Nimedine

Nimedine

imipenem + cilastatin

Manufacturer:

Anfarm Hellas

Distributor:

Averroes Pharma
Concise Prescribing Info
Contents
Imipenem 500 mg, cilastatin Na 500 mg
Indications/Uses
Polymicrobic, mixed aerobic/anaerobic, intra-abdominal, gynecological, bone & joint, skin & soft tissue, lower resp tract & GUT infections; septicemia; endocarditis.
Dosage/Direction for Use
IV infusion Administer doses ≤500 mg over 20-30 min & >500 mg over 40-60 min. Max: 4 g daily. Infection w/ full susceptibility Adult w/ CrCl ≥90 mL/min 500 mg every 6 hr or 1,000 mg every 8 hr, 60-90 mL/min 400 or 500 mg every 6 hr, 30-60 mL/min 300 mg every 6 hr or 500 mg every 8 hr, 15-30 mL/min & hemodialysed patient w/ CrCl <15 mL/min 200 mg every 6 hr or 500 mg every 12 hr. Intermediate susceptibility Adult w/ CrCl ≥90 mL/min 1,000 mg every 6 hr, 60-90 mL/min 750 mg every 8 hr, 30-60 mL/min 500 mg every 6 hr, 15-30 mL/min & hemodialysed patient w/ CrCl <15 mL/min 500 mg every 12 hr. Non-CNS infections Ped ≥3 mth 15-25 mg/kg every 6 hr, 4 wk-3 mth 25 mg/kg every 6 hr, 1-4 wk 25 mg/kg every 8 hr, <1 wk 25 mg/kg every 12 hr. Max: 4 g daily.
Contraindications
Hypersensitivity to imipenem, cilastatin or any other carbapenem & β-lactam antibacterial agent eg, penicillins or cephalosporins.
Special Precautions
Discontinue use if allergic reaction occurs. Not for direct infusion. Not recommended as therapy for meningitis. Antibacterial spectrum in skin & soft tissue infections. C. difficile-associated diarrhoea & pseudomembranous colitis. CNS disorders eg, brain lesions or history of seizures. +ve direct or indirect Coombs' test. Hemodialysis patients. Patients on controlled Na diet. Closely monitor hepatic function during treatment. Not to be given w/ medicinal products inhibiting peristalsis. Not recommended in concomitant use w/ valproic acid/Na valproate. May affect ability to drive & use machines. Not to be used in patients w/ CrCl ≤5 mL/min/1.73 m2 unless hemodialysis is instituted w/in 48 hr. Renal impairment; pre-existing hepatic disorders. Pregnancy & lactation. Not recommended in childn <30 kg. Childn w/ known risk factors for seizures or on concomitant treatment w/ drugs lowering seizures threshold.
Adverse Reactions
Eosinophilia; thrombophlebitis; diarrhoea, vomiting, nausea, medicinal product-related nausea &/or vomiting in granulocytopenic patients; rash; increased serum transaminases & alkaline phosphatase.
Drug Interactions
Risk of generalized seizure w/ ganciclovir. Decreased valproic acid levels. Increased anti-coagulant effects of oral anti-coagulant agents eg, warfarin. Minimal increased plasma levels & imipinem t½ w/ probenecid. Chemically incompatible w/ lactate.
MIMS Class
Other Beta-Lactams
ATC Classification
J01DH51 - imipenem and cilastatin ; Belongs to the class of carbapenems. Used in the systemic treatment of infections.
Presentation/Packing
Form
Nimedine powd for infusion
Packing/Price
1's
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