CEFTADIME 500
-
Chemical Name:
Ceftazidime -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Broad Spectrum Antibiotic -
Pharmaceutical Form:
Vial -
Composition:
Ceftazidime 500mg
CEFTADIME
For Injection (Vial)
Ceftazidime
1-PHARMACOLOGICAL PROPERTIES:
Ceftazidime is a third generation bactericidal cephalosporin antibiotic which is resistant to most beta-lactamases and is active against a wide range of gram-positive and gram-negative bacteria especially pseudomonas spp.
Ceftazidime is exerting its effect by inhibition of enzymes responsible for bacterial cell wall synthesis, including strains resistant to gentamycin and other aminoglycosides.
2-INDICATIONS:
CEFTADIME is indicated for the treatment of single infections and for mixed infections caused by two or more susceptible organisms. CEFTADIME, because of its broad antibacterial spectrum, may be used alone as first choice drug, depending on sensitivity test results.
The indications of CEFTADIME include:
-Biliary-tract infections.
-Cystic fibrosis (Respiratory-tract infections).
-Infections in immunocompromised patients (Neutropenia).
-Meningitis.
-Peritonitis.
-Pneumonia.
-Septicaemia.
-Skin infections (including burns, ecthyma gangrenosum, and ulceration).
3-CONTRAINDICATIONS:
CEFTADIME is contra-indicated in patients with known hypersensitivity to cephalosporin antibiotics.
4-WARNINGS:
As with other broad spectrum antibiotics, prolonged use of CEFTADIME may result in overgrowth of non-susceptible organisms (e.g., Candida, Enterococci) which may require interruption of treatment or adoption of appropriate measures.
The physician should be notified of any allergic symptoms or allergy already happened during a previous treatment with penicillin or cephalosporin.
If an allergic reaction to CEFTADIME occurs, the drug should be discontinued immediately. Serious acute hypersensitivity reactions may require emergency treatment measures.
Pseudomembranous colitis has been reported with the use of cephalosporin (and other broad spectrum antibiotics); therefore, it is important to consider its diagnosis in patients who develop diarrhea in association with antibiotic use. Treatment with broad spectrum antibiotics alters normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by clostridium difficile is one primary cause of antibiotic-associated colitis.
Cholestyramine and colestipol resins have been shown to bind to the toxin in vitro.
Mild cases of colitis may respond to drug discontinuation alone. Moderate to severe cases should be managed with fluid, electrolyte, metronidazole and protein supplementation as indicated.
When the colitis is not relieved by drug discontinuation or when it is severe, oral vancomycin is the treatment of choice for antibiotic-associated pseudomembranous colitis produced by c.difficile. Other causes of colitis should also be considered.
5-PRECAUTIONS:
Great care should be taken in patients who have experienced an anaphylactic reaction to penicillins.
Cephalosporin antibiotics at high dosage should be given with caution to patients receiving concurrent treatment with nephrotoxic drugs like aminoglycosides and potent diuretics.
Clinical experience with CEFTADIME has shown that this is not likely to be a problem at the recommended dose levels, as with all drugs.
6-PREGNANCY & LACTATION:
CEFTADIME should be administered with caution during the early months of pregnancy and in early infancy. CEFTADIME is excreted in human milk in low concentrations and it should be given with caution in lactating mothers.
7-SIDE EFFECTS:
CEFTADIME is generally well tolerated with only infrequent adverse reactions, e.g., pain and/or inflammation after I.M. administration, phlebitis and/or thrombophlebitis after I.V. administration, rashes, fever, pruritus, anaphylaxis, gastrointestinal disturbances, headache, dizziness, paraesthesia and bad taste.
Transient changes in laboratory values may occur including: eosinophilia, a positive coomb’s test, thrombocytosis, leukopenia, thrombocytopenia and slight rises in hepatic enzymes.
8-DRUG & LABORATORY INTERACTIONS:
-CEFTADIME does not interfere with enzyme-based tests for glycosuria. Slight interference with copper reduction methods may be observed.
-CEFTADIME does not interfere in the alkaline picrate assay for creatinine.
-CEFTADIME and aminoglycosides should not be mixed in the same giving set or syringe.
9-DOSAGE & ADMINISTRATION:
Adults:
CEFTADIME 1 g to 6 g I.M. or I.V. per day and by the I.P. route 125 to 250 mg per two liters of dialysis fluid. Divided into doses of ( 8 – 12 ) hours.
Urinary tract infections: 500 mg – 1 g each 12 hours.
Bone and joint infections: 2 g each 12 hours.
Respiratory tract infections: 500 mg – 1 g each 8 hours.
Gynecological infections: 2 g each 8 hours.
Meningitis: 2 g each 8 hours.
Neonates, infants and children:
Up to two months: 25 to 60 mg/kg/day given as two divided doses has proved to be effective. In the neonates the serum half-life of ceftazidime can be three to four times that in adults.
Over two months: 30 to100 mg/kg/day given as two or three divided doses.
Dosage in renal impairment:
In impaired renal function, the dosage of ceftazidime should be reduced when the glomerular filtration rate (GFR) falls below 50 ml/min. An initial loading dose of 1 g may be given to patients with suspected renal insufficiency. Maintenance Dose depends on creatinine clearance value.
RECONSTITUTION:
CEFTADIME 500:
(IM): Add 1.5 mL of diulent to the vial and shake well and inject after 1 –2 minutes.
(IV): Add 5 mL of diluent to the vial and shake well to dissolve and inject after 1 –2 minutes.
CEFTADIME 1000:
(IM): Add 3 mL of diulent to the vial and shake well and inject after 1 –2 minutes.
(IV): Add 10 mL of diluent to the vial and shake well to dissolve and inject after 1 –2 minutes.
10-PACKAGING & COMPOSITION:
-CEFTADIME 500 – For Injection: A pack of 1 vial. Each vial contains sterile Ceftazidime (Pentahydrate) 500 mg.
-CEFTADIME 1000 – For Injection: A pack of 1 vial. Each vial contains sterile Ceftazidime (Pentahydrate) 1000 mg.
11-STORAGE CONDITIONS:
Store CEFTADIME – For Injection at temperature between (15 – 30)°C. Protect from light.
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