FORTUM 1GM INJECTION
Ceftazidime (Fortum) for powder for injection/infusion contains 500 mg, 1 g, 2 g ceftazidime (as pentahydrate).
Ceftazidime pentahydrate is formulated in a mixture with sodium carbonate. When constituted, this mixture provides a solution of ceftazidime sodium.
Indications / Uses :
Treatment of single or multiple infections caused by susceptible organisms.
May be used alone as first choice drug before the results of sensitivity tests are available.
May be used in combination with an aminoglycoside or most other beta-lactam antibiotics.
May be used with an antibiotic against anaerobes when the presence of Bacteroides fragilis is suspected.
Susceptibility to Ceftazidime (Fortum) will vary with geography and time and local susceptibility data should be consulted where available (see Pharmacology: Pharmacodynamics: Pharmacodynamic Effects under Actions).
Indications include: Severe infections e.g. septicaemia, bacteraemia, peritonitis, meningitis; infections in immunosuppressed patients; infections in patients in intensive care, e.g. infected burns.
Respiratory tract infections including lung infections in cystic fibrosis; ear, nose and throat infections; urinary tract infections; skin and soft tissue infections; gastrointestinal, biliary and abdominal infections; bone and joint infections; infections associated with haemo- and peritoneal dialysis and with continuous ambulatory peritoneal dialysis (CAPD); prophylaxis [prostatic surgery (transurethral resection)].
Patients with known hypersensitivity to cephalosporin antibiotics; hypersensitivity to ceftazidime pentahydrate or to any of the excipients of the injection.
Special Precautions :
Before beginning treatment establish whether the patient has a history of hypersensitivity reactions to ceftazidime, cephalosporins, penicillins or other drugs.
Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams.
If an allergic reaction to Ceftazidime (Fortum) occurs discontinue the drug. Serious hypersensitivity reactions may require epinephrine (adrenaline), hydrocortisone, antihistamine or other emergency measures.
Concurrent treatment with high doses of cephalosporins and nephrotoxic drugs such as aminoglycosides or potent diuretics (e.g. furosemide) may adversely affect renal function. Clinical experience has shown that this is not likely to be a problem with Ceftazidime (Fortum) at the recommended dose levels. There is no evidence that Ceftazidime (Fortum) adversely affects renal function at normal therapeutic doses.
Ceftazidime is eliminated via the kidneys, therefore the dosage should be reduced according to the degree of renal impairment. Neurological sequelae have occasionally been reported when the dose has not been reduced in patients with renal impairment (see Renal Impairment under Dosage & Administration and Adverse Reactions).
As with other broad spectrum antibiotics, prolonged use may result in the overgrowth of non-susceptible organisms (e.g. Candida, enterococci) which may require interruption of treatment or appropriate measures. Repeated evaluation of the patient’s condition is essential.
Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. If prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.
As with other extended-spectrum cephalosporins and penicillins, some initially susceptible strains of Enterobacter spp. and Serratia spp. may develop resistance during Ceftazidime (Fortum) therapy. When clinically appropriate during therapy of such infections, periodic susceptibility testing should be considered.
Effects on Ability to Drive and Use Machines: None reported.