Qurapenem Injection

Qurapenem

COMPOSITION:
Each vial contains
Sterile Meropenem USP (As Trihydrate)
Eq. to Meropenem Anhydrous 500 mg 
(Also contains 45.1 mg of sodium as sodium carbonate)
Each vial contains
Sterile Meropenem USP (As Trihydrate)
Eq. to Meropenem Anhydrous 1000 mg 
(Also contains 90.2 mg of sodium as sodium carbonate)

INDICATIONS:
Qurapenem Injection is indicated for:

  • Intra abdominal infections: Complicated Appendicitis and Peritonitis caused by Streptococci, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa
  • Bacterial meningitis caused by Streptococci pneumoniae and Haemophilus influenzae. It is also effective in eliminating concurrent Bacteraemia in association with Bacterial meningitis.
  • Complicated skin and skin structure infections.
  • Respiratory tract infections such as Bacterial pneumonia, Nosocomial pneumonia, Pseudomonas respiratory tract infection in Cystic fibrosis.
  • Septicemia such as Bacterial septicemia, Sepsis of newborn, Pediatric fever without a source.
  • Urinary Tract infections, Anthrax and Acinetobacter infections.

DESCRIPTION:
Qurapenem is a sterile, pyrogen-free synthetic, broad-spectrum, carbapenem antibiotic for intravenous administration. It exerts bactericidal activity by inhibiting cell wall synthesis. It penetrates the cell wall of most gram-positive and gram-negative bacteria to reach penicillin-binding–protein (PBP). It is effective against following strains of bacteria:
Gram-positive aerobes: Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridians.
Gram-negative aerobes: Pseudomonas aeruginosa, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoea, Neisseria meningitides, Klebsiella pneumoniae, Proteus mirabilis, Acinetobacter.
Anaerobic bacteria: Bacteroides fragilis, Clostridium spp. including C. perfringens, Eubacterium lentum, Fusobacterium spp., Mobiluncus curtisii, Bacillus anthracis.
A 5 minute intravenous bolus injection of Meropenem in normal volunteers results in peak plasma levels of approximately 52 µg/mL for the 500 mg dose and 112µg/mL for the 1 g dose. Plasma protein binding of Meropenem is approximately 2%. Approximately 70% of the intravenous administered dose is recovered as unchanged in the urine over 12 hours.

CONTRA-INDICATIONS:
Qurapenem Injection is contraindicated in patients with known hypersensitivity to Meropenem or other Carbapenem, Penicillins or other β-lactam antibiotics.

SIDE EFFECTS:
Inflammation, Thrombophlebitis, Nausea, Vomiting and Diarrhoea may occur. If symptoms persist, please consult the physician.

PRECAUTIONS:
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving β-lactams. If an allergic reaction to Qurapenem injection occurs, discontinue the drug immediately. Do not use if reconstituted solution contains visible particulate matter.
Check the expiry date on the pack and do not use after expiry.

DOSAGE:
Adults: Usual dose 500 mg to 1 g of Meropenem for Injection by intravenous administration every 8 hours depending on type and severity of infection, the known or suspected susceptibility of the pathogen and the condition of the patient.
Children: For infants and children over 3 months and up to 12 years of age the recommended intravenous dose is 10-40 mg/kg every 8 hours depending on type and severity of infection, the known or suspected susceptibility of the pathogen and the condition of the patient. In children over 50 kg weight, adult dosage should be used.

STORAGE:
Store in a cool, dark & dry place. Keep out of reach of children.

PRESENTATION:
20 ml/50 ml vial packed in a monocarton with insert.