Inpen

Meropenam

Meropenam

Presentation
InpenTM 500 mg IV injection: Each vial contains Meropenem USP 500 mg.
InpenTM 1 g IV injection: Each vial contains Meropenem USP 1 g.
Mode of Action
Meropenem is a carbapenem antibiotic for parenteral use, that is stable to human dehydropeptidase-I (DHP-I). It Is structurally similar to imipenem. 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 -
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.
Indications
InpenTM 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:
l    Lower Respiratory Tract Infections, l    Urinary Tract Infections, including complicated infections l    Intra-abdominal Infections, l    Gynaecological infections, including
postpartum infections, l    Skin and Skin Structure Infections, l    Meningitis, l    Septicaemia, l    Empiric treatment, including initial monotherapy, for presumed bacterial
infections in host-compromised, neutropenic patient.
Because of its broad spectrum or bactericidal activity against Gram-positive and Gram-negative aerobic and anaerobic bacteria. InpenTM is effective for the treatment of
polymicrobial infections.
Dosage and Administration
ADULTS:
Usual dose: 500 mg to 1 g by intravenous administration every 8 hours depending on type end severity of Infection.
Exceptions: 1.    Febrile episodes to neutropenic patients - the dose should be I g every 8 hours. 2.    Meningitis- the dose should be 2 g every 8 hours.
As with other antibiotic, caution may be required in using Meropenem as monotherapy in critically iII patients with known or suspected Pseudomonas aeruginosa lower
respiratory tract erections. Regular sensitivity testing is recommended when treating Pseudomonas aeruginosa infections.
InpenTM 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.
Exceptions
1.    Febrile episodes in neutropenic patients-the dose should be 20 mg/kg every 8 hours. 2.    Meningitis- the does should be 40 mg/kg every 8 hours.
InpenTM 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.
InpenTM is cleared by haemodialysis. If continued treatment with InpenTM 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
InpenTM 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.
InpenTM 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.
InpenTM 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% ages 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.
Contraindications
InpenTM is contraindicated in patients who have demonstrated hypersensitivity to this product.
Warnings and Precautions
Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitive to InpenTM. As with all betalactam
antibiotics rare hypersensitivity reactions have been reported.
Rarely, pseudomembranous colitis has been reported with InpenTM as with virtually all antibiotics; therefore, its diagnosis should be considered in patients who develop
diarrhea in association with the use of InpenTM. Inpen® may reduce serum valproic acid levels.
Use in Children
Efficacy and tolerability in infants under 3 months old have not been established; therefore, InpenTM is not recommended for use below this age.
Use in Patients with Liver Disease
Patients with pre-existing liver disorders should have liver function monitored during treatment with InpenTM.
Use in Pregnancy & Lactation
Pregnancy category B. The safety of InpenTM in human pregnancy has not been established, although animal studies have not shown an adverse effect on the
developing foetus. InpenTM should not be used in pregnancy unless the potential benefit justifies the potential risk to the foetus.
Meropenem is detectable at very low concentrations in animal breast milk. InpenTM should not be used in breast-feeding women unless the potential benefit justifies the
potential risk to the baby.
Adverse Effect
InpenTM is generally well tolerated. Adverse events rarely lead to cessation of treatment. Serious adverse events are rare thrombocythaemia, nausea, vomiting,
diarrhoea, increases in serum transaminases, bilirubin, alkaline phosphates, lactic dehydrogenase, inflammation, thrombophlebitis, pain, eosinophilia,
thrombocytopenia, headache. paresthesiae, rash, unrticaria, pruritis, leucopenia, neutropenia, agranulocytosis, convulsions, oral and vaginal candidiasis, haemolytic
anaemia, angioedema, manifestations of anaphylaxis, pseudoniembranous colitis, erythema multiforme, stevens-Johnson syndrome, toxic epidermal necrolysis.
Drug Interactions
Probenecid competes with meropenem for active tubular secretion and thus inhibitis the renal excretion of meropenem with the effect of increasing the elimination halflife
and plasma concentration of meropenem. As the potency and duration of action of InpenTM without probenecid are adequate, the co-administration of probenecid
with InpenTM is not recommended. However, the protein binding is so low (approximately 2%) that no interactions with other compounds would be expected on the basis
of this mechanism.
InpenTM has been administered concomitantly with many other medications without apparent adverse interaction. However, no specific drug interaction studies other
than with probenecid were conducted.
Overdose
Intentional overdosing of InpenTM 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 InpenTM and its metabolite.
Storage Condition
Store in a cool and dry place, away from light. Keep out of reach of the children.
Commercial Supply
InpenTM 500 mg IV Injection: Each combipack contains 1 vial of Meropenem USP 500 mg and 1 ampoule of 10 ml WFI. It also contains a sterile disposable syringe (10
ml), vein set, alcohol pad and strip bandage.
InpenTM 1 g IV Injection: Each combipack contains 1 vial of Meropenem USP 1 g and 2 ampoules of 10 ml WFI. It also contains a sterile disposable syringe (20 ml),
vein set, alcohol pad and strip bandage.