Europe — EMA
Imipenem/Cilastatin Actavis
GNH USA supplies Imipenem/Cilastatin Actavis (Imipenem/Cilastatin), a carbapenem antibiotic for complicated intra‑abdominal, urinary and respiratory
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What is Cilastatin Sodium, Imipenem Monohydrate?
Imipenem/Cilastatin, the active ingredient in Imipenem/Cilastatin Actavis, is a carbapenem antibiotic presented as an injectable solution for intravenous use. It treats a range of serious bacterial infections in hospitalized adults and children, including intra‑abdominal, urinary, skin, respiratory and neutropenic infections.
GNH USA supplies Imipenem/Cilastatin Actavis as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres and pharmacies worldwide.
What is Cilastatin Sodium, Imipenem Monohydrate used for?
Imipenem/Cilastatin is a broad‑spectrum carbapenem used for severe bacterial infections affecting several organ systems. - Complicated intra‑abdominal infections: provides bacterial eradication in patients with intra‑abdominal sepsis. - Complicated urinary tract infections: clears resistant uropathogens in complicated cystitis and pyelonephritis. - Skin and soft‑tissue infections: treats deep or necrotizing infections caused by Gram‑negative and Gram‑positive organisms. - Lower respiratory tract infections (pneumonia): effective against hospital‑acquired and ventilator‑associated pneumonia. - Febrile neutropenia: offers rapid coverage for high‑risk neutropenic patients with suspected bacterial infection.
What are the side effects of Cilastatin Sodium, Imipenem Monohydrate?
Adverse reactions may occur with any antimicrobial therapy and should be monitored during treatment.
Common Side Effects: - Nausea: mild to moderate gastrointestinal upset. - Diarrhea: may be watery and self‑limiting. - Vomiting: occasional emesis after infusion. - Headache: transient cranial discomfort. - Infusion site phlebitis: local irritation at the IV site. - Elevated liver enzymes: transient increase in transaminases.
Serious or Rare Side Effects: - Seizures: especially in patients with renal impairment or CNS disease. - Anaphylaxis: severe allergic reaction requiring immediate intervention. - Clostridioides difficile colitis: antibiotic‑associated diarrhea. - Renal impairment: worsening kidney function. - Thrombocytopenia: reduced platelet count. - Neutropenia: decreased neutrophil count increasing infection risk.
What precautions apply to Cilastatin Sodium, Imipenem Monohydrate?
Careful assessment and monitoring are required before and during therapy. - Renal function monitoring: adjust dose in patients with reduced creatinine clearance. - Central nervous system effects: avoid in patients with a history of seizures. - Hypersensitivity: discontinue if signs of allergic reaction appear. - Pregnancy safety: category B; use only when benefit outweighs risk. - Concomitant nephrotoxic drugs: increase vigilance for renal toxicity. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.
What does Cilastatin Sodium, Imipenem Monohydrate interact with?
Drug‑drug interactions can modify efficacy or safety.
Major Interactions (Avoid): - Valproic acid: co‑administration may reduce valproate levels and increase seizure risk. - Other carbapenems: concurrent use can increase neurotoxicity. - Probenecid: may decrease renal clearance of imipenem, raising plasma concentrations.
Moderate Interactions (Monitor Closely): - Diuretics: monitor electrolytes and renal function. - NSAIDs: increased risk of renal impairment. - Anticoagulants (e.g., warfarin): watch for altered INR values.
Frequently asked questions
What infections is Imipenem/Cilastatin Actavis used for?+
How does Imipenem/Cilastatin work?+
What is the usual dose of Imipenem/Cilastatin Actavis?+
Is Imipenem/Cilastatin safe during pregnancy or breastfeeding?+
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