Mervex

Mervex

meropenem

Manufacturer:

Facta Farmaceutici

Distributor:

Panpharma Healthcare
Full Prescribing Info
Contents
Meropenem trihydrate.
Description
Each vial contains: Meropenem trihydrate (Equivalent to 1 g anhydrous meropenem) 1 g.
Excipients/Inactive Ingredients: Each vial contains: Sodium carbonate (Equates to approximately 4.0 mEq of sodium approximately 90 mg) 208 mg.
Indications/Uses
For the treatment of susceptible infections including intra abdominal infections, gynaecological infections, meningitis, respiratory tract infections (including in cystic fibrosis patients) septicaemia, skin and skin structure infections, urinary tract infection and infection in immunocompromised patients.
Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Dosage/Direction for Use
The tables as follows 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 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 nosocomial infections due to Pseudomonas aeruginosa or Acinobacter spp.
Additional considerations for dosing are needed when treating patients with renal insufficiency.
Adults and Adolescents: See Table 1.

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Management 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 adolescents 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.
Elderly: 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 appropriate regimen.
Children from 3 months to 11 years and up to 50 kg body weight: The recommended dose regimens are shown in Table 3: 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.
Administration: 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 data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Hypersensitivity to any other carbapenem antibacterial agent.
Severe hypersensitivity (eg. Anaphylactic reaction, severe skin reaction) to any other part of betalactam antibacterial agent (eg. Penicillins or cephalosporins).
Special Precautions
The selection of Meropenem to treat an individual patient should take into account the appropriateness of using a carbapenem antibacterial agent based on factors such as severity if the infection, the prevalence of resistance to other suitable antibacterial agents and risk of selecting for carbapenem-resistant bacteria.
And with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported.
Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitive to meropenem. Before initiating therapy with meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.
If a severe allergic reaction occurs, the medicinal product should be discontinued and appropriate measures taken.
Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all anti-bacterial agents, including meropenem, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea during or subsequent to the administration of 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 have infrequently been reported during treatment with carbapenems, including meropenem.
Hepatic function should be closely monitored during treatment with meropenem due to the risk of hepatic toxicity (hepatic dysfunction with cholestasis and cytolysis).
Use in Patients with Liver Disease: Patients with pre-existing liver disorders should have liver function monitored during treatment with meropenem. There is no dose adjustment necessary.
A positive direct or indirect Coombs test may develop during treatment with meropenem.
The concomitant use of meropenem and valproic acid/sodium valproate is not recommended.
Meropenem Contains Sodium: This medicinal product contains approximately 4.0 mEq of sodium per 1 g dose which should be taken into consideration by patients on a controlled sodium diet.
Effects on Ability to Drive and Use Machines: No studies on the effects on the ability to drive and use of machines have been performed.
Use In Pregnancy & Lactation
Use in Pregnancy: There are no or limited amount of data from the use of meropenem in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
As a precautionary measure, it is preferable to avoid the use of meropenem during pregnancy.
Use in Lactation: It is unknown whether meropenem is excreted in human milk. Meropenem is detectable at very low concentrations in animal breast milk. 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.
Adverse Reactions
In a review of 4,872 patients with 5,026 meropenem treatment exposures, meropenem-related adverse reactions most frequently reported were diarrhea (2.3%), rash (1.4%), nausea/vomiting (1.4%) and injection site inflammation (1.1%). The most commonly reported meropenem-related laboratory adverse effects were thrombocytocis (1.6%) and increased hepatic enzymes (1.5-4.3%).
Adverse reactions listed in the table with a frequency of "not known" were not observed in the 2,367 patients who were included in preauthorization clinical studies with intravenous and intramuscular meropenem but have been reported during the post-marketing period.
In the table below all adverse reactions are listed by system organ class and frequency: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See Table 4.)

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Drug Interactions
No specific medicinal product interaction studies other than probenecid were conducted. Probenecid competes with meropenem for active tubular secretion and thus the renal excretion of meropenem with the effect of increasing the elimination half-life and plasma concentration of meropenem. Caution is required if probenecid is co-administered with meropenem.
The potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. However, the protein binding is so low that no interactions with other compounds would be expected on the basis of this mechanism.
Decreases in blood levels of valproic acid have been reported when it is co-administered with carbapenem agents resulting in a 60-100% decrease in valproic acid levels in about two days. Due to rapid onset and the extent of the decrease, co-administration of valproic acid with carbapenem agents is not considered to be manageable and therefore should be avoided.
Oral Anti-Coagulants: Simultaneous administration of antibiotics with warfarin may augment its anti-coagulant effects. There have been many reports of increases in the anti-coagulant effects of orally administered anti-coagulant agents, including warfarin in patients who are concomitantly receiving antibacterial agents. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of the antibiotic to the increase in INR (International Normalised Ratio) is difficult to assess. It is recommended that the INR should be monitored frequently during and shortly after co-administration of antibiotics with an oral anti-coagulant agent.
MIMS Class
ATC Classification
J01DH02 - meropenem ; Belongs to the class of carbapenems. Used in the systemic treatment of infections.
Presentation/Packing
Powd for inj (vial) 1 g x 10's.
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