shaped tablets) debossed with and ” on one side and plain on the other side, respectively. They are supplied as follows:The 125 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX831”NDCNDCNDC The 250 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX832”NDCNDCNDC The 500 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX833”NDCNDCNDCNDC Store at 20 25°C (68 77°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
After oral administration, cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolyzed by nonspecific esterases in the intestinal mucosa and blood to cefuroxime. Cefuroxime is subsequently distributed throughout the extracellular fluids. The axetil moiety is metabolized to acetaldehyde and acetic acid.
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 ).
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 tablets 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.
CEFUROXIME AXETIL TABLETS IN CLINICAL TRIALS: Multiple-Dose Dosing Regimens:
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).
5-Day Experience (see section):
In Clinical Trials for Early Lyme Disease With 20 Days Dosing:
Single-Dose Regimen for Uncomplicated Gonorrhea:
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.
POSTMARKETING EXPERIENCE WITH CEFUROXIME AXETIL PRODUCTS
In addition to adverse events reported from clinical trials, the following events have been identified during clinical practice in patients treated with cefuroxime axetil tablets or with cefuroxime axetil for oral suspension and were reported spontaneously. Data are generally insufficient to allow an estimate if incidence or to establish causation.
General:
Gastrointestinal:
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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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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