Skip to Content

IMIPENEM 500MG / CILASTATIN 500MG POWDER FOR SOLUTION FOR INFUSION

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER
Imipenem 500 mg/cilastatin 500 mg powder for solution for infusion
imipenem/cilastatin
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor or pharmacist.
- This medicine has been 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 or pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet
1. What Imipenem 500 mg/cilastatin 500 mg is and what it is used for
2. What you need to know before you use Imipenem 500 mg/cilastatin 500 mg
3. How to use Imipenem 500 mg/cilastatin 500 mg
4. Possible side effects
5. How to store Imipenem 500 mg/cilastatin 500 mg
6. Contents of the pack and other information
1. WHAT IMIPENEM 500 MG/CILASTATIN 500 MG IS AND WHAT IT IS USED FOR
Imipenem 500 mg/cilastatin 500 mg belongs to a group of medicines called carbapenem antibiotics. It
kills a wide range of bacteria (germs) that cause infections in various parts of the body in adults and
children one year of age and above.
Treatment
Your doctor has prescribed Imipenem 500 mg/cilastatin 500 mg because you have one (or more) of
the following types of infection:
 Complicated infections in the abdomen
 Infection affecting the lungs (pneumonia)
 Infections that you can catch during or after the delivery
 Complicated urinary tract infections
 Complicated skin and soft tissue infections
Imipenem 500 mg/cilastatin 500 mg may be used in the management of patients with low white blood
cell counts, who have fever that is suspected to be due to a bacterial infection.
Imipenem 500 mg/cilastatin 500 mg may be used to treat bacterial infection of the blood which might
be associated with a type of infection mentioned above.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE IMIPENEM 500 MG/CILASTATIN
500 MG
Do not use Imipenem 500 mg/cilastatin 500 mg
- if you are allergic (hypersensitive) to imipenem, cilastatin or any of the other ingredients of
Imipenem 500mg/cilastatin 500 mg
- if you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or
carbapenems

1

Warnings and precautions
Tell your doctor about any medical condition you have or have had including:
- allergies to any medicines including antibiotics (sudden life-threatening allergic reactions require
immediate medical treatment)
- colitis or any other gastrointestinal disease
- any central nervous system disorders such as localized tremors or epileptic seizures
- liver, kidney or urinary problems
You may develop a positive test (Coombs test) which indicates the presence of antibodies that may
destroy red blood cells. Your doctor will discuss this with you.
Tell your doctor if you are taking medicines called valproic acid or sodium valproate (see Other
medicines and Imipenem 500 mg/cilastatin 500 mg below).
Children
Imipenem 500 mg/cilastatin 500 mg is not recommended in children less than one year of age or
children with kidney problems.
Other medicines and Imipenem 500 mg/cilastatin 500 mg
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any
other medicines.
Tell your doctor if you are taking ganciclovir which is used to treat some viral infections.
Also, tell your doctor if you are taking valproic acid or sodium valproate (used to treat epilepsy,
bipolar disorder, migraine, or schizophrenia) or any blood thinners such as warfarin.
Your doctor will decide whether you should use Imipenem 500 mg/cilastatin 500 mg in combination
with these medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before using this medicine.
Imipenem/cilastatin has not been studied in pregnant women. This medicine should not be used
during pregnancy unless your doctor decides the potential benefit justifies the potential risk to the
foetus.
Small amounts of this medicine may pass into breast milk and it may affect the baby. Therefore, your
doctor will decide whether you should receive this medicine while breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There are some side effects associated with this product (such as seeing, hearing, or feeling something
that is not there, dizziness, sleepiness, and a spinning sensation) that may affect some patients' ability
to drive or operate machinery (see section 4).
Imipenem 500 mg/cilastatin 500 mg contains sodium
This medicinal product contains approximately 37.6 mg of sodium per 500 mg dose which should be
taken into consideration by patients on a controlled sodium diet.

2

3. HOW TO USE IMIPENEM 500 MG/CILASTATIN 500 MG
Imipenem 500 mg/cilastatin 500 mg will be prepared and given to you by a doctor or another health
care professional. Your doctor will decide how much imipenem/cilastatin you need.
Adults and adolescents
The recommended dose of imipenem/cilastatin for adults and adolescents is 500 mg/500 mg every 6
hours or 1,000 mg/1,000 mg every 6 or 8 hours. If you have kidney problems or weigh less than 70 kg,
your doctor may lower your dose.
Children
The recommended dose for children one year of age or older is 15/15 or 25/25 mg/kg/dose every 6
hours. Imipenem/cilastatin is not recommended in children under one year of age and children with
kidney problems.
Method of administration
Imipenem/cilastatin is given intravenously (into a vein) over 20-30 minutes for a dose of ≤ 500
mg/500 mg or 40-60 minutes for a does of > 500 mg/500 mg.
If you use more Imipenem 500 mg/cilastatin 500 mg than you should
Symptoms of overdose may include seizures, confusion, tremors, nausea, vomiting, low blood
pressure and slow heart rate. If you are concerned that you may have been given too much
imipenem/cilastatin, contact your doctor or another healthcare professional immediately.
If you forget to use Imipenem 500 mg/cilastatin 500 mg
If you are concerned that you may have missed a dose, contact your doctor or another healthcare
professional immediately.
Do not use a double dose to make up for a forgotten dose.
If you stop using Imipenem 500 mg/cilastatin 500 mg
Do not stop using Imipenem 500 mg/cilastatin 500 mg until your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
 very common: affects more than 1 user in 10
 common: affects 1 to 10 users in 100
 uncommon: affects 1 to 10 users in 1,000
 rare: affects 1 to 10 users in 10,000
 very rare: affects less than 1 user in 10,000
 not known: frequency cannot be estimated from the available data
Common
 Nausea, vomiting, diarrhoea. Nausea and vomiting appear to occur more frequently in patients
with low number of white blood cells
 Swelling and redness along a vein which is extremely tender when touched
3

 Rash
 Abnormal liver function detected by blood tests
 Increase in some white blood cells
Uncommon















Local skin redness
Local pain and formation of a firm lump at the injection site
Skin itchiness
Hives
Fever
Blood disorders affecting the cell components of the blood and usually detected by blood tests
(symptoms may be tiredness, paleness of skin, and prolonged bruising after injury)
Abnormal kidney, liver and blood function detected by blood tests
Tremors and uncontrolled twitching of muscles
Seizures
Psychic disturbances (such as mood swings and impaired judgment)
Seeing, hearing or feeling something that is not there (hallucinations)
Confusion
Dizziness, sleepiness
Low blood pressure

Rare
 Allergic reactions including rash, swelling of the face, lips, tongue and/or throat (with difficulty in
breathing or swallowing), and/or low blood pressure. If these side-effects occur while receiving
or after receiving Imipenem 500 mg/cilastatin 500 mg, the medicine must be stopped and your
doctor contacted immediately.
 Skin peeling (toxic epidermal necrolysis)
 Severe skin reactions (Stevens-Johnson syndrome and erythema multiforme)
 Severe skin rash with loss of skin and hair (exfoliative dermatitis)
 Fungal infection (candidiasis)
 Staining of the teeth and/or tongue
 Inflammation of the colon with severe diarrhoea
 Disturbances in taste
 Inability of the liver to perform normal function
 Inflammation of the liver
 Inability of the kidney to perform normal function
 Changes in the amount of urine, changes in urine colour
 Disease of the brain, tingling sensation (pins and needles), localised tremor
 Hearing loss
Very rare





Severe loss of liver function due to inflammation (fulminant hepatitis)
Inflammation of stomach or intestine (gastro-enteritis)
Inflammation of intestine with bloody diarrhoea (haemorrhagic colitis)
Red swollen tongue, overgrowth of the normal projections on the tongue giving it a hairy
appearance, heartburn, sore throat, increase in the production of saliva
 Stomach pain
 A spinning sensation (vertigo), headache
 Ringing in the ears (tinnitus)
4

 Pain in several joints, weakness
 Irregular heartbeat, the heart beating forcefully or rapidly
 Chest discomfort, difficulty breathing, abnormally fast and superficial breathing, pain in the upper
spine
 Flushing, bluish discoloration of the face and lips, skin texture changes, excessive sweating
 Itching of the vulva in women
 Changes in the amounts of blood cells
 Worsening of a rare disease associated with muscle weakness (aggravation of myasthenia gravis)
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet.
5. HOW TO STORE IMIPENEM 500 MG/CILASTATIN 500 MG
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and the vial label. The expiry date
refers to the last day of that month.
Before opening:
Keep the vials in the outer carton in order to protect from light.
Do not store above 25 °C.
After reconstitution:
Reconstituted/diluted solutions should be used immediately.
The time interval between the beginning of reconstitution and the end of intravenous infusion should
not exceed 2 hours.
Do not freeze the reconstituted solution.
For single use only.
Discard any ununsed solution.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Imipenem 500 mg/cilastatin 500 mg contains
- The active substances are imipenem and cilastatin. Each vial contains imipenem monohydrate
equivalent to 500 mg imipenem and cilastatin sodium equivalent to 500 mg cilastatin.
- The other ingredient is sodium hydrogen carbonate.
What Imipenem 500 mg/cilastatin 500 mg looks like and contents of the pack
Imipenem 500 mg/cilastatin 500 mg is a white to light yellow powder for solution for infusion in a
glass vial.
Pack sizes: 1 vial, 5 vials, 10 vials, 12 vials, 20 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 ULM, Germany

5

Manufacturer:
VENUS PHARMA GmbH, Am Bahnhof 1-3, D-59368 Werne, Germany

This medicinal product is authorised in the Member States of the EEA under the following
names:
Country
UK
AT
DE
ES
FR
IT
PL
PT

Product Name
Imipenem 500 mg/cilastatin 500 mg powder for solution for infusion
Imipenem/Cilastatin ratiopharm 500 mg/
500 mg Pulver zur Herstellung einer Infusionslösung
Imipenem/Cilastatin-ratiopharm 500 mg/
500 mg Pulver zur Herstellung einer Infusionslösung
Imipenem/Cilastatina ratiopharm 500 mg/500 mg polvo para solución para
infusión EFG
Imipénème Cilastatine Teva® 500 mg/500 mg, poudre pour solution pour
perfusion
Imipenem cilastatina ratiopharm 500 mg/500 mg polvere per soluzione per
infusione
Cilapenem
Imipenem+Cilastatina ratiopharm

This leaflet was last revised in
01/2012
----------------------------------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
Each vial is for single use only.
Reconstitution
Contents of each vial must be transferred to 100 ml of an appropriate infusion solution (see
Incompatibility and After reconstitution): 0.9% sodium chloride. In exceptional circumstances
where 0.9% sodium chloride cannot be used for clinical reasons, 5% glucose may be used instead.
A suggested procedure is to add approximately 10 ml of the appropriate infusion solution to the vial.
Shake well and transfer the resulting mixture to the infusion solution container.
CAUTION: THE MIXTURE IS NOT FOR DIRECT INFUSION.
Repeat with an additional 10 ml of infusion solution to ensure complete transfer of vial contents to the
infusion solution. The resulting mixture should be agitated until clear.
The concentration of the reconstituted solution following the above procedure is approximately 5
mg/ml for both imipenem and cilastatin.
The reconstituted solution should be inspected visually for particulate matter and discoloration prior
to administration. The reconstituted solution is clear and free of particles.

6

Incompatibility
This medicinal product is chemically incompatible with lactate and should not be reconstituted in
diluents containing lactate. However, it can be administered into an I.V. system through which a
lactate solution is being infused.
This medicinal product must not be mixed with other medicinal products except those mentioned
under Reconstitution.
After reconstitution
Diluted solutions should be used immediately.
The time interval between the beginning of reconstitution and the end of intravenous infusion should
not exceed 2 hours.
Do not freeze the reconstituted solution.
Any unused product or waste material should be disposed of in accordance with local requirements.

7

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide