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Second generation Cephalosporins

Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.

Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days 
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.

Generally Cefuroxime-Clavulanic Acid is 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.

Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.

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

Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.

While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

Store in a cool, dry place (below 30^o C), away from light and moisture. Keep out of the reach of children.

Second generation Cephalosporins

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.

Tablet or Suspension-

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

• Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
• Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
• Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
• Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
• Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
• 
  Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
• In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).

In Meningitis:

• Adult: 3 gm IV injection three times daily.
• Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
• Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.

In bone and joint infections:

• Adult: 1.5 gm IV injection four times daily.
• Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.

The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5^o C

Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.

Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.

No potentially hazardous interactions have been reported.

US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.

For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

Store in a cool, dry place (below 30^o C), away from light & moisture. Keep out of the reach of children.

Second generation Cephalosporins

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.

Tablet or Suspension-

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

• Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
• Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
• Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
• Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
• Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
• 
  Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
• In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).

In Meningitis:

• Adult: 3 gm IV injection three times daily.
• Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
• Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.

In bone and joint infections:

• Adult: 1.5 gm IV injection four times daily.
• Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.

The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5^o C

Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.

Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.

No potentially hazardous interactions have been reported.

US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.

For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

Store in a cool, dry place (below 30^o C), away from light & moisture. Keep out of the reach of children.

Second generation Cephalosporins

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.

Tablet or Suspension-

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

• Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
• Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
• Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
• Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
• Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
• 
  Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
• In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).

In Meningitis:

• Adult: 3 gm IV injection three times daily.
• Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
• Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.

In bone and joint infections:

• Adult: 1.5 gm IV injection four times daily.
• Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.

The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5^o C

Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.

Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.

No potentially hazardous interactions have been reported.

US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.

For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

Store in a cool, dry place (below 30^o C), away from light & moisture. Keep out of the reach of children.

Second generation Cephalosporins

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.

Tablet or Suspension-

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

• Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
• Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
• Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
• Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
• Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
• 
  Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
• In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).

In Meningitis:

• Adult: 3 gm IV injection three times daily.
• Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
• Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.

In bone and joint infections:

• Adult: 1.5 gm IV injection four times daily.
• Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.

The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5^o C

Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.

Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.

No potentially hazardous interactions have been reported.

US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.

For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

Store in a cool, dry place (below 30^o C), away from light & moisture. Keep out of the reach of children.

Second generation Cephalosporins

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.

Tablet or Suspension-

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

• Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
• Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
• Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
• Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
• Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
• 
  Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
• In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).

In Meningitis:

• Adult: 3 gm IV injection three times daily.
• Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
• Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.

In bone and joint infections:

• Adult: 1.5 gm IV injection four times daily.
• Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.

The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5^o C

Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.

Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.

No potentially hazardous interactions have been reported.

US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.

For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

Store in a cool, dry place (below 30^o C), away from light & moisture. Keep out of the reach of children.

Second generation Cephalosporins

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.

Tablet or Suspension-

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

• Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
• Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
• Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
• Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
• Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
• 
  Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
• In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).

In Meningitis:

• Adult: 3 gm IV injection three times daily.
• Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
• Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.

In bone and joint infections:

• Adult: 1.5 gm IV injection four times daily.
• Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.

The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5^o C

Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.

Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.

No potentially hazardous interactions have been reported.

US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.

For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

Store in a cool, dry place (below 30^o C), away from light & moisture. Keep out of the reach of children.

Second generation Cephalosporins

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.

Tablet or Suspension-

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

• Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
• Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
• Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
• Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
• Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
• 
  Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
• In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).

In Meningitis:

• Adult: 3 gm IV injection three times daily.
• Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
• Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.

In bone and joint infections:

• Adult: 1.5 gm IV injection four times daily.
• Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.

The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5^o C

Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.

Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.

No potentially hazardous interactions have been reported.

US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.

For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

Store in a cool, dry place (below 30^o C), away from light & moisture. Keep out of the reach of children.

Second generation Cephalosporins

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.

Tablet or Suspension-

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

• Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
• Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
• Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
• Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
• Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
• 
  Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
• In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).

In Meningitis:

• Adult: 3 gm IV injection three times daily.
• Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
• Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.

In bone and joint infections:

• Adult: 1.5 gm IV injection four times daily.
• Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.

The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5^o C

Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.

Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.

No potentially hazardous interactions have been reported.

US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.

For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

Store in a cool, dry place (below 30^o C), away from light & moisture. Keep out of the reach of children.

Second generation Cephalosporins

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.

Tablet or Suspension-

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

• Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
• Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
• Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
• Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
• Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
• 
  Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
• In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).

In Meningitis:

• Adult: 3 gm IV injection three times daily.
• Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
• Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.

In bone and joint infections:

• Adult: 1.5 gm IV injection four times daily.
• Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.

The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5^o C

Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.

Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.

No potentially hazardous interactions have been reported.

US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.

For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

Store in a cool, dry place (below 30^o C), away from light & moisture. Keep out of the reach of children.

Second generation Cephalosporins

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.

Tablet or Suspension-

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

• Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
• Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
• Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
• Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
• Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
• 
  Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
• In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).

In Meningitis:

• Adult: 3 gm IV injection three times daily.
• Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
• Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.

In bone and joint infections:

• Adult: 1.5 gm IV injection four times daily.
• Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.

The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5^o C

Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.

Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.

No potentially hazardous interactions have been reported.

US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.

For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

Store in a cool, dry place (below 30^o C), away from light & moisture. Keep out of the reach of children.

Second generation Cephalosporins

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.

Tablet or Suspension-

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

• Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
• Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
• Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
• Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
• Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
• 
  Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
• In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).

In Meningitis:

• Adult: 3 gm IV injection three times daily.
• Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
• Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.

In bone and joint infections:

• Adult: 1.5 gm IV injection four times daily.
• Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.

The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5^o C

Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.

Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.

No potentially hazardous interactions have been reported.

US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.

For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

Store in a cool, dry place (below 30^o C), away from light & moisture. Keep out of the reach of children.

Immunosuppressant

Everolimus, a proliferation signal inhibitor, prevents allograft rejection in rodent and nonhuman primate models of allotransplantation. It exerts its immunosuppressive effect by inhibiting the proliferation and thus, clonal expansion, of antigen-activated T cells which is driven by T cell-specific interleukins eg, interleukin-2 and interleukin-15. Everolimus inhibits an intracellular signaling pathway that normally leads to cell proliferation when triggered by the binding of these T cell growth factors to their receptors. The blockage of this signal by everolimus causes cells to be arrested at the G1 stage of the cell cycle.

At the molecular level, everolimus forms a complex with the cytoplasmic protein FKBP-12. In the presence of everolimus, the growth factor-stimulated phosphorylation of the p70 S6 kinase is inhibited. Since p70 S6 kinase phosphorylation is under the control of FRAP (also called m-TOR), this finding suggests that the everolimus-FKBP-12 complex binds to and thus, interferes with the function of FRAP. FRAP is a key regulatory protein which governs cell metabolism, growth and proliferation; disabling FRAP function thus explains the cell cycle arrest caused by everolimus.

General kidney & heart transplant population: Initially 0.75 mg bd administered as soon as possible after transplantation. 

Hepatic transplant: 1 mg bd with initial dose starting 4 wk after transplantation.

Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer, Advanced NET, Advanced RCC, And Renal Angiomyolipoma With TSC: The recommended dose is 10 mg, to be taken once daily at the same time every day. Administer either consistently with food or consistently without food. Everolimus Tablets should be swallowed whole with a glass of water. Do not break or crush tablets. Continue treatment until disease progression or unacceptable toxicity occurs.

Stomatitis, Constipation, Infections, Asthenia, Fatigue, Cough, Diarrhea, Rash, Anemia, Nausea, Anorexia, Edema, peripheral, Dyspnea, Pyrexia, Vomiting, Headache, Epistaxis, Decreased lymphocytes, Grade 3, Increased glucose, Grade 3, Pneumonitis, Pruritus, Dry skin, Decreased Hgb, Grade 3, Menstrual irregularities, Dysgeusia, Hypertension, Hemorrhage, Tachycardia, CHF

Patients with hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients. Hypersensitivity reactions manifested by symptoms including, but not limited to, anaphylaxis, dyspnea, flushing, chest pain, or angioedema (e.g., swelling of the airways or tongue, with or without respiratory impairment) have been observed with everolimus and other rapamycin derivatives

Patients taking concomitant ACE inhibitor therapy may be at increased risk for angioedema. Interstitial lung disease/noninfectious pneumonitis; monitor for clinical symptoms or radiological changes; fatal cases have occurred; manage by dose reduction or discontinuation until symptoms resolve, and consider use of corticosteroids; pulmonary hypertension (including pulmonary arterial hypertension) as a secondary event reported

Elicits immunosuppressive effects and may increase risk for infections; some infections have been severe or fatal; monitor for signs and symptoms and treat promptly. Pneumocystis jiroveci pneumonia, some with a fatal outcome, reported; this may be associated with concomitant use of corticosteroids or other immunosuppressive agents

Mouth ulcers, stomatitis, and oral mucositis are common; management includes mouthwashes (without alcohol or peroxide) and topical treatments May delay wound healing and increase wound-related complications (eg, dehiscence, wound infection, incisional hernia, lymphocele, and seroma)

• Cases of renal failure (including acute renal failure), some fatal, have been observed
• May cause angioedema and fluid accumulation
• Decreases Hgb, lymphocytes, ANC, platelets; increases cholesterol, TG, glucose, creatinine
• Elevations of serum creatinine, urinary protein, blood glucose, and lipids may occur;
• decreases in hemoglobin, neutrophils, and platelets may also occur; monitor renal
• function, blood glucose, lipids, and hematologic parameters prior to treatment and periodically thereafter
• May impair male fertility
• Child-Pugh Class C hepatic impairment
• Avoid use of live vaccines during treatment and close contact with live vaccine recipients
• Can cause fetal harm when administered to a pregnant woman; advise female patients of reproductive potential to use highly effective contraception while receiving everolimus and for up to 8 weeks after ending treatment.

CYP3A4 inhibitors &/or inducers, CYP2D6 substrates with narrow therapeutic index, PgP inhibitors, rifampicin, ACE inhibitors, grapefruit juice & live vaccines.

Pregnancy Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Lactation: Distribution into breast milk is unknown; not recommended

Immunosuppressant

Everolimus, a proliferation signal inhibitor, prevents allograft rejection in rodent and nonhuman primate models of allotransplantation. It exerts its immunosuppressive effect by inhibiting the proliferation and thus, clonal expansion, of antigen-activated T cells which is driven by T cell-specific interleukins eg, interleukin-2 and interleukin-15. Everolimus inhibits an intracellular signaling pathway that normally leads to cell proliferation when triggered by the binding of these T cell growth factors to their receptors. The blockage of this signal by everolimus causes cells to be arrested at the G1 stage of the cell cycle.

At the molecular level, everolimus forms a complex with the cytoplasmic protein FKBP-12. In the presence of everolimus, the growth factor-stimulated phosphorylation of the p70 S6 kinase is inhibited. Since p70 S6 kinase phosphorylation is under the control of FRAP (also called m-TOR), this finding suggests that the everolimus-FKBP-12 complex binds to and thus, interferes with the function of FRAP. FRAP is a key regulatory protein which governs cell metabolism, growth and proliferation; disabling FRAP function thus explains the cell cycle arrest caused by everolimus.

General kidney & heart transplant population: Initially 0.75 mg bd administered as soon as possible after transplantation. 

Hepatic transplant: 1 mg bd with initial dose starting 4 wk after transplantation.

Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer, Advanced NET, Advanced RCC, And Renal Angiomyolipoma With TSC: The recommended dose is 10 mg, to be taken once daily at the same time every day. Administer either consistently with food or consistently without food. Everolimus Tablets should be swallowed whole with a glass of water. Do not break or crush tablets. Continue treatment until disease progression or unacceptable toxicity occurs.

Stomatitis, Constipation, Infections, Asthenia, Fatigue, Cough, Diarrhea, Rash, Anemia, Nausea, Anorexia, Edema, peripheral, Dyspnea, Pyrexia, Vomiting, Headache, Epistaxis, Decreased lymphocytes, Grade 3, Increased glucose, Grade 3, Pneumonitis, Pruritus, Dry skin, Decreased Hgb, Grade 3, Menstrual irregularities, Dysgeusia, Hypertension, Hemorrhage, Tachycardia, CHF

Patients with hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients. Hypersensitivity reactions manifested by symptoms including, but not limited to, anaphylaxis, dyspnea, flushing, chest pain, or angioedema (e.g., swelling of the airways or tongue, with or without respiratory impairment) have been observed with everolimus and other rapamycin derivatives

Patients taking concomitant ACE inhibitor therapy may be at increased risk for angioedema. Interstitial lung disease/noninfectious pneumonitis; monitor for clinical symptoms or radiological changes; fatal cases have occurred; manage by dose reduction or discontinuation until symptoms resolve, and consider use of corticosteroids; pulmonary hypertension (including pulmonary arterial hypertension) as a secondary event reported

Elicits immunosuppressive effects and may increase risk for infections; some infections have been severe or fatal; monitor for signs and symptoms and treat promptly. Pneumocystis jiroveci pneumonia, some with a fatal outcome, reported; this may be associated with concomitant use of corticosteroids or other immunosuppressive agents

Mouth ulcers, stomatitis, and oral mucositis are common; management includes mouthwashes (without alcohol or peroxide) and topical treatments May delay wound healing and increase wound-related complications (eg, dehiscence, wound infection, incisional hernia, lymphocele, and seroma)

• Cases of renal failure (including acute renal failure), some fatal, have been observed
• May cause angioedema and fluid accumulation
• Decreases Hgb, lymphocytes, ANC, platelets; increases cholesterol, TG, glucose, creatinine
• Elevations of serum creatinine, urinary protein, blood glucose, and lipids may occur;
• decreases in hemoglobin, neutrophils, and platelets may also occur; monitor renal
• function, blood glucose, lipids, and hematologic parameters prior to treatment and periodically thereafter
• May impair male fertility
• Child-Pugh Class C hepatic impairment
• Avoid use of live vaccines during treatment and close contact with live vaccine recipients
• Can cause fetal harm when administered to a pregnant woman; advise female patients of reproductive potential to use highly effective contraception while receiving everolimus and for up to 8 weeks after ending treatment.

CYP3A4 inhibitors &/or inducers, CYP2D6 substrates with narrow therapeutic index, PgP inhibitors, rifampicin, ACE inhibitors, grapefruit juice & live vaccines.

Pregnancy Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Lactation: Distribution into breast milk is unknown; not recommended

Immunosuppressant

Everolimus, a proliferation signal inhibitor, prevents allograft rejection in rodent and nonhuman primate models of allotransplantation. It exerts its immunosuppressive effect by inhibiting the proliferation and thus, clonal expansion, of antigen-activated T cells which is driven by T cell-specific interleukins eg, interleukin-2 and interleukin-15. Everolimus inhibits an intracellular signaling pathway that normally leads to cell proliferation when triggered by the binding of these T cell growth factors to their receptors. The blockage of this signal by everolimus causes cells to be arrested at the G1 stage of the cell cycle.

At the molecular level, everolimus forms a complex with the cytoplasmic protein FKBP-12. In the presence of everolimus, the growth factor-stimulated phosphorylation of the p70 S6 kinase is inhibited. Since p70 S6 kinase phosphorylation is under the control of FRAP (also called m-TOR), this finding suggests that the everolimus-FKBP-12 complex binds to and thus, interferes with the function of FRAP. FRAP is a key regulatory protein which governs cell metabolism, growth and proliferation; disabling FRAP function thus explains the cell cycle arrest caused by everolimus.

General kidney & heart transplant population: Initially 0.75 mg bd administered as soon as possible after transplantation. 

Hepatic transplant: 1 mg bd with initial dose starting 4 wk after transplantation.

Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer, Advanced NET, Advanced RCC, And Renal Angiomyolipoma With TSC: The recommended dose is 10 mg, to be taken once daily at the same time every day. Administer either consistently with food or consistently without food. Everolimus Tablets should be swallowed whole with a glass of water. Do not break or crush tablets. Continue treatment until disease progression or unacceptable toxicity occurs.

Stomatitis, Constipation, Infections, Asthenia, Fatigue, Cough, Diarrhea, Rash, Anemia, Nausea, Anorexia, Edema, peripheral, Dyspnea, Pyrexia, Vomiting, Headache, Epistaxis, Decreased lymphocytes, Grade 3, Increased glucose, Grade 3, Pneumonitis, Pruritus, Dry skin, Decreased Hgb, Grade 3, Menstrual irregularities, Dysgeusia, Hypertension, Hemorrhage, Tachycardia, CHF

Patients with hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients. Hypersensitivity reactions manifested by symptoms including, but not limited to, anaphylaxis, dyspnea, flushing, chest pain, or angioedema (e.g., swelling of the airways or tongue, with or without respiratory impairment) have been observed with everolimus and other rapamycin derivatives

Patients taking concomitant ACE inhibitor therapy may be at increased risk for angioedema. Interstitial lung disease/noninfectious pneumonitis; monitor for clinical symptoms or radiological changes; fatal cases have occurred; manage by dose reduction or discontinuation until symptoms resolve, and consider use of corticosteroids; pulmonary hypertension (including pulmonary arterial hypertension) as a secondary event reported

Elicits immunosuppressive effects and may increase risk for infections; some infections have been severe or fatal; monitor for signs and symptoms and treat promptly. Pneumocystis jiroveci pneumonia, some with a fatal outcome, reported; this may be associated with concomitant use of corticosteroids or other immunosuppressive agents

Mouth ulcers, stomatitis, and oral mucositis are common; management includes mouthwashes (without alcohol or peroxide) and topical treatments May delay wound healing and increase wound-related complications (eg, dehiscence, wound infection, incisional hernia, lymphocele, and seroma)

• Cases of renal failure (including acute renal failure), some fatal, have been observed
• May cause angioedema and fluid accumulation
• Decreases Hgb, lymphocytes, ANC, platelets; increases cholesterol, TG, glucose, creatinine
• Elevations of serum creatinine, urinary protein, blood glucose, and lipids may occur;
• decreases in hemoglobin, neutrophils, and platelets may also occur; monitor renal
• function, blood glucose, lipids, and hematologic parameters prior to treatment and periodically thereafter
• May impair male fertility
• Child-Pugh Class C hepatic impairment
• Avoid use of live vaccines during treatment and close contact with live vaccine recipients
• Can cause fetal harm when administered to a pregnant woman; advise female patients of reproductive potential to use highly effective contraception while receiving everolimus and for up to 8 weeks after ending treatment.

CYP3A4 inhibitors &/or inducers, CYP2D6 substrates with narrow therapeutic index, PgP inhibitors, rifampicin, ACE inhibitors, grapefruit juice & live vaccines.

Pregnancy Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Lactation: Distribution into breast milk is unknown; not recommended

Multi-vitamin & Multi-mineral combined preparations

This is a film coated tablet, which combines 32 high potency vitamins and minerals. This preparation maintains a healthy body and active life-style.

One tablet daily or as recommended by the physician.

Generally, this preparation is well tolerated. Diarrhoea may occasionally occur during treatment with beta carotene and the skin may assume a slightly yellow discoloration. Vitamin C and vitamin E may cause diarrhoea and other gastrointestinal disturbances.

This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

Long term intake of high level of vitamin A (excluding that sourced from beta carotene) may increase the risk of osteoporosis in postmenopausal women.

No drug interactions have been reported.

Recommended by the consultation with physician.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Cytotoxic Chemotherapy

Lapatinib is a 4-anilinoquinazoline tyrosine kinase inhibitor of both Epidermal Growth Factor Receptor (EGFR [ErbB1]) and Human Epidermal Receptor Type 2 (HER2 [ErbB2]) receptors. It blocks the phosphorylation and activation of downstream 2nd messengers (Erk1/2 and Akt) which regulate cellular proliferation and survival of ErbB- and ErbB2-expressing tumours.

The recommended dosage of Lapatinib for advanced or metastatic breast cancer is 1,250 mg (5 tablets) given orally once daily on Days 1-21 continuously in combination with capecitabine 2,000 mg/m2/day (administered orally in 2 doses approximately 12 hours apart) on Days 1-14 in a repeating 21 day cycle.

The recommended dose of Lapatinib for hormone receptor positive, HER2 positive metastatic breast cancer is 1500 mg (6 tablets) given orally once daily continuously in combination with letrozole. When Lapatinib is coadministered with letrozole, the recommended dose of letrozole is 2.5 mg once daily.

• Lapatinib should be taken at least one hour before or one hour after a meal. However, capecitabine should be taken with food or within 30 minutes after food.
• Lapatinib should be taken once daily. Do not divide daily doses of Lapatinib.
• Modify dose for cardiac and other toxicities, severe hepatic impairment, and CYP3A4 drug interactions.

Should be taken on an empty stomach. Take at least 1 hr before or 1 hr after a meal. Do not eat/drink grapefruit products.

GI disturbances, dermatological reactions (e.g. palmar-plantar erythrodysesthesia, rash), fatigue, decreases in LVEF, QT interval prolongation, stomatitis, mucosal inflammation, pain in extremities, back pain, dyspnoea, insomnia, epistaxis, alopecia, nail disorders (e.g. paronychia), interstitial lung disease, pneumonitis and hypersensitivity reactions including anaphylaxis.

Contraindicated to hypersensitivity to any other ingredient of this product.

Patient with hypokalaemia or hypomagnesaemia, congenital QT prolongation. Severe hepatic impairment. Pregnancy and lactation.

May increase the serum levels of CYP3A4, CYP2C8 and P-glycoprotein substrates. Increased exposure with CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, atazanavir, ritonavir). CYP3A4 inducers (e.g. carbamazepine, rifampicin) may reduce exposure to lapatinib. Increased risk of QT prolongation with drugs known to prolong QT intervals (e.g. antiarrythmic agents, cumulative high-dose anthracycline therapy). May increase serum levels of digoxin.

Pregnancy category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Patient on potent CYP3A4 inhibitor-

• HER2 overexpressing advanced or metastatic breast cancer: Increase gradually from 1.25 g daily up to 4.5 g daily.
• HER2 overexpressing hormone receptor positive metastatic breast cancer: Increase gradually from 1.5 g daily up to 5.5 g daily.

Hepatic Impairment (Severe)-

• HER2 overexpressing advanced or metastatic breast cancer: 750 mg once daily.
• HER2 overexpressing hormone receptor positive metastatic breast cancer: 1 g once daily.

Store between 15-30° C.

Papillomavirus vaccine is indicated in females from 9 years of age onwards for the prevention of persistent infection, premalignant cervical lesions and cervical cancer (squamous cell carcinoma and adenocarcinoma) caused by oncogenic human papillomaviruses (HPV).

Vaccines, Anti-sera & Immunoglobulin

Human Papillomavirus (HPV) type 16 and 18 cause about 70% of cervical cancer. HPV bivalent (types 16 and 18) vaccine is a non-infectious vaccine produced by recombinant technology, which contains virus-like particles (VLP) of the major capsid LI protein of oncogenic HPV types 16 and 18. Efficacy of vaccine may be mediated by the production of IgG neutralizing antibodies against the HPV-L1 capsid proteins.

Adult: Females 10-25 yr (or between 10-45 yr in some countries): 3 doses of 0.5 ml each given at 0,1 and 6 mth, preferably administered into deltoid muscle.

Child: Not recommended for use in girls beiow 9 yr of age.

Injection site pain, erythema, and inflammation Fatigue, Headache, Myalgia, GI symptoms, Arthralgia

Known hypersensitivity to any component. Postpone admin in patient suffering from an acute febrile illness.

Observe patient for 15 min after admin as syncope, sometimes accompanied by transient tonic clonic movements and other seizure-like activity may occur during recovery. Caution in patients with thrombocytopenia or other coagulation disorders as IM admin can cause bleeding. Not to be administered by IV, SC, or intradermal route. Immunocompromised individuals may have diminished immune response to the vaccine. As vaccination will not provide protection against every HPV infection or existing HPV infections, routine cervical screening should still be performed. Not recommended for use during pregnancy; caution in lactation.

Immunosuppressive therapies e.g. irradiation, cytotoxic drugs and corticorsteroids may reduce a patient's immune response to the vaccine.

Pregnancy Category- B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. Unknown whether distributed in breast milk

Store refrigerated at 2 to 8°C. Do not freeze. Protect from light. Human Papillomavirus Bivalent should be administered as soon as possible after being removed from refrigeration.

It is indicated for the relief of symptoms associated with seasonal & perennial allergic rhinitis. It is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria and allergen induced asthma.

Sedating Anti-histamine

Cetirizine Hydrochloride is a potent H1 receptor antagonist without any significant anticholinergic and antiserotonic effects. At pharmacologically active dose levels, it has almost no drowsiness effect and does not cause behavioral changes. It inhibits the histamine-mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the late phase of the allergic reaction.

Pharmacokinetics: Cetirizine 10 mg achieves peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children). Food does not affect the extent of absorption, but it may slightly reduce the rate. Peak blood levels 0.3 micrograms/ml are reached between thirty & sixty minutes after administration of 10 mg dose of Cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately nine hours.

Adults and Children 6 years and older: 1 tablet or 2 teaspoonfuls daily (or 1 teaspoonful twice daily).

Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily.

Children 6 months to 2 years : 1/2 teaspoonful once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.

The most common side effects that occurred more frequently on Cetirizine is somnolence.

It is contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine.

Caution should be exercised when driving a car or operating a heavy machinery.

No clinically significant drug interactions have been found with Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole or Erythromycin and with other drugs.

US FDA Pregnancy Category of Cetirizine Hydrochloride is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cetirizine Hydrochloride has been shown to be excreted in human milk. So, caution should be exercised when Cetirizine Hydrochloride is administered to a nursing woman.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Cisplatin is indicated as first line therapy for lung cancer, head & neck cancer and for the treatment of advanced and metastatic ovarian carcinoma, bladder carcinoma and testis carcinoma.

Cytotoxic Chemotherapy

Cisplatin modifies cell cycle by interfering with DNA structure and function. Effects are most prominent during the S phase but cells are killed at all stages. Cisplatin synergises with other anticancer drugs e.g. fluorouracil. It has a narrow therapeutic margin and is highly toxic.

Metastatic ovarian cancer: As monotherapy: 100 mg/m² per cycle, given as a single dose infused in 0.9% sodium chloride or glucose once every 4 wk. For combination therapy with cyclophosphamide: 75-100 mg/m² on day 1 of every 4-wk cycle.

Metastatic testicular tumours: 20 mg/m² BSA daily for 5 days per cycle.

Advanced bladder cancer: 50-70 mg/m² per cycle once every 3-4 wk, depending on the extent of prior exposure to radiation and/or chemotherapy treatment. An initial dose of 50 mg/m² every 4 wk may be used in heavily pre-treated patients.

Usual dosage and schedule: 40 to 120 mg/m² I.V. on day 1 as infusion every 3 weeks. 15 to 20 mg/m² I.V. on days 1 to 5 as infusion every 3 to 4 weeks. The usual dose in adults and children when used as single agent therapy is 50-100 mg/m².

Severe nausea and vomiting. Serious toxic effects on the kidneys, bone marrows and ears. Hypomagnesaemia, hypocalcaemia, hyperuricaemia. Peripheral neuropathies, papilloedema, optic neuritis, seizures. Ototoxicity (children) manifested as tinnitus, loss of hearing, deafness or vestibular toxicity.

Cisplatin is contraindicated in patients with pre-existing renal impairment. Cisplatin should not be employed in myelosuppressed patients, or patients with hearing impairment. It is also contraindicated in patients with a history of allergic reactions to cisplatin or other platinum-containing compounds.

Patients with renal or hepatic disorder, myelosuppression. Monitor renal, neurological and auditory function. Perform blood counts regularly. Maintain adequate hydration before and 24 hr after admin to minimise nephrotoxicity.

Synergistic with 5-fluorouracil and etoposide. Efficacy increased and toxicity reduced when combined with radioprotecting agent WR 2721. At doses ≤100 mg, cisplatin is an ideal drug to combine with other cytotoxic drugs; unlike other antineoplastic drugs, it causes little myelosuppression.

Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Acute overdosage may result in kidney failure, liver failure, deafness, ocular toxicity, significant myelosuppression, intractable nausea and vomiting and/or neuritis. Death may also occur following overdosage. Treatment should include general supportive measures.

Cisplatin lyophilized powder for injection 10 mg and 50 mg should be reconstituted with 10 ml and 50 ml of water for inj. respectively.

Cisplatin solution after reconstitution should be added to 2 liters of 5% glucose or 0.9% saline and intravenously administered in 6-8 hours; after administration an adequate hydration and diuresis should be maintained during 24 hours.

Stability: The cisplatin remaining in vial following initial entry is stable for 28 days protected from light or for 7 days under fluorescent room light.

Storage: Product should be stored at controlled room temperature 25° C and protected from light.