Sianem

Imipenem monohydrate 500 mg, cilastatin Na 500 mg

Susceptible infections eg, lower resp tract, complicated & uncomplicated urinary tract, intra-abdominal, gynecologic, bone & joint, skin & skin structure, & polymicrobic infections; bacterial septicemia; endocarditis caused by penicillinase-producing Staph aureus.

IV infusion Infused over 20-30 min or 40-60 min for doses >500 mg in adults & over 15-30 min for doses ≤500 mg or over 40-60 min for doses >500 in childn. Adult Max: 50 mg/kg or 4 g daily, whichever is lower. Surgical infection prophylaxis Imipenem 1 g IV on anesth induction, followed by further 1 g 3 hr later w/ additional 500 mg twice w/ 8 hr interval after induction if necessary. Normal renal function (CrCl ≥70 mL/min/1.73 m²) & weighing at least 70 kg Fully susceptible organisms: Mild infection, uncomplicated UTI 250 mg every 6 hr. Total daily dose: 1 g. Moderate infection 500 mg every 8 or 6 hr. Total daily dose: 1.5 or 2 g. Severe life-threatening infection, complicated UTI 500 mg every 6 hr. Total daily dose: 2 g. Moderately susceptible organisms, primarily some strains of Pseudomonas aeruginosa: Mild infection, complicated UTI 500 mg every 6 hr. Total daily dose: 2 g. Moderate infection 500 mg every 6 hr or 1 g every 8 hr. Total daily dose: 2 or 3 g. Severe life-threatening infection 1 g every 8 or 6 hr. Total daily dose: 3 or 4 g. Uncomplicated UTI 250 mg every 6 hr. Total daily dose: 1 g. Patient >12 yr w/ cystic fibrosis & normal renal function Imipenem up to 90 mg/kg in divided doses. Max: 4 g daily. Renal impairment If total daily dose for normal renal function is 1 g daily: CrCl ≥71 mL/min/1.73 m² weighing ≥70 kg 250 mg every 6 hr, 60 kg 250 mg every 8 hr, 40-50 kg 125 mg every 6 hr, 30 kg 125 mg every 8 hr. CrCl 41-70 mL/min/1.73 m² weighing ≥70 kg 250 mg every 8 hr, 50-60 kg 125 mg every 6 hr, 30-40 kg 125 mg every 8 hr. CrCl 21-40 mL/min/1.73 m² weighing 60 to ≥70 kg 250 mg every 12 hr, 50 kg 125 mg every 8 hr, 30-40 kg 125 mg every 12 hr. CrCl 6-20 mL/min/1.73 m² weighing ≥70 kg 250 mg every 12 hr, 30-60 kg 125 mg every 12 hr. If total daily dose for normal renal function is 1.5 g daily: CrCl ≥71 mL/min/1.73 m² weighing ≥70 kg 500 mg every 8 hr, 50-60 kg 250 mg every 6 hr, 40 kg 250 mg every 8 hr, 30 kg 125 mg every 6 hr. CrCl 41-70 mL/min/1.73 m² weighing ≥70 kg 250 mg every 6 hr, 50-60 kg 250 mg every 8 hr, 40 kg 125 mg every 6 hr, 30 kg 125 mg every 8 hr. CrCl 21-40 mL/min/1.73 m² weighing 60 to ≥70 kg 250 mg every 8 hr, 50 kg 250 mg every 12 hr, 30-40 kg 125 mg every 8 hr. CrCl 6-20 mL/min/1.73 m² weighing 50 to ≥70 kg 250 mg every 12 hr, 30-40 kg 125 mg every 12 hr. If total daily dose for normal renal function is 2 g daily: CrCl ≥71 mL/min/1.73 m² weighing ≥70 kg 500 mg every 6 hr, 60 kg 500 mg every 8 hr, 40-50 kg 250 mg every 6 hr, 30 kg 250 mg every 8 hr. CrCl 41-70 mL/min/1.73 m² weighing ≥70 kg 500 mg every 8 hr, 50-60 kg 250 mg every 6 hr, 40 kg 250 mg every 8 hr, 30 kg 125 mg every 6 hr. CrCl 21-40 mL/min/1.73 m² weighing ≥70 kg 250 mg every 6 hr, 50-60 kg 250 mg every 8 hr, 40 kg 250 mg every 12 hr, 30 kg 125 mg every 8 hr. CrCl 6-20 mL/min/1.73 m² weighing 40 to ≥70 kg 250 mg every 12 hr, 30 kg 125 mg every 12 hr. If total daily dose for normal renal function is 3 g daily: CrCl ≥71 mL/min/1.73 m² weighing ≥70 kg 1,000 mg every 8 hr, 60 kg 750 mg every 8 hr, 50 kg 500 mg every 6 hr, 40 kg 500 mg every 8 hr, 30 kg 250 mg every 6 hr. CrCl 41-70 mL/min/1.73 m² weighing ≥70 kg 500 mg every 6 hr, 50-60 kg 500 mg every 8 hr, 40 kg 250 mg every 6 hr, 30 kg 250 mg every 8 hr. CrCl 21-40 mL/min/1.73 m² weighing 60 to ≥70 kg 500 mg every 8 hr, 50 kg 250 mg every 6 hr, 30-40 kg 250 mg every 8 hr. CrCl 6-20 mL/min/1.73 m² weighing 60 to ≥70 kg 500 mg every 12 hr, 30-50 kg 250 mg every 12 hr. If total daily dose for normal renal function is 4 g daily: CrCl ≥71 mL/min/1.73 m² weighing ≥70 kg 1,000 mg every 6 hr, 60 kg 1,000 mg every 8 hr, 50 kg 750 mg every 8 hr, 40 kg 500 mg every 6 hr, 30 kg 500 mg every 8 hr. CrCl 41-70 mL/min/1.73 m² weighing 60 to ≥70 kg 750 mg every 8 hr, 50 kg 500 mg every 6 hr, 40 kg 500 mg every 8 hr, 30 kg 250 mg every 6 hr. CrCl 21-40 mL/min/1.73 m² weighing ≥70 kg 500 mg every 6 hr, 50-60 kg 500 mg every 8 hr, 40 kg 250 mg every 6 hr, 30 kg 250 mg every 8 hr. CrCl 6-20 mL/min/1.73 m² weighing 50 to ≥70 kg 500 mg every 12 hr, 30-40 kg 250 mg every 12 hr. Childn Non CNS-infections 15-25 mg/kg daily every 6 hr. Max: Imipenem 2 g daily in infections caused by fully susceptible bacteria or 4 g daily in infections caused by moderately susceptible bacteria (eg, some strains of Pseudomonas aeruginosa). Childn ≥3 mth 15-25 mg/kg every 6 hr, 4 wk to 3 mth weighing at least 1.5 kg 25 mg/kg every 6 hr, 1-4 wk weighing at least 1.5 kg 25 mg/kg every 8 hr, up to 1 wk weighing at least 1.5 kg 25 mg/kg every 12 hr.

Hypersensitivity to imipenem & cilastatin or carbapenem antibiotics. Meningitis. Childn w/ CNS infections.

Discontinue therapy if hypersensitivity reactions occur. Not indicated for CNS infection. Nausea &/or vomiting or diarrhea. Superinfection w/ prolonged use. Clostridium difficile-associated diarrhea & colitis. Patients w/ CNS disorders (eg, history of seizures, recent head trauma); restricted Na. Previous hypersensitivity reactions to β-lactam antibiotics including penicillins & cephalosporins. Evaluate renal, hepatic & hematologic systems periodically during prolonged therapy. Monitor patients w/ history of epilepsy in co-administration w/ anticonvulsants; on hemodialysis. Renal impairment. Pregnancy. Interrupt breastfeeding during therapy. Seizure in neonates & childn ≤3 mth; high incidence of seizure in childn 3 mth to 12 yr. Not be used in childn w/ CNS infections; weighing <30 kg w/ renal impairment.

Nausea, vomiting, diarrhea, pseudomembranous colitis, hemorrhagic colitis, teeth &/or tongue staining, gastroenteritis, abdominal pain, glossitis, papillar hypertrophy of tongue, heartburn, pharyngeal pain, increased salivation & taste perversion; fever, seizure, dizziness, somnolence, tremor, confusion, myoclonus, paresthesia, vertigo, headache, myoclonus, encephalopathy, psychic disturbances including hallucinations; rash, pruritus, urticaria, allergic dermatitis, erythema multiforme, SJS, angioedema, TEN, flushing, cyanosis, candidiasis, hyperhidrosis, pruritus vulvae, inj site pain & erythema, phlebitis; eosinophilia, leucopenia, neutropenia, agranulocytosis, pancytopenia, thrombocytopenia, bone marrow depression, hemolytic anemia; increased BUN &/or serum creatinine conc, oliguria/anuria, polyuria, urine discoloration, proteinuria, acute renal failure; increased serum conc of AST, ALT, alkaline phosphatase, LDH & bilirubin, jaundice, hepatitis; chest discomfort, dyspnea, hyperventilation, thoracic spine pain; hypotension, palpitation, tachycardia; hearing loss, tinnitus, polyarthralgia.

Concomitant use w/ aminoglycosides. Increased CNS side effect w/ cyclosporine. Generalized seizures w/ gancyclovir. Higher & prolonged serum conc of cilastatin w/ probenecid.

Other Beta-Lactams

J01DH51 - imipenem and cilastatin ; Belongs to the class of carbapenems. Used in the systemic treatment of infections.

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