Cefixime is a medicine used to treat bacterial infections of different parts of the body. It belongs to the class of medicines called cephalosporins. It works by killing bacteria or inhibiting their growth. It is mostly available in capsule, tablet, and powder suspension forms. It is only indicated for Bacterial infections and does not work for viral infections, such as flu and cold.
Mechanism of Action
Cefixime is a semisynthetic cephalosporin antibacterial drug. As with other cephalosporins, the bactericidal action of Cefixime results from the inhibition of cell wall synthesis. Cefixime is stable in the presence of certain beta-lactamase enzymes. As a result, certain organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases may be susceptible to Cefixime. Antimicrobial Activity: Cefixime has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections.
Gram-positive Bacteria: Streptococcus pneumonia & Streptococcus pyogenes. Gram-negative Bacteria: Escherichia coli, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae & Proteus mirabilis.
Only 40-50% of an oral dose of Cefixime is absorbed from the gastrointestinal tract, whether taken before or after meals, although the rate of absorption may be decreased in the presence of food. Cefixime is better absorbed from oral suspension than capsules. Absorption is fairly slow; peak plasma concentrations of 2 to 3 micrograms/mL and 3.7-4.6 micrograms/mL have been reported between 2-6 hours after single doses of 200 and 400mg, respectively. The plasma half-life is usually about 3 to 4 hours and may be prolonged when there is renal impairment. About 65% of Cefixime is bound to plasma proteins. Cefixime crosses the placenta. Relatively high concentrations may be achieved in bile and urine. About 20% of an oral dose (or 50% of an absorbed dose) is excreted unchanged in the urine within 24 hours. Up to 60% may be eliminated by normal mechanisms; there is no evidence of metabolism but some are probably excreted into feces from bile. It is not substantially removed by dialysis.
Cefixime (Secure) is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months of age or older with the following infections when caused by susceptible isolates of the designated bacteria.
Uncomplicated Urinary Tract Infections: Uncomplicated Urinary Tract Infections caused by Escherichia coli and Proteus mirabilis. Otitis Media: Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes. (Efficacy for Streptococcus pyogenes in this organ system was studied in fewer than 10 infections).
Note: For patients with otitis media caused by Streptococcus pneumoniae, the overall response was approximately 10% lower for Cefixime than for the comparator. Pharyngitis and Tonsillitis: Pharyngitis and Tonsillitis are caused by Streptococcus pyogenes. Cefixime (Secure) is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of Cefixime (Secure) in the subsequent prevention of rheumatic fever are not available.
Acute Exacerbations of Chronic Bronchitis: Acute Exacerbations of Chronic Bronchitis caused by Streptococcus pneumoniae and Haemophilus influenza. Uncomplicated Gonorrhea (cervical/urethral): Uncomplicated Gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates).
Carbamazepine: Elevated Carbamazepine levels have been reported in postmarketing experience when Cefixime (Secure) is administered concomitantly. Warfarin & Anticoagulants: Increased prothrombin time, with or without clinical bleeding, has been reported when Cefixime (Secure) is administered concomitantly. Drug/Laboratory Test Interactions: A false-positive reaction for ketones in the urine may occur with tests using Nitroprusside but not with those using Nitroferricyanide. The administration of Cefixime may result in a false-positive reaction for glucose in the urine. A false-positive direct Coombs test has been reported during treatment with other cephalosporins; therefore, it should be recognized that a positive Coombs test may be due to the drug.
ADVERSE DRUG REACTIONS:
The following adverse reactions have been reported following the use of Cefixime (Secure): Gastrointestinal: Several cases of documented pseudomembranous colitis were identified in clinical trials. The onset of pseudomembranous colitis symptoms may occur during or after therapy.
Hypersensitivity Reactions: Anaphylactic/anaphylactoid reactions (including shock and fatalities), skin rashes, urticaria, drug fever, pruritus, angioedema, and facial edema. Erythema multiforme, Stevens-Johnson syndrome, and serum sickness-like reactions have been reported.
Hepatic: Transient elevations in SGPT, SGOT, alkaline phosphatase, hepatitis, and jaundice.
Renal: Transient elevations in BUN or creatinine, acute renal failure. Central Nervous System: Headaches, dizziness, seizures. Hemic and Lymphatic System: Transient thrombocytopenia, leukopenia, neutropenia, prolongation in prothrombin time, elevated LDH, pancytopenia, agranulocytosis, and eosinophilia.
Abnormal Laboratory Tests: Hyperbilirubinemia.
Other Adverse Reactions: Genital pruritus, vaginitis, candidiasis, and toxic epidermal necrolysis. Adverse Reactions Reported for Cephalosporin-class Drugs Allergic reactions, superinfection, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, and colitis. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
Store in a cool & dry place below 25ºC.
Protect from light, heat and moisture.
Keep out of reach of children.