CEROXIM . 500 mg 10 tablets

CEROXIM tablets are indicated for the treatment of the following infections caused by susceptible organisms;
   Infections of the lower respiratory tract
   Infections of the upper respiratory tract, including ENT infections
   Genitourinary tract infections
   Infections of skin and soft tissue
   Acute uncomplicated gonorrhea



CEROXIM  . 500 mg 10 tablets
 

Qualitative and quantitative composition:

Each tablet contains cefuroxime axetil equivalent to 250 mg or 500 mg cefuroxime.
 

 Formulation

 
Tablets.
 

 Clinical Data

 
Witness
CEROXIM tablets are indicated for the treatment of the following infections caused by susceptible organisms;
  Infections of the lower respiratory tract
  Infections of the upper respiratory tract, including ENT infections
  Genitourinary tract infections
  Infections of skin and soft tissue
  Acute uncomplicated gonorrhea
 
  Dosage and method of administration
 
Adults:
 
Most infections respond to a dose of 250 mg twice daily. Bronchitis 125 mg twice daily dose is usually adequate. For pneumonia, severe ENT infections or skin and soft tissue should be given as 500 mg twice daily. A single 1 g dose is recommended in treating uncomplicated gonorrhea st.
 
Children over 5 years of age (who can swallow tablets whole):
 
The usual dose is 125 mg twice daily. In otitis recommended 250 mg twice daily.
 
Elderly and patients with impaired renal function
 
There is no need to take special measures in patients with renal impairment or in patients undergoing hemodialysis, and in elderly patients with normal dosage not to exceed a maximum dose of 1 g daily.
 
CEROXIM tablets should be taken 15 to 30 minutes after meals for optimal absorption.
 
 Contraindications
 
Cefuroxime axetil is contraindicated in patients with known hypersensitivity to antibiotics such as cephalosporins or to any of the excipients of the tablet CEROXIM.
 
 
 Special warnings and precautions for use
 
Because cross-sensitivity between the two groups-beta-lactam penicillins and cephalosporins (5-10%), special care is indicated in patients with a history of previous manifestations of allergy (especially anaphylaxis) caused by penicillin.
 
As with other broad-spectrum antibiotics, prolonged use of cefuroxime axetil may result in overgrowth of non-susceptible organisms (eg Candida, Enterococci, Clostridium difficile), which may necessitate discontinuation of therapy.
 
Pseudomembranous colitis has been reported with the use of broad-spectrum antibiotics, which is why it is important to bear in mind its diagnosis in patients who have severe diarrhea during or after antibiotic use. If superinfection occur during therapy should be discontinued cefuroxime axetil and treated appropriately (eg oral vancomycin 250 mg four times daily). You have to identify the pathogen. Medicinal products that inhibit peristalsis are contraindicated.
 
 
 Interactions
 
Probenecid slows excretion of cefuroxime by reducing its renal tubular sekretsiya.Nefrotoksichnost: renal function has been observed after administration of antibiotics in this group, especially after use with aminoglycosides. Potent diuretics such as furosemide and ethacrynic acid increases the risk of nephrotoxicity of cephalosporins.
 
You can get a positive reaction to Coombs in patients taking cephalosporins. In patients receiving cefuroxime axetil for blood / plasma glucose levels, it is recommended to use either the glucose oxidase or hexokinase method. This antibiotic does not interfere with alkaline picrate creatinine measurement.
 
  Pregnancy and lactation
 
No experimental evidence embriopatichen or teratogenic effect of cefuroxim axetil, but as with other drugs, it should be administered with caution during the early months of pregnancy. Cefuroxime is excreted in breast milk, so it is necessary to caution his appointment in lactating women. The possibility of sensitization, diarrhea or colonization of the mucous membranes of the yeast cell fungi should not be excluded in infants who breastfeed.
 Ness effects to drive and use machines
 
No data cefuroxime to have any effect on ability to drive and use machines.
 
  Adverse reactions
 
Commonly occurring side effects include: nausea, vomiting, abdominal cramps, mild diarrhea, svahchuvstvitelnost reactions, eosinophilia and transient increase in serum AST, ALT and LDH. Can often arise: glavrbolie, rash, chest pain, ulcers in the mouth and drowsiness. Rarely: muscle cramps, tachycardia, and vaginosis.
 
 
 Overdose
 
Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Plasma levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.
 

 Pharmacological

 
 Pharmacodynamic properties
 
Mode of action
 
In vivo bactericidal activity of cefuroxime axetil is due to the derivative component cefuroxime. Cefuroxime is a well known and effective antibacterial agent whose broad spectrum of bactericidal activity against a large number of common pathogens including beta-lactamase producing strains. Cefuroxime has good stability to bacterial beta-lactamase and consequently is active against many strains resistant to ampicillin and amoxicillin. The bactericidal action of cefuroxime results from inhibition of bacterial cell wall synthesis by binding to essential target proteins.
 
Antibacterial spectrum of cefuroxime includes the following organisms In vitro:
 
Susceptible and moderately susceptible organisms: Aerobic
 
Gram-(+);
 
Staphylococcus aureus (including penicillinases producing strains but excluding methicillin-resistant strains) Staphylococcus epidermidis (including penicillinases producing strains but excluding methicillin-resistant strains) Streptococcus pneumoniaeStreptococcus pyogenes (and beta-hemolytic streptococci) Streptococcus Group B (Streptococcus agalactiae) Propionibacterium spp.
 
 
Gram-(-): Escherichia coli Haemophilus influenzae (including ampicillin-resistant strains of Haemophilus parainfluenzae Klebsiella spp Moraxefla catarrhalis Neisseria gonorrhoeae (including penicillinases and nepenitsilaza producing strains).
 
Proteus mirabilisProteus inconstansProteus rettgeriProvidencia spp
 
Anaerobes
 
Gram-(+) and Gram-(-) cocci (including Peptococcus and Peptostreptococcus spp) Gram-(+) bacilli (including Clostridium spp) Gram-(+) bacilli (including Bacteroides and Fusobacterium).
 
Other microorganisms
 
Borrelia burgdorferi.
 
Resistant microorganisms:
 
Aerobes
 
Gram-(+): Listeria strains monocytogenesOpredeleni enterococci, and Streptococcus faecalis, ca rezistentni.Gram-(-): Acinetobacter calcoaceticus, Campylobacter spp, Legionella spp, Pseudomonas sppNyakoi strains of Citrobacter spp, Enterobacter spp, and Morganella morganii are shown in in vitro testing resistance to cefuroxime and other beta-lactam antibiotitsi.Povecheto strains Proteus vulgaris and Serratia are resistant to many cephalosporins, including cefuroxime.
 
Anaerobes
 
Most strains of Bacteroides fragilis are resistant.
 
Most strains of Clostridium difficile are resistant to cefuroxime.
 
  Pharmacokinetics
 
Cefuroxime axetil is well absorbed from the gastrointestinal tract after oral administration and is rapidly hydrolyzed by nonspecific esterases in the intestinal mucosa and blood to cefuroxime. Its absorption is greater when taken after meals. Peak plasma concentrations are reached 2-3 hours after oral administration. Plasma protein binding is about 33%. Cefuroxime is widely distributed in the body including pleural fluid, sputum, bone, synovial fluid, body fluid, and cerebrospinal fluid (with inflamed meninges). Cefuroxime is excreted by glomerular filtration and renal tubular secretion, reaching high concentrations in urine. The half-life is about 70 minutes.
 
  Preclinical safety data
 
Animal studies gave no evidence of carcinogenic potential, such is not found in cefuroxime axetil in micronucleus tests and a series of tests for bacterial mutation. Reproduction studies in rats at doses up to 1000 mg / kg daily (nine times the maximum recommended human dose based on mg / m2) no evidence of impaired fertility.
 

 Pharmaceutical Data

 
List of excipients
 
Sodium Lauryl Sulphate 50.00
 
Colloidal Anhydrous Silica 10.00
 
Microcrystalline cellulose 49.88
 
Calcium carbonate 15.00
 
Croscarmellose sodium 60.00
 
Sucrose 80.00
 
Povidone 35.00
 
Monosodium citrate 50.00
 
Stearic acid 10.00
 
 Incompatibilities
 
No.
 
Expiration date
 
2 years
 
  Special precautions for storage
 
Store at temperatures below 25 ° C in the original package.
 
Keep away from moisture.
 
  Packaging Data
 
P \ / C / Aslar blister strips of 10 tablets packed in a cardboard box.