CEFURO-XLEach 5 ml of the reconstituted suspension contains: Cefuroxime axetil USP eq. to cefuroxime 125 mg.

CEFURO- XL-250Each film coated Tablets contains: Cefuroxime axetil USP eq. to anhydrous cefuroxime    250 mg

.CEFURO- XL-500Each film coated Tablet contains: Cefuroxime axetil USP eq. to anhydrous cefuroxime   500 mg. 

PHARMACOLOGICAL CLASSIFICATION  Beta lactum antibiotic (Antibacterial agent) 

MECHANISM OF ACTION:
Cefuroxime, like the penicillins, is a beta-lactam antibiotic. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, it inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cefuroxime interferes with an autolysin inhibitor.

PHARMACOKINETICS: Cefuroxime axetil is absorbed from the gastrointestinal tract and is rapidly hydrolysed in the intestinal mucosa and blood to cefuroxime; absorption is enhanced in the presence of food. Peak plasma concentration is reported about 2 to 3 hours after an oral dose. Up to 50% of cefuroxime in the circulation is bound to plasma proteins. The plasma half life is about 70 minutes and is prolonged in patients with renal impairments and in neonates.cefuroxime axetil is widely distributed in the body including plural fluid, sputum bone synovial fluid, and aqueous humour, but only achieves therapeutic concentration in the CSF when the meninges are inflamed. It crosses the placenta and has been detected in breast milk. Cefuroxime is excreted unchanged, by glomerular filtration and renal tubular secretion, and high concentration is achieved in urine. Probenecid competes for renal tubular secretion with cefuroxime resulting in higher and more prlonged plasma concentration of cefuroxime. Small amounts of cefuroxime are excreted in bile.

INDICATIONS:

CEFURO-XL are indicated for the treatment the following infections caused by susceptible strains of the designated microorganisms.

Pharyngitis/Tonsillitis caused by Streptococcus pyogenes

Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes.

Acute Bacterial Maxillary Sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae.

Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, and Haemophilus parainfluenzae

Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus or Streptococcus pyogenes. Uncomplicated Urinary Tract Infections caused by Escherichia coli or Klebsiella pneumoniae. Uncomplicated Gonorrhea, urethral and endocervical, caused by penicillinase-producing and non-penicillinase–producing strains of Neisseria gonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by non-penicillinase–producing strains of Neisseria gonorrhoeae.

PATIENT INFORMATION:

BEFORE YOU TAKE CEFURO-XL

TELL YOUR DOCTOR IF YOU:

Have previously experienced an allergic reaction to CEFURO-XL, cefuroxime, any other antibiotics (e.g. penicillin) or any of the other ingredients. If you are pregnant, If Are you breast-feeding, taking the medicine probenecid for the treatment of gout. If you are diabetic or do you have sugar intolerance.

DRIVING AND USING MACHINES

Dizziness has been reported. If you feel affected you should not drive, operate machinery or take part in activities where you may put yourself or others at risk.HOW TO TAKE CEFURO-XLLook at the label - it should say who should take it, how much and when. If it does not say all this or you are not sure, ask your doctor or pharmacist. If prescribed for a child make sure the medicine is taken as the label says.The usual dose is 125 mg (one 5 ml spoonful) twice a day for a child or 250 mg (two 5 ml spoonfuls) twice a day for an adult, taken for seven days.In children, aged 2 years or older, with more severe infections the dose is 250 mg (two 5 ml spoonfuls) twice a day.In Lyme disease, for adults and children over 12 years of age, a dose of 500 mg (four 5 ml spoonfuls) twice a day may be needed for up to 20 days.To treat gonorrhoea a single dose of 1 g (eight 5 ml spoonfuls) should be taken.The duration of your treatment with CEFURO-XL will depend on how severe your infection is and how well you are responding to the treatment.CEFURO-XL tablets can be taken on a full or empty stomach. However, Cefuroxime axetil enters the bloodstream and works faster when taken after meals. CEFURO-XL oral suspension must be taken with food. Shake the suspension well before each use.Take CEFURO-XL exactly as prescribed: It is important that you finish taking all of Cefuroxime axetil to obtain the maximum benefit.The crushed tablet has a strong, persistent, bitter taste. Children who cannot swallow the tablet whole should take the oral suspension. Shake the oral suspension well before each use. 

IF YOU MISS A DOSE Take it as soon as you remember. If it is almost time for your next dose skip the one you missed and go back to the regular schedule. Do not take 2 doses at once.

WHAT TO DO IF AN OVERDOSE IS TAKEN

 In that case do not delay, ask your doctor immediately what to do or contact your nearest hospital emergency department.WHILE YOU ARE USING CEFURO-XLContinued or prolonged use of CEFURO-XL may result in an overgrowth of bacteria that do not respond to Cefuroxime axetil and can cause a second infection. You should take CEFURO-XL only when it is prescribed by your doctor, even if you have symptoms like those of a previous infection. Tell your doctor if you have any kidney problems. If you do, the drug must be used cautiously.If you are allergic to penicillin you may also be allergic to CEFURO-XL. Make sure your doctor is aware of any allergies you have.Cephalosporin antibiotics such as CEFURO-XL sometimes trigger a tendency to bleed, especially in people with liver or kidney damage, individuals who are malnourished, those on long courses of antibiotic therapy, and people taking blood-thinning medications. If you fall into one of these categories, the doctor will monitor you carefully. If you are pregnant or plan to become pregnant, inform your doctor immediately. CEFURO-XL appears in breast milk and could affect a nursing infant. If Cefuroxime axetil is essential to your health, your doctor may advise you to discontinue breastfeeding until your treatment with Cefuroxime axetil is finished. SIDE EFFECTS Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking CEFURO-XL.More common side effects may include:
Diaper rash in infants, diarrhea, nausea, vomiting CEFURO-XL has also been reported to occasionally cause allergic reactions, blood disorders, colitis, kidney and liver problems, jaundice (yellowing of the skin and eyes), peeling skin, seizures, severe blisters in the mouth and eyes, and impaired blood clotting.