Cefuroxime 500 MG Oral Tablet

Generic Name: CEFUROXIME AXETIL
Brand Name: cefuroxime axetil
  • Substance Name(s):
  • CEFUROXIME AXETIL

DRUG INTERACTIONS

7 •Oral Contraceptives: Effects on gut flora may lower estrogen reabsorption and reduce efficacy of oral contraceptives.

(7.1) •Drugs that reduce gastric acidity may lower the bioavailability of cefuroxime axetil tablets.

(7.2) •Coadministration with probenecid increases systemic exposure to cefuroxime axetil tablets and is therefore not recommended.

(7.3) 7.1 Oral Contraceptives Cefuroxime axetil may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

Counsel patients to consider alternate supplementary (non-hormonal) contraceptive measures during treatment.

7.2 Drugs that Reduce Gastric Acidity Drugs that reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with administration in the fasting state.

Administration of drugs that reduce gastric acidity may negate the food effect of increased absorption of cefuroxime axetil when administered in the postprandial state.

Administer cefuroxime axetil at least 1 hour before or 2 hours after administration of short-acting antacids.

Histamine-2 (H2) antagonists and proton pump inhibitors should be avoided.

7.3 Probenecid Concomitant administration of probenecid with cefuroxime axetil tablets increases serum concentrations of cefuroxime [see CLINICAL PHARMACOLOGY (12.3)].

Coadministration of probenecid with cefuroxime axetil is not recommended.

7.4 Drug/Laboratory Test Interactions A false-positive reaction for glucose in the urine may occur with copper reduction tests (e.g., Benedict’s or Fehling’s solution), but not with enzyme-based tests for glycosuria.

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.

OVERDOSAGE

10 Overdosage of cephalosporins can cause cerebral irritation leading to convulsions or encephalopathy.

Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.

DESCRIPTION

11 Cefuroxime axetil tablets USP contain cefuroxime as cefuroxime axetil.

Cefuroxime axetil is a semisynthetic, cephalosporin antibacterial drug for oral administration.

The chemical name of cefuroxime axetil (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: Cefuroxime axetil tablets USP are film-coated and contain the equivalent of 250 or 500 mg of cefuroxime as cefuroxime axetil.

Cefuroxime axetil tablets USP contain the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, propylene glycol, polyethylene glycol, sodium lauryl sulfate, talc and titanium dioxide.

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CLINICAL STUDIES

14 14.1 Acute Bacterial Maxillary Sinusitis One adequate and well-controlled trial was performed in subjects with acute bacterial maxillary sinusitis.

In this trial, each subject had a maxillary sinus aspirate collected by sinus puncture before treatment was initiated for presumptive acute bacterial sinusitis.

All subjects had radiographic and clinical evidence of acute maxillary sinusitis.

In the trial, the clinical effectiveness of cefuroxime axetil in treating acute maxillary sinusitis was comparable to an oral antimicrobial agent containing a specific β-lactamase inhibitor.

However, microbiology data demonstrated cefuroxime axetil to be effective in treating acute bacterial maxillary sinusitis due only to Streptococcus pneumoniae or non-β-lactamase–producing Haemophilus influenzae.

Insufficient numbers of β-lactamase–producing Haemophilus influenzae and Moraxella catarrhalis isolates were obtained in this trial to adequately evaluate the effectiveness of cefuroxime axetil in treating acute bacterial maxillary sinusitis due to these 2 organisms.

This trial randomized 317 adult subjects, 132 subjects in the U.

S.

and 185 subjects in South America.

Table 12 shows the results of the intent-to-treat analysis.

Table 12.

Clinical Effectiveness of Cefuroxime Axetil Tablets in the Treatment of Acute Bacterial Maxillary Sinusitis U.S.

Subjects 95% confidence interval around the success difference [-0.08, +0.32].

South American Subjects 95% confidence interval around the success difference [-0.10, +0.16].

Cefuroxime Axetil Tablets 250 mg Twice Daily (n = 49) Controlc (n = 43) Cefuroxime Axetil Tablets 250 mg Twice Daily (n = 49) Controlc (n = 43) Clinical success (cure + improvement) 65% 53% 77% 74% Clinical cure 53% 44% 72% 64% Clinical improvement 12% 9% 5% 10% In this trial and in a supporting maxillary puncture trial, 15 evaluable subjects had non β-lactamase–producing Haemophilus influenzae as the identified pathogen.

Of these, 67% (10/15) had this pathogen eradicated.

Eighteen (18) evaluable subjects had Streptococcus pneumoniae as the identified pathogen.

Of these, 83% (15/18) had this pathogen eradicated.

14.2 Early Lyme Disease Two adequate and well-controlled trials were performed in subjects with early Lyme disease.

All subjects presented with physician-documented erythema migrans, with or without systemic manifestations of infection.

Subjects were assessed at 1 month posttreatment for success in treating early Lyme disease (Part I) and at 1 year posttreatment for success in preventing the progression to the sequelae of late Lyme disease (Part II).

A total of 355 adult subjects (181 treated with cefuroxime axetil and 174 treated with doxycycline) were randomized in the 2 trials, with diagnosis of early Lyme disease confirmed in 79% (281/355).

The clinical diagnosis of early Lyme disease in these subjects was validated by 1) blinded expert reading of photographs, when available, of the pretreatment erythema migrans skin lesion, and 2) serologic confirmation (using enzyme-linked immunosorbent assay [ELISA] and immunoblot assay [“Western” blot]) of the presence of antibodies specific to Borrelia burgdorferi, the etiologic agent of Lyme disease.

The efficacy data in Table 14 are specific to this “validated” patient subset, while the safety data below reflect the entire patient population for the 2 trials.

Clinical data for evaluable subjects in the “validated” patient subset are shown in Table 13.

Table 13.

Clinical Effectiveness of Cefuroxime Axetil Tablets Compared with Doxycycline in the Treatment of Early Lyme Disease Part I (1 Month after 20 Days of Treatment) 95% confidence interval around the satisfactory difference for Part I (-0.08, +0.05).

Part II (1 Year after 20 Days of Treatment) 95% confidence interval around the satisfactory difference for Part II (-0.13, +0.07).

Cefuroxime Axetil Tablets 500 mg Twice Daily (n = 125) Doxycycline 100 mg 3 Times Daily (n = 108) Cefuroxime Axetil Tablets 500 mg Twice Daily (n = 105 n’s include subjects assessed as unsatisfactory clinical outcomes (failure + recurrence) in Part I (Cefuroxime Axetil Tablets – 11 [5 failure, 6 recurrence]; doxycycline – 8 [6 failure, 2 recurrence]).

) Doxycycline 100 mg 3Times Daily (n = 83 ) Satisfactory clinical outcomeSatisfactory clinical outcome includes cure + improvement (Part I) and success + improvement (Part II).

91% 93% 84% 87% Clinical cure/success 72% 73% 73% 73% Clinical improvement 19% 19% 10% 13% Cefuroxime axetil and doxycycline were effective in prevention of the development of sequelae of late Lyme disease.

While the incidence of drug-related gastrointestinal adverse reactions was similar in the 2 treatment groups (cefuroxime axetil – 13%; doxycycline – 11%), the incidence of drug-related diarrhea was higher in the cefuroxime axetil arm versus the doxycycline arm (11% versus 3%, respectively).

HOW SUPPLIED

16 /STORAGE AND HANDLING Cefuroxime axetil tablets USP, 250 mg of cefuroxime (as cefuroxime axetil), are white to off-white, capsule-shaped, film-coated tablets with “LUPIN” debossed on one side and “302” on the other side, supplied in bottles of 20 and 60.

Bottle of 20 – 68788-9700-2 Bottle of 30 – 68788-9700-3 Bottle of 60 – 68788-9700-6 Cefuroxime axetil tablets USP, 500 mg of cefuroxime (as cefuroxime axetil), are white to off-white, capsule-shaped, film-coated tablets with “LUPIN” debossed on one side and “303” on the other side, supplied in bottles of 20 and 60.

Bottle of 20 – 68788-9701-2 Bottle of 30 – 68788-9701-3 Bottle of 60 – 68788-9701-6 Store the tablets at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].

Replace cap securely after each opening.

RECENT MAJOR CHANGES

Indications and Usage, Acute Bacterial Exacerbations 11/2016 of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis: Secondary Bacterial Infections of Acute Bronchitis (1.4)-Removed Dosage and Administration, Dosage for CEFTIN Tablets: 11/2016 Secondary Bacterial Infections of Acute Bronchitis (2.2)-Removed

GERIATRIC USE

8.5 Geriatric Use Of the total number of subjects who received cefuroxime axetil in 20 clinical trials, 375 were aged 65 and older while 151 were aged 75 and older.

No overall differences in safety or effectiveness were observed between these subjects and younger adult subjects.

Reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out.

Cefuroxime is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

DOSAGE FORMS AND STRENGTHS

3 •Tablets: 250 mg and 500 mg (3) Cefuroxime axetil tablets USP are off-white, capsule-shaped, film-coated tablets available in the following strengths: •250 mg of cefuroxime (as cefuroxime axetil) are white to off-white, capsule-shaped, film-coated tablets with “LUPIN” debossed on one side and “302” on the other side.

•500 mg of cefuroxime (as cefuroxime axetil) are white to off-white, capsule-shaped, film-coated tablets with “LUPIN” debossed on one side and “303” on the other side.

MECHANISM OF ACTION

12.1 Mechanism of Action Cefuroxime axetil is an antibacterial drug [see CLINICAL PHARMACOLOGY (12.4)].

INDICATIONS AND USAGE

1 Cefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1) •Pharyngitis/tonsillitis (adults and pediatric patients) (1.1) •Acute bacterial otitis media (pediatric patients) (1.2) •Acute bacterial maxillary sinusitis (adults and pediatric patients) (1.3) •Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) (1.4) •Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) (1.5) •Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) (1.6) •Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) (1.7) •Early Lyme disease (adults and pediatric patients 13 years and older) (1.8) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil tablets and other antibacterial drugs, cefuroxime axetil tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

1.1 Pharyngitis/Tonsillitis Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (13 years and older) with mild-to-moderate pharyngitis/tonsillitis caused by susceptible strains of Streptococcus pyogenes.

Limitations of Use •The efficacy of cefuroxime axetil in the prevention of rheumatic fever was not established in clinical trials.

•The efficacy of cefuroxime axetil in the treatment of penicillin-resistant strains of Streptococcus pyogenes has not been demonstrated in clinical trials.

1.2 Acute Bacterial Otitis Media Cefuroxime axetil tablets are indicated for the treatment of pediatric patients (who can swallow tablets whole) with acute bacterial otitis media caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase–producing strains), Moraxella catarrhalis (including β-lactamase–producing strains), or Streptococcus pyogenes.

1.3 Acute Bacterial Maxillary Sinusitis Cefuroxime axetil tablets are indicated for the treatment of adult and pediatric patients (13 years and older) with mild-to-moderate acute bacterial maxillary sinusitis caused by susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae (non-β-lactamase–producing strains only).

Limitations of Use The effectiveness of cefuroxime axetil for sinus infections caused by β-lactamase–producing Haemophilus influenzae or Moraxella catarrhalis in patients with acute bacterial maxillary sinusitis was not established due to insufficient numbers of these isolates in the clinical trials [see CLINICAL STUDIES (14.1)].

1.4 Acute Bacterial Exacerbations of Chronic Bronchitis Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with mild-to-moderate acute bacterial exacerbations of chronic bronchitis caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae (β-lactamase–negative strains), or Haemophilus parainfluenzae (β-lactamase–negative strains).

1.5 Uncomplicated Skin and Skin-Structure Infections Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated skin and skin-structure infections caused by susceptible strains of Staphylococcus aureus (including β-lactamase–producing strains) or Streptococcus pyogenes.

1.6 Uncomplicated Urinary Tract Infections Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated urinary tract infections caused by susceptible strains of Escherichia coli or Klebsiella pneumoniae.

1.7 Uncomplicated Gonorrhea Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated gonorrhea, urethral and endocervical, caused by penicillinase producing and non-penicillinase–producing susceptible strains of Neisseria gonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by non-penicillinase–producing susceptible strains of Neisseria gonorrhoeae.

1.8 Early Lyme Disease (erythema migrans) Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with early Lyme disease (erythema migrans) caused by susceptible strains of Borrelia burgdorferi.

1.10 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil and other antibacterial drugs, 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.

PEDIATRIC USE

8.4 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 trials 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 INDICATIONS AND USAGE (1), DOSAGE AND ADMINISTRATION (2), ADVERSE REACTIONS (6), CLINICAL PHARMACOLOGY (12.3)].

PREGNANCY

8.1 Pregnancy Pregnancy Category B.

There are no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, cefuroxime axetil should be used during pregnancy only if clearly needed.

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 body surface area) and in rats at doses up to 1,000 mg/kg/day (9 times the recommended maximum human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to cefuroxime axetil.

NUSRING MOTHERS

8.3 Nursing Mothers Because cefuroxime is excreted in human milk, caution should be exercised when cefuroxime axetil is administered to a nursing woman.

WARNING AND CAUTIONS

5 WARNINGS AND PRECAUTIONS •Serious hypersensitivity (anaphylactic) reactions: In the event of a serious reaction, discontinue cefuroxime axetil tablets and institute appropriate therapy.

(5.1) • Clostridium difficile -associated diarrhea (CDAD): If diarrhea occurs, evaluate patients for CDAD.

(5.2) 5.1 Anaphylactic Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on β-lactam antibacterials.

These reactions are more likely to occur in individuals with a history of β-lactam hypersensitivity and/or a history of sensitivity to multiple allergens.

There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins.

Cefuroxime axetil is contraindicated in patients with a known hypersensitivity to cefuroxime axetil or other β-lactam antibacterial drugs [see CONTRAINDICATIONS (4)].

Before initiating therapy with cefuroxime axetil, inquire about previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.

If an allergic reaction occurs, discontinue cefuroxime axetil and institute appropriate therapy.

5.2 Clostridium difficile-Associated Diarrhea Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefuroxime axetil, and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.

difficile.

C.

difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin producing strains of C.

difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.

difficile may need to be discontinued.

Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.

difficile, and surgical evaluation should be instituted as clinically indicated.

5.3 Potential for Microbial Overgrowth The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy.

5.4 Development of Drug-Resistant Bacteria Prescribing cefuroxime axetil either 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.

5.6 Interference with Glucose Tests A false-positive result for glucose in the urine may occur with copper reduction tests, and a false-negative result for blood/plasma glucose may occur with ferricyanide tests in subjects receiving cefuroxime axetil [see DRUG INTERACTIONS (7.4)].

INFORMATION FOR PATIENTS

17 PATIENT COUNSELING INFORMATION Allergic Reactions Inform patients that cefuroxime axetil is a cephalosporin that can cause allergic reactions in some individuals [see WARNINGS AND PRECAUTIONS (5.1)].

Clostridium difficile-Associated Diarrhea Inform patients that diarrhea is a common problem caused by antibacterials, and it usually ends when the antibacterial is discontinued.

Sometimes after starting treatment with antibacterials, 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 their last dose of the antibacterial.

If this occurs, advise patients to contact their physician as soon as possible.

Crushing Tablets Instruct patients to swallow the tablet whole, without crushing the tablet.

Patients who cannot swallow the tablet whole should receive the oral suspension.

Drug Resistance Inform patients that antibacterial drugs, including cefuroxime axetil, should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold).

When cefuroxime axetil is prescribed to treat a bacterial infection, inform patients 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 or other antibacterial drugs in the future.

Manufactured for: Lupin Pharmaceuticals, Inc.

Baltimore, Maryalnd 21202 United States.

Manufactured by: Lupin Limited Mandideep 462 046 INDIA.

Revised: January 2017 ID#:250342 Repackaged by: Preferred Pharmaceuticals Inc.

DOSAGE AND ADMINISTRATION

2 •Tablets and oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis.

(2.1) •Administer tablets with or without food.

(2.2) •Administer cefuroxime axetil tablets as described in the dosage guidelines.

(2.2) •Dosage adjustment is required for patients with impaired renal function.

(2.5) Adult Patients and Pediatric Patients Dosage Guidelines for Cefuroxime Axetil Tablets Infection Dosage Duration (Days) Adults and Adolescents (13 years and older) Pharyngitis/tonsillitis (mild to moderate) 250 mg every 12 hours 10 Acute bacterial maxillary sinusitis (mild to moderate) 250 mg every 12 hours 10 Acute bacterial exacerbations of chronic bronchitis (mild to moderate) 250 or 500 mg every 12 hours 10 Uncomplicated skin and skin-structure infections 250 or 500 mg every 12 hours 10 Uncomplicated urinary tract infections 250 mg every 12 hours 7 to 10 Uncomplicated gonorrhea 1,000 mg single dose Early Lyme disease 500 mg every 12 hours 20 Pediatric Patients younger than 13 years (who can swallow tablets whole) Acute bacterial otitis media 250 mg every 12 hours Acute bacterial maxillary sinusitis 250 mg every 12 hours 2.1 Important Administration Instructions •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 (12.3)] .

•Administer cefuroxime axetil tablets as described in the appropriate dosage guidelines [see (2.2)].

•Administer cefuroxime axetil tablets with or without food.

•Pediatric patients (aged 13 years and older) who cannot swallow the cefuroxime axetil tablets whole should receive cefuroxime axetil for oral suspension because the tablet has a strong, persistent bitter taste when crushed [see (2.2)].

2.2 Dosage for Cefuroxime Axetil Tablets Administer cefuroxime axetil tablets as described in the dosage guidelines table below with or without food.

Table 1.

Adult Patients and Pediatric Patients Dosage Guidelines for Cefuroxime Axetil Tablets Infection Dosage Duration (Days) Adults and Adolescents (13 years and older) Pharyngitis/tonsillitis (mild to moderate) 250 mg every 12 hours 10 Acute bacterial maxillary sinusitis (mild to moderate) 250 mg every 12 hours 10 Acute bacterial exacerbations of chronic bronchitis (mild to moderate) 250 or 500 mg every 12 hours 10The safety and effectiveness of cefuroxime axetil administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.

Uncomplicated skin and skin-structure infections 250 or 500 mg every 12 hours 10 Uncomplicated urinary tract infections 250 mg every 12 hours 7 to 10 Uncomplicated gonorrhea 1,000 mg single dose Early Lyme disease 500 mg every 12 hours 20 Pediatric Patients younger than 13 years (who can swallow tablets whole) When crushed, the tablet has a strong, persistent bitter taste.

Therefore, patients who cannot swallow the tablet whole should receive the oral suspension.

Acute bacterial otitis media 250 mg every 12 hours 10 Acute bacterial maxillary sinusitis 250 mg every 12 hours 10 2.5 Dosage in Patients with Impaired Renal Function A dosage interval adjustment is required for patients whose creatinine clearance is <30 mL/min, as listed in Table 4 below, because cefuroxime is eliminated primarily by the kidney [see CLINICAL PHARMACOLOGY (12.3)].

Table 4.

Dosing in Adults with Renal Impairment Creatinine Clearance (mL/min) Recommended Dosage ≥30 No dosage adjustment 10 to ˂30 Standard individual dose given every 24 hours ˂10 (without hemodialysis) Standard individual dose given every 48 hours Hemodialysis A single additional standard dose should be given at the end of each dialysis