Miroxime-500
Miroxime-500
Cefuroxime Axetil Tablets
USP 500 mg
DESCRIPTION
White colored oval shape standard concave, film coated tablet plain on both sides. CLINICAL PHARMACOLOGY
Pharmacodynamics
Mechanism of action:
Cefuroxime axetil undergoes hydrolysis by esterase enzymes to the active antibiotic, cefuroxime.
Cefuroxime inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs). This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death. Mechanism of resistance: Organisms that have acquired resistance to other injectable cephalosporins are expected to be resistant to cefuroxime. Depending on the mechanism of resistance, organisms with acquired resistance to penicillins may demonstrate reduced susceptibility or resistance to cefuroxime.
Pharmacokinetics
Absorption: After oral administration cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolysed in the intestinal mucosa and blood to release cefuroxime into the circulation. Optimum absorption occurs when it is administered shortly after a meal.
Distribution:
Protein binding has been stated as 33 to 50% depending on the methodology used. Following a single dose of cefuroxime axetil 500 mg tablet to 12 healthy volunteers, the apparent volume of distribution was 50 L (CV%=28%).
Biotransformation: Cefuroxime is not metabolised.
Elimination: The serum half-life is between 1 and 1.5 hours. Cefuroxime is excreted by glomerular filtration and tubular secretion. The renal clearance is in the region of 125 to 148 mL/min/1.73 m'.
Special patient populations
Paediatric population: There is no clinical triai data available on the use of cefuroxime axetil in children under the age of 3 months.
Renal impairment: The safety and efficacy of cefuroxime axetil in patients with renal failure have not been established.
Hepatic impairment: There are no data available for patients with hepatic impairment.
PK/PD relationship: For cephalosporins, the most important pharmacokinetic-pharmacodynamic index correlating with in vivo efficacy has been shown to be the percentage of the dosing interval (%T) that the unbound concentration remains above the minimum inhibitory concentration (MIC) of cefuroxime for individual target species (i.e. %T>MIC).
INDICATIONS AND USAGE
White colored oval shape standard concave, film coated tablet plain on both sides. CLINICAL PHARMACOLOGY
Pharmacodynamics
Mechanism of action:
Cefuroxime axetil undergoes hydrolysis by esterase enzymes to the active antibiotic, cefuroxime.
Cefuroxime inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs). This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death. Mechanism of resistance: Organisms that have acquired resistance to other injectable cephalosporins are expected to be resistant to cefuroxime. Depending on the mechanism of resistance, organisms with acquired resistance to penicillins may demonstrate reduced susceptibility or resistance to cefuroxime.
Pharmacokinetics
Absorption: After oral administration cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolysed in the intestinal mucosa and blood to release cefuroxime into the circulation. Optimum absorption occurs when it is administered shortly after a meal.
Distribution:
Protein binding has been stated as 33 to 50% depending on the methodology used. Following a single dose of cefuroxime axetil 500 mg tablet to 12 healthy volunteers, the apparent volume of distribution was 50 L (CV%=28%).
Biotransformation: Cefuroxime is not metabolised.
Elimination: The serum half-life is between 1 and 1.5 hours. Cefuroxime is excreted by glomerular filtration and tubular secretion. The renal clearance is in the region of 125 to 148 mL/min/1.73 m'.
Special patient populations
Paediatric population: There is no clinical triai data available on the use of cefuroxime axetil in children under the age of 3 months.
Renal impairment: The safety and efficacy of cefuroxime axetil in patients with renal failure have not been established.
Hepatic impairment: There are no data available for patients with hepatic impairment.
PK/PD relationship: For cephalosporins, the most important pharmacokinetic-pharmacodynamic index correlating with in vivo efficacy has been shown to be the percentage of the dosing interval (%T) that the unbound concentration remains above the minimum inhibitory concentration (MIC) of cefuroxime for individual target species (i.e. %T>MIC).
INDICATIONS AND USAGE
- For acute streptococcal tonsillitis and pharyngitis.
- For acute bacterial sinusitis.
- For acute otitis media.
- For acute exacerbations of chronic bronchitis.
- For cystitis
- For pyelonephritis:
- For uncomplicated skin and soft tissue infections.
- For treatment of early Lyme disease.
- Consideration should be given to official guidance on the appropriate use of antibacterial agents.
CONTRA-INDICATIONS
