Xiclav 500mg+125mg

Tablet
Cefuroxime Axetil + Clavulanic Acid
Ziska Pharmaceuticals Limited

Other Strength:
- Xiclav 250mg+62.50mg

Alternative:
- Furotil Plus 500mg+125mg
- Clavurox 500mg+125mg
- Cerox CV 500mg+125mg
- Claviator-CV 500mg+125mg
- Axeclav 500mg+125mg
- Axim CV 500mg+125mg
- Benkill CV 500mg+125mg
- Cefotil Plus 500mg+125mg
- Famiclav 500mg+125mg
- Turboclav 500mg+125mg
- Furoclav 500mg+125mg



Xiclav
Presentation
Xiclav® 250: Each film coated tablet contains Cefuroxime Axetil USP equivalent to Cefuroxime 250 mg and Potassium Clavulanate BP equivalent to Clavulanic Acid 62.5 mg.
Xiclav® 500: Each film coated tablet contains Cefuroxime Axetil USP equivalent to Cefuroxime 500 mg and Potassium Clavulanate BP equivalent to Clavulanic Acid 125 mg.
Xiclav® Granules for Suspension: Each 5 ml of reconstituted suspension contains Cefuroxime Axetil USP equivalent to Cefuroxime 125 mg and Potassium Clavulanate BP equivalent to Clavulanic Acid 31.25 mg.

Description
Cefuroxime 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. It is indicated for the treatment of infections caused by sensitive bacteria.
Clavulanic acid has a similar structure to the beta-lactam antibiotics but binds irreversibly to the beta-lactamase enzymes and inactivates them. Clavulanic acid in Xiclav® gives protection of cefuroxime from degradation by beta-lactamase enzyme and provides a solution for treatment of
bacterial infections caused by beta lactam resistant pathogens.

Indications
Storage
Store at controlled room temperature, 20-25 °C (68-77 °F), avoid freezing and protect from light.



Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or Streptococcus pyogenes
Acute Bacterial Maxillary Sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non-beta-lactamase-producing strains only)
Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains), or Haemophilus parainfluenzae (beta-lactamase negative strains)
Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp and Enterobacter spp
Urinary Tract Infections caused by Escherichia coli or Klebsiella pneumoniae
Gonorrhea: Uncomplicated and disseminated gonococcol infections due to Neiseria gonorrheae (penicillinase- and non-penicillinase-producing strains), in both males and females
Early Lyme disease (erythema migrans) caused by Borrelia burgdorferi
Impetigo caused by Staphylococcus aureus (including beta-lactamase-producing strains) or Streptococcus pyogenes.
Switch therapy (injectable to oral) after surgery when patients condition is improved

Dosage & Administration
Xiclav® should be taken after food for optimum absorption.

Xiclav® Tablet
Population Infections Dosage Duration (days)
Adolescents and Adults(13 years and older) Pharyngitis/tonsillitis 250 mg twice daily 10
Acute bacterial maxillary sinusitis 250 mg twice daily 10
Acute bacterial exacerbations of chronic bronchitis 250 or 500 mg twice daily 10
Secondary bacterial infections of acute bronchitis 250 or 500 mg twice daily 5-10
Uncomplicated skin and skin-structure infections 250 or 500 mg twice daily 10
Uncomplicated urinary tract infections 250 mg twice daily 7-10
Uncomplicated gonorrhea 1000 mg Single dose
Early Lyme disease 500 mg twice daily 20


Population Infections Dosage Duration (days)
Paediatric patients (who can swallow tablet whole) Acute otitis media 250 mg twice daily 10
Acute bacterial maxillary sinusitis 250 mg twice daily 10


Population Infections Dosage Duration (days)
Paediatric patient (3 months to 12 years) Pharyngitis/tonsillitis 20 mg/kg/day in two divided doses 10
Acute otitis media 30 mg/kg/day in two divided doses 10
Acute bacterial maxillary sinusitis 30 mg/kg/day in two divided doses 10
Impetigo 30 mg/kg/day in two divided doses

Side Effects
Generally cefuroxime and clavulanic acid are 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 & clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.20%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

Precautions
Xiclav® should be given with care to patients receiving concurrent treatment with potent diuretics and who have history of colitis

Contraindications
Patients with known hypersensitivity to cephalosporins & pseudomembraneous colitis are contraindicated.

Use in Pregnancy & Lactation
During Pregnancy: While all antibiotics should be avoided in the first trimester if possible, however Xiclav® can be safely used in later pregnancy to treat urinary and other infections. During lactation: Because Xiclav® is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

Commercial Packaging
Xiclav® 250mg Tablet: Each box contains 1x10's tablets in Tropical blister (Alu-PVC-Alu) pack.
Xiclav® 500mg Tablet: Each box contains 1x10's tablets in Tropical blister (Alu-PVC-Alu) pack. Xiclav® Granules for Suspension: Each carton contains a large bottle containing Cefuroxime and Clavulanic acid dry granules for reconstituting 70 ml of suspension and a small bottle containing diluents along with a measuring cup, a spoon and a dropper

Drug Interaction
Probenecid increases Xiclav® blood levels; drugs lowering gastric acidity may decrease Xiclav®bioavailability.
Overdosage :
Signs and symptoms: Overdosage of Xiclav® can cause cerebral irritation leading to convulsions.
Management: Serum levels of Xiclav® can be reduced by haemodialysis and peritoneal dialysis.

Storage
Xiclav® Tablet : Store in a cool & dry place, protected from light.
Xiclav® Granules for suspension : Before reconstitution, store dry granules between 2degree & 30degree C. After reconstitution immediately store suspension between 2degree & 8degree C in a refrigerator. Discard after 07 days.

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