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Pronunciation:

(kloks a SIL in)

Synonyms:

Cloxacillin Sodium

Generic Available:

Yes

Canadian Brand Names:

Apo-Cloxi®; Novo-Cloxin; Nu-Cloxi; Riva-Cloxacillin

Use:

Treatment of susceptible bacterial infections, notably penicillinase-producing staphylococci causing respiratory tract, skin and skin structure, bone and joint, urinary tract infections

Use - Dental:

Treatment of susceptible orofacial infections (notably penicillinase-producing staphylococci)

Restrictions:

Not available in U.S.

Pregnancy Risk Factor:

Lactation:

Excretion in breast milk unknown

Contraindications:

Hypersensitivity to cloxacillin, any component of the formulation, or penicillins

Warnings/Precautions:

Monitor PT if patient concurrently on warfarin, elimination of drug is slow in renally impaired; use with caution in patients allergic to cephalosporins due to a low incidence of cross-hypersensitivity

Adverse Reactions:

1% to 10%: Gastrointestinal: Nausea, diarrhea, abdominal pain

<1%: Fever, seizure with extremely high doses and/or renal failure, rash (maculopapular to exfoliative), vomiting, pseudomembranous colitis, vaginitis, eosinophilia, leukopenia, neutropenia, thrombocytopenia, agranulocytosis, anemia, hemolytic anemia, prolonged PT, hepatotoxicity, transient elevated LFTs, hematuria, interstitial nephritis, increased BUN/creatinine, serum sickness-like reactions, hypersensitivity

Overdosage/Toxicology:

Symptoms of penicillin overdose include neuromuscular hypersensitivity (agitation, hallucinations, asterixis, encephalopathy, confusion, and seizures) and electrolyte imbalance with potassium or sodium salts, especially in renal failure

Hemodialysis may be helpful to aid in the removal of the drug from the blood, otherwise most treatment is supportive or symptom-directed

Drug Interactions:

Methotrexate: Penicillins may increase the exposure to methotrexate during concurrent therapy; monitor.

Oral contraceptives: Anecdotal reports suggesting decreased contraceptive efficacy with penicillins have been refuted by more rigorous scientific and clinical data.

Probenecid, disulfiram: May increase levels of penicillins (cloxacillin)

Warfarin: Effects of warfarin may be increased

Stability:

Refrigerate oral solution after reconstitution; discard after 14 days; stable for 3 days at room temperature

Mechanism of Action:

Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.

Pharmacodynamics/Kinetics:

Absorption: Oral: ~50%

Distribution: Widely to most body fluids and bone; penetration into cells, into eye, and across normal meninges is poor; crosses placenta; enters breast milk; inflammation increases amount that crosses blood-brain barrier

Protein binding: 90% to 98%

Metabolism: Extensively hepatic to active and inactive metabolites

Half-life elimination: 0.5-1.5 hours; prolonged with renal impairment and in neonates

Time to peak, serum: 0.5-2 hours

Excretion: Urine and feces

Dosage:

Oral:

Children >1 month (<20 kg): 50-100 mg/kg/day in divided doses every 6 hours; up to a maximum of 4 g/day

Children (>20 kg) and Adults: 250-500 mg every 6 hours

Hemodialysis: Not dialyzable (0% to 5%)

Monitoring Parameters:

Observe for signs and symptoms of anaphylaxis during first dose

Test Interactions:

May interfere with urinary glucose tests using cupric sulfate (Benedict's solution, Clinitest®); may inactivate aminoglycosides in vitro; false-positive urine and serum proteins; false-positive in uric acid, urinary steroids

Dietary Considerations:

Should be taken 1 hour before or 2 hours after meals with water.

Sodium content of 250 mg capsule: 13.8 mg (0.6 mEq)

Sodium content of suspension 5 mL of 125 mg/5 mL: 11 mg (0.48 mEq)

Patient Education:

Take 1 hour before or 2 hours after meals with water. Finish all medication; do not skip doses. Take around-the-clock. If you have diabetes, drug may cause false test results with Clinitest® urine glucose monitoring; use of glucose oxidase methods (Clinistix®) or serum glucose monitoring is preferable. Immediately report any signs or symptoms of anaphylactic reactions (eg, chills, fever, wheezing, tightness in chest), excessive GI side effects, or signs or symptoms of opportunistic infection (eg, white spots or sores in mouth, vaginal discharge or sores, fever, fatigue, unhealed sores or wounds). Breast-feeding precaution: Inform prescriber if breast-feeding.

Nursing Implications:

Monitor CBC with differential, urinalysis, BUN, serum creatinine, and liver enzymes

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Prolonged use of penicillins may lead to development of oral candidiasis.

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

Penicillins have been reported to cause apprehension, illusions, agitation, insomnia, depersonalization, and encephalopathy

Mental Health: Effects on Psychiatric Treatment:

Rare reports of agranulocytosis; use caution with clozapine and carbamazepine

Dosage Forms:

Capsule, as sodium: 250 mg, 500 mg

Powder for oral suspension, as sodium: 125 mg/5 mL (100 mL, 200 mL)

International Brand Names:

Apo-Cloxi® (CA); Cloxacilina® (CL); Cloxam® (TH); Cloxapen® (CL); Cloxgen® (TH); Navaclox® (BD); Novo-Cloxin (CA); Nu-Cloxi (CA); Omniclox® (BD); Orbenil® (IL); Orbenin® (HR, KW, LU, SI, TH); Riva-Cloxacillin (CA); T-Clox® (BD); Theraclox® (TH); Ultraxin® (BG, JO, KW, LB, MA, MY, SY); Vaclox ® (TH)

References

Bluhm G, Jacobson B, Julander I, et al, "Antibiotic Prophylaxis in Pacemaker Surgery - A Prospective Study,"Scand J Thorac Cardiovasc Surg, 1984, 18(3):227-34.

Donowitz GR and Mandell GL, "Beta-Lactam Antibiotics,"N Engl J Med, 1988, 318(7):419-26 and 318(8):490-500.

Wright AJ, "The Penicillins,"Mayo Clin Proc, 1999, 74(3):290-307.

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