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IMIPENEM/CILASTATIN 250MG/250MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): CILASTATIN SODIUM / IMIPENEM MONOHYDRATE

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Imipenem/Cilastatin 250mg/250mg Powder for Solution for Infusion
Read all of this leaflet carefully before you start taking this medicine medicine because it contains
important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are
the same as yours.
 If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
or pharmacist.
 The full name of this product is Imipenem/Cilastatin 250mg/250mg Powder for Solution for Infusion but within the
leaflet it will be referred to as Imipenem/Cilastatin powder.

What is in this leaflet:
1.
What Imipenem/Cilastatin powder is and what it is used for
2.
What you need to know before you use
3.
How to use
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.

What Imipenem/Cilastatin powder is and what it is used for
Imipenem/Cilastatin powder 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/Cilastatin powder 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/Cilastatin powder 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/Cilastatin powder 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
Do not use Imipenem/Cilastatin powder if you
 are allergic to imipenem, cilastatin or any of the other ingredients of this medicine (listed in section 6).
 are allergic to other antibiotics such as penicillins, cephalosporins or carbapenems
 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
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 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
Imipenen/Cilastatin below).
Children
Imipenem/Cilastatin powder is not recommended in children less than one year of age or children with kidney
problems.

Other medicines and Impipenem /Cilastatin
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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/Cilastatin powder in combination with these
medicines.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine.
Imipenem/Cilastatin powder has not been studied in pregnant women. Imipenem/Cilastatin powder 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 use Imipenem/Cilastatin powder 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/Cilastatin powder contains sodium
This medicinal product contains less than 1mmol sodium (23mg) per dose, i.e. essentially ‘sodiumfree’.

3.

How to use
Imipenem/Cilastatin powder will be prepared and given to you by a doctor or another health care professional.
Your doctor will decide how much Imipenem/Cilastatin powder you need.
Adults and adolescents
The usual dose of Imipenem/Cilastatin powder 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 usual dose for children one year of age or older is 15/15 or 25/25 mg/kg/dose every 6 hours.
Imipenem/Cilastatin powder is not recommended in children under one year of age and children with kidney
problems.
Method of administration
Imipenem/Cilastatin powder 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.
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If you use more Imipenem/Cilastatin powder 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 powder, contact
your doctor or another healthcare professional immediately.

If you forget to use Imipenem/Cilastatin powder
If you are concerned that you may have missed a dose, contact your doctor or another healthcare professional
immediately.
Do not take a double dose to make up for a forgotten dose.

If you stop using Imipenem/Cilastatin powder
Do not stop using Imipenem/Cilastatin powder until your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them

Common (may affect up to 1 in 10 people):
 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
 Rash
 Abnormal liver function detected by blood tests
 Increase in some white blood cells
Uncommon (may affect up to 1 in 100 people):
 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 (may affect up to 1 in 1,000 people):
 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/Cilastatin powder, 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
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 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 (may affect up to 1 in 10,000 people):
 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)
 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)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store
Keep this medicine out of the sight and reach of children.
Do not use the powder for solution for infusion after the expiry date stated on the carton and on the vials (EXP).
The expiry date refers to the last day of that month.
Vials of dry Imipenem/Cilastatin powder do not require any special storage conditions.
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 two hours.
Do not freeze the reconstituted solution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information
What Imipenem/Cilastatin powder contains
 The active substances are imipenem (as the monohydrate) and cilastatin (as the sodium salt).
Each vial of Imipenem/cilastatin 250mg/250mg powder for solution for infusion contains 250mg imipenem (as
265mg imipenem monohydrate) and 250mg cilastatin (as 265mg cilastin sodium salt).
 The other ingredient is sodium hydrogen carbonate.

What Imipenem/Cilastatin powder looks like and contents of the pack
Imipenem/cilastatin 250mg strength is available in uncoloured glass vials type III having a capacity of 20ml
stoppered with bromobutyl rubber stoppers having a diameter of 20mm and with flip-off cap.
Pack size: 1 x 250mg vial

4

Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
Iceland

Manufacturer
Facta Farmaceutici
Nucleo Industriale S. Atto, S. Nicolò a Tordino
64100Teramo
Italy
This leaflet was last revised in November 2015

If you would like a leaflet with larger text, please contact 01271 311257.

Logo Actavis
Actavis, Barnstaple, EX32 8NS, UK
---------------------------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Each vial is for single use only.
Preparation of intravenous solution
The following table is provided for convenience in reconstituting Imipenem/Cilastatin powder for intravenous
infusion.
Strength
Imipenem/Cilastatin powder
500 mg

Recommended volume of diluent
added (ml)
50

Approximate concentration of
imipenem (mg/ml)
5

Reconstitution of Imipenem/Cilastatin powder 250mg:
Contents of the vials must be dissolved and transferred to an appropriate infusion solution to reach a final
volume of 50ml.
A suggested procedure is to add approximately 10ml from the appropriate infusion solution (see ‘Compatibility
and stability’) to the vial. Shake well and transfer the resulting suspension to the infusion solution container.
CAUTION: THE SUSPENSION IS NOT FOR DIRECT INFUSION.
Repeat with an additional 10ml of infusion solution to ensure complete transfer of vial contents to the infusion
solution container. Take to 50.0 with the same infusion solution. The resulting mixture should be agitated until a
clear solution is obtained.
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 expected visually for particulate matter and discoloration prior to
administration. When reconstituted, Imipenem/Cilastatin powder ranges from colourless to yellow. Variation of
colour within this range does not affect the potency of product.
Compatibility and stability
Reconstituted solutions should be used immediately. The time interval between the beginning of reconstitution
and the end of intravenous infusion should not exceed two hours.
Imipenem/Cilastatin powder can be reconstituted in WFI or Sodium chloride 9mg/ml (0.9%) solution for
infusion. Do not freeze the reconstituted solution.
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Any unused product or waste material should be disposed of in accordance with local requirements.

6

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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.

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