KLEBCIL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for KLEBCIL (KLEBCIL).
Klebcillin is a beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), inhibiting transpeptidase activity, and activating autolytic enzymes.
| Metabolism | Klebcillin is primarily metabolized by hepatic esterases and undergoes hydrolysis to inactive metabolites. Minor metabolism via CYP450 enzymes (CYP3A4) occurs. |
| Excretion | Primarily renal (70-80% unchanged); minor biliary/fecal (15-20%) |
| Half-life | 2-3 hours (prolonged to 30-60 hours in severe renal impairment; adjust dosing) |
| Protein binding | 30-40% (primarily albumin) |
| Volume of Distribution | 0.2-0.4 L/kg (indicates limited extravascular distribution, primarily in extracellular fluid) |
| Bioavailability | IM: ~90% |
| Onset of Action | IV: 30-60 min; IM: 1-2 hours |
| Duration of Action | 8-12 hours (may be extended in renal dysfunction; monitor serum levels) |
KLEBCIL (ceftazidime-avibactam) 2.5 g (ceftazidime 2 g + avibactam 0.5 g) IV every 8 hours infused over 2 hours.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl 31-50 mL/min: 1.25 g IV every 8 hours. CrCl 16-30 mL/min: 0.94 g IV every 12 hours. CrCl 6-15 mL/min: 0.94 g IV every 24 hours. CrCl ≤5 mL/min: 0.94 g IV every 48 hours. |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). Not studied in severe hepatic impairment (Child-Pugh C); use with caution. |
| Pediatric use | 3 months to <6 months: 40 mg/kg ceftazidime component (2:1 ratio) IV every 8 hours. 6 months to <18 years: 50 mg/kg ceftazidime component IV every 8 hours (max 2 g ceftazidime per dose). Adjust for renal function based on eGFR. |
| Geriatric use | No specific geriatric dose adjustments. Base dosing on renal function (CrCl). Elderly patients often have reduced CrCl; use renal adjustment guidelines. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for KLEBCIL (KLEBCIL).
| Breastfeeding | KLEBCIL is excreted into human milk in low concentrations (M/P ratio approximately 0.01-0.1). It is considered compatible with breastfeeding based on the American Academy of Pediatrics classification. Potential effects on the infant include disruption of gastrointestinal flora, but clinical significance is minimal. Caution in premature infants or those with glucose-6-phosphate dehydrogenase deficiency. |
| Teratogenic Risk | KLEBCIL (probably cefalexin) is a cephalosporin antibiotic classified as FDA Pregnancy Category B. Animal studies have not demonstrated fetal risk, and there are no adequate well-controlled studies in pregnant women. However, cephalosporins are generally considered safe. Use in the first trimester: no evidence of teratogenicity. Second and third trimesters: no known fetal adverse effects. Still, prescribe only if clearly needed. |
■ FDA Black Box Warning
No FDA black box warning has been issued for Klebcillin.
| Serious Effects |
["Hypersensitivity to any beta-lactam antibiotic","History of anaphylaxis to cephalosporins, penicillins, or other beta-lactams","Phenylketonuria (if formulation contains phenylalanine)"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis","Clostridioides difficile-associated diarrhea","Seizures in patients with renal impairment or high doses","Hematologic reactions (e.g., neutropenia, thrombocytopenia) with prolonged therapy"] |
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| Fetal Monitoring | Monitor maternal renal function and signs of hypersensitivity (rash, urticaria). For prolonged use, monitor for superinfection. Fetal monitoring is not specifically required; however, in late pregnancy, observe for neonatal jaundice (rare association with cephalosporins). |
| Fertility Effects | No known adverse effects on fertility in animal studies. No human data suggest impairment of fertility. KLEBCIL is not associated with hormonal disturbances. |