Generic

Cefuroxime+Clavulanic Acid

Therapeutic Class

Antibacterial

Pack Size

Rofuclav 250 mg / 62.5 mg tablet: Each box contains 14 tablets (2 x 7's) in Alu-Alu blister pack.
Rofuclav 500 mg / 125 mg tablet: Each box contains 14 tablets (2 x 7's) in Alu-Alu blister pack.
Each blister supplied in light protected temper evident
zipper pouch with desiccant.

Indications

<b>Pharyngitis/ tonsillitis</b> caused by Streptococcus pyogenes <b>Acute bacterial otitis media</b> caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Moraxella Catarrhalis (including beta-lactamase-producing strains) or Streptococcus pyogenes <b>Acute bacterial maxillary sinusitis</b> caused by Streptococcus pneumoniae or Haemophilus influenzae ( nonbeta lactamase-producing strains only ) <b>Lower respiratory tract infections</b> including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pyogenes, Escherichia coli <b>Acute bacterial exacerbations of chronic bronchitis and secondary bacterial infections of acute bronchitis</b>caused by Streptococcus pneumoniae, Haemophilus influenza (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains) <b>Skin and Skin-Structure infections</b> caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp. and Enterobacter spp. <b>Urinary tract infections</b> caused by Escherichia coli or Klebsiella pneumoniae Bone and Joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains) <b>Gonorrhea:</b> Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase and non-penicillinase producing strains) in both males and females <b>Early Lyme disease (erythema migrans)</b> caused by Borrelia burgdorferi Septicemia caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenza (including ampicillin-resistant strains), and Klebsiella spp. <b>Meningitis</b> caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitis and Staphylococcus aureus (penicillinase and non-penicillinase producing strains) <b>Switch therapy (injectable to oral)</b> after surgery when patient\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\'s condition is improved.

Therapeutic Class

Antibacterial

Dosage & Administration

Adolescents & adults:
Pharyngitis or Tonsillitis- 250 mg twice daily - 5 -10 days
Acute bacterial maxillary sinusitis - 250 mg twice daily - 10 days
Acute bacterial exacerbation of chronic bronchitis - 250-500 mg twice daily - 10 days
Secondary bacterial infections of acute bronchitis - 250-500 mg twice daily - 5 -10 days
Community-acquired pneumonia - 250-500 mg twice daily - 5 -10 days
Uncomplicated skin & skin-structure infections - 250-500 mg twice daily - 5 -10 days
MDR Typhoid fever- 500 mg twice daily - 10-14 days
Uncomplicated urinary tract infection - 250 mg twice daily - 7-10 days
Uncomplicated gonorrhea - 1000 mg single dose
Lyme disease - 500 mg twice daily - 20 days
Paediatric patients (3 months to 12 years):
Pharyngitis or Tonsillitis - 20 mg/kg/day in two divided doses - 5 -10 days
Acute otitis media - 30 mg/kg/day in two divided doses - 10 days
Acute bacterial maxillary sinusitis - 30 mg/kg/day in two divided doses - 10 days
Community-acquired pneumonia - 30 mg/kg/day in two divided doses - 5-10 days
MDR Typhoid fever - 30 mg/kg/day in two divided doses - 10-14 days
Uncomplicated skin & skin-structure infections - 30 mg/kg/day in two divided doses - 10 days
Uncomplicated urinary tract infection - 20 mg/kg/day in two divided doses - 7-10 days
RofuclavTM may be administered without regard to meals.

Contraindications

Patients with known allergy to cephalosporins & pseudomembranous colitis are contraindicated.

Side Effects

Generally Cefuroxime and Clavulanic acid are well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

Pregnancy & Lactation

<b>During pregnancy:</b> All antibiotics should be avoided in the first trimester if possible. However, Rofuclav can be safely used in later pregnancy to treat urinary and other infections.</br> <b>During lactation:</b> Rofuclav is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

Precautions

Rofuclav should be given with care to patients receiving concurrent treatment with potent diuretics & who have history of colitis.

Storage Conditions

Store in a dry place at below 25° C, protect from light. Keep out of reach of children.