Adverse Reactionsinterstitial nephritis (rare).
| Body System | Effect | | Gastrointestinal | Nausea, vomiting, epigastric discomfort, flatulence, loose stools. | | Local | Phlebitis with iv administration. |
C. difficile-associated diarrhea and pseudomembranous colitis have been reported rarely. Other uncommon GI effects include black or hairy tongue and oral lesions such as stomatitis or glossitis. rash, fever, chills, pruritus, serum-sickness, anaphylaxis. Rarely: transient neutropenia, leukopenia, granulocytopenia, thrombocytopenia; more commonly associated with high-dose parenteral administration but can occur with oral therapy. elevated liver enzymes; cholestatic jaundice.
Indications and Clinical UseCloxacillin is indicated for treatment of bacterial infections caused by susceptible strains of penicillinase-producing staphylococci. It is considered a drug of choice for the treatment of endocarditis, osteomyelitis, pneumonia, sepsis and skin and soft-tissue infections caused by methicillin-sensitive S. aureus (MSSA). The oral route should not be used initially to administer cloxacillin in the treatment of severe, life-threatening infections as it is poorly absorbed. OverdosageFor management of a suspected drug overdose, CPhA recommends that you contact your regional Poison Control Centre. See the eCPS Directories section for a list of Poison Control Centres. Warnings and PrecautionsPlasma levels and the elimination half-life of cloxacillin are higher in neonates. Recommended dosing intervals are longer for this age group (see Table 5). Although cloxacillin has not been proven to be safe in pregnancy, it is generally considered to pose no significant teratogenic risk. Based on the knowledge that some penicillins are excreted in breast milk, it should be expected that cloxacillin is as well. Although possible effects on a nursing infant include alteration of the gut flora (potentially resulting in oral thrush or diarrhea), obscured diagnosis of fever and hypersensitivity reactions, cloxacillin is generally considered to be compatible with breast-feeding.
Storage and StabilityReconstituted oral solution should be stored in the refrigerator. Action and Clinical PharmacologyCloxacillin is rapidly but incompletely absorbed from the gastrointestinal tract. Food decreases both the rate and extent of absorption and it is therefore best taken 1 hour before or 2 hours after food. Peak plasma levels are attained approximately 1 hour after oral dosing. Cloxacillin is highly protein bound (>90%). It is widely distributed in body fluids except in the CSF where minimal concentrations are reached unless the meninges are inflamed. Elimination is via renal and hepatic mechanisms. The elimination half-life is reported to be 0.4 to 0.8 hours and increases to 0.8 to 2.3 hours in severe renal impairment; dosage adjustment is not necessary. Cloxacillin is not appreciably removed by hemodialysis. Cloxacillin is a semi-synthetic isoxazolyl penicillin developed for use against penicillinase-producing staphylococci. It is also active against many streptococci but is less active than natural penicillins in penicillin-sensitive strains. Like other β-lactams it exerts its bactericidal effect by inhibition of cell wall peptidoglycan synthesis.
ContraindicationsPatients who are hypersensitive to cloxacillin, to any ingredient in the formulation or component of the container, or to any penicillin.
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