Source: Health Sciences Authority (SG) Revision Year: 2020 Publisher: United Italian Trading Corporation (Pte) Ltd, 28 Tai Seng Street, #06-01 Singapore, 534106, Tel: +65 6284 8889 Name and adress of manufacturer: Pharma Vision San. Ve Tic. A.Ş., Davutpaşa Caddesi No: 145, ...
It is contraindicated in patients allergic to Cephalosporin group of antibiotics, penicillins and beta-lactam antibiotics or any of the excipients.
In patients decreasing in urinary excretion due to renal failure (creatinine clearance ≤50 mL/min) or in patients with other diseases suppressing renal function, dose of ROXIPIME should be adjusted to compensate the slower rate of renal elimination. Because high and prolonged antibiotic concentrations may occur from usual dosages in patients with renal impairment or other conditions that may compromise renal function, the maintenance dosage should be reduced when Cefepime is administered to patients. Maintenance dosage should be determined according to degree of renal impairment, severity of infection, and susceptibility of the causative organism (see, section 4.2). In safety research after drug is presented to use, backreflexive encephalopathy (loss of consciousness including confusion, hallucinations, stupor and coma), myoclonus, seizures (including non-convulsive epileptic state), and/or renal impairment has been recorded (see, section 4.8). Many of these cases occurred in patients with renal impairment and who are taken doses of ROXIPIME that exceeded the recommended dosages. In general, symptoms of neurotoxicity disappears after discontinuation of cefepime and/or after hemodialysis but some cases have been fatal.
In patients (adult and pediatric) at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying haematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients.
Cefepime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. If neutropenia occurs as a result of prolonged therapy, cefepime should be discontinued and alternative antibiotic therapy used.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ROXIPIME, and may range in severity from mild diarrhea to fatal colitis. Because up to two months after the use of antibacterial agents, diarrhea related with C. difficile has been reported, conscious drug use is needed in this duration. If CDAD is diagnosed or this diagnosis is suspected, continuing and not directed against C. difficile antibiotic use may need to be discontinued.
Renal function should be monitored carefully if drugs with a nephrotoxic potential such as aminoglycosides and potent diuretics are administered with ROXIPIME.
Particularly in patients showing allergic reaction to drugs, antibiotics should be administered carefully. If an allergic reaction occurs in administration of ROXIPIME, drug should be discontinued immediately and the necessary treatment should be administered to the patient. If serious hypersensitivity reactions are seen, epinephrine or other supporting treatment may be required.
As with other antibiotics, ROXIPIME may lead to overgrowth of non-susceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken.
In clinical studies, 16% of more than 6400 adults treated with cefepime were 75 years old and older and 35% of them are 65 years and older. In clinical studies, in elderly patients received the usual recommended adult dose, in case of not have renal impairment, clinical efficacy and safety of cefepime is reported not to be different from adults. Compared to younger patients, a little prolongation in the elimination half-life and decrease in renal clearance values are observed. Dose adjustment in elderly patients with reduced renal function is recommended. (See;Section 4.2).
Cefepime is known to be substantially excreted by the kidney, and the risk of toxic reactions of this drug may be greater in patients with impaired renal function.
In patients with creatinine clearance less than 60 mL/min, dose of cefepime should be decreased absolutely.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal functions should be monitored (See, Section 4.4 and 4.8 and 5.2).
Back-reflexive encephalopathy (loss of consciousness including confusion, hallucinations, stupor), myoclonus, seizures (including non-convulsive epileptic state), and/or renal impairment have occurred with normal doses of Cefepime in elderly patients with renal insufficiency (See, Section 4.4 and 4.8).
If the findings of non-compulsive status epileticus (mental status change, confusion and reaction- including extension of time of response) or seizure are occurred, it should be evaluated that stopping cefepime or dose adjustment should be done.
Solutions of ROXIPIME like many beta-lactam antibiotics should not be mixed to metronidazole, vancomycin, gentamicin, tobramycin sulfate and netilmicin sulfate solution due to potential interaction. Because physical or chemical instability are possible. However, if concurrent therapy with ROXIPIME is necessary, these antibiotics should be administered separately.
Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with ROXIPIME because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Probenecid reduces kidney tubular secretion and cause to increase elimination life of cephalosporins excreted by this way and toxicity risk. Nephrotoxicity has been reported following concomitant administration of cephalosporins with potent diuretics such as furosemide.
In patients treated with ROXIPIME, false positive glycosuria reactions may occur. False positive reactions with methods suppressing glucose oxidase have not been observed.
Pregnancy Category: B.
In organogenesis period, in rats up to 1000mg/kg/day dose (1.6 times of maximum recommended daily human dose calculated on the basis mg/m²), in mice up to 1200mg/kg/day dose (maximum recommended daily human dose calculated on the basis mg/m²) or in rabbits up to100mg/kg/day dose (0.3 times of maximum recommended daily human dose calculated on the basis mg/m²), administered cefepime is not teratogenic or embryocidal. ROXIPIME may reduce the effectiveness of birth control pills and cause pregnancy.
There are no adequate clinical data for cefepime for exposure in pregnancy. Studies on animals does not show that there are direct or indirect harmful effects regarding pregnancy/embryonal/fetal development/birth or postnatal development. Caution should be taken when prescribing to pregnant women.
Cefepime is excreted by breastmilk in very low concentrations. Care should be taken while cefepime is administered to nursing women.
No lack of fertility was observed in rats.
Effects of ROXIPIME on ability to drive and use machines have not been examined.
ROXIPIME is generally well tolerated. In clinical trials (N=5598) the most common side effects regarding to ROXIPIME were gastrointestinal symptoms and hypersensitivity reactions.
Side effects associated with ROXIPIME are as follows:
Following frequency groups are used: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data).
Very common: redness, rash, urticaria
Very common: Headache
Common: dizziness, paresthesia
Common: Vasodilation
Common: Dyspnea
Very common: Nausea, vomiting, oral moniliasis, diarrhea, colitis (including pseudomembranous colitis)
Common: abdominal pain, constipation
Very common: Fever, vaginitis, erythema
Common: genital pruritus, taste disorders, tremors and non-specific moniliasis
Clinically significant events seen less frequently than 0.05% are anaphylaxis and seizures.
Local reactions such as phlebitis (2.9%) and inflammation (0.1%) at the site of I.V. infusion may occur. These reactions occurred in 5.2% of patients.
In addition to the side effects reported during North American clinical trials with cefepime, the following adverse experiences have been reported during worldwide post marketing experience. However, because of the uncontrolled spontaneous reports, these side effects could not be determined whether or not it is connected to ROXIPIME.
As with other drugs in the same class, encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor and coma), seizures, myoclonus, and/or renal impairment have been recorded. Many of these are occurred in patients with renal impairment and received doses of ROXIPIME that exceeded the recommended dosage.
As in other cephalosporins, anaphylaxis including anaphylactic shock, transient leukopenia, neutropenia, agranulocytosis and thrombocytopenia has been recorded.
Side effects were registered when the cephalosporin group of antibiotics is used and varying laboratory findings are as follows: Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage and false positive test for urine glucose.
Laboratory Test Abnormalities that developed during clinical trials in patients with normal baseline values were transient. Temporary laboratory test abnormalities occurred at a frequency between 1% and 2% (unless otherwise noted) are: alanine aminotransferase (3.6%), aspartate aminotransferase (2.5%), alkaline phosphatase, total bilirubin, anemia, eosinophilia, prolonged prothrombin time, partial thromboplastin time (2.8%); positive Coombs' test without hemolysis (18.7%). Transient elevations of blood urea nitrogen and/or serum creatinine and transient thrombocytopenia were observed in 0.5% to 1% of patients. Transient leukopenia and neutropenia were also seen (<0.5%).
ROXIPIME safety profile recorded in children are similar in adults. In clinical trials, the most common recorded side effect is rash.
Solutions of ROXIPIME like many beta-lactam antibiotics should not be mixed to metronidazole, vancomycin, gentamicin, tobramycin sulfate and netilmicin sulfate solution due to potential interaction. Because of physical or chemical incompatibility are present. However, if concurrent therapy with ROXIPIME is necessary, each of these antibiotics should be administered separately.
It is recommended not to mix ROXIPIME and other drugs, when administering intravenously.
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