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Ximoclav

Cefuroxime Axetil + Clavulanic Acid
Tablet 250 mg+62.5 mg Allopathic Second generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
  • Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
  • Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
  • Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
  • Lower respiratory tract infections 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, E. coli.
  • Acute bacterial exacerbation of chronic bronchitis and secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
  • Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
  • Uncomplicated urinary tract infections caused by E.coli or Klebsiella pneumoniae.
  • Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
  • Uncomplicated Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
  • Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
  • Septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, E.coli, Haemophilus influenzae (including ampicillin-resistant strains) & Klebsiella spp.
  • Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis & Staphylococcus aureus (penicillinase and non-penicillinase producing strains)
  • Switch therapy (Injectable to oral)
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
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.
DosageView
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
AdministrationView
Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.
Side effectsView
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.
ContraindicationsView
Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.
PrecautionsView
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.
InteractionsView
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.
Pregnancy & lactationView
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.
StorageView
Store in a cool, dry place (below 30o C), away from light and moisture. Keep out of the reach of children.

Ximorox

Cefuroxime Axetil
Powder for Suspension 125 mg/5 ml Allopathic Second generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
  • Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
  • Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
  • Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
  • Lower respiratory tract infections 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, E. coli
  • Acute bacterial exacerbation of chronic bronchitis and Secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
  • Skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
  • Urinary tract infections caused by E.coli or Klebsiella pneumoniae.
  • Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
  • Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
  • Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
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.
DosageView

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.
AdministrationView
The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5o C
Side effectsView
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.
ContraindicationsView
Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.
PrecautionsView
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.
InteractionsView
No potentially hazardous interactions have been reported.
Pregnancy & lactationView
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.
ReconstitutionView
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.
StorageView
Store in a cool, dry place (below 30o C), away from light & moisture. Keep out of the reach of children.

Ximorox

Cefuroxime Axetil
Tablet 500 mg Allopathic Second generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
  • Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
  • Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
  • Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
  • Lower respiratory tract infections 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, E. coli
  • Acute bacterial exacerbation of chronic bronchitis and Secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
  • Skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
  • Urinary tract infections caused by E.coli or Klebsiella pneumoniae.
  • Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
  • Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
  • Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
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.
DosageView

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.
AdministrationView
The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5o C
Side effectsView
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.
ContraindicationsView
Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.
PrecautionsView
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.
InteractionsView
No potentially hazardous interactions have been reported.
Pregnancy & lactationView
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.
ReconstitutionView
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.
StorageView
Store in a cool, dry place (below 30o C), away from light & moisture. Keep out of the reach of children.

Ximorox

Cefuroxime Axetil
Tablet 250 mg Allopathic Second generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
  • Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
  • Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
  • Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
  • Lower respiratory tract infections 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, E. coli
  • Acute bacterial exacerbation of chronic bronchitis and Secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
  • Skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
  • Urinary tract infections caused by E.coli or Klebsiella pneumoniae.
  • Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
  • Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
  • Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
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.
DosageView

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.
AdministrationView
The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5o C
Side effectsView
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.
ContraindicationsView
Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.
PrecautionsView
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.
InteractionsView
No potentially hazardous interactions have been reported.
Pregnancy & lactationView
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.
ReconstitutionView
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.
StorageView
Store in a cool, dry place (below 30o C), away from light & moisture. Keep out of the reach of children.

Xinarox

Cefuroxime Axetil
IV Injection 1.5 gm/vial Allopathic Second generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
  • Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
  • Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
  • Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
  • Lower respiratory tract infections 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, E. coli
  • Acute bacterial exacerbation of chronic bronchitis and Secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
  • Skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
  • Urinary tract infections caused by E.coli or Klebsiella pneumoniae.
  • Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
  • Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
  • Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
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.
DosageView

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.
AdministrationView
The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5o C
Side effectsView
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.
ContraindicationsView
Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.
PrecautionsView
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.
InteractionsView
No potentially hazardous interactions have been reported.
Pregnancy & lactationView
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.
ReconstitutionView
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.
StorageView
Store in a cool, dry place (below 30o C), away from light & moisture. Keep out of the reach of children.

Xinarox

Cefuroxime Axetil
IM/IV Injection 750 mg/vial Allopathic Second generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
  • Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
  • Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
  • Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
  • Lower respiratory tract infections 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, E. coli
  • Acute bacterial exacerbation of chronic bronchitis and Secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
  • Skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
  • Urinary tract infections caused by E.coli or Klebsiella pneumoniae.
  • Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
  • Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
  • Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
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.
DosageView

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.
AdministrationView
The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5o C
Side effectsView
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.
ContraindicationsView
Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.
PrecautionsView
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.
InteractionsView
No potentially hazardous interactions have been reported.
Pregnancy & lactationView
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.
ReconstitutionView
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.
StorageView
Store in a cool, dry place (below 30o C), away from light & moisture. Keep out of the reach of children.

Xinarox

Cefuroxime Axetil
Tablet 500 mg Allopathic Second generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
  • Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
  • Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
  • Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
  • Lower respiratory tract infections 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, E. coli
  • Acute bacterial exacerbation of chronic bronchitis and Secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
  • Skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
  • Urinary tract infections caused by E.coli or Klebsiella pneumoniae.
  • Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
  • Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
  • Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
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.
DosageView

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.
AdministrationView
The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5o C
Side effectsView
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.
ContraindicationsView
Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.
PrecautionsView
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.
InteractionsView
No potentially hazardous interactions have been reported.
Pregnancy & lactationView
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.
ReconstitutionView
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.
StorageView
Store in a cool, dry place (below 30o C), away from light & moisture. Keep out of the reach of children.

Xinarox

Cefuroxime Axetil
Tablet 250 mg Allopathic Second generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
  • Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
  • Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
  • Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
  • Lower respiratory tract infections 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, E. coli
  • Acute bacterial exacerbation of chronic bronchitis and Secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
  • Skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
  • Urinary tract infections caused by E.coli or Klebsiella pneumoniae.
  • Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
  • Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
  • Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
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.
DosageView

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.
AdministrationView
The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5o C
Side effectsView
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.
ContraindicationsView
Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.
PrecautionsView
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.
InteractionsView
No potentially hazardous interactions have been reported.
Pregnancy & lactationView
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.
ReconstitutionView
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.
StorageView
Store in a cool, dry place (below 30o C), away from light & moisture. Keep out of the reach of children.

Xinarox CV

Cefuroxime Axetil + Clavulanic Acid
Tablet 500 mg+125 mg Allopathic Second generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
  • Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
  • Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
  • Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
  • Lower respiratory tract infections 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, E. coli.
  • Acute bacterial exacerbation of chronic bronchitis and secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
  • Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
  • Uncomplicated urinary tract infections caused by E.coli or Klebsiella pneumoniae.
  • Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
  • Uncomplicated Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
  • Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
  • Septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, E.coli, Haemophilus influenzae (including ampicillin-resistant strains) & Klebsiella spp.
  • Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis & Staphylococcus aureus (penicillinase and non-penicillinase producing strains)
  • Switch therapy (Injectable to oral)
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
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.
DosageView
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
AdministrationView
Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.
Side effectsView
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.
ContraindicationsView
Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.
PrecautionsView
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.
InteractionsView
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.
Pregnancy & lactationView
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.
StorageView
Store in a cool, dry place (below 30o C), away from light and moisture. Keep out of the reach of children.

Xinarox CV

Cefuroxime Axetil + Clavulanic Acid
Tablet 250 mg+62.5 mg Allopathic Second generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
  • Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
  • Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
  • Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
  • Lower respiratory tract infections 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, E. coli.
  • Acute bacterial exacerbation of chronic bronchitis and secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
  • Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
  • Uncomplicated urinary tract infections caused by E.coli or Klebsiella pneumoniae.
  • Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
  • Uncomplicated Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
  • Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
  • Septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, E.coli, Haemophilus influenzae (including ampicillin-resistant strains) & Klebsiella spp.
  • Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis & Staphylococcus aureus (penicillinase and non-penicillinase producing strains)
  • Switch therapy (Injectable to oral)
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
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.
DosageView
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
AdministrationView
Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.
Side effectsView
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.
ContraindicationsView
Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.
PrecautionsView
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.
InteractionsView
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.
Pregnancy & lactationView
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.
StorageView
Store in a cool, dry place (below 30o C), away from light and moisture. Keep out of the reach of children.

Xinc

Zinc Sulfate Monohydrate
Syrup 10 mg/5 ml Allopathic Specific mineral preparations

Indications

Zinc deficiency

Indication detailsView
Zinc Sulfate Monohydrate is indicated in zinc deficiency and/or zinc losing conditions. Zinc deficiency can occur as a result of inadequate diet or malabsorption. Excessive loss of zinc can occur in trauma, burns, diarrhoea and protein losing conditions. A zinc supplement is given until clinical improvement occurs but it may need to be continued in severe malabsorption, metabolic disease or in zinc losing states.
Therapeutic classView
Specific mineral preparations
PharmacologyView
Zinc sulphate monohydrate is an essential trace element and is involved in a number of body enzyme systems. The body needs zinc for normal growth and health. Zinc is also vital for sexual maturation and reproduction, dark vision adaptation, olfactory and gustatory activity, insulin storage & release and for a variety of host immune defenses. Zinc deficiency may lead to impaired immune function, delayed wound healing, a decrease in sense of taste and smell, a reduced ability to fight infections, poor night vision, increased risk of abortion, alopecia, mental lethargy, skin changes and poor development of reproductive organs.
DosageView
Child under 10 kg: 5 ml (1 teaspoonful) 2 times daily after food.
Child between 10-30 kg: 10 ml (2 teaspoonfuls) 1-3 times daily after food.
Adults and child over 30 kg: 20 ml (4 teaspoonfuls) 1-3 times daily after food.

This drug is most effective if they are taken at least 1 hour before or 2 hour after meals. However, if causes stomach upset, this may be taken with a meal.
AdministrationView
For dispersible tablet-
  • Place the tablet in a teaspoon
  • Add adequate amount of water
  • Let the tablet dissolve completely
  • Give the entire spoonful solution
Side effectsView
Zinc may cause nausea, vomiting, diarrhoea, stomach upset, heartburn and gastritis.
ContraindicationsView
It is contraindicated in those who are hypersensitive to any component of the ingredient of this preparation.
PrecautionsView
In acute renal failure, zinc accumulation may occur in body; so dose adjustment is needed.
InteractionsView
Concomitant intake of a tetracycline and zinc may decrease the absorption of both the tetracycline and zinc. Similarly concomitant administration of zinc and quinolone drug may also decrease the absorption of both. Concomitant intake of penicillamine and zinc may decrese absorption of zinc.
Pregnancy & lactationView
The safety of this product in human pregnancy has not been established. Zinc crosses the placenta and is present in breast milk.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.

Xinc

Zinc Sulfate Monohydrate
Tablet 20 mg Allopathic Specific mineral preparations

Indications

Zinc deficiency

Indication detailsView
Zinc Sulfate Monohydrate is indicated in zinc deficiency and/or zinc losing conditions. Zinc deficiency can occur as a result of inadequate diet or malabsorption. Excessive loss of zinc can occur in trauma, burns, diarrhoea and protein losing conditions. A zinc supplement is given until clinical improvement occurs but it may need to be continued in severe malabsorption, metabolic disease or in zinc losing states.
Therapeutic classView
Specific mineral preparations
PharmacologyView
Zinc sulphate monohydrate is an essential trace element and is involved in a number of body enzyme systems. The body needs zinc for normal growth and health. Zinc is also vital for sexual maturation and reproduction, dark vision adaptation, olfactory and gustatory activity, insulin storage & release and for a variety of host immune defenses. Zinc deficiency may lead to impaired immune function, delayed wound healing, a decrease in sense of taste and smell, a reduced ability to fight infections, poor night vision, increased risk of abortion, alopecia, mental lethargy, skin changes and poor development of reproductive organs.
DosageView
Child under 10 kg: 5 ml (1 teaspoonful) 2 times daily after food.
Child between 10-30 kg: 10 ml (2 teaspoonfuls) 1-3 times daily after food.
Adults and child over 30 kg: 20 ml (4 teaspoonfuls) 1-3 times daily after food.

This drug is most effective if they are taken at least 1 hour before or 2 hour after meals. However, if causes stomach upset, this may be taken with a meal.
AdministrationView
For dispersible tablet-
  • Place the tablet in a teaspoon
  • Add adequate amount of water
  • Let the tablet dissolve completely
  • Give the entire spoonful solution
Side effectsView
Zinc may cause nausea, vomiting, diarrhoea, stomach upset, heartburn and gastritis.
ContraindicationsView
It is contraindicated in those who are hypersensitive to any component of the ingredient of this preparation.
PrecautionsView
In acute renal failure, zinc accumulation may occur in body; so dose adjustment is needed.
InteractionsView
Concomitant intake of a tetracycline and zinc may decrease the absorption of both the tetracycline and zinc. Similarly concomitant administration of zinc and quinolone drug may also decrease the absorption of both. Concomitant intake of penicillamine and zinc may decrese absorption of zinc.
Pregnancy & lactationView
The safety of this product in human pregnancy has not been established. Zinc crosses the placenta and is present in breast milk.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.

Xinc B

Vitamin B Complex + Zinc
Syrup Allopathic Specific mineral & vitamin combined preparations

Indications

Vitamins B and Zinc deficiencies

Indication detailsView
This is indicated for the treatment and prevention of zinc and vitamin B deficiencies.
Therapeutic classView
Specific mineral & vitamin combined preparations
PharmacologyView
Zinc is vital for many biological functions such as immunity enhancement, wound healing, digestion, reproduction, physical growth and mental development. Zinc supports normal growth and development during pregnancy, childhood, and adolescence. Zinc also has some antioxidant properties. Zinc is used to treat ADHD (Attention Deficit Hyper-activity Disorder) in children. In adult, due to zinc deficiency loss of appetite, poor sense of taste and smell, tendency towards depression, white marks on fingernails, frequent infections, low fertility, prostate problems, mental problems, poor wound healing, a poor immune system, diarrhoea, mental lethargy, rough skin and weight loss may occur.

B-Vitamins are needed to release energy from food. They play an important role in ensuring healthy brain and nerve function, healthy red blood cells formation in children & adults. They are specially needed for healthy growth and development of children. B-Vitamin deficiencies in adult cause profound fatigue and various types of neurologic manifestations, which may include weakness, poor balance, confusion, irritability, memory loss, nervousness, tingling of the limbs and loss of coordination. Additional symptoms of vitamin B deficiency are sleep disturbances, nausea, poor appetite, frequent infections, and skin lesions.
DosageView
Syrup-
  • Adults: 10 ml (2 teaspoonful) 2 to 3 times daily or as recommended by the physician.
  • Children: 10 ml (2 teaspoonful) 1 to 3 times daily or as recommended by the physician.
  • Infants: 5 ml (1 teaspoonful) 1 to 2 times daily or as recommended by the physician.
Tablet-
  • Adults & Children over 30 kg: 1 to 2 tablets 2 to 3 times daily or as recommended by the physician.
Side effectsView
This is generally well tolerated. However, a few side effects like nausea, vomiting, diarrhoea & stomach upset may occur. Side effects have been reported with specific vitamins but generally at levels substantially higher than recommended doses.
ContraindicationsView
Vitamin B Complex & Zinc is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.
PrecautionsView
In acute renal failure, zinc accumulation may occur, so dosage adjustment is needed. This is not intended for the treatment of severe specific deficiencies.
InteractionsView
Concomitant intake of tetracyclines and zinc may decrease the Gl absorption and serum levels of tetracyclines. Similarly concomitant administration of zinc and fluroquinolones may decrease the Gl absorption and serum  levels of some fluroquinolones. Coadministration of Niacin and HMG-CoA reductase inhibitors (eg. lovastatin) may result mayopathy and rhabdomyolysis. Pyridoxine reduces levodopa's effectiveness by increasing its peripheral metabolism. Co-administration of pyridoxine with phenytoin may decrease serum levels of phenytoin.
Pregnancy & lactationView
This is recommended in pregnancy and lactation.
Overdose effectsView
In case of overdosage, initially epigastric pain, diarrhoea and vomiting can occur. In that case, one should seek emergency medical attention. Initially, an emetic should be given and then gastric lavage and general supportive measures should be employed.
StorageView
Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.

Xinc B

Vitamin B Complex + Zinc
Tablet Allopathic Specific mineral & vitamin combined preparations

Indications

Vitamins B and Zinc deficiencies

Indication detailsView
This is indicated for the treatment and prevention of zinc and vitamin B deficiencies.
Therapeutic classView
Specific mineral & vitamin combined preparations
PharmacologyView
Zinc is vital for many biological functions such as immunity enhancement, wound healing, digestion, reproduction, physical growth and mental development. Zinc supports normal growth and development during pregnancy, childhood, and adolescence. Zinc also has some antioxidant properties. Zinc is used to treat ADHD (Attention Deficit Hyper-activity Disorder) in children. In adult, due to zinc deficiency loss of appetite, poor sense of taste and smell, tendency towards depression, white marks on fingernails, frequent infections, low fertility, prostate problems, mental problems, poor wound healing, a poor immune system, diarrhoea, mental lethargy, rough skin and weight loss may occur.

B-Vitamins are needed to release energy from food. They play an important role in ensuring healthy brain and nerve function, healthy red blood cells formation in children & adults. They are specially needed for healthy growth and development of children. B-Vitamin deficiencies in adult cause profound fatigue and various types of neurologic manifestations, which may include weakness, poor balance, confusion, irritability, memory loss, nervousness, tingling of the limbs and loss of coordination. Additional symptoms of vitamin B deficiency are sleep disturbances, nausea, poor appetite, frequent infections, and skin lesions.
DosageView
Syrup-
  • Adults: 10 ml (2 teaspoonful) 2 to 3 times daily or as recommended by the physician.
  • Children: 10 ml (2 teaspoonful) 1 to 3 times daily or as recommended by the physician.
  • Infants: 5 ml (1 teaspoonful) 1 to 2 times daily or as recommended by the physician.
Tablet-
  • Adults & Children over 30 kg: 1 to 2 tablets 2 to 3 times daily or as recommended by the physician.
Side effectsView
This is generally well tolerated. However, a few side effects like nausea, vomiting, diarrhoea & stomach upset may occur. Side effects have been reported with specific vitamins but generally at levels substantially higher than recommended doses.
ContraindicationsView
Vitamin B Complex & Zinc is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.
PrecautionsView
In acute renal failure, zinc accumulation may occur, so dosage adjustment is needed. This is not intended for the treatment of severe specific deficiencies.
InteractionsView
Concomitant intake of tetracyclines and zinc may decrease the Gl absorption and serum levels of tetracyclines. Similarly concomitant administration of zinc and fluroquinolones may decrease the Gl absorption and serum  levels of some fluroquinolones. Coadministration of Niacin and HMG-CoA reductase inhibitors (eg. lovastatin) may result mayopathy and rhabdomyolysis. Pyridoxine reduces levodopa's effectiveness by increasing its peripheral metabolism. Co-administration of pyridoxine with phenytoin may decrease serum levels of phenytoin.
Pregnancy & lactationView
This is recommended in pregnancy and lactation.
Overdose effectsView
In case of overdosage, initially epigastric pain, diarrhoea and vomiting can occur. In that case, one should seek emergency medical attention. Initially, an emetic should be given and then gastric lavage and general supportive measures should be employed.
StorageView
Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.

Xinc DS

Zinc Sulfate Monohydrate
Syrup 20 mg/5 ml Allopathic Specific mineral preparations

Indications

Zinc deficiency

Indication detailsView
Zinc Sulfate Monohydrate is indicated in zinc deficiency and/or zinc losing conditions. Zinc deficiency can occur as a result of inadequate diet or malabsorption. Excessive loss of zinc can occur in trauma, burns, diarrhoea and protein losing conditions. A zinc supplement is given until clinical improvement occurs but it may need to be continued in severe malabsorption, metabolic disease or in zinc losing states.
Therapeutic classView
Specific mineral preparations
PharmacologyView
Zinc sulphate monohydrate is an essential trace element and is involved in a number of body enzyme systems. The body needs zinc for normal growth and health. Zinc is also vital for sexual maturation and reproduction, dark vision adaptation, olfactory and gustatory activity, insulin storage & release and for a variety of host immune defenses. Zinc deficiency may lead to impaired immune function, delayed wound healing, a decrease in sense of taste and smell, a reduced ability to fight infections, poor night vision, increased risk of abortion, alopecia, mental lethargy, skin changes and poor development of reproductive organs.
DosageView
Child under 10 kg: 5 ml (1 teaspoonful) 2 times daily after food.
Child between 10-30 kg: 10 ml (2 teaspoonfuls) 1-3 times daily after food.
Adults and child over 30 kg: 20 ml (4 teaspoonfuls) 1-3 times daily after food.

This drug is most effective if they are taken at least 1 hour before or 2 hour after meals. However, if causes stomach upset, this may be taken with a meal.
AdministrationView
For dispersible tablet-
  • Place the tablet in a teaspoon
  • Add adequate amount of water
  • Let the tablet dissolve completely
  • Give the entire spoonful solution
Side effectsView
Zinc may cause nausea, vomiting, diarrhoea, stomach upset, heartburn and gastritis.
ContraindicationsView
It is contraindicated in those who are hypersensitive to any component of the ingredient of this preparation.
PrecautionsView
In acute renal failure, zinc accumulation may occur in body; so dose adjustment is needed.
InteractionsView
Concomitant intake of a tetracycline and zinc may decrease the absorption of both the tetracycline and zinc. Similarly concomitant administration of zinc and quinolone drug may also decrease the absorption of both. Concomitant intake of penicillamine and zinc may decrese absorption of zinc.
Pregnancy & lactationView
The safety of this product in human pregnancy has not been established. Zinc crosses the placenta and is present in breast milk.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.

Xinc DT

Zinc Sulfate Monohydrate
Dispersible Tablet 20 mg Allopathic Specific mineral preparations

Indications

Zinc deficiency

Indication detailsView
Zinc Sulfate Monohydrate is indicated in zinc deficiency and/or zinc losing conditions. Zinc deficiency can occur as a result of inadequate diet or malabsorption. Excessive loss of zinc can occur in trauma, burns, diarrhoea and protein losing conditions. A zinc supplement is given until clinical improvement occurs but it may need to be continued in severe malabsorption, metabolic disease or in zinc losing states.
Therapeutic classView
Specific mineral preparations
PharmacologyView
Zinc sulphate monohydrate is an essential trace element and is involved in a number of body enzyme systems. The body needs zinc for normal growth and health. Zinc is also vital for sexual maturation and reproduction, dark vision adaptation, olfactory and gustatory activity, insulin storage & release and for a variety of host immune defenses. Zinc deficiency may lead to impaired immune function, delayed wound healing, a decrease in sense of taste and smell, a reduced ability to fight infections, poor night vision, increased risk of abortion, alopecia, mental lethargy, skin changes and poor development of reproductive organs.
DosageView
Child under 10 kg: 5 ml (1 teaspoonful) 2 times daily after food.
Child between 10-30 kg: 10 ml (2 teaspoonfuls) 1-3 times daily after food.
Adults and child over 30 kg: 20 ml (4 teaspoonfuls) 1-3 times daily after food.

This drug is most effective if they are taken at least 1 hour before or 2 hour after meals. However, if causes stomach upset, this may be taken with a meal.
AdministrationView
For dispersible tablet-
  • Place the tablet in a teaspoon
  • Add adequate amount of water
  • Let the tablet dissolve completely
  • Give the entire spoonful solution
Side effectsView
Zinc may cause nausea, vomiting, diarrhoea, stomach upset, heartburn and gastritis.
ContraindicationsView
It is contraindicated in those who are hypersensitive to any component of the ingredient of this preparation.
PrecautionsView
In acute renal failure, zinc accumulation may occur in body; so dose adjustment is needed.
InteractionsView
Concomitant intake of a tetracycline and zinc may decrease the absorption of both the tetracycline and zinc. Similarly concomitant administration of zinc and quinolone drug may also decrease the absorption of both. Concomitant intake of penicillamine and zinc may decrese absorption of zinc.
Pregnancy & lactationView
The safety of this product in human pregnancy has not been established. Zinc crosses the placenta and is present in breast milk.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.

Xinc OT

Zinc Orotate
Tablet 60 mg Allopathic Specific mineral preparations

Indications

Severe diarrhea

Indication detailsView
Oral zinc therapy is indicated in zinc deficiency and/or zinc losing conditions like- Hair loss, Skin rashes, Major depression, Loss of smell, taste and memory, White spots on the fingernails, Increased susceptibility to infection, Loss of activity of growth hormone (GH), Visual impairment, fingernails, Diarrhea, Male infertility, Sickle cell anemia, Delayed wound healing, Type-2 diabetes.
Therapeutic classView
Specific mineral preparations
PharmacologyView
Zinc, a major mineral, plays a part in almost all the body's cellular and enzymatic processes. Its bioavailability and digestive assimilation increases significantly when bound to orotic acid. An essential component of over 80 enzymes, it plays a role in all metabolism and has a specific antioxidant, anti-free radical action.
DosageView
Adults: One tablet twice daily with meal.
Side effectsView
Zinc might cause nausea, vomiting, metallic taste and stomach upset etc.
PrecautionsView
Patients with diabetes & acute renal failure should use zinc products cautiously.
InteractionsView
Concomitant intake of tetracycline, quinolone and penicillamine along with zinc may decrease the absorption of both drugs.
Pregnancy & lactationView
It should be used in pregnant or lactating mother after consultation with a health care professional.
Overdose effectsView
Taking doses higher than 40 mg (elemental zinc) daily might cause fever, cough, upset stomach.
StorageView
Store in a cool and dry place, away from light & moisture. Keep out of the reach of children.

Xindal

Clindamycin
Capsule 300 mg Allopathic Macrolides

Indications

Toxic shock syndrome

Indication detailsView
Clindamycin has been shown to be effective in the treatment of the following infections when caused by susceptible anaerobic bacteria or susceptible strains of gram positive bacteria such as Streptococci, Staphylococci and Pneumococci; Upper respiratory infections, Lower respiratory infections, Skin and soft tissue infections, Bone and joint infections, Pelvic infections, Intra-abdominal infections, Septicemia and endocarditis, Dental infections. As an alternative therapy when used in combination with quinine or amodiaquine for the treatment of multi-drug resistant Plasmodium falciporum infection.
Therapeutic classView
Macrolides
DosageView
Dosage of Clindamycin Capsule:
  • Serious Infections: 150 mg-300 mg every six hours.
  • More severe infections: 300 mg-450 mg every six hours.
To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC90 for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:
  • Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
  • Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
  • More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.
In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-
  • Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
  • More severe infections: 1200-2700 mg/day in 2-4 equal doses.
  • For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
  • Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.
Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):
  • 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
  • Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
  • In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.
Side effectsView
The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.
ContraindicationsView
Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.
PrecautionsView
Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
InteractionsView
Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.
Pregnancy & lactationView
Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.
Pediatric usageView
Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric use: Dose adjustment of Clindamycin is not necessary.
Overdose effectsView
Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.
ReconstitutionView
Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.

Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.
  • Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
  • Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

Physico-Chemical Stability of diluted solutions of Clindacin Injection-
  • Room temperature: 16 days at 25°C.
  • Refrigeration: 32 days at 4°C.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Xindal

Clindamycin
Capsule 150 mg Allopathic Macrolides

Indications

Toxic shock syndrome

Indication detailsView
Clindamycin has been shown to be effective in the treatment of the following infections when caused by susceptible anaerobic bacteria or susceptible strains of gram positive bacteria such as Streptococci, Staphylococci and Pneumococci; Upper respiratory infections, Lower respiratory infections, Skin and soft tissue infections, Bone and joint infections, Pelvic infections, Intra-abdominal infections, Septicemia and endocarditis, Dental infections. As an alternative therapy when used in combination with quinine or amodiaquine for the treatment of multi-drug resistant Plasmodium falciporum infection.
Therapeutic classView
Macrolides
DosageView
Dosage of Clindamycin Capsule:
  • Serious Infections: 150 mg-300 mg every six hours.
  • More severe infections: 300 mg-450 mg every six hours.
To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC90 for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:
  • Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
  • Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
  • More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.
In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-
  • Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
  • More severe infections: 1200-2700 mg/day in 2-4 equal doses.
  • For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
  • Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.
Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):
  • 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
  • Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
  • In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.
Side effectsView
The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.
ContraindicationsView
Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.
PrecautionsView
Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
InteractionsView
Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.
Pregnancy & lactationView
Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.
Pediatric usageView
Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric use: Dose adjustment of Clindamycin is not necessary.
Overdose effectsView
Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.
ReconstitutionView
Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.

Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.
  • Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
  • Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

Physico-Chemical Stability of diluted solutions of Clindacin Injection-
  • Room temperature: 16 days at 25°C.
  • Refrigeration: 32 days at 4°C.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Xinolax DR

Duloxetine Hydrochloride
Capsule (Delayed Release) 60 mg Allopathic Serotonin-norepinephrine reuptake inhibitor (SNRI)

Indications

Urinary incontinence

Indication detailsView
Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for-
  • Major Depressive Disorder (MDD)
  • Generalized Anxiety Disorder (GAD)
  • Diabetic Peripheral Neuropathic Pain (DPNP)
  • Fibromyalgia and
  • Chronic Musculoskeletal Pain.
Therapeutic classView
Serotonin-norepinephrine reuptake inhibitor (SNRI)
PharmacologyView
Duloxetine Hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Duloxetine is a less potent inhibitor of dopamine reuptake. Duloxetine has no significant affinity for dopaminergic, adrenergic, cholinergic, histaminergic, opioid, glutamate, and GABA receptors in vitro. Duloxetine does not inhibit monoamine oxidase (MAO). Orally administered Duloxetine hydrochloride is well absorbed. Elimination of Duloxetine is mainly through hepatic metabolism.
DosageView
Major Depressive Disorder (MDD)-
  • Starting Dose: 40 mg/day to 60 mg/day
  • Target Dose: Acute: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance: 60 mg/day
  • Maximum Dose: 120 mg/day
Generalized Anxiety Disorder (GAD)-
  • Starting Dose: 60 mg/day
  • Target Dose: 60 mg/day (once daily)
  • Maximum Dose: 120 mg/day
Diabetic Peripheral Neuropathic Pain (DPNP)-
  • Starting Dose: 60 mg/day
  • Target Dose: 60 mg/day (once daily)
  • Maximum Dose: 60 mg/day
Fibromyalgia-
  • Starting Dose: 30 mg/day
  • Target Dose: 60 mg/day (once daily)
  • Maximum Dose: 60 mg/day
Chronic Musculoskeletal Pain-
  • Starting Dose: 30 mg/day
  • Target Dose: 60 mg/day (once daily)
  • Maximum Dose: 60 mg/day
Some patients may benefit from starting at 30 mg once daily. There is no evidence that doses greater than 60 mg/day confers an additional benefit, while some adverse reactions were observed to be dose-dependent. A gradual dose reduction is recommended to avoid discontinuation symptoms.
Side effectsView
The most commonly observed adverse events in Duloxetine hydrochloride treated patients were nausea, dizziness, dry mouth, constipation, decreased appetite, fatigue, somnolence, increased sweating, hyperhidrosis and asthenia. It may slightly increase blood pressure. No clinically significant differences were observed for QT, PR, and QRS intervals between Duloxetine-treated and placebo-treated patients.
ContraindicationsView
Duloxetine is contraindicated in patients with a known hypersensitivity to this drug or any of the inactive ingredients. Duloxetine is not approved for use in treating bipolar depression. Duloxetine should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. In clinical trials, Duloxetine was associated with an increased risk of mydriasis; therefore, it should be used cautiously in patients with controlled narrow-angle glaucoma.
PrecautionsView
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes. Blood pressure should be measured prior to initiating treatment and periodically measured throughout treatment. Patients should be cautioned about the risk of bleeding associated with the concomitant use of Duloxetine and NSAIDs, aspirin, or other drugs that affect coagulation. Duloxetine should be used cautiously in patients with a history of mania. Duloxetine should be prescribed with care in patients with a history of a seizure disorder.
InteractionsView
Both CYP1A2 and CYP2D6 isozymes are responsible for Duloxetine metabolism. When Duloxetine was co-administered with fluvoxamine, a potent CYP1A2 inhibitor, the AUC, Cmax and t of Duloxetine was increased. Other drugs that inhibit CYP1A2 metabolism include cimetidine and quinolone antimicrobials such as ciprofloxacin and enoxacin would be expected to have similar effects and these combinations should be avoided. Because CYP2D6 is involved in Duloxetine metabolism, concomitant use of Duloxetine with potent inhibitors of CYP2D6 may result in higher concentrations of Duloxetine.
Pregnancy & lactationView
Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women; therefore, Duloxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery: The effect of Duloxetine on labor and delivery in humans is unknown. Duloxetine should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is unknown whether or not Duloxetine and/or it's metabolites are excreted into human milk, but nursing while on Duloxetine is not recommended
Pediatric usageView
Use in the pediatric population: Safety and efficacy in pediatric patients have not been established
Overdose effectsView
There is limited clinical experience with Duloxetine overdose in humans. There is no specific antidote to Duloxetine. In case of acute overdose, treatment should consist of those general measures employed in the management of overdose with any drug. An adequate airway, oxygenation, and ventilation should be assured, and cardiac rhythm and vital signs should be monitored. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients. Activated charcoal may be useful in limiting the absorption of Duloxetine from the gastrointestinal tract.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.