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

Active substance(s): CILASTATIN SODIUM / IMIPENEM

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Package Leaflet: Information for the patient
Imipenem/Cilastatin 500mg/500 mg Powder for Solution for Infusion
(imipenem with cilastatin)
Read all of this leaflet carefully before you start taking this 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, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
If you get any side effects tell your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Imipenem/Cilastatin is and what it is used for
What do you need to know before you use Imipenem/Cilastatin
How to use Imipenem/Cilastatin
Possible side effects
How to store Imipenem/Cilastatin
Contents of the pack and other information.

1. What Imipenem/Cilastatin is and what it is used for
Imipenem/Cilastatin 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 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 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 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/Cilastatin
Do not use Imipenem/Cilastatin
-

if you are allergic to imipenem, cilastatin or any of the other ingredients of this medicine
(listed in section 6)

-

if you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins,
or carbapenems

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Imipenem/Cilastatin
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
kidney or urinary problems, including reduced kidney function (Imipenem/Cilastatin
blood levels increase in patients with reduced kidney function. Central nervous system
adverse reactions may occur if the dose is not adjusted to the kidney function)
any central nervous system disorders such as localized tremors or epileptic seizures
liver 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/Cilastatin below).
Children
Imipenem/Cilastatin is not recommended in children less than one year of age or children
with kidney problems.
Other medicines and Imipenem/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 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 taking this medicine.
Imipenem/Cilastatin has not been studied in pregnant women. Imipenem/Cilastatin should not
be used during pregnancy unless your doctor decides the potential benefit justifies the
potential risk to the developing baby.
It is important that you tell your doctor if you are breast-feeding or if you intend to breastfeed before receiving Imipenem/Cilastatin. 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 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 contains sodium
This medicinal product contains approximately 1.63 mmol (approximately 37.5 mg) of
sodium per 500 mg dose which should be taken into consideration by patients on a controlled
sodium diet.
3. How to use Imipenem/Cilastatin
Imipenem/Cilastatin 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.
Use in adults and adolescents
The usual 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.
Use in 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 is not recommended in children under one year of age and
children with kidney problems.
Route and 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 dose of >500 mg/500 mg. The rate of infusion may
be slowed if you feel sick.
If you use more Imipenem/Cilastatin 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/Cilastatin
If you are concerned that you may have missed a dose, contact your doctor or another
healthcare professional immediately.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Do not take a double dose to make up for a forgotten dose.
If you stop using Imipenem/Cilastatin
Do not stop using Imipenem/Cilastatin until your doctor tells you to.

4. Possible side effects

Like all medicines, this medicine cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
 very common: may affect more than 1 in 10 people
 common: may affect up to 1 in 10 people
 uncommon: may affect up to 1 to in 100 people
 rare: may affect up to 1 in 1,000 people
 very rare: may affect up to 1 in 10,000 people
 not known: frequency cannot be estimated from the available data
The following side-effects occur rarely, however if they do occur, while receiving or after
receiving Imipenem/Cilastatin, the medicine must be stopped and your doctor contacted
immediately.
Allergic reactions including rash, swelling of the face, lips, tongue, and/or throat (with
difficulty in breathing or swallowing), and/or low blood pressure
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)
Other possible side effects:

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
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 (fits)
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




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)
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)

Not known



Abnormal movements
Agitation

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Imipenem/Cilastatin
Keep this medicine out of the sight and reach of children.
Do not use Imipenem/Cilastatin after the expiry date which is stated on the vial and carton
after {Exp}.
The expiry date refers to the last day of that month.
Do not store above 25°C.
The container should be kept in the outer carton until immediately before use.

After reconstitution:
Diluted solutions should be used immediately.
Do not freeze the reconstituted solution.
Do not throw away 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 contains
The active substances are imipenem and cilastatin. Each vial/monovial/infusion bottle
contains imipenem monohydrate equivalent to 500 mg imipenem and cilastatin sodium
equivalent to 500 mg cilastatin.
The other ingredient is sodium bicarbonate.
What Imipenem/Cilastatin looks like and contents of the pack
Imipenem/Cilastatin is a white to light yellow powder for solution for infusion.
Imipenem/Cilastatin 500mg/500mg Powder for Solution for Infusion is available as:
- 30 ml single vial and in package of 10 vials of 30 ml each
- 100 ml infusion bottles and in package of 10 bottles of 100 ml each
- a monovial which has a built-in transfer needle to allow constitution of the product
directly into an infusion bag

Not all pack types may be marketed in your country.
Marketing Authorisation Holder
Ranbaxy (UK) Limited
5th floor, Hyde Park, Hayes 3
11 Millington Road
Hayes, UB3 4AZ
United Kingdom
Manufacturer
Terapia S.A
Str. Fabricii Nr. 124
400632, Cluj-Napoca
Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
This leaflet was last revised in July 2016.

The following information is intended for medical or healthcare professionals only:

Reconstitution
Preparation of intravenous solution
The following table is provided for convenience in reconstituting Imipenem/Cilastatin
for intravenous infusion. 0.9 % Sodium Chloride is the recommended solvent.

Strength

Imipenem/Cilastatin
500mg/500mg

Volume of solvent
(0.9%
Sodium
Chloride) added (ml)
100

Approximate
concentration of
imipenem (mg/ml)
5

Addition of Imipenem/Cilastatin in a Monovial to an infusion solution
1. Check before use that there is no foreign material in the powder and that the seal between
the cap and the vial is intact.
2. Remove the cap by twisting and pulling until the seal breaks.
3. The cannula is inserted into the addition port of the infusion bag. Push the cannula
protector against the vial until you hear a click.
4. Hold the vial upright and squeeze the infusion bag a few times so that 2/3 of the vial is
filled with the solvent (0.9% Sodium Chloride). Shake the vial until the powder is completely
dissolved.
5. Invert the vial and transfer the content of the vial back into the infusion bag by squeezing
the infusion bag.
Repeat steps 4 and 5 until the vial is completely empty.
6. A part of the label of the vial may be detached and affixed to the infusion bag.
The bottle can be removed or can remain on the infusion bag.
Preparation of intravenous solution (30ml vial)
The following table is provided for convenience in reconstituting. 0.9 % Sodium Chloride is
the recommended solvent.

Imipenem/Cilastatin
for intravenous
infusion. Strength
Imipenem/Cilastatin
500mg/500mg

Volume of solvent
(0.9% Sodium
Chloride) added (ml)
100

Approximate
concentration of
imipenem (mg/ml)
5

The preparation of the intravenous solution must be performed in appropriate conditions and
environment.
Contents of the vials must be suspended and transferred to 100 ml of an appropriate infusion
solution . A suggested procedure is:
1. Check before use that there is no foreign material in the powder and that the seal between
the cap and the vial is intact.
2. Remove the cap by twisting and pulling until the seal breaks.
3. Add approximately 10 ml from the appropriate infusion solution to the vial shake well
4. Transfer the resulting suspension to the infusion solution container
5. Repeat the step 3 and 4.
CAUTION: THE SUSPENSION IS NOT FOR DIRECT INFUSION.
6. The resulting mixture should be agitated until clear.

The reconstituted solution should be inspected visually for particulate matter and
discoloration prior to administration. Variations of colour, from colourless to yellow, do not
affect the potency of the product.
Incompatibility
This medicinal product is chemically incompatible with lactate and should not be
reconstituted with solvent containing lactate. However, it can be administered into an IV
tubing 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
After reconsitution: The product should be used immediately.
Any unused solution and the vial should be adequately disposed of, in accordance with
local requirements.

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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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