CILAPENEM^®

Imipenem/Cilastatin

Powder for Solution for Infusion 250 mg/ 250 mg & 500 mg/500 mg

 

Read all of this leaflet carefully before you starts taking this medicine because it contains important information for you.

 

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.

If you have any further questions, ask your doctor or pharmacist.

 

Warnings and precautions

Do not use Imipenem/Cilastatin

If you are allergic to imipenem, cilastatin or any of the other ingredients of this medicine

If you are allergic to other antibiotics such as penicillins, cephalosporins, or carbapenems

Talk to your doctor or nurse before using Imipenem/Cilastatin 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 (fits)

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.

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, 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 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.

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.

 

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.

 

Imipenem/Cilastatin contains sodium

This medicinal product contains approximately 1.6 mmol (approximate 37.5 mg) of sodium per 500 mg dose which should be taken into consideration by patients on a controlled sodium diet.

 

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

Lower Respiratory Tract, Skin/Skin Structure, & Gynecologic Infections

Mild to moderate: 500-750 mg IV q12hr

Intra-abdominal Infections

Mild to moderate: 250-500 mg IV q6hr

Severe: 500 mg IV q6hr or 1 g q8hr for 4-7 days, provided that infection is brought under control

Pseudomonas Infections

500 mg IV q6hr; higher dosages may be administered, depending on organism sensitivity

Urinary Tract Infections

Uncomplicated: 250 mg IV q6hr

Complicated: 500 mg IV q6hr

Use in 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 dose of >500 mg/500 mg. The rate of infusion may be slowed if you feel sick.

 

Reconstitution of Imipenem/Cilastatin

Contents of the vials must be dissolved and transferred to an appropriate infusion solution to reach a final volume of 100 ml.

A suggested procedure is to add approximately 10 ml from the appropriate infusion solution (WFI or Sodium chloride 9 mg/ml (0.9%)) 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 10 ml of the infusion solution to ensure complete transfer of vial contents to the infusion solution container. The resulting mixture should be agitated until a clear solution is obtained.

The concentration of the reconstituted solution following the above procedure is approximately 2.5-5 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 500mg/500mg Powder for Solution for Infusion ranges from colourless to yellow. Variation of colour within this range does not affect the potency of product.

 

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.

Do not freeze the reconstituted solution.

 

If you use more Imipenem/Cilastatin than you should

Symptoms of overdose may include seizures (fits), 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.

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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

 

Possible side effects

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

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

1-10%

Phlebitis (2-5%)

Eosinophilia (4%)

Miscellaneous dermatologic effects (<3%)

Potentially false-positive Coombs test (2%)

Miscellaneous hematologic effects (<2%)

Transient increase in blood urea nitrogen (BUN) or serum creatinine (<2%)

Seizures (1.5%)

Nausea, diarrhea, vomiting (1-2%)

<1%

Abnormal urinalysis

Agitation

Anaphylaxis

Anemia

Confusion (acute)

Dizziness

Dyskinesia

Emergence of resistant strains of Pseudomonas aeruginosa

Fever

Hypersensitivity

Hypotension

Elevated liver function test (LFT) results

Increased prothrombin time (PT)

Neutropenia (including agranulocytosis)

Palpitations

Pruritus

Pseudomembranous colitis

 

How to store Imipenem/Cilastatin

Keep this medicine out of the sight and reach of children

Do not use this medicine after the expiry date which is stated on the vial label and carton. The expiry date refers to the last day of that month.

Prior to reconstitution, this medicinal product does not require any special storage conditions.

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. Prepared solutions should not be frozen.

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.

 

Contents of the pack and other information

What Imipenem/Cilastatin contains

The active substances are imipenem and cilastatin. Each vial contains 250 mg of imipenem as monohydrate and 250 mg of cilastatin as sodium and 500 mg of imipenem as monohydrate and 500 mg of cilastatin as sodium.

The other ingredient is sodium hydrogen carbonate.

 

What Imipenem/Cilastatin looks like and contents of the pack

This medicine is an off white to yellowish white hygroscopic powder for solution for infusion in a glass vial.

 

 

CILAPENEM®

Each vial contains:

Imipenem/Cilastatin 250 mg/250 mg Powder for Solution for Infusion

Imipenem/Cilastatin 500 mg/500 mg Powder for Solution for Infusion

Manufacture by Afa chemie pharmaceutical co. Tehran-Iran.