Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2023 Publisher: Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom
Meropenem is indicated for the treatment of the following infections in adults and children aged 3 months and older (see sections 4.4 and 5.1):
Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The tables below provide general recommendations for dosing.
The dose of meropenem administered and the duration of treatment should take into account the type of infection to be treated, including its severity, and the clinical response.
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 or Acinetobacter spp.) or very severe infections.
Additional considerations for dosing are needed when treating patients with renal insufficiency (see further below).
| Infection | Dose to be administered every 8 hours |
|---|---|
| Severe pneumonia including hospital and ventilatorassociated 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 (see section 6.2, 6.3 and 6.6).
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.
The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 ml/min, as shown below. There are limited data to support the administration of these dose adjustments for a unit dose of 2 g.
| 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 after completion of the haemodialysis cycle.
There are no established dose recommendations for patients receiving peritoneal dialysis.
No dose adjustment is necessary in patients with hepatic impairment (see section 4.4).
No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min.
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 (see section 5.2).
The recommended dose regimens are shown in the table below:
| 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 |
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 (see sections 6.2, 6.3, and 6.6). Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Meropenem is a white to pale yellow crystalline powder for solution for injection or infusion in vial.
Product after reconstitution is clear colourless to yellow solution.
Relative overdose may be possible in patients with renal impairment if the dose is not adjusted as described in section 4.2. Limited post-marketing experience indicates that if adverse reactions occur following overdose, they are consistent with the adverse reaction profile described in section 4.8, 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.
2 years.
Intravenous bolus injection administration:
A solution for bolus injection is prepared by dissolving the drug product meropenem in sterile water for injection to a final concentration of 50 mg/ml.
Chemical and physical in-use stability for a prepared solution for bolus injection has been demonstrated up to 3 hours at controlled room temperature (15-25°C) or up to 8 hours under refrigerated conditions (2-8°C). From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately.
If not used immediately in-use storage times and conditions are the responsibility of the user.
Intravenous infusion administration:
A solution for infusion is prepared by dissolving the drug product meropenem in either 0.9% sodium chloride solution for infusion or 5% glucose (dextrose) solution for infusion to a final concentration of 1 to 20 mg/ml.
Chemical and physical in-use stability for a prepared solution for infusion using 0.9% sodium chloride solution has been demonstrated for 6 hours at controlled room temperature (15-25°C) or upto12 hours under refrigerated conditions (2-8°C). In this case, the prepared solution if stored under refrigeration (i.e. 2-8°C) should be used within 1 hour after it has left the refrigerator.
From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately. If not used immediately in-use storage times and conditions are the responsibility of the user.
Reconstituted solution of meropenem in 5% glucose (dextrose) solution should be used immediately, i.e. within 30 minutes following reconstitution.
Do not freeze the reconstituted solution.
The medicinal product does not require any special storage condition.
1349.56 mg powder in a 40ml Type-I, tubular, clear glass vial with stopper (bromobutyl rubber with aluminum seals having white colour polypropylene discs).
The medicinal product is supplied in pack sizes of 1 or 10 vials.
Not all pack sizes may be marketed.
Meropenem to be used for bolus intravenous injection should be constituted with sterile water for injection.
In order to avoid a coring phenomenon of the plug, when inserting the needle into the rubber stopper, it is recommended to use a needle with a 21-gauge or smaller diameter needle for the reconstitution of the product.
Needle should be inserted only at the center of the rubber stopper, in vertical direction.
For intravenous infusion meropenem vial may be directly constituted with 0.9% sodium chloride or 5% glucose (dextrose) solutions for infusion.
Each vial is for single use only.
Standard aseptic techniques should be used for solution preparation and administration.
The solution should be shaken before use. The solutions should be inspected visually for particles and discolouration prior to administration. Only clear colourless to yellow solution, free from particles should be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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