Xitil 500mg

Tablet
Cefuroxime Axetil
Ziska Pharmaceuticals Limited

Other Strength:
- Xitil 250mg

Alternative:
- Cefotil® 500mg
- Furotil 500mg
- Cefobac 500mg
- Cerox-A Tablet 500mg
- Roximax 500mg
- Axicef 500mg
- Axetil 500mg
- Axefur 500mg
- Axim 500mg
- C-2 500mg
- Benkill 500mg
- Famicef 500mg
- Furocef 500mg



Xitil
Presentation
Xitil 500 mg Tablet:Each film coated tablet contains 500 mg of Cefuroxime as Cefuroxime Axetil BP.Xitil 250 mg Tablet:Each film coated tablet contains 250 mg of Cefuroxime as Cefuroxime Axetil BP.
Xitil Powder for Suspension: After reconstitution each 5 ml suspension contains 125 mg of Cefuroxime as Cefuroxime Axetil US

Description


Cefuroxime (Xitil) is a broad-spectrum second generation cephalosporin which is active against both gram (+)ve & gram (-)ve aerobes and also anerobes. It has bactericidal activity against a wide range of common pathogens including beta-lactamase producing strains. Consequently cefuroxime is active against many ampicillin & amoxycillin resistant strains. Cefuroxime kills bacteria interfering the synthesis of bacterial cell wall by inhibiting the transpeptidase enzyme

Pharmacokinetics:
After oral administration, cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolysed to cefuroxime by nonspecific esterases in the intestinal mucosa and blood. Cefuroxime is subsequently distributed throughout the extracellular fluids. The axetil moiety is metabolised to acetaldehyde and acetic acid. It is approx. 50% protein bound & the half-life is 1.2 hrs. Absorption is greater when taken after food. The drug is excreted unchanged in the urine; in adults, approx. 50% of the administered dose is recovered in the urine within 12 hours. As cefuroxime is renally excreted, the serum half-life is prolonged in patients with reduced renal function. Despite the lower elimination of cefuroxime in geriatric patients, dosage adjustment
based on age is not necessary

Indications


Xitil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:


Pharyngitis/Tonsillitis caused by Streptococcus pyogenes Acute bacterial otitis media caused by S. pneumoniae, H. influenzae (including beta-lactamase producing strains),M. catarrhalis (including beta-lactamase producing strains) or S. pyogenes.Acute bacterial maxillary sinusitis caused by S. pneumoniae or H. influenzae (non-beta-lactamase producing strains only) Acute bacterial exacerbations of chronic bronchitis and secondary bacterial infections of acute bronchitis caused by S. pneumoniae, H. influenzae (beta-lactamase negative strains), or H. parainfluenzae (beta-lactamase negative strains) Uncomplicated skin and skin-structure infections caused by S. aureus (including beta-lactamase producing strains), or S. pyogenesUncomplicated urinary tract infections caused by E. coil or K. pneumoniae Uncomplicated gonorrhoea, urethral and endocervical infections caused by penicillinase producing and non-penicillinase producing strains of N. gonorrhoeae and uncomplicated rectal gonorrhoea in females caused by non-penicillinase producing strains of N. gonorrhoeaeEarly Lyme disease (Erythema migrans) caused byBorrelia burgdorferi.Obstetric and gynaecological infection,
pelvic inflammatory diseases.Other infections including septicemia and meningitis

Direction for Reconstitution:
Suspension: Shake the bottle well to loosen the powder. Add 35 ml (with the help of supplied measuring cup) of boiled and cooled water to the dry mixture in the bottle. Shake the bottle vigorously until all the powder is in suspension. Always keep the bottle tightly closed.

Dosage & Administration
Oral: Xitil should be taken after food for optimum absorption.
Population Infection Dosage Duration(days)
Adolescents
and Adults
(13 years
and older







Pharyngitis/Tonsillitis
Acute bacterial maxillary sinusitis
Acute bacterial exacerbations of chronic bronchitis
Secondary bacterial infections of acute bronchitis
Uncomplicated skin and skin-structure infections
Uncomplicated urinary tract infections
Uncomplicated gonorrhea
Early Lyme Disease








50 mg bid
250 mg bid
250 or 500 mg bid
250 or 500 mg bid
250 or 500 mg bid
125 or 250 mg bid
1000 mg once
500 mg bid








10
10

10

5-10

10



7-10
single dose

20
Paediatric
(who can
swallow
tablet Pharyngitis/Tonsillitis
Acute otitis media
Acute bacterial maxillary sinusitis 125 mg bid
250 mg bid
250 mg bid

10
10
10
10



Powder for Suspension: Usual dose: 20-30 mg/kg twice daily
Infection Dosage Duration (days)
Pharyngitis/Tonsillitis 20 mg/kg bid 10
Acute otitis media 30 mg/kg bid 10 10
Acute bacterial maxillary sinusitis 30 mg/kg bid 10 10
Impetigo and other skin infections 30 mg/kg bid 10 10

Shake the bottle vigorously before every use

Side Effects
Generally cefuroxime is well tolerated. However, a few side effects like nausea, vomiting, diarrhoea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of cefuroxime may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.20%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

Precautions
Penicillin sensitivity; renal impairment; pregnancy & breast-feeding; false positive urinary glucose & false positive Coomb's test.

Contraindications
It is contraindicated in patients with known hypersensitivity to the cephalosporin group of antibiotics

Use in Pregnancy & Lactation
Because cefuroxime is excreted in human milk, consideration should be given to discontinuing nursing temporarily during treatment with cefuroxime

Commercial Packaging
strong>Each box contains 1x7's tablets in Alu-Alu blister pack.
Xitil 250 mg Tablet: Each box contains 2x7's tablets in Alu-Alu blister pack.
Xitil Powder for Suspension: Each bottle contains dry powder to aeconstitute 70 ml suspension

Drug Interaction
Probenecid increases cefuroxime blood levels; drugs lowering gastric acidity may decrease acefuroxime bioavailability.

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