Cefuroxime Axetil (Page 6 of 6)

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 -250 mg (20 Tablets Bottle)
(click image for full-size original)

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 500 mg (20 Tablets Bottle)
(click image for full-size original)

CEFUROXIME AXETIL cefuroxime axetil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-400
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFUROXIME AXETIL (CEFUROXIME) CEFUROXIME 250 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYDROGENATED COTTONSEED OIL
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL (CAPSULE-SHAPED) Size 16mm
Flavor Imprint Code A33
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-400-01 20 TABLET in 1 BOTTLE None
2 NDC:16714-400-02 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065308 03/29/2006
CEFUROXIME AXETIL cefuroxime axetil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-401
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFUROXIME AXETIL (CEFUROXIME) CEFUROXIME 500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYDROGENATED COTTONSEED OIL
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL (CAPSULE-SHAPED) Size 20mm
Flavor Imprint Code A34
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-401-01 20 TABLET in 1 BOTTLE None
2 NDC:16714-401-02 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065308 03/29/2006
Labeler — NorthStar Rx LLC (830546433)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917639 ANALYSIS (16714-400), ANALYSIS (16714-401), MANUFACTURE (16714-400), MANUFACTURE (16714-401)

Revised: 04/2021 NorthStar Rx LLC

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.