BDMERO 500/BDMERO 1000

BDMERO 500/BDMERO 1000

meropenem

Manufacturer:

Ambica

Distributor:

Ambica
Full Prescribing Info
Contents
Meropenem.
Description
BDMERO 500: Each vial contains: Meropenem trihydrate eq. to Meropenem 500 mg, Sodium carbonate 45.1 mg.
BDMERO 1000: Each vial contains: Meropenem trihydrate eq. to Meropenem 1g, Sodium carbonate 90.2 mg.
Action
Pharmacology: The following list of pathogens is derived from clinical experience and therapeutic guidelines.
Commonly susceptible species: Gram-positive aerobes: Enterococcus faecalis, Staphylococcus aureus (methicillin-susceptible), Staphylococcus species (methicillin-susceptible including Staphylococcus epidermidis), Streptococcus agalactiae (Group B), Streptococcus milleri group (S. anginosus, S. constellatus, and S. intermidius), Streptococcus pneumoniae, Streptococcus pyogenes (Group A).
Gram-negative aerobes: Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Neisseria meningitidis, Proteus mirabilis, Proteus vulgaris, Serratia marcescens.
Gram-positive anaerobes: Clostridium perfringens, Peptoniphilus asaccharolyticus, Peptostreptococcus species (including P. micros, P. anaerobius, P. magnus).
Gram-negative anaerobes: Bacteroides caccae, Bacteroides fragilis group, Prevotella bivia, Prevotella disiens.
Other mircro-organisms: Chlamydophila pneumoniae, Chlamydophila psittaci, Coxiella burnetii, Mycoplasma pneumonia.
Pharmacokinetics: Distribution: The average plasma protein binding of meropenem was approximately 2% and was independent of concentration. After rapid administration (5 minutes or less) the pharmacokinetics are biexponential but this is much less evident after 30 minutes infusion. Meropenem has been shown to penetrate well into several body fluids and tissues: including lung, bronchial secretions, bile, cerebrospinal fluid, gynaecological tissues, skin, fascia, muscle, and peritoneal exudates.
Metabolism: Meropenem is metabolised by hydrolysis of the beta-lactam ring generating a microbiologically inactive metabolite. In vitro meropenem shows reduced susceptibility to hydrolysis by human dehydropeptidase-I (DHP-I) compared to imipenem and there is no requirement to co-administer a DHP-I inhibitor.
Elimination: Meropenem is primarily excreted unchanged by the kidneys: approximately 70% (50-75%) of the dose is excreted unchanged within 12 hours. A further 28% is recovered as the microbiologically inactive metabolite. Faecal elimination represents only approximately 2% of the dose. The measured renal clearance and the effect of probenecid show that meropenem undergoes both filtration and tubular secretion.
Toxicology: Preclinical Safety Data: Animal studies indicate that meropenem is well tolerated by the kidney. Histological evidence of renal tubular damage was seen in mice and dogs only at doses of 2000 mg/kg and above.
Meropenem is generally well tolerated by the CNS. Effect were seen only at very high doses of 2000 mg/kg and above.
The IV of meropenem is rodents is greater than 2000 mg/kg. In repeat dose studies of up to months duration only minor effects were seen including a small decrease in red cell parameters and an increase in liver weight in dogs at 500 mg/kg.
There was no evidence of mutagenic potential in the 5 tests conducted and no evidence of reproductive toxicity including teratogenic potential in studies at the highest possible level in rats and monkeys. (The no effect dose level of a small reduction in body weight in rats was 120 mg/kg).
There was increased evidence of abortions at 500 mg/kg in a preliminary study in monkeys.
There was no evidence of increased sensitivity to meropenem in juveniles compared to adult animals. The intravenous formulation was well tolerated in animal studies. The intramuscular formulation caused reversible injection site necrosis.
The sole metabolite of meropenem had a similar low profile of toxicity in animal studies.
Indications/Uses
Meropenem is indicated in adults and children over 3 months of age in the: Treatment of infections caused by susceptible organism, including pneumonia, respiratory tract infections (including cystic fibrosis), urinary tract infections, intra-abdominal infections, intra and post-partum infections, skin and soft tissue infections, and bacterial meningitis.
Management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
Dosage/Direction for Use
A dose of up to 2 g three times daily in adults and adolescents and a dose of up to 40 mg/kg three times daily in children may be particularly appropriate when treating some types of infections, such as nosocomial infections due to Pseudomonas aeruginosa or Acinetobacter spp.
Additional considerations for dosing are needed when treating patients with renal insufficiency (see further as follows). (See Table 1.)

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Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes.
Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes. There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection.
Renal Impairment: The dose for adults and adolescent should be adjusted when creatinine clearance is less than 51 mL/min. as shown as follows. There are limited data to support the application of these dose adjustments for a unit dose of 2 g. (See Table 2.)

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Meropenem is cleared by haemodialysis and haemofiltration. The required dose should be administered after completion of the haemodialysis cycle.
There are no established dose recommendations for patients receiving peritoneal dialysis.
Hepatic impairment: No dose adjustment is necessary in patients with hepatic impairment.
Dose in elderly patients: No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 mL/min.
Paediatric population: Children under 3 months of age: The safety and efficacy of meropenem in children under 3 months of age have not been established and the optimal dose regimen has not been identified. However, limited pharmacokinetic data suggest that 20 mg/kg every 8 hours may be an appropriate regimen.
Children from 3 months to 11 years of age and up to 50 kg body weight: The recommended dose regimens are shown in the table as follows: (see Table 3.)

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Children over 50 kg body weight: The adult dose should be administered.
There is no experience in children with renal impairment.
Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes. Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. There are limited safety date available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection.
MEROPENEM FOR INJECTION USP for intravenous infusion maybe directly constituted with a compatible infusion fluid and then further diluted (50 to 200 mL) with the compatible infusion fluid, as needed.
MEROPENEM FOR INJECTION USP 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 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; normosol-M in 51/6 glucose intravenous infusion.
Overdosage
Intentional overdosing of MEROPENEM FOR INJECTION USP 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 Reactions, 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 MEROPENEM FOR INJECTION USP and its metabolite.
Contraindications
MEROPENEM FOR INJECTION USP in contraindicated in patients who have demonstrated hypersensitivity to the active substance or any of the excipients. It is also contraindicated in patients who have hypersensitivity to any other carbapenem or β-lactam antibacterial agents.
Special Precautions
Patients who have a history of hypersensitivity to carbapenem, penicillins or other beta-lactam antibiotics may also be hypersensitive to MEROPENEM. As with all beta-lactam antibiotics rare hypersensitivity reactions have been reported. (See Adverse Reactions.)
As with other antibiotics, overgrowth of non-susceptible organisms may occur and repeated evaluation of each patient is necessary.
Rarely, pseudomembranous colitis has been reported with MEROPENEM FOR INJECTION USP as with virtually all antibiotics; therefore, its diagnosis should be considered in patients who develop diarrhoea in association with the use of MEROPENEM.
MEROPENEM FOR INJECTION USP may reduce serum valproic acid levels. Subtherapeutic levels may be reached in some patients. A positive direct or indirect Coombs test may develop.
Use In Patients with Liver Disease: Patients with pre-existing liver disorders should have liver function monitored during treatment with MEROPENEM.
Effect on Ability to Drive or Operate Machinery: No data are available, but it is not anticipated that MEROPENEM FOR INJECTION USP will affect the ability to drive and operate machinery.
Use in Children: Efficacy and tolerability in infants under 3 months old have not been established; therefore, MEROPENEM FOR INJECTION USP is not recommended for use below this age.
Use in Pregnancy: The safely of MEROPENEM FOR INJECTION USP in human pregnancy has not been established, although animal studies have not shown an adverse effect on the developing fetus. MEROPENEM FOR INJECTION USP should not be used in pregnancy unless the potential benefit justifies the potential risk to the fetus.
Use in Lactation: Meropenem is detectable at very low concentrations in animal breast milk. MEROPENEM FOR INJECTION USP should not be used in breast-feeding women unless the potential benefit justifies the potential risk to the baby.
Use In Pregnancy & Lactation
Use in Pregnancy: The safely of MEROPENEM FOR INJECTION USP in human pregnancy has not been established, although animal studies have not shown an adverse effect on the developing fetus. MEROPENEM FOR INJECTION USP should not be used in pregnancy unless the potential benefit justifies the potential risk to the fetus.
Use in Lactation: Meropenem is detectable at very low concentrations in animal breast milk. MEROPENEM FOR INJECTION USP should not be used in breast-feeding women unless the potential benefit justifies the potential risk to the baby.
Adverse Reactions
MEROPENEM FOR INJECTION USP is generally well tolerated. Adverse events rarely lead to cessation of treatment. Serious adverse events are rare. (See Table 4.)

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Drug Interactions
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 MEROPENEM FOR INJECTION USP dosed without probenecid are adequate the co-administration of probenecid with MEROPENEM FOR INJECTION USP is not recommended. The potential effect of MEROPENEM FOR INJECTION USP 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.
MEROPENEM FOR INJECTION USP has been administered concomitantly with many other medications without apparent adverse interaction. MEROPENEM FOR INJECTION USP 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.
Caution For Usage
Incompatibilities: MEROPENEM FOR INJECTION USP is compatible with the solutions listed in Storage and should not be mixed with or physically added to solutions containing other medicines.
Storage
Store at temperatures not exceeding 30°C.
To reduce microbiological hazard, solutions of MEROPENEM FOR INJECTION USP should be used as soon as practicable after reconstitution. If storage is necessary, hold at 2° to 8°C for not more than 24 hours, or the period shown in the following table, which ever is the lesser. (See Table 5.)

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Solutions of MEROPENEM FOR INJECTION USP should not be frozen.
Shelf-Life: 2 Years.
MIMS Class
ATC Classification
J01DH02 - meropenem ; Belongs to the class of carbapenems. Used in the systemic treatment of infections.
Presentation/Packing
BDMERO 500: Powd for inj (vial) 500 mg x 20 mL x 1's. BDMERO 1000: Powd for inj (vial) 1,000 mg x 30 mL x 1's.
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