APR MORPENAM

INFORMATION FOR THE USER

Meropenem 1g Injection

Read all of this information carefully before you start taking this medicine because it contains important information for you.
• Keep this information. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine is prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this information.

1. COMPOSITION:
Each vial contains:
Meropenem–1000mg

2. DESCRIPTION:
Meropenem is an anti-bacterial. It belongs to a class of antibiotics known as carbapenems and is very useful for the treatment of bacterial infections.

3. PHARMACOLOGICAL ACTION:
Meropenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram (+) & Gram (-) bacteria through binding to penicillin-binding proteins. It thus inhibits bacterial cell wall synthesis leading to the death of the bacteria. Similar to other beta-lactam antibacterial agents, the time that meropenem concentrations exceed the MIC (T>MIC) has been shown to best correlate with efficacy. In preclinical models meropenem demonstrated activity when plasma concentrations exceeded the MIC of the infecting organisms for approximately 40% of the dosing interval. This target has not been established clinically.
4. CLINICAL PHARMACOKINETICS:
Absorption is rapid & complete following IV administration. The average plasma protein binding was ~2% & is independent of concentration. After rapid administration the pharmacokinetics are biexponential but this is less evident after 30 minutes infusion. It has been shown to penetrate well into several body fluids & tissues: including lung, bronchial secretions, bile, CSF, gynaecological tissues, skin, fascia, muscle & peritoneal exudates. It 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 compared to imipenem & there is no requirement to co-administer a DHP-I inhibitor. It is primarily excreted unchanged by the kidneys. Approx. 70% of the dose is excreted unchanged within 12 hours. A further 28% is recovered as the microbiologically inactive metabolite. Faecal elimination represents only approx. 2% of the dose. The measured renal clearance & the effect of probenecid show that meropenem undergoes both filtration & tubular secretion.
5. INDICATIONS:
Meropenem is indicated for the treatment of the following infections in adults and children aged 3 months and older:
– Severe pneumonia, including hospital & ventilator-associated pneumonia.
– Broncho-pulmonary infections in cystic fibrosis
– Complicated urinary tract infections
– Complicated intra-abdominal infections
– Intra& post-partum infections
– Complicated skin & soft tissue infections
– Acute bacterial meningitis
– Management of neutropenic patients with fever that is suspected to be due to a bacterial infection.

6. CONTRAINDICATIONS:
Meropeneminjection is contraindicated in the following cases:

– Hypersensitivity to the active substance or to any of the excipients.
– Hypersensitivity to any other carbapenem antibacterial agent.
– Severe hypersensitivity to any other type of beta-lactam antibacterial agent.

7. WARNINGS AND PRECAUTIONS:
Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp. Resistance: Prescribers are advised to take into account the local prevalence of resistance.
Hypersensitivity reactions: Serious & occasionally fatal hypersensitivity reactions have been reported. 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.
Seizures: Seizures have infrequently been reported
Hepatic function monitoring: Hepatic function should be closely monitored during treatment due to the risk of hepatic toxicity.
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.
Direct antiglobulin test (Coombs test) seroconversion: A positive direct or indirect Coombs test may develop.
Concomitant use with valproic acid/sodium valproate/valpromide: The concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended.
8. ADVERSE EFFECTS:
Common side effects include:
– Headache
– Diarrhoea, vomiting, nausea, abdominal pain
– Antibiotic associated colitis
– Rash, pruritis
– Inflammation, pain at the site of injection
– Increased liver enzymes level
9. DRUG INTERACTIONS:
Probenecid: Inhibits 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.
Valproate: Decreases in blood levels of valproic acid have been reported when it is co-administered with meropenem.
Warfarin: Simultaneous administration with warfarin may augment its anti-coagulant effects.

10. DOSAGE:
Adults:Upto 2g three times a day.
Pediatrics: 40mg/kg three times a day.

11. ADMINISTRATION:
Can be administered either by intravenous injection. To be administered by a healthcare professional under appropriate hospital setting.
12. PRESENTATION:
13. STORAGE:
Store below 25°C in a cool and dry pace. Protect from direct sunlight. Keep away from the reach of children.

Do not freeze.

14. MANUFACTURED BY:
15. MARKETED BY:

This leaflet was last revised on May 2019.