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TAZICEF
Overview
What is TAZICEF?
Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibacterial drug for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4-thiazolyl)[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-, hydroxide, inner salt, [6R-[6α,7β(Z)]]. It has the following structure:
The molecular formula is CHNOS, representing a molecular weight of 636.6.
Tazicef (ceftazidime for injection, USP) is a sterile, dry-powdered mixture of ceftazidime pentahydrate and sodium carbonate. The sodium carbonate at a concentration of 118 mg/g of ceftazidime activity has been admixed to facilitate dissolution. The total sodium content of the mixture is approximately 54 mg (2.3 mEq)/g of ceftazidime activity.
Tazicef in sterile crystalline form is supplied in vials equivalent to 1 g or 2 g of anhydrous ceftazidime.
Solutions of Tazicef range in color from light yellow to amber, depending on the diluent and volume used. The pH of freshly constituted solutions usually ranges from 5 to 7.5.
What does TAZICEF look like?
What are the available doses of TAZICEF?
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What should I talk to my health care provider before I take TAZICEF?
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How should I use TAZICEF?
Tazicef (ceftazidime for injection) is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:
Tazicef (ceftazidime for injection, USP) may be used alone in cases of confirmed or suspected sepsis. Ceftazidime has been used successfully in clinical trials as empiric therapy in cases where various concomitant therapies with other antibacterial drugs have been used.
Tazicef may also be used concomitantly with other antibacterial drugs, such as aminoglycosides, vancomycin, and clindamycin; in severe and life-threatening infections; and in the immunocompromised patient. When such concomitant treatment is appropriate, prescribing information in the labeling for the other antibacterial drugs should be followed. The dose depends on the severity of the infection and the patient's condition.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tazicef (ceftazidime) and other antibacterial drugs, Tazicef (ceftazidime) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Dosage
The usual adult dosage is 1 gram administered intravenously or intramuscularly every 8 to 12 hours. The dosage and route should be determined by the susceptibility of the causative organisms, the severity of infection, and the condition and renal function of the patient.
The guidelines for dosage of Tazicef (ceftazidime for injection, USP) are listed in . The following dosage schedule is recommended.
Impaired Hepatic Function
No adjustment in dosage is required for patients with hepatic dysfunction.
Impaired Renal Function
Ceftazidime is excreted by the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function (glomerular filtration rate [GFR] <50 mL/min), it is recommended that the dosage of ceftazidime be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1 gram of ceftazidime may be given. An estimate of GFR should be made to determine the appropriate maintenance dosage. The recommended dosage is presented in .
When only serum creatinine is available, the following formula (Cockcroft's equation) may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function:
Males: Creatinine clearance (mL/min) =
72 x serum creatinine (mg/dL)
Females: 0.85 x male value
In patients with severe infections who would normally receive 6 grams of Tazicef daily were it not for renal insufficiency, the unit dose given in the table above may be increased by 50% or the dosing frequency may be increased appropriately. Further dosing should be determined by therapeutic monitoring, severity of the infection, and susceptibility of the causative organism.
In pediatric patients as for adults, the creatinine clearance should be adjusted for body surface area or lean body mass, and the dosing frequency should be reduced in cases of renal insufficiency.
In patients undergoing hemodialysis, a loading dose of 1 gram is recommended, followed by 1 gram after each hemodialysis period.
Tazicef (ceftazidime for injection, USP) can also be used in patients undergoing intraperitoneal dialysis and continuous ambulatory peritoneal dialysis. In such patients, a loading dose of 1 gram of Tazicef may be given, followed by 500 mg every 24 hours. In addition to IV use, Tazicef can be incorporated in the dialysis fluid at a concentration of 250 mg for 2 L of dialysis fluid.
Note:
Administration
Tazicef may be given intravenously or by deep IM injection into a large muscle mass such as the upper outer quadrant of the gluteus maximus or lateral part of the thigh. Intra-arterial administration should be avoided (see ).
Intramuscular Administration
For IM administration, Tazicef should be constituted with one of the following diluents: Sterile Water for Injection, Bacteriostatic Water for Injection, or 0.5% or 1% Lidocaine Hydrochloride Injection. Refer to .
Intravenous Administration
The IV route is preferable for patients with bacterial septicemia, bacterial meningitis, peritonitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or pending.
Intermittent intravenous infusion with a Y-type administration set
Freezing solutions of ceftazidime for injection is not recommended.
All vials of Tazicef as supplied are under reduced pressure. When Tazicef is dissolved, carbon dioxide is released and a positive pressure develops. For ease of use please follow the recommended techniques of constitution described on the detachable Instructions for Constitution section of this insert.
Solutions of Tazicef, like those of most beta-lactam antibacterial drugs, should not be added to solutions of aminoglycoside antibacterial drugs because of potential interaction.
However, if concurrent therapy with Tazicef and an aminoglycoside is indicated, each of these antibacterial drugs can be administered separately to the same patient.
What interacts with TAZICEF?
Tazicef
What are the warnings of TAZICEF?
Chlordiazepoxide HCl may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a vehicle or operating machinery. Similarly, it may impair mental alertness in children. The concomitant use of alcohol or other central nervous system depressants may have an additive effect. PATIENTS SHOULD BE WARNED ACCORDINGLY.
BEFORE THERAPY WITH TAZICEF IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFTAZIDIME, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS- HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBACTERIAL DRUGS HAVE BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO TAZICEF OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IV FLUIDS, IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of , and surgical evaluation should be instituted as clinically indicated.
Elevated levels of ceftazidime in patients with renal insufficiency can lead to seizures, nonconvulsive status epilepticus (NCSE), encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia (see ).
What are the precautions of TAZICEF?
General
High and prolonged serum ceftazidime concentrations can occur from usual dosages in patients with transient or persistent reduction of urinary output because of renal insufficiency. The total daily dosage should be reduced when ceftazidime is administered to patients with renal insufficiency (see ). Elevated levels of ceftazidime in these patients can lead to seizures, nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organisms.
As with other antibacterial drugs, prolonged use of Tazicef (ceftazidime for injection, USP) may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient's condition is essential.
If superinfection occurs during therapy, appropriate measures should be taken.
Inducible type I beta-lactamase resistance has been noted with some organisms (e.g., spp., spp., and spp.). As with other extended-spectrum beta-lactam antibacterial drugs, resistance can develop during therapy, leading to clinical failure in some cases.
When treating infections caused by these organisms, periodic susceptibility testing should be performed when clinically appropriate. If patients fail to respond to monotherapy, an aminoglycoside or similar agent should be considered.
Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal and hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.
Tazicef should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Distal necrosis can occur after inadvertent intra-arterial administration of ceftazidime.
Prescribing Tazicef (ceftazidime) in the absence of a 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.
Information for Patients
Patients should be counseled that antibacterial drugs, including Tazicef (ceftazidime) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Tazicef (ceftazidime) 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 Tazicef (ceftazidime) or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, 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 drug. If this occurs, patients should contact their physician as soon as possible.
Drug Interactions
Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibacterial drugs or potent diuretics such as furosemide. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs. Nephrotoxicity and ototoxicity were not noted when ceftazidime was given alone in clinical trials.
Chloramphenicol has been shown to be antagonistic to beta-lactam antibacterial drugs, including ceftazidime, based on studies and time kill curves with enteric gram-negative bacilli. Due to the possibility of antagonism , particularly when bactericidal activity is desired, this drug combination should be avoided.
In common with other antibacterial drugs, ceftazidime may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Drug/Laboratory Test Interactions
The administration of ceftazidime may result in a false-positive reaction for glucose in the urine when using CLINITEST tablets, Benedict's solution, or Fehling's solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX) be used.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential. However, a mouse micronucleus test and an Ames test were both negative for mutagenic effects.
Pregnancy
Array
Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to TAZICEF. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
Ceftazidime is excreted in human milk in low concentrations. Caution should be exercised when TAZICEF is administered to a nursing woman.
Pediatric Use
See .
Geriatric Use
Of the 2,221 subjects who received ceftazidime in 11 clinical studies, 824 (37%) were 65 and older while 391 (18%) were 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater susceptibility of some older individuals to drug effects cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see ).
What are the side effects of TAZICEF?
Ceftazidime is generally well tolerated. The incidence of adverse reactions associated with the administration of ceftazidime was low in clinical trials. The most common were local reactions following IV injection and allergic and gastrointestinal reactions. Other adverse reactions were encountered infrequently. No disulfiram-like reactions were reported.
The following adverse effects from clinical trials were considered to be either related to ceftazidime therapy or were of uncertain etiology:
Local Effects,
Hypersensitivity Reactions,
Gastrointestinal Symptoms,
Central Nervous System Reactions
Seizures have been reported with several cephalosporins, including ceftazidime. In addition, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported in renally impaired patients treated with unadjusted dosing regimens of ceftazidime (see ).
Less Frequent Adverse Events
Hematologic
Rare cases of hemolytic anemia have been reported.
Laboratory Test Changes
Postmarketing Experience with Tazicef (ceftazidime for injection, USP) Products
In addition to the adverse events reported during clinical trials, the following events have been observed during clinical practice in patients treated with Tazicef and were reported spontaneously. For some of these events, data are insufficient to allow an estimate of incidence or to establish causation.
General
Anaphylaxis; allergic reactions, which, in rare instances, were severe (e.g., cardiopulmonary arrest); urticaria; pain at injection site.
Hepatobiliary Tract
Hyperbilirubinemia, jaundice.
Renal and Genitourinary
Renal impairment.
Cephalosporin-Class Adverse Reactions
In addition to the adverse reactions listed above that have been observed in patients treated with ceftazidime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibacterial drugs:
Adverse Reactions
Colitis, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage.
Altered Laboratory Tests
Prolonged prothrombin time, false-positive test for urinary glucose, pancytopenia.
To report , contact Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What should I look out for while using TAZICEF?
Tazicef
BEFORE THERAPY WITH TAZICEF IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFTAZIDIME, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS- HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBACTERIAL DRUGS HAVE BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO TAZICEF OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IV FLUIDS, IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
Clostridium difficile
C. difficile
C. difficile
C. difficile
If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of , and surgical evaluation should be instituted as clinically indicated.
Elevated levels of ceftazidime in patients with renal insufficiency can lead to seizures, nonconvulsive status epilepticus (NCSE), encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia (see ).
What might happen if I take too much TAZICEF?
Ceftazidime overdosage has occurred in patients with renal failure. Reactions have included seizure activity, encephalopathy, asterixis, neuromuscular excitability, and coma. Patients who receive an acute overdosage should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis or peritoneal dialysis may aid in the removal of ceftazidime from the body.
How should I store and handle TAZICEF?
Tazicef in the dry state should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and protected from light. Tazicef (ceftazidime for injection, USP) is a dry, white to off-white powder supplied in vials as follows:Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram (tray of 25): NDC 0409-5082-162 gram (tray of 10): NDC 0409-5084-11Also available as:Pharmacy Bulk Package Bottles: 6 gram (tray of 10): NDC 0409-5086-11ADD-Vantage Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram: NDC 0409-5092-162 gram: NDC 0409-5093-11Tazicef in the dry state should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and protected from light. Tazicef (ceftazidime for injection, USP) is a dry, white to off-white powder supplied in vials as follows:Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram (tray of 25): NDC 0409-5082-162 gram (tray of 10): NDC 0409-5084-11Also available as:Pharmacy Bulk Package Bottles: 6 gram (tray of 10): NDC 0409-5086-11ADD-Vantage Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram: NDC 0409-5092-162 gram: NDC 0409-5093-11Tazicef in the dry state should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and protected from light. Tazicef (ceftazidime for injection, USP) is a dry, white to off-white powder supplied in vials as follows:Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram (tray of 25): NDC 0409-5082-162 gram (tray of 10): NDC 0409-5084-11Also available as:Pharmacy Bulk Package Bottles: 6 gram (tray of 10): NDC 0409-5086-11ADD-Vantage Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram: NDC 0409-5092-162 gram: NDC 0409-5093-11Tazicef in the dry state should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and protected from light. Tazicef (ceftazidime for injection, USP) is a dry, white to off-white powder supplied in vials as follows:Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram (tray of 25): NDC 0409-5082-162 gram (tray of 10): NDC 0409-5084-11Also available as:Pharmacy Bulk Package Bottles: 6 gram (tray of 10): NDC 0409-5086-11ADD-Vantage Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram: NDC 0409-5092-162 gram: NDC 0409-5093-11Tazicef in the dry state should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and protected from light. Tazicef (ceftazidime for injection, USP) is a dry, white to off-white powder supplied in vials as follows:Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram (tray of 25): NDC 0409-5082-162 gram (tray of 10): NDC 0409-5084-11Also available as:Pharmacy Bulk Package Bottles: 6 gram (tray of 10): NDC 0409-5086-11ADD-Vantage Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram: NDC 0409-5092-162 gram: NDC 0409-5093-11Tazicef in the dry state should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and protected from light. Tazicef (ceftazidime for injection, USP) is a dry, white to off-white powder supplied in vials as follows:Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram (tray of 25): NDC 0409-5082-162 gram (tray of 10): NDC 0409-5084-11Also available as:Pharmacy Bulk Package Bottles: 6 gram (tray of 10): NDC 0409-5086-11ADD-Vantage Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram: NDC 0409-5092-162 gram: NDC 0409-5093-11Tazicef in the dry state should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and protected from light. Tazicef (ceftazidime for injection, USP) is a dry, white to off-white powder supplied in vials as follows:Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram (tray of 25): NDC 0409-5082-162 gram (tray of 10): NDC 0409-5084-11Also available as:Pharmacy Bulk Package Bottles: 6 gram (tray of 10): NDC 0409-5086-11ADD-Vantage Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram: NDC 0409-5092-162 gram: NDC 0409-5093-11Tazicef in the dry state should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and protected from light. Tazicef (ceftazidime for injection, USP) is a dry, white to off-white powder supplied in vials as follows:Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram (tray of 25): NDC 0409-5082-162 gram (tray of 10): NDC 0409-5084-11Also available as:Pharmacy Bulk Package Bottles: 6 gram (tray of 10): NDC 0409-5086-11ADD-Vantage Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram: NDC 0409-5092-162 gram: NDC 0409-5093-11Tazicef in the dry state should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and protected from light. Tazicef (ceftazidime for injection, USP) is a dry, white to off-white powder supplied in vials as follows:Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram (tray of 25): NDC 0409-5082-162 gram (tray of 10): NDC 0409-5084-11Also available as:Pharmacy Bulk Package Bottles: 6 gram (tray of 10): NDC 0409-5086-11ADD-Vantage Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram: NDC 0409-5092-162 gram: NDC 0409-5093-11Tazicef in the dry state should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and protected from light. Tazicef (ceftazidime for injection, USP) is a dry, white to off-white powder supplied in vials as follows:Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram (tray of 25): NDC 0409-5082-162 gram (tray of 10): NDC 0409-5084-11Also available as:Pharmacy Bulk Package Bottles: 6 gram (tray of 10): NDC 0409-5086-11ADD-Vantage Vials: equivalent to 1 gram and 2 grams of ceftazidime.1 gram: NDC 0409-5092-162 gram: NDC 0409-5093-11
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Mechanism of Action
Ceftazidime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Ceftazidime has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria.
Mechanism of Resistance
Resistance to ceftazidime is primarily through hydrolysis by beta-lactamase, alteration of penicillin-binding proteins (PBPs), and decreased permeability.
Interaction with Other Antimicrobials
In an study, antagonistic effects have been observed with the combination of chloramphenicol and ceftazidime.
Ceftazidime has been shown to be active against most isolates of the following bacteria, both and in clinical infections as described in the section:
Gram-negative bacteria
Gram-positive bacteria
Anaerobic bacteria
The following data are available, but their clinical significance is unknown. At least 90 percent of the following microorganisms exhibit an minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for ceftazidime. However, the efficacy of ceftazidime in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials.
Gram-negative bacteria
Gram-positive bacteria
Anaerobic bacteria
Non-Clinical Toxicology
TazicefBEFORE THERAPY WITH TAZICEF IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFTAZIDIME, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS- HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBACTERIAL DRUGS HAVE BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO TAZICEF OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IV FLUIDS, IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
Clostridium difficile
C. difficile
C. difficile
C. difficile
If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of , and surgical evaluation should be instituted as clinically indicated.
Elevated levels of ceftazidime in patients with renal insufficiency can lead to seizures, nonconvulsive status epilepticus (NCSE), encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia (see ).
Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibacterial drugs or potent diuretics such as furosemide. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs. Nephrotoxicity and ototoxicity were not noted when ceftazidime was given alone in clinical trials.
Chloramphenicol has been shown to be antagonistic to beta-lactam antibacterial drugs, including ceftazidime, based on studies and time kill curves with enteric gram-negative bacilli. Due to the possibility of antagonism , particularly when bactericidal activity is desired, this drug combination should be avoided.
In common with other antibacterial drugs, ceftazidime may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
High and prolonged serum ceftazidime concentrations can occur from usual dosages in patients with transient or persistent reduction of urinary output because of renal insufficiency. The total daily dosage should be reduced when ceftazidime is administered to patients with renal insufficiency (see ). Elevated levels of ceftazidime in these patients can lead to seizures, nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organisms.
As with other antibacterial drugs, prolonged use of Tazicef (ceftazidime for injection, USP) may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient's condition is essential.
If superinfection occurs during therapy, appropriate measures should be taken.
Inducible type I beta-lactamase resistance has been noted with some organisms (e.g., spp., spp., and spp.). As with other extended-spectrum beta-lactam antibacterial drugs, resistance can develop during therapy, leading to clinical failure in some cases.
When treating infections caused by these organisms, periodic susceptibility testing should be performed when clinically appropriate. If patients fail to respond to monotherapy, an aminoglycoside or similar agent should be considered.
Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal and hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.
Tazicef should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Distal necrosis can occur after inadvertent intra-arterial administration of ceftazidime.
Prescribing Tazicef (ceftazidime) in the absence of a 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.
Ceftazidime is generally well tolerated. The incidence of adverse reactions associated with the administration of ceftazidime was low in clinical trials. The most common were local reactions following IV injection and allergic and gastrointestinal reactions. Other adverse reactions were encountered infrequently. No disulfiram-like reactions were reported.
The following adverse effects from clinical trials were considered to be either related to ceftazidime therapy or were of uncertain etiology:
Local Effects,
Hypersensitivity Reactions,
Gastrointestinal Symptoms,
Central Nervous System Reactions
Seizures have been reported with several cephalosporins, including ceftazidime. In addition, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported in renally impaired patients treated with unadjusted dosing regimens of ceftazidime (see ).
Less Frequent Adverse Events
Hematologic
Rare cases of hemolytic anemia have been reported.
Laboratory Test Changes
Postmarketing Experience with Tazicef (ceftazidime for injection, USP) Products
In addition to the adverse events reported during clinical trials, the following events have been observed during clinical practice in patients treated with Tazicef and were reported spontaneously. For some of these events, data are insufficient to allow an estimate of incidence or to establish causation.
General
Anaphylaxis; allergic reactions, which, in rare instances, were severe (e.g., cardiopulmonary arrest); urticaria; pain at injection site.
Hepatobiliary Tract
Hyperbilirubinemia, jaundice.
Renal and Genitourinary
Renal impairment.
Cephalosporin-Class Adverse Reactions
In addition to the adverse reactions listed above that have been observed in patients treated with ceftazidime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibacterial drugs:
Adverse Reactions
Colitis, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage.
Altered Laboratory Tests
Prolonged prothrombin time, false-positive test for urinary glucose, pancytopenia.
To report , contact Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).