Drug: Ceftin

CEFTIN (cefuroxime axetil) Tablets and CEFTIN (cefuroxime axetil) for Oral Suspension contain cefuroxime as cefuroxime axetil. CEFTIN (cefuroxime axetil) is a semisynthetic, broad-spectrum cephalosporin antibiotic for oral administration. Chemically, cefuroxime axetil, the 1-(acetyloxy) ethyl ester of cefuroxime, is (RS)-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72-(Z)-(O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula: CEFTIN (cefuroxime axetil) Tablets are film-coated and contain the equivalent of 250 or 500 mg of cefuroxime as cefuroxime axetil. CEFTIN (cefuroxime axetil) Tablets contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, methylparaben, microcrystalline cellulose, propylene glycol, propylparaben, sodium benzoate, sodium lauryl sulfate, and titanium dioxide. CEFTIN (cefuroxime axetil) for Oral Suspension, when reconstituted with water, provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL of suspension. CEFTIN (cefuroxime axetil) for Oral Suspension contains the inactive ingredients acesulfame potassium, aspartame, povidone K30, stearic acid, sucrose, tutti-frutti flavoring, and xanthan gum.

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CEFTIN (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 4. Adverse Reactions-CEFTIN (cefuroxime axetil) Tablets
Multiple-Dose Dosing Regimens-Clinical Trials Incidence ≥ 1% Diarrhea/loose stools 3.7% Nausea/vomiting 3.0% Transient elevation in AST 2.0% Transient elevation in ALT 1.6% Eosinophilia 1.1% Transient elevation in LDH 1.0% Incidence
< 1% but > 0.1% Abdominal pain Abdominal cramps Flatulence Indigestion Headache Vaginitis Vulvar itch Rash Hives Itch Dysuria Chills Chest pain Shortness of breath Mouth ulcers Swollen tongue Sleepiness Thirst Anorexia Positive Coombs test 5-Day Experience (see CLINICAL STUDIES section) In clinical trials using CEFTIN (cefuroxime axetil) 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, 1,061 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 5. Adverse Reactions-CEFTIN (cefuroxime axetil) Tablets
1-g Single-Dose Regimen for Uncomplicated Gonorrhea-Clinical Trials Incidence ≥ 1% Nausea/vomiting 6.8% Diarrhea 4.2% Incidence
< 1% but > 0.1% Abdominal pain Dyspepsia Erythema Rash Pruritus Vaginal candidiasis Vaginal itch Vaginal discharge Headache Dizziness Somnolence Muscle cramps Muscle stiffness Muscle spasm of Tightness/pain in Bleeding/pain in Kidney pain Tachycardia Lockjaw-type Ceftin (cefuroxime axetil) For Oral Suspension In Clinical Trials 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 US 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 US patients). Table 6. Adverse Reactions-CEFTIN (cefuroxime axetil) for Oral Suspension
Multiple-Dose Dosing Regimens-Clinical Trials Incidence ≥ 1% Diarrhea/loose stools8.6% Dislike of taste 5.0% Diaper rash 3.4% Nausea/vomiting 2.6% Incidence
< 1% but > 0.1% Abdominal pain Flatulence Gastrointestinal Candidiasis Vaginal irritation Rash Hyperactivity Irritable behavior Eosinophilia Positive direct Coombs Elevated liver Viral illness Upper respiratory Sinusitis Cough Urinary tract Joint swelling Arthralgia Fever Ptyalism Postmarketing Experience With Ceftin (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 CEFTIN (cefuroxime axetil) Tablets or with CEFTIN (cefuroxime axetil) for Oral Suspension 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. Read the Ceftin (cefuroxime axetil) Side Effects Center for a complete guide to possible side effectsLearn More »

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NOTE: CEFTIN (cefuroxime axetil) TABLETS AND CEFTIN (cefuroxime axetil) FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY). Table 7. CEFTIN (cefuroxime axetil) Tablets
(May be administered without regard to meals.) Population/Infection Dosage Duration (days) Adolescents and Adults (13 years and older) Pharyngitis/tonsillitis 250 mg b.i.d. 10 Acute bacterial maxillary sinusitis 250 mg b.i.d. 10 Acute bacterial exacerbations of chronic bronchitis 250 or 500 mg b.i.d. 10* Secondary bacterial infections of acute bronchitis 250 or 500 mg b.i.d. 5-10 Uncomplicated skin and skin-structure infections 250 or 500 mg b.i.d. 10 Uncomplicated urinary tract infections 250 mg b.i.d. 7-10 Uncomplicated gonorrhea 1,000 mg once single dose Early Lyme disease 500 mg b.i.d. 20 Pediatric Patients (who can swallow tablets whole) Acute otitis media 250 mg b.i.d. 10 Acute bacterial maxillary sinusitis 250 mg b.i.d. 10 *The safety and effectiveness of CEFTIN administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established. CEFTIN (cefuroxime axetil) for Oral Suspension CEFTIN (cefuroxime axetil) for Oral Suspension may be administered to pediatric patients ranging in age from 3 months to 12 years, according to dosages in Table 8: Table 8. CEFTIN (cefuroxime axetil) for Oral Suspension
(Must be administered with food. Shake well each time before using.) Population/Infection Dosage Daily
Maximum
Dose Duration
(days) Pediatric Patients (3 months to 12 years) Pharyngitis/tonsillitis 20 mg/kg/day divided b.i.d. 500 mg 10 Acute otitis media 30 mg/kg/day divided b.i.d. 1,000 mg 10 Acute bacterial maxillary sinusitis 30 mg/kg/day divided b.i.d. 1,000 mg 10 Impetigo 30 mg/kg/day divided b.i.d. 1,000 mg 10 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. Directions for Mixing CEFTIN (cefuroxime axetil) for Oral Suspension Prepare a suspension at the time of dispensing as follows:
  1. Shake the bottle to loosen the powder.
  2. Remove the cap.
  3. Add the total amount of water for reconstitution (see Table 9) and replace the cap.
  4. Invert the bottle and vigorously rock the bottle from side to side so that water rises through the powder.
  5. Once the sound of the powder against the bottle disappears, turn the bottle upright and vigorously shake it in a diagonal direction.
Table 9. Amount of Water Required for Reconstitution of Labeled Volumes of CEFTIN (cefuroxime axetil) for Oral Suspension CEFTIN for Oral
Suspension Labeled Volume After
Reconstitution Amount of Water Required
for Reconstitution 125 mg/5 mL 100 mL 37 mL 250 mg/5 mL 50 mL 19 mL 100 mL 35 mL NOTE: SHAKE THE ORAL SUSPENSION WELL BEFORE EACH USE. Replace cap securely after each opening. Store the reconstituted suspension between 2° and 8°C (36° and 46°F) (in a refrigerator). DISCARD AFTER 10 DAYS.

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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 CEFTIN (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. Read the Ceftin Drug Interactions Center for a complete guide to possible interactions Learn More »

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NOTE: CEFTIN (cefuroxime axetil) TABLETS AND CEFTIN (cefuroxime axetil) FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY). CEFTIN (cefuroxime axetil) Tablets CEFTIN (cefuroxime axetil) Tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
  1. Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. CEFTIN (cefuroxime axetil) Tablets are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime in the subsequent prevention of rheumatic fever are not available. Please also note that in all clinical trials, all isolates had to be sensitive to both penicillin and cefuroxime. There are no data from adequate and well-controlled trials to demonstrate the effectiveness of cefuroxime in the treatment of penicillin-resistant strains of Streptococcus pyogenes.
  2. Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or Streptococcus pyogenes.
  3. Acute Bacterial Maxillary Sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non-beta-lactamase-producing strains only). (See CLINICAL STUDIES section.) NOTE: In view of the insufficient numbers of isolates of beta-lactamase-producing strains of Haemophilus influenzae and Moraxella catarrhalis that were obtained from clinical trials with CEFTIN (cefuroxime axetil) Tablets for patients with acute bacterial maxillary sinusitis, it was not possible to adequately evaluate the effectiveness of CEFTIN (cefuroxime axetil) Tablets for sinus infections known, suspected, or considered potentially to be caused by beta-lactamase-producing Haemophilus influenzae or Moraxella catarrhalis.
  4. Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains), or Haemophilus parainfluenzae (beta-lactamase negative strains). (See DOSAGE AND ADMINISTRATION section and CLINICAL STUDIES section.)
  5. Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including beta-lactamase-producing strains) or Streptococcus pyogenes.
  6. Uncomplicated Urinary Tract Infections caused by Escherichia coli or Klebsiella pneumoniae.
  7. Uncomplicated Gonorrhea, urethral and endocervical, caused by penicillinase-producing and non-penicillinase-producing strains of Neisseria gonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by non-penicillinase-producing strains of Neisseria gonorrhoeae.
  8. Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
CEFTIN (cefuroxime axetil) for Oral Suspension CEFTIN (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 CEFTIN (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.
  1. Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. CEFTIN (cefuroxime axetil) for Oral Suspension is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime in the subsequent prevention of rheumatic fever are not available. Please also note that in all clinical trials, all isolates had to be sensitive to both penicillin and cefuroxime. There are no data from adequate and well-controlled trials to demonstrate the effectiveness of cefuroxime in the treatment of penicillin-resistant strains of Streptococcus pyogenes.
  2. Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or Streptococcus pyogenes.
  3. Impetigo caused by Staphylococcus aureus (including beta-lactamase-producing strains) or Streptococcus pyogenes.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CEFTIN (cefuroxime axetil) and other antibacterial drugs, CEFTIN (cefuroxime axetil) 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.

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CEFTIN (cefuroxime axetil) products are contraindicated in patients with known allergy to the cephalosporin group of antibiotics. Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

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

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CEFTIN (cefuroxime axetil) Tablets CEFTIN Tablets, 250 mg of cefuroxime (as cefuroxime axetil), are white, capsule-shaped, film-coated tablets engraved with “GX ES7” on one side and blank on the other side as follows: 20 Tablets/Bottle NDC 0173-0387-00 CEFTIN Tablets, 500 mg of cefuroxime (as cefuroxime axetil), are white, capsule-shaped, film-coated tablets engraved with “GX EG2” on one side and blank on the other side as follows: 20 Tablets/Bottle NDC 0173-0394-00
60 Tablets/Bottle NDC 0173-0394-42 Store the tablets between 15° and 30°C (59° and 86°F). Replace cap securely after each opening. CEFTIN (cefuroxime axetil) for Oral Suspension CEFTIN (cefuroxime axetil) for Oral Suspension is provided as dry, white to off-white, tutti-frutti-flavored powder. When reconstituted as directed, CEFTIN (cefuroxime axetil) for Oral Suspension provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL of suspension. It is supplied in amber glass bottles as follows: 125 mg/5 mL 100-mL Suspension NDC 0173-0740-00 250 mg/5 mL 50-mL Suspension NDC 0173-0741-10
100-mL Suspension NDC 0173-0741-00 Before reconstitution, store dry powder between 2° and 30°C (36° and 86°F). After reconstitution, immediately store suspension between 2° and 8°C (36° and 46°F), in a refrigerator. DISCARD AFTER 10 DAYS. GlaxoSmithKline., Research Triangle Park, NC 27709
CEFTIN (cefuroxime axetil) is a registered trademark of GlaxoSmithKline.
CLINITEST and CLINISTIX are registered trademarks of Ames Division, Miles Laboratories, Inc.
January 2007. FDA rev date: 7/23/2007 Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

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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 CEFTIN (cefuroxime axetil) 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. 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. 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 in vitro chromosome aberration assay; however, negative results were found in an in vivo 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/m²) have revealed no impairment of fertility. Pregnancy Teratogenic Effects 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/m²) and in rats at doses up to 1,000 mg/kg/day (9 times the recommended maximum human dose based on mg/m²) 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 CEFTIN (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 CEFTIN (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 CLINICAL PHARMACOLOGY, INDICATIONS AND USAGE, ADVERSE REACTIONS, DOSAGE AND ADMINISTRATION, and CLINICAL STUDIES). Geriatric Use Of the total number of subjects who received cefuroxime axetil in 20 clinical studies of CEFTIN (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. Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

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