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)].
Clostridioides 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: Northstar Rx LLC
Memphis, TN 38141
Manufactured by: Aurobindo Pharma Limited
Chitkul (V)-502 307, India.
M.L.No.: 78/MD/AP/96/F/B/R
Revised: 04/2021
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -250 mg (20 Tablets Bottle)
NDC 16714-400-01 Rx only
Cefuroxime Axetil
Tablets, USP
250 mg*
20 TabletsNORTHSTARTM
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg (20 Tablets Bottle)
Rx only
NDC 16714-401-01
Cefuroxime Axetil
Tablets, USP
500 mg*
20 Tablets
NORTHSTARTM
CEFUROXIME AXETIL cefuroxime axetil tablet |
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CEFUROXIME AXETIL cefuroxime axetil tablet |
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Revised: 04/2021 NorthStar Rx LLC
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