American C4-Axetil-250 Tablets

INFORMATION FOR THE USER

Cefuroxime axetil 250mg Tablets

Read all of this information carefully before you start taking this medicine because it contains important information for you.
Keep this information. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine is prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this information.

COMPOSITION:
Each tablet contains:
Cefuroxime axetil – 250mg

For oral use only.

DESCRIPTION:
Cefuroxime is an anti-bacterial. It belongs to the class of anti bacterials known as cephalosporins and is highly useful in curing bacterial infections. Cefuroxime axetil is the pro drug of cefuroxime and is converted to cefuroxime in the body via metabolic processes.

PHARMACOLOGICAL 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.
CLINICAL PHARMACOKINETICS:
After oral administration cefuroxime axetil is absorbed from the GI tract & rapidly hydrolysed in the intestinal mucosa & blood to release cefuroxime into circulation. Optimum absorption occurs when administered shortly after meal. Peak serum levels (2.9 μg/mL for a 125 mg dose, 4.4 μg/mL for a 250 mg dose, 7.7 μg/mL for a 500 mg dose and 13.6 μg/mL for a 1000 mg dose) occur 2.4 hours after dosing when taken with food. The pharmacokinetics are linear over the oral dosage range of 125 to 1000 mg. No accumulation of cefuroxime occurs following repeat oral doses of 250-500 mg. Protein binding has been stated as 33-50%. The apparent volume of distribution was 50 L. Concentrations in excess of the minimum inhibitory levels for common pathogens can be achieved in the tonsilla, sinus tissues, bronchial mucosa, bone, pleural fluid, joint fluid, synovial fluid, interstitial fluid, bile, sputum & aqueous humor. It passes the blood-brain barrier when the meninges are inflamed. It is not metabolised. Serum half-life is between 1-1.5 hours. It is excreted by glomerular filtration & tubular secretion. The renal clearance is in the region of 125-148 mL/min/1.73 m2.
INDICATIONS:
Cefuroxime axetil is indicated for the treatment of the infections listed below in adults and children from the age of 3 months:
Acute streptococcal tonsillitis and pharyngitis
Acute bacterial sinusitis
Acute otitis media
Acute exacerbations of chronic bronchitis
Cystitis
Pyelonephritis.
Uncomplicated skin and soft tissue infections
Treatment of early Lyme disease

CONTRAINDICATIONS:
The use of cefuroxime axetil is contraindicated in:
Hypersensitivity to the active substance or to any of the excipients.
Patients with known hypersensitivity to cephalosporin antibiotics. 
History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of betalactam antibacterial agent (penicillins, monobactams and carbapenems).

WARNINGS AND PRECAUTIONS:
Hypersensitivity reactions: Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactam antibiotics because there is a risk of cross-sensitivity. Caution should be used if cefuroxime is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents. 
Jarisch-Herxheimer reaction: Has been seen following cefuroxime axetil treatment of Lyme disease. Patients should be reassured that this is a common and usually self-limiting consequence of antibiotic treatment of Lyme disease. 
Overgrowth of non-susceptible microorganisms: May result in the overgrowth of Candida. Prolonged use may also result in the overgrowth of other non-susceptible microorganisms (e.g. enterococci and Clostridium difficile), which may require interruption of treatment. 
Interference with diagnostic tests: The development of a positive Coomb’s Test associated with the use of cefuroxime may interfere with cross matching of blood. 
It is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving cefuroxime axetil.

ADVERSE EFFECTS:
Common adverse effects include:
Candida overgrowth
Eosinophilia
Headache, dizziness
Diarrhoea, nausea, abdominal pain, vomiting
Transient increase in hepatic enzyme levels

DRUG INTERACTIONS:
– Drugs which reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with that of the fasting state and tend to cancel the effect of enhanced absorption after food. 
– Concomitant use of probenecid is not recommended. Concurrent administration of probenecid – significantly increases the peak concentration, area under the serum concentration time curve and elimination half-life of cefuroxime. 
– Concomitant use with oral anticoagulants may give rise to increased INR.

DOSAGE:
Adults: 1-2 tablets daily.

ADMINISTRATION:
For oral administration only.
Cefuroxime axetil tablets are supplied for oral administration and should be swallowed whole with a sufficient quantity of liquid. Do not crush or chew the tablets.

STORAGE:
Do not store above 25°C. Store in the original package. Keep away from children. Do not expose to direct sunlight.

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Last revised on May 2019.