Cefuroxime Axetil (Page 5 of 6)

14 CLINICAL STUDIES

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 11 shows the results of the intent-to-treat analysis.

Table 11. Clinical Effectiveness of Cefuroxime Axetil Tablets in the Treatment of Acute Bacterial Maxillary Sinusitis

	US Subjectsa		South American Subjectsb
	Cefuro xime Axetil Tablets 250 mg Twice Daily (n = 49)	Control c (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%

^a 95% confidence interval around the success difference [-0.08, +0.32]

^b 95% confidence interval around the success difference [-0.10, +0.16].^c Control was an antibacterial drug containing a β-lactamase inhibitor.

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 12 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 12.

Table 12. 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)a		Part II (1 Year after 20 Days of Treatment)b
	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 = 105c)	Doxycycline 100 mg 3 Times Daily (n = 83c)
Satisfactory clinical outcomed	91%	93%	84%	87%
Clinical cure/success	72%	73%	73%	73%
Clinical improvement	19%	19%	10%	13%

^a 95% confidence interval around the satisfactory difference for Part I (-0.08, +0.05).

^b 95% confidence interval around the satisfactory difference for Part II (-0.13, +0.07).

^c n’s include subjects assessed as unsatisfactory clinical outcomes (failure + recurrence) in Part I (cefuroxime axetil — 11 [5 failure, 6 recurrence]; doxycycline — 8 [6 failure, 2 recurrence]).

^d Satisfactory clinical outcome includes cure + improvement (Part I) and success + improvement (Part II).

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).

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-2157

NDC: 50090-2157-0 20 TABLET, FILM COATED in a BOTTLE

Product: 50090-2158

NDC: 50090-2158-0 20 TABLET, FILM COATED in a BOTTLE

NDC: 50090-2158-3 14 TABLET, FILM COATED in a BOTTLE

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.

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Mumbai — 400 013, INDIA

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Revised: August,2019 PT 0996-06