Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

CEFTAZIDIME IN DEXTROSE CONTAINER (NDA-050823)

(CEFTAZIDIME)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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10/20/2021 (SUPPL-9)

Approved Drug Label (PDF)

4 Contraindications

Hypersensitivity Reactions to Ceftazidime or the Cephalosporin Class of Antibacterials, Penicillins, or Other Beta-lactam Antibacterials

(Section title revised)

(Additions and/or revisions underlined)

Ceftazidime for Injection and Dextrose Injection is contraindicated in patients who have a history of immediate hypersensitivity reactions (e.g., anaphylaxis, serious skin reactions) to ceftazidime products or the cephalosporin class of antibacterial drugs, penicillins, or other beta-lactam antibacterial drugs. [see Warnings and Precautions (5.1)]

5 Warnings and Precautions

5.3 Clostridioides difficile-associated Diarrhea

(Additions and/or revisions underlined)

(Section title revised)

Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ceftazidime products, 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 antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

5.4 Neurologic Adverse Reactions

(Additions and/or revisions underlined)

(Section title revised)

Seizures, nonconvulsive status epilepticus (NCSE), encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonus have been reported in patients treated with ceftazidime, including Ceftazidime for Injection and Dextrose Injection particularly in the setting of renal impairment. Adjust dosing based on creatinine clearance in patients with renal impairment [see Dosage and Administration (2.3)].

5.6 Risk of Development of Drug-resistant Bacteria

(Additions and/or revisions underlined)

Prescribing Ceftazidime for Injection and Dextrose Injection in the absence of 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.

5.7 Drug/Laboratory Test Interactions

(Additions and/or revisions underlined)

Urinary Glucose

The administration of Ceftazidime for Injection and Dextrose Injection may result in a false-positive reaction with glucose in the urine when using glucose tests based on Benedict’s copper reduction reaction that determine the amount of reducing substances like glucose in the urine. It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.

6 Adverse Reactions

(Additions and/or revisions underlined)

The following serious adverse reactions to ceftazidime are described below and elsewhere in the labeling:

Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
Hemolytic Anemia [see Warnings and Precautions (5.2)]
Clostridioides difficile-associated diarrhea [see Warnings and Precautions (5.3)]
Neurological Adverse Reactions [see Warnings and Precautions (5.4)]

7 Drug Interactions

7.3 Drug/Laboratory Test Interactions

(Newly added subsection)

The administration of ceftazidime may result in a false-positive reaction for glucose in the urine with certain methods. It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used [see Warnings and Precautions (5.7)].

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion. Please refer to label for complete information.)

8.2 Lactation

(PLLR conversion. Please refer to label for complete information.)

8.3 Females and Males of Reproductive Potential Infertility

(PLLR conversion. Please refer to label for complete information.)

8.4 Pediatric Use

(Newly added information)

Ceftazidime for injection and Dextrose injection is indicated for the treatment of lower respiratory tract infections, skin and skin structure infections, bacterial septicemia, bone and joint infections, gynecological infections, intra-abdominal infections and central nervous system infections in pediatric patients for whom appropriate dosing with this formulation can be achieved [see Indications and Usage (1.1-1.7)] and Dosage and Administration (2.3)].

Because of the limitations of the available strengths and administration requirements (i.e., administration of fractional doses is not recommended) of Ceftazidime for Injection and Dextrose Injection, and to avoid unintentional overdose, this is not recommended for use if a dose of Ceftazidime for Injection and Dextrose Injection that does not equal 1 gram or 2 grams is required and an alternative formulation of ceftazidime should be considered [see Dosage and Administration (2)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

(Newly added subsection titles)

(Additions and/or revisions underlined)

Allergic reactions

Patients should be advised that allergic reactions, including serious allergic reactions could occur and that serious reactions require immediate treatment and discontinuation of Ceftazidime for Injection and Dextrose Injection. Patients should report to their health care provider any previous allergic reactions to ceftazidime, cephalosporins, penicillins, or other similar antibacterials.

Neurologic Adverse Reactions

Advise patients of central nervous system reactions including neurological adverse reactions that could occur with Ceftazidime for Injection and Dextrose Injection use. Instruct patients to inform a healthcare provider at once of any neurological signs and symptoms, including encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, and seizures, for immediate treatment, dosage adjustment, or discontinuation of Ceftazidime for Injection and Dextrose Injection.

Diarrhea

Patients should be advised that diarrhea is a common problem caused by antibacterials which 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 the last dose of the antibacterial. If this occurs, patients should contact their physician as soon as possible.

Antibacterial Resistance

Patients should be counseled that antibacterial drugs, including Ceftazidime for Injection and Dextrose Injection, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Ceftazidime for Injection and Dextrose Injection is prescribed to treat a bacterial infection, patients should be told 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 Ceftazidime for Injection and Dextrose Injection or other antibacterial drugs in the future.