Cilapnem® vial (imipenem/cilastatin)

Cilapenem®

Imipenem-Cilastatin Injection Powder 250/250 and 500/500 mg

This medicine has been prescribed for your current condition. Therefore, do not use it in similar cases or recommend it to others.

General instructions:

Before using this medicine, consult your doctor in the following cases:

If you have a history of allergy to penicillins, cephalosporins or other allergens.

If you have gum or dental diseases.

If you have other diseases such as kidney failure, CNS disorders, history of seizures or brain injuries.

If you are taking other medications.

If you are pregnant or breastfeeding.

Use during pregnancy and breastfeeding:

Pregnancy: This medicine is classified as FDA category C. Use of this medicine during pregnancy should be under the advice of a specialist.

Breastfeeding: It is not known whether imipenem-cilastatin is excreted in breast milk. Use of this drug during breastfeeding should be under the advice of a specialist.

Warnings:

In case of any allergic reaction to the drug, stop taking the drug. In severe cases, urgent medical measures are required.

Take the drug at regular intervals and complete the course of treatment.

If the symptoms of the disease do not improve, inform the doctor.

In case of diarrhea, contact the doctor and avoid taking antidiarrheal drugs on your own.

In patients with renal failure, the dosage should be adjusted according to the severity of the disease.

Avoid intravenous injection of the initial suspension.

In patients with a history of seizures, anticonvulsant drugs should be continued.

This drug is for hospital use only.

This drug is for intravenous infusion over 20-30 hours only.

Each 250/250 mg vial of this product contains 0.8 milliequivalents of sodium and each 500/500 mg vial of this product contains 1.6 milliequivalents of sodium. Therefore, this drug should be used with caution in patients with sodium restrictions.

Dosage:

The dosage of the drug is determined by the doctor. However, the usual dosage of the drug is as follows:

Adults:

In the treatment of mild infections: 250 to 500 mg every 6 hours.

In the treatment of moderate infections: 500 mg every 6-8 hours to 1 gram every 8 hours.

In the treatment of severe and life-threatening infections: 500 mg every 6 hours to 1 gram every 6-8 hours.

Note: Lower doses are usually used in the treatment of gram-positive, anaerobic, and sensitive gram-negative infections. Treatment of infections caused by other gram-negative organisms requires higher doses.

For uncomplicated urinary tract infections: 250 mg every 6 hours.

For complicated urinary tract infections: 500 mg every 6 hours.

For febrile neutropenia: 500 mg every 6 hours to 1 g every 8 hours.

Children:

In children under 12 years of age, the dosage is determined by a specialist.

In children over 12 years of age (or weighing more than 40 kg), the usual adult dosage is used.

Note: Given that benzyl alcohol poisoning has been observed in infants under 3 months of age, it is recommended that solvents containing benzyl alcohol not be used to prepare this drug for intravenous infusion in this group of patients.

How to prepare the drug:

For intravenous infusion, first add 10 ml of one of the injectable solutions of 0.9% sodium chloride, 5 or 10% dextrose, 5% dextrose containing 0.9% sodium chloride, 5 or 10% mannitol to the contents of the vial and shake it well. Transfer the prepared suspension to 100 ml of the same suitable injectable solution. Add 10 ml of the solvent used for the initial dilution to the empty vial, shake well and then transfer it to the infusion container. Shake the resulting mixture until it becomes clear. Then infuse the prepared solution over 20-30 minutes.

Avoid injecting a cloudy solution.

Avoid intravenous injection of the initial suspension.

The prepared solution for infusion should be colorless to yellow, clear and free of visible particles. If the color changes to brown, do not use it.

Drug interactions:

Mixing the solution of imipenem-cilastatin with aminoglycosides can lead to a decrease in the effect of both. If simultaneous administration is required, these drugs should be injected at two separate sites.

Side effects:

Each drug may cause some unwanted effects in parallel with the desired therapeutic effect.

Side effects that require medical attention: Allergic reactions including fever, hives, itching, skin rashes and wheezing, CNS toxicity in the form of dizziness, convulsions, tremors or impaired consciousness, thrombophlebitis, pseudomembranous colitis.

Side effects that disappear over time or if the body adapts to the drug, but require medical attention if they persist or intensify: Gastrointestinal disorders including diarrhea, nausea and vomiting.

In patients who show symptoms of dizziness, nausea, sweating and fatigue during the infusion of this drug, the infusion rate should be reduced.

Note: Pseudomembranous colitis may also occur after discontinuation of the drug, in which case medical attention is also required.

Storage conditions:

Store the dry product at a temperature below 30 ° C, away from light and in the box until use.

Inject the resulting solution immediately after preparation and discard the remaining medicine after a single use.

Avoid using expired medicine.

Keep the medicine out of the reach of children.

Dosage forms and packaging:

Cilapenem® 250/250 mg powder for injection: Each vial contains 250 mg of imipenem (as monohydrate) and 250 mg of cilastatin (as sodium), packaged in a box of 10 with a leaflet.

Cilapenem® 500/500 mg powder for injection: Each vial contains 500 mg of imipenem (as monohydrate) and 500 mg of cilastatin (as sodium), packaged in a box of 10 with a leaflet.