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CEFTAZIDIME FOR is a brand name for Ceftazidime, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: [02/2022] 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment [02/2022] 7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis, Sensitivity/Resistance, Skin and Sodium Content [02/2022] 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women [02/2022] TABLE OF CONTENTS Sections or subsections that are…
Verbatim from this product's HC label. Tap a section to expand.
1 Pregnant Women [02/2022] TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 4 Administration .....................................................................................................
11 5 OVERDOSAGE............................................................................................................... 11
). As with other antibiotics, prolonged use of Ceftazidime for Injection, USP may result in the overgrowth of non-susceptible organisms including species originally sensitive to the drug. Repeated evaluation of the patient's condition is essential.
If superinfection occurs during therapy, appropriate measures should be taken. Resistance has developed during therapy with ceftazidime by Staphylococcus aureus, Enterobacteriaceae, Acinetobacter species, and Pseudomonas species. Hematologic Hemolytic Anemia Ceftazidime for Injection, USP should not be used in patients with a history of cephalosporin-associated hemolytic anemia since the recurrence of hemolysis is much more severe.
An immune mediate hemolytic anemia has been observed in patients receiving cephalosporin class antibacterials, including Ceftazidime for Injection, USP. Severe cases of hemolytic anemia, including Product Monograph Master Template Template Date: September 2020 Ceftazidime for Injection, USP Page 14 of 45 fatalities, have been reported in both adults and children.
If a patient develops anemia anytime during, or within 2 - 3 weeks subsequent to the administration of Ceftazidime for Injection, USP, the diagnosis of a cephalosporin-associated anemia should be considered and the drug discontinued until the etiology is determined.
Patients may benefit from periodic monitoring for signs and symptoms of hemolytic anemia, including measurement of hematological parameters or drug-induced antibody testing, where appropriate (see 8 ADVERSE REACTIONS). Immune Hypersensitivity Before therapy with Ceftazidime for Injection, USP is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to ceftazidime, cephalosporins, penicillins, or other drugs.
Ceftazidime for injection, USP should be administered with caution to any patient who has demonstrated some form of allergy, particularly to drugs. This product should be given with caution to patients with type i hypersensitivity reactions to penicillin.
1 Pregnant Women [02/2022] TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 4 Administration .....................................................................................................
11 5 OVERDOSAGE............................................................................................................... 11 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ......................................... 12 7 WARNINGS AND PRECAUTIONS ......................................................................................
1 Special Populations ............................................................................................... 1 Pregnant Women .................................................................................................
2 Breast-feeding ..................................................................................................... 3 Pediatrics ............................................................................................................
4 Geriatrics ............................................................................................................ 16 8 ADVERSE REACTIONS.....................................................................................................
1 Adverse Reaction Overview.................................................................................... 2 Clinical Trial Adverse Reactions............................................................................... 3 Less Common Clinical Trial Adverse Reactions...........................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ................................................................................................................... 5 Post-Market Adverse Reactions ..............................................................................
Ceftazidime for Injection, USP is contraindicated in patients who have shown hypersensitivity to ceftazidime or the cephalosporin group of antibiotics. See 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If this product is to be given to penicillin-sensitive patients, caution should be exercised because cross- hypersensitivity among -lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy.
If an allergic reaction to Ceftazidime for Injection, USP occurs, discontinue treatment with the drug. Serious acute hypersensitivity reactions may require epinephrine and other emergency measures. Monitoring and Laboratory Tests A false-positive reaction for glucose in the urine may occur with Benedict's or Fehling's solution or with CLINITEST tablets.
As with some other cephalosporins, transient elevations of blood urea, blood urea nitrogen, and/or serum creatinine, hepatic enzymes [aspartate transaminase (AST)/serum glutamic oxaloacetic transaminase (SGOT), alanine transaminase (ALT)/serum glutamic pyruvic transaminase (SGPT), lactic dehydrogenase (LDH) and alkaline phosphatases] were observed occasionally.
Transient leukopenia, neutropenia, agranulocytosis, thrombocytopenia and lymphocytosis were very rarely seen. 2 Recommended Dose and Dosage Adjustment). High and prolonged serum antibiotic concentrations can occur from normal dosages in patients with transient or persistent reduction of urinary output because of renal insufficiency.
2 Recommended Dose and Dosage Adjustment and 5 OVERDOSAGE). Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism. Nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics or potent diuretics, such as furosemide.
Although transient elevations of BUN and serum creatinine have been observed in clinical studies, there is no evidence that ceftazidime, when administered alone, is significantly nephrotoxic.
Product Monograph Master Template Template Date:
September 2020 Ceftazidime for Injection, USP Page 15 of 45 Sensitivity/Resistance Development of Drug-Resistant Bacteria Prescribing Ceftazidime for Injection, USP in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
Development of resistance during the administration of Ceftazidime for Injection, USP has been observed for Staphylococcus aureus, members of the Enterobacteriaceae family, Acinetobacter species, Pseudomonas species, and Serratia species.
The prevalence of acquired resistance is geographically and time dependent and for select species may be very high. Local information on resistance and prevalence of extended spectrum beta lactamase (ESBLs) producing organisms is desirable, particularly when treating severe infections.
Potential for Microbial Overgrowth Prolonged treatment with Ceftazidime for Injection, USP may result in the overgrowth of nonsusceptible organisms, including species originally sensitive to the drug. Repeated evaluation of the patient's condition is essential.
If superinfection occurs during therapy, appropriate measures should be taken. Skin Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCAR) such as acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported in association with beta-lactam treatment.
When SCAR is suspected, Ceftazidime for Injection, USP should be discontinued and appropriate therapy and/or measures should be […]
17 9 DRUG INTERACTIONS .................................................................................................... 2 Drug Interactions Overview....................................................................................
4 Drug-Drug Interactions .......................................................................................... 5 Drug-Food Interactions.......................................................................................... 6 Drug-Herb Interactions..........................................................................................
7 Drug-Laboratory Test Interactions........................................................................... 19 10 CLINICAL PHARMACOLOGY ............................................................................................ 1 Mechanism of Action ............................................................................................
2 Pharmacodynamics............................................................................................... 3 Pharmacokinetics ................................................................................................. 20 11 STORAGE, STABILITY AND DISPOSAL ...............................................................................
27 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................. 28 PART II: SCIENTIFIC INFORMATION .............................................................................................
29 13 PHARMACEUTICAL INFORMATION .................................................................................. 29 14 CLINICAL TRIALS............................................................................................................
29 15 MICROBIOLOGY ............................................................................................................ 29 16 NON-CLINICAL TOXICOLOGY...........................................................................................
34 17 SUPPORTING PRODUCT MONOGRAPHS........................................................................... 39 PATIENT MEDICATION INFORMATION ........................................................................................
40 Product Monograph Master Template Template Date: September 2020 Ceftazidime for […]