Each 5 mL of the reconstituted suspension contains: Cefixime Trihydrate eq. to. Anhydrous Cefixime, USP 100 mg.
Pharmacotherapeutic group: antibacterial for systemic use, belonging to the class of cephalosporins.
Pharmacology: Pharmacodynamics: Mode of action: Cefixime is an antibiotic belonging to the third generation cephalosporin group. Like other cephalosporins, cefixime exerts antibacterial activity by binding to and inhibiting the action of penicillin-binding proteins involved in the synthesis of bacterial cell walls. This leads to bacterial cell lysis and cell death.
Mechanism of resistance: Bacterial resistance to cefixime may be due to one or more of the following mechanisms: Hydrolysis by extended-spectrum beta-lactamases and/or by chromosomally-encoded (AmpC) enzymes that may be induced or de-repressed in certain aerobic gram negative bacterial species.
Reduced affinity of penicillin-binding proteins.
Reduced permeability of the outer membrane of certain gram-negative organisms restricting access to penicillin-binding proteins.
Drug efflux pumps.
More than one of these mechanisms of resistance may co-exist in a single bacterial cell. Depending on the mechanism(s) present, bacteria may express cross-resistance to several or all beta-lactams and/or antibacterial drugs of other classes.
Pharmacokinetics: Cefixime, given orally is about 40% to 50% absorbed whether administered with or without food; however, time for maximal absorption is increased approximately 0.8 hours when administered with food without alteration in other pharmacokinetic parameters.
A single 200 mg tablet of Cefixime produces an average peak serum concentration of approximately 2.7 mcg/mL. No biologically active metabolites of Cefixime have been discovered. It is approximately 70% protein bound. Very high concentration is found in bile and hence used in biliary tract infections.
The mean elimination half life is 3 hours. Urinary excretion accounts for between 12% to 34% of orally administered dose. The biliary recovery of Cefixime in 24 hours is 5% of orally administered dose.
The t1/2 is prolonged in patients with severely impaired renal function. Hence dosage adjustment is necessary in severe renal impairment i.e. Creatinine clearance < 20 mL/min. Peak serum concentration following oral administration of the absorbed dose is excreted unchanged in the urine in 24 hours.
Cefixime is indicated for the treatment of following infections when caused by susceptible organisms. Sequential treatment after initial I.V. Chemotherapy with parenteral cephalosporin, respiratory tract infections, otitis media, urinary tract infections, gonorrhoea and typhoid fever.
For Children: The recommended dose is 8 mg/kg/day of the suspension. This may be administered as a single dose or in two divided doses is recommended, as 4 mg/kg every 12 hours. In typhoid the dose is 20 mg/kg/day in two divided doses or as a single dose in the treatment of infections due to S. pyogenes, a therapeutic dosage of Cefixime should be administered for at least 10 days. Or as prescribed by the physician.
There is no experience with overdoses with Cefixime. Adverse reactions seen at dose levels up to 2 g of cefixime in normal subjects did not differ from the profile seen in patients treated at the recommended doses. Gastric lavage may be indicated in overdosage. No specific antidote exists. Cefixime is not removed from the circulation in significant quantities by dialysis.
Patients with known hypersensitivity to cefixime, other cephalosporin antibiotics or to any of the excipients.
Cefixime is also contraindicated in patients with previous, immediate and/or severe hypersensitivity to penicillin or any beta-lactam antibiotics and preterm and term newborn infants (0-27 days).
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 sigmoidoscopy, appropriate bacteriologic studies, fluids, electrolyte 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.
Pregnancy: For cefixime, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Caution should be exercised when prescribing to pregnant women. Cefixime should not be used in pregnant mothers unless considered essential by the physician.
Breast-feeding: It is unknown whether cefixime is excreted in human milk and non-clinical studies have shown excretion of cefixime in animal milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with cefixime should be made taking into account the benefit of breastfeeding to the child and the benefit of cefixime therapy to the woman. However, until further clinical experience is available, cefixime should not be prescribed to breast-feeding mothers.
Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self limiting in nature.
Gastrointestinal disturbances: The most frequent side effects with Cefixime are diarrhoea and stool changes. Some case of moderate to severe diarrhoea have been reported; this has occasionally warranted cessation of therapy. Cefixime should be discontinued if marked diarrhoea occurs. Other gastrointestinal side effects seen less frequently are nausea, abdominal pain, dyspepsia, vomiting and flatulence, Pseudomembranous colitis has been reported.
Central nervous system: Headache and dizziness.
Hypersensitivity reactions: Allergies in the form of rash, pruritis, urticaria, drug fever and arthralgia have been observed. These reactions usually subsided upon discontinuation of therapy.
Haematological and clinical chemistry: Thrombocytopenia, leukopenia and eosinophilia have been reported. These reactions were infrequent and reversible. Mild transient changes in liver and renal function tests have been observed.
Care should be exercised in patients receiving anticoagulants and cefixime due to possibility that cefixime may increase prothrombin times.
Direction for Reconstitution: Add boiled and cooled water up to the mark on the bottle and shake well. Adjust the volume up to the mark by adding more water if necessary. The constituted suspension should be stored in a cool place and used within 7 days.
Store at temperatures not exceeding 30°C.
J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Triocef Pfos powd for oral susp 100 mg/5mL
60 mL x 1's
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