IMIPENEM AND CILASTATIN SODIUM

Electrolyte / Mineral

Brand names: Imipenem and Cilastatin

Intravenous

Mechanism of Action

12.1 Mechanism of Action Imipenem and Cilastatin for Injection (I.V.) is a combination of imipenem and cilastatin. Imipenem is a penem antibacterial drug [see Microbiology ( 12.4 )] . Cilastatin is a renal dehydropeptidase inhibitor that limits the renal metabolism of imipenem.

Indications

1 INDICATIONS AND USAGE Imipenem and Cilastatin for Injection

USP for intravenous use is a combination of imipenem

a penem antibacterial

and cilastatin

a renal dehydropeptidase inhibitor

USP (I.V.) is not indicated in patients with meningitis because safety and efficacy have not been established ( 1.9 ). Imipenem and Cilastatin for Injection

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams
The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures
) and may range in severity from mild diarrhea to fatal colitis
1 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams

Known Side Effects

4 documented side effects by frequency

Drug Not Working

>10%

Fever

1-10%

Nausea

0.1-1%

Vomiting

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous