Triolev-200/Triolev Special Precautions

Triolev-200: Encephalopathy: Beta-lactams, including Cefixime, predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.
Severe cutaneous adverse reactions: Severe cutaneous adverse reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS) have been reported in some patients on Cefixime. When severe cutaneous adverse reactions occur, Cefixime should be discontinued and appropriate therapy and/or measures should be taken. Cefixime should be given with caution to patients who have shown hypersensitivity to other drugs.
Hypersensitivity to penicillins: As with other cephalosporins, Cefixime should be given with caution to patients with a history of hypersensitivity to penicillin, as there is some evidence of partial cross-allergenicity between the penicillins and cephalosporins. Patients have had severe reactions (including anaphylaxis) to both classes of drugs. If an allergic effect occurs with Cefixime, the drug should be discontinued and the patient treated with appropriate agents if necessary.
Hemolytic anaemia: Drug-induced hemolytic anaemia, including severe cases with a fatal outcome, has been described for cephalosporins (as a class). The recurrence of hemolytic anaemia after re-administration of cephalosporins in a patient with a history of cephalosporin (including Cefixime) associated hemolytic anemia has also been reported.
Acute renal failure: As with other cephalosporins, Cefixime may cause acute renal failure including tubulointerstitial nephritis as an underlying pathological condition. When acute renal failure occurs, Cefixime should be discontinued and appropriate therapy and/or measures should be taken.
Renal impairment: Cefixime should be administered with caution in patients with markedly impaired renal function.
Use in children: Safety of Cefixime in premature or newborn infant has not been established.
Treatment with broad spectrum antibiotics alters the normal flora of the colon and may permit overgrowth of Clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of antibiotic-associated diarrhea. Pseudomembranous colitis is associated with the use of broad-spectrum antibiotics (including macrolides, semi-synthetic penicillins, lincosamides and cephalosporins); it is therefore important to consider its diagnosis in patients who develop diarrhea in association with the use of antibiotics. Symptoms of pseudomembranous colitis may occur during or after antibiotic treatment.
Management of pseudomembranous colitis should include sigmoidoscopy, appropriate bacteriologic studies, fluids, electrolytes and protein supplementation. If the colitis does not improve after the drug has been discontinued, or if the symptoms are severe, oral vancomycin is the drug of choice for antibiotic-associated pseudomembranous colitis produced by C. difficile. Other causes of colitis should be excluded.
Triolev: Cefixime should be given with caution to patients who have shown hypersensitivity to other drugs. Cephalosporins should be given with caution to penicillin-sensitive patients, as there is some evidence of partial cross-allergenicity between penicillin and cephalosporins. Patients have had severe reactions (including anaphylaxis) to both classes of drugs. Special care is indicated in patients who have experienced any allergic reaction to penicillins or any beta-lactam antibiotics as cross-reactions may occur.
If severe hypersensitivity reactions or anaphylactic reactions occur after administration of Cefixime, the medicine should be discontinued immediately and appropriate emergency measures should be initiated.
Prolonged use of cefixime may result in the overgrowth of non-susceptible organisms. Treatment with a broad spectrum of antibiotics alters the normal flora of the colon and may permit the overgrowth of Clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause for antibiotic-associated diarrhoea.
Pseudomembranous colitis is associated with the use of broad-spectrum antibiotics (including macrolides, semi-synthetic penicillins, lincosamides and cephalosporins). It is therefore important to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics.
In patients who develop severe diarrhoea during or after use of cefixime, the risk of life threatening pseudo-membranous colitis should be taken into account. The use of cefixime should be discontinued and appropriate treatment measures should be established. Management of pseudomembranous colitis should include symptomatic therapy, appropriate bacteriologic studies, fluids, electrolytes and protein supplementation. If the colitis does not improve after the drug has been discontinued or if the symptoms are severe, oral vancomycin is the drug of choice for antibiotic associated pseudomembranous colitis produced by C. difficile. Other causes of colitis should be excluded. The use of medicinal products inhibiting the intestinal peristalsis is contraindicated.
Cefixime contains sucrose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Use of Nifedipine, a calcium channel blocker, may increase bioavailability of Cefixime up to 70%.
Renal insufficiency: Cefixime should be administered with caution in adult patients with creatinine clearance <20 mL/min. There are insufficient data regarding use of cefixime in the pediatric and adolescent age group in the presence of renal insufficiency; the use of cefixime in these patient-groups is not recommended.