MEROPENEM ELSaad 500
-
Chemical Name:
Meropenem -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Antibiotic, Carbapenem -
Pharmaceutical Form:
Vial -
Composition:
Meropenem 500mg
MEROPENEM ELSaad
Powder for solution for IV injection or infusion (Vial)
Meropenem
1-COMPOSITION:
MEROPENEM ELSaad– Powder for solution for IV injection or infusion: Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem.
MEROPENEM ELSaad– Powder for solution for IV injection or infusion: Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem.
2-MECHANISM of ACTION:
Meropenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs).
3-PHARMACOKINETICS:
Absorption: Peak tissue time: 1 hr after infusion.
Distribution: it Penetrates well into most body fluids and tissues; CSF concentrations approximate those in plasma, Protein bound: 2%.
Metabolism: it is Metabolized in liver to open beta-lactam form (inactive)
Elimination: Half-life: in case of Normal renal function 1-1.5 hr, in case of CrCl>30-80 mL/min 1.9-3.3 hr and in case of CrCl>2-30 mL/min 3.82-5.7 hr. Excretion is in the Urine (~25% as inactive metabolites).
4-INDICATIONS:
Meropenem is indicated for the treatment of the following infections in adults and children over 3 months of age:
- Severe pneumonia, including hospital and ventilator-associated pneumonia.
- Broncho-pulmonary infections in cystic fibrosis
- Complicated urinary tract infections
- Complicated intra-abdominal infections
- Intra- and post-partum infections
- Complicated skin and soft tissue infections
- Acute bacterial meningitis
- Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
- Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
5-CONTRAINDICATIONS:
- Hypersensitivity to the active substance or to any of the excipients .
- Hypersensitivity to any other carbapenem antibacterial agent.
- Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. penicillins or cephalosporins).
6-ADVERSE EFFECTS:
Common: headache, diarrhea, vomiting, nausea, abdominal Pain, rash, pruritis, inflammation and pain in site of admistration, thrombocythaemia, transaminases increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased.
Uncommon: oral and vaginal candidiasis, eosinophilia, thrombocytopenia,
leucopenia, neutropenia, agranulocytosis, haemolytic anaemia, angioedema, anaphylaxis, paraesthesiae, antibiotic-associated colitis, blood bilirubin increased, urticaria, toxic epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme., blood creatinine increased, blood urea Increased, Thrombophlebitis, pain at the injection
site.
7-EFFECTS on ABILITY to DRIVE and USE MACHINES:
When driving or operating machines, it should be taken into account that headache, paraesthesiae and convulsions have been reported for meropenem.
8-WARNINGS and PRECAUTIONS:
Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp. Resistance:
Prescribers are advised to take into account the local prevalence of resistance in these bacteria to penems.
Hypersensitivity reactions:
Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also behypersensitive to meropenem. If a severe allergic reaction occurs, the medicinal product should be discontinued and appropriate measures taken.
Antibiotic-associated colitis:
Antibiotic-associated colitis and pseudomembranous colitis have been reported with meropenem. Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
Seizures:
Seizures have infrequently been reported during treatment with meropenem.
Hepatic function monitoring:
Hepatic function should be closely monitored during treatment with meropenem due to the risk of hepatic toxicity (hepatic dysfunction with cholestasis and cytolysis).
This product contains sodium:
This medicinal product contains sodium which should be taken into consideration by patients on a controlled sodium diet.
9-DRUG INTERACTIONS:
- Probenecid competes with meropenem for active tubular secretion. Caution is required if probenecid is co-administered with meropenem.
- Decreases in blood levels of valproic acid have been reported when it is co-administered with carbapenem agents therefore, co-administration of valproic acid/sodium valproate with carbapenem should be avoided.
- Simultaneous administration of antibiotics with warfarin may augment its anti-coagulant effects. It is recommended that the INR should be monitored frequently during and shortly after co-administration of antibiotics with an oral anti-coagulant agent.
10-PREGNANCY, Category B:
As a precautionary measure, it is preferable to avoid the use of meropenem during pregnancy.
11-LACTATION:
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from meropenem therapy taking into account the benefit of therapy for the woman.
12-DOSAGE and ADMINISTRATION:
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 infections due to less susceptible bacterial species (e.g. Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp.), or very severe infections.
Adults and Adolescents:
| Infection | Dose to be administered every 8 hours |
| Severe pneumonia including hospital and ventilator associated pneumonia. | 500 mg or 1 g |
| Broncho-pulmonary infections in cystic fibrosis | 2 g |
| Complicated urinary tract infections | 500 mg or 1 g |
| Complicated intra-abdominal infections | 500 mg or 1 g |
| Intra- and post-partum infections | 500 mg or 1 g |
| Complicated skin and soft tissue infections | 500 mg or 1 g |
| Acute bacterial meningitis | 2 g |
| Management of febrile neutropenic patients | 1 g |
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.
Renal impairment:
The dose for adults and adolescents should be adjusted when creatinine clearance is less than51 ml/min, as shown below:
| Creatinine clearance (ml/min) |
Dose
(based on “unit” dose range of 500 mg
or 1 g or 2 g, see table above)
|
Frequency |
| 26-50 | one unit dose | every 12 hours |
| 10-25 | half of one unit dose | every 12 hours |
| <10 | half of one unit dose | every 24 hours |
Meropenem is cleared by haemodialysis and haemofiltration. The required dose should be administered aftercompletion 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.
Pediatric 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:
| Infection | Dose to be administered every 8 hours |
| Severe pneumonia including hospital and ventilator associated pneumonia | 10 or 20 mg/kg |
| Broncho-pulmonary infections in cystic fibrosis | 40 mg/kg |
| Complicated urinary tract infections | 10 or 20 mg/kg |
| Complicated intra-abdominal infections | 10 or 20 mg/kg |
| Complicated skin and soft tissue infections | 10 or 20 mg/kg |
| Acute bacterial meningitis | 40 mg/kg |
| Management of febrile neutropenic patients | 20 mg/kg |
Children over 50 kg body weight:
The adult dose should be administered.
13-DIRECTIONS:
- 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 5minutes.
- Each vial is for single use only.
- The solution should be shaken before use.
- There are limited safety data available to support the administration of a 40 mg/kg dose in children as an
intravenous bolus injection.
14-PREPARATION OF SOLUTION :
-Intravenous bolus injection administration:
A solution for bolus injection is prepared by dissolving it in water for injection to a final concentration of 50 mg/ml(10 ml of water added to vial 500mg meropenem and 20 ml of water added to vial 1 g meropenem).
-Intravenous infusion administration:
A solution for infusion is prepared by dissolving the drug product in either 0.9% sodium chloride solution for infusion or5% dextrose solution for infusion to a final concentration of 1 to 20 mg/ml.
Chemical and physical in-use stability for aprepared solution for infusion using 0.9% sodium chloride solution has been demonstrated for 3 hours at up to 25°C or24 hours under refrigerated conditions (2-8°C). Reconstituted solution of the product in 5% dextrose solution should be used immediately. The constituted solutions should not be frozen.
15-OVERDOSAGE:
If adverse reactions occur following overdose which are generally mild in severity and resolve on withdrawal or dose reduction. Symptomatic treatments should be considered. In individuals with normal renal function, rapid renal elimination will occur. Haemodialysis will remove meropenem and its metabolite.
16-PACKAGING:
MEROPENEM ELSaad 500 – For Injection: A pack of 1 or 10 vials of 10 or 30mL.
MEROPENEM ELSaad 1000 – For Injection: A pack of 1 or 10 vials of 20 or 30mL.
17-STORAGE CONDITIONS:
Store MEROPENEM ELSaad– For Injection at temperature between (15-30)°C.
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