Meropex

Composition
Meropex 1 gm IV injection: Each vial contains sterile Meropenem for injection USP equivalent to 1 gm of Meropenem.
Pharmacology
Meropenem is a carbapenem antibiotic for parenteral use, that is stable to human dehydropeptidase-I (DHP-I). Meropenem
exerts its bactericidal action by interfering with vital bacterial cell wall synthesis. The ease with which it penetrates bacterial
cells, its high level of stability to all serine b-lactamases and its marked affinity for the Penicillin Binding Proteins (PBPs)
explain the potent bactericidal activity of Meropenem against a broad spectrum of aerobic and anaerobic bacteria. In vitro
tests show that Meropenem can act synergistically with various antibiotics. It has been demonstrated both in vitro and in vivo
that Meropenem has a post-antibiotic effect against Gram-positive and Gram-negative organisms. The in vitro antibacterial
spectrum of Meropenem includes the majority of clinically significant Gram-positive and Gram-negative, aerobic and
anaerobic strains of bacteria.
Indication
Meropex is indicated for treatment, in adults and children, of the following infections caused by single or multiple susceptible
bacteria and as empiric therapy prior to the identification of the causative organisms:

• Lower Respiratory Tract Infections
• Urinary Tract Infections
• Intra-abdominal Infections
• Gynaecological Infections, including postpartum infections
• Skin and Skin Structure Infections
• Meningitis
• Septicaemia
• Empiric treatment, including initial monotherapy, for presumed bacterial
  
  infections in host-compromised, neutropenic patient because of its broad spectrum of bactericidal activity against
  Gram-positive and Gram-negative aerobic and anaerobic bacteria, Meropex is effective for the treatment of polymicrobial
  infections.
  Dosage and Administration
  Adults: Usual dose 500 mg to 1 gm by intravenous administration every 8 hours depending on type and severity of
  infection, the known or expected susceptibility of the pathogen(s) and the condition of the patient.
  Exception:
  1. Febrile episodes in neutropenic patients: the dose should be 1 gm every 8 hours.
  2. Meningitis: the dose should be 2 gm every 8 hours.
  As with other antibiotics, caution may be required in using Meropenem as monotherapy in critically ill patients with known or
  suspected Pseudomonas aeruginosa associated lower respiratory tract infections. Regular sensitivity testing is recommended
  when treating Pseudomonas aeruginosa associated infections. Meropex should be given as an intravenous bolus injection
  over approximately 5 minutes or by intravenous infusion over approximately 15 to 30 minutes (see Method of Administration).
  Elderly: No dosage adjustment is required for the elderly with normal renal function or creatinine clearance values above 50
  ml/min.
  CHILDREN: For infants and children over 3 months and up to 12 years of age the recommended intravenous dose is 10 to 40
  mg/kg every 8 hours depending on type and severity of infection, the known or suspected susceptibility of the pathogen(s)
  and the condition of the patient. In children over 50 kg weight, adult dosage should be used.
  Exception:
  1. Febrile episodes in neutropenic patients - the dose should be 20 mg/kg every 8 hours.
  2. Meningitis - the dose should be 40 mg/kg every 8 hours. Meropex should be given as an IV bolus over approximately 5
  minutes or by intravenous infusion over approximately 15 to 30 minutes. There is no experience in children with renal
  impairment. Dosage Schedule for Adults with Impaired Renal Function: Dosage should be reduced in patients with creatinine
  clearance less than 51 ml/min, as scheduled below.
  Meropex is cleared by haemodialysis. If continued treatment with Meropex is necessary, the unit dose (based on the type
  and severity of infection) is recommended at the completion of the haemodialysis procedure to re-institute effective
  treatment.
  Use in Adults with Hepatic Insufficiency: No dosage adjustment is necessary in patients with impaired hepatic
  metabolism.
  Method of Administration :

Meropex to be used for bolus intravenous injection should be constituted with sterile water for injection (10 ml per 500 mg
Meropenem). This provides an approximate available concentration of 50 mg/ml. Constituted solutions are clear or pale yellow.
Meropex for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200
ml) with the compatible infusion fluid, as needed. Meropex IV is compatible with the following infusion fluids: 0.9% sodium
chloride intravenous infusion, 5% or 10% glucose intravenous infusion, 5% glucose intravenous infusion with 0.02% sodium
bicarbonate, 5% glucose and 0.9% sodium chloride intravenous infusion, 5% glucose with 0.225% sodium chloride intravenous
infusion, 5% glucose with 0.15% potassium chloride intravenous infusion, 2.5% and 10% mannitol intravenous infusion.
Contraindication
Meropex is contraindicated in patients who have demonstrated hypersensitivity to this product.
Precaution
Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be
hypersensitive to Meropex. As with all beta-lactam antibiotics rare hypersensitivity reactions have been reported. Rarely,
pseudomembranous colitis has been reported with Meropex as with virtually all antibiotics; therefore, its diagnosis should be
considered in patients who develop diarrhoea in association with the use of Meropex. Meropex may reduce serum valproic
acid levels. Subtherapeutic levels may be reached in some patients.
Use in Patients with Liver Disease: Patients with pre-existing liver disorders should have liver function monitored during
treatment with Meropex.
Side Effect
Meropex is generally well tolerated. Adverse events rarely lead to cessation of treatment. Serious adverse events are rare
thrombocythaemia, nausea, vomiting, diarrhea, increases in serum transaminases, bilirubin, alkaline phosphatase, lactic
dehydrogenase, inflammation, thrombophlebitis, pain, eosinophilia, thrombocytopenia, headache, paresthesia, rash,
urticaria, pruritus, leucopenia, neutropenia, agranulocytosis, convulsions, oral and vaginal candidiasis, haemolytic anaemia,
angioedema, manifestations of anaphylaxis, pseudomembranous colitis, erythema multiforme, Stevens -Johnson syndrome,
toxic epidermal necrolysis.
Use in special group :
Pregnancy: Pregnancy category B. The safety of Meropex in human pregnancy has not been established, although animal
studies have not shown an adverse effect on the developing foetus. Meropex should not be used in pregnancy unless the
potential benefit justifies the potential risk to the foetus.
Lactation: Meropenem is detectable at very low concentrations in animal breast milk. Meropex should not be used in
breast-feeding women unless the potential benefit justifies the potential risk to the baby.
Use in Children: Efficacy and tolerability in infants under 3 months old have not been established; therefore, Meropex is not
recommended for use below this age.
Drug Interaction
Probenecid competes with Meropenem for active tubular secretion and thus inhibits the renal excretion of Meropenem with the
effect of increasing the elimination half-life and plasma concentration of Meropenem. As the potency and duration of action of
Meropex dosed without probenecid are adequate the co-administration of probenecid with Meropex is not recommended. The
potential effect of Meropex on the protein binding of other medicines or metabolism has not been studied. However, the protein
binding is so low (approximately 2%) that no interactions with other compounds would be expected on the basis of this
mechanism. Meropex has been administered concomitantly with many other medications without apparent adverse interaction.
Meropex may reduce serum valproic acid levels. Subtherapeutic levels may be reached in some patients. However, no specific
drug interaction studies other than with probenecid were conducted.
Overdosage
Intentional overdosing of Meropex is unlikely, although overdosing could occur during therapy particularly in patients with
renal impairment. Limited post-marketing experience indicates that if adverse events occur following overdosage, they are
consistent with the adverse event profile described in Adverse effects, are generally mild in severity and resolve on
withdrawal or dose reduction. Symptomatic treatments should be considered. In normal individuals rapid renal elimination
will occur. Haemodialysis will remove Meropex and its metabolite.

Storage Conditions

Store in a cool & dry place below 25ºC, protect from light. Keep out of reach of children.