Mipecid 500 mg/500 mg powder for solution for infusion – imipenem and cilastatin for serious bacterial infections

Mipecid is a carbapenem antibiotic. It contains imipenem, which kills a wide range of bacteria, and cilastatin, which prevents the breakdown of imipenem in the kidneys and so prolongs its action. It is used to treat serious infections in adults and children aged one year and older.

In Serbia it is authorised as Mipecid®, 500 mg/500 mg, powder for solution for infusion (PharmaSwiss d.o.o. Belgrade), in packs of 10 glass vials. It is a hospital medicine: it is prepared and given by a doctor or other healthcare professional as an intravenous infusion.

What is Mipecid used for and how is it given?

Key facts about the medicine

What is Mipecid used for?

According to the package leaflet, Mipecid is used in adults and children from 1 year to treat:

• complicated abdominal infections;
• severe pneumonia, including hospital-acquired and ventilator-associated pneumonia;
• infections during and after childbirth;
• complicated urinary tract infections;
• complicated skin and soft tissue infections.

It may also be used in patients with low white blood cell counts and fever suspected to be bacterial, and for bacterial blood infections associated with the infections above. It is used in line with official guidance on the appropriate use of antibiotics.

How is it given and dosed?

The doctor decides the dose depending on the type and severity of infection, bacterial susceptibility and kidney function. According to the leaflet:

• It is given by intravenous infusion: doses up to 500 mg/500 mg over 20–30 minutes, higher doses over 40–60 minutes; the infusion rate may be slowed if nausea occurs.
• The reconstituted solution must be used immediately – no more than 2 hours may pass from the start of preparation to the end of the infusion. It must not be reconstituted with lactate-containing solutions.

Special patient groups

• Kidney impairment: the dose is reduced; without adjustment, nervous system side effects may occur. Patients on haemodialysis receive the medicine after dialysis, with careful monitoring.
• Liver impairment and elderly patients with normal kidney function: no dose adjustment is needed.
• Children: not recommended in children under 1 year and in children with kidney problems.

Contraindications – when the medicine must not be used

Mipecid must not be given if you are allergic (hypersensitive) to:

• imipenem, cilastatin or the excipient;
• other antibiotics such as penicillins, cephalosporins or carbapenems.

Warnings and precautions

Tell your doctor about any drug allergies (especially to antibiotics), colitis or other bowel diseases, kidney or urinary tract disease, nervous system disorders (tremor, seizures) and liver disease. Blood levels of the medicine rise when kidney function is reduced.

A positive Coombs test (antibodies that can destroy red blood cells) may occur during treatment – your doctor will explain this. One vial contains 37.5 mg sodium (1.9% of the recommended maximum daily intake).

Interactions with other medicines, food and drink

• ganciclovir (for viral infections) – tell your doctor;
• valproic acid or sodium valproate (epilepsy, bipolar disorder, migraine) – the doctor decides on concomitant use;
• medicines that prevent blood clotting, such as warfarin.

Pregnancy and breast-feeding

• Pregnancy: the medicine has not been studied in pregnant women and should not be used during pregnancy unless the doctor considers the benefit greater than the risk to the baby.
• Breast-feeding: small amounts may pass into milk; the doctor decides whether you may receive the medicine while breast-feeding.

Driving and using machines

Some side effects (hallucinations, dizziness, drowsiness) may affect the ability to drive or use machines.

Possible side effects

Rare but serious: allergic reactions (rash, swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, low blood pressure), skin peeling (toxic epidermal necrolysis), Stevens-Johnson syndrome, erythema multiforme and exfoliative dermatitis – administration is stopped immediately.

• Common (up to 1 in 10): nausea, vomiting, diarrhoea, swelling and redness along the vein, rash, changes in liver test results, increase in certain white blood cells.
• Uncommon (up to 1 in 100): redness, pain and a hard lump at the injection site, itching, hives, fever, changes in blood counts and kidney and liver tests, trembling and muscle twitching, seizures, mental disturbances, hallucinations, confusion, dizziness, drowsiness, low blood pressure.
• Rare (up to 1 in 1,000): candidiasis, staining of teeth or tongue, colitis with severe diarrhoea, taste disturbance, hepatitis, kidney dysfunction and urine changes, hearing loss, pins and needles.
• Very rare: fulminant hepatitis, haemorrhagic colitis, ringing in the ears, irregular heartbeat, difficulty breathing, worsening of myasthenia gravis and others.

Report any suspected side effect to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: symptoms may include seizures, confusion, muscle trembling, nausea, vomiting, low blood pressure and slow heart rate – inform the doctor or nurse immediately.
• Missed dose: healthcare staff ensure regular administration; a double dose is never given. Tell the doctor if you think a dose has been missed.

Composition, pack and manufacturer

• Active substances: 500 mg imipenem (as imipenem monohydrate) and 500 mg cilastatin (as cilastatin sodium) per vial.
• Excipient: sodium hydrogen carbonate; one vial contains 37.5 mg sodium.
• Pack: carton with 10 colourless 20 ml glass vials with bromobutyl rubber stoppers.
• Marketing authorisation holder and manufacturer: PharmaSwiss d.o.o. Belgrade, Batajnički drum 5A, Belgrade, Republic of Serbia.

Storage

• The unopened medicine does not require any special storage conditions; shelf life of the unopened medicine is 3 years.
• Use the reconstituted solution immediately (no more than 2 hours from the start of preparation to the end of infusion); do not freeze.
• Keep out of the sight and reach of children.

Frequently asked questions

Can I receive Mipecid if I am allergic to penicillin?

No – according to the leaflet, the medicine must not be given if you are allergic to other antibiotics such as penicillins, cephalosporins or carbapenems. Tell the doctor about any previous allergy.

How is Mipecid given?

Only by intravenous infusion in hospital: doses up to 500 mg/500 mg over 20–30 minutes and higher doses over 40–60 minutes. It is prepared and given by a healthcare professional.

Why is kidney function important?

With reduced kidney function blood levels of the medicine rise, so the dose is reduced according to creatinine clearance; without adjustment, nervous system side effects including seizures may occur.

Can Mipecid be used in children?

Yes, in children aged 1 year and older, at 15/15 or 25/25 mg/kg every 6 hours. It is not recommended in children under 1 year or in children with kidney disease.

Sources

• ALIMS – Summary of Product Characteristics Mipecid® 500 mg/500 mg powder for solution for infusion (SmPC, Serbian)
• ALIMS – Package leaflet Mipecid® 500 mg/500 mg powder for solution for infusion (PIL, Serbian)

Date sources checked: 25.10.2026.