Contenido
Update: January 2022
Forms, strengths and route of administration
- Powder for injection, in vial of 500 mg imipenem monohydrate/500 mg cilastatin sodium, to be reconstituted with 20 ml of 0.9% sodium chloride (25 mg imipenem/ml).
- Each dose is to be diluted in 100 ml of 0.9% sodium chloride and to be administered by IV infusion:
- over 30 minutes for doses ≤ 500 mg/500 mg
- over 60 minutes for doses > 500 mg/500 mg
- Use a deep line, preferably an implantable venous access device (Port-a-Cath).
Dosage (expressed in imipenem)
- Adolescent 15 years and over (and ≥ 30 kg) and adult: 1000 mg (2 vials) 2 times daily with 10 hours minimum between infusions
- Maximum dose: 2000 mg daily
- Renal insufficiency: 750 mg every 12 hours for CrCl 20-40 ml/minute; 500 mg every 12 hours for CrCl < 20 ml/minute
|
Weight |
Daily dose |
Daily dose (ml) - IV infusion |
|---|---|---|
|
5-29 |
Do not used in patients < 15 years and < 30 kg |
|
|
|
||
|
30-33 |
2000 |
2 vials (40 ml) in 100 ml of 0.9% NaCl x 2 |
|
34-40 |
2000 |
2 vials (40 ml) in 100 ml of 0.9% NaCl x 2 |
|
41-45 |
2000 |
2 vials (40 ml) in 100 ml of 0.9% NaCl x 2 |
|
46-50 |
2000 |
2 vials (40 ml) in 100 ml of 0.9% NaCl x 2 |
|
51-70 |
2000 |
2 vials (40 ml) in 100 ml of 0.9% NaCl x 2 |
|
> 70 |
2000 |
2 vials (40 ml) in 100 ml of 0.9% NaCl x 2 |
Contra-indications, adverse effects, precautions
- Do not administer to patients with hypersensitivity to carbapenems.
- Administer with caution to patients with hypersensitivity to other betalactams (cross-hypersensitivity may occur).
- May cause:
- nausea, vomiting (the infusion rate may be slowed down in case of nausea), diarrhoea;
- nervous sytem disorders: confusional state, seizures (most frequently in patients with history of seizures or renal impairment);
- hypersensitivity reactions;
- local reactions (phlebitis/thrombophlebitis).
- For the management of adverse effects, see Appendix 17.
- Avoid or monitor combination with: valproic acid (decreased plasma concentration of valproic acid and risk of seizures), oral or injectable ganciclovir (risk of seizures).
- Pregnancy and breastfeeding: use only if the benefits outweigh the risks (safety not established).
Monitoring
- Symptomatic monitoring.
Remarks
- Administer clavulanic acid 60 minutes before each dose of imipenem/cilastatin.
- Do not mix with Ringer lactate (incompatibility) but may be administered via Y-site.
- Do not mix with other drugs in the infusion bag.
Storage
– Below 25 °C
- Once reconstituted, solution:
- remains stable 4 hours at room temperature or 24 hours between 2 to 8 °C,
- may darken from colourless to yellow (this does not indicate a loss of potency),
- should be discarded if it becomes brown.