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Product Name
:
CLAVOXIL (Vial)
Chemical Name
:
Clavulanic Acid (Potassium Clavulanate) +Amoxicillin (Ttrihydrate)
Therapeutic Category
:
Antimicrobial
Pharmacologic Category
:
Antibiotic, Penicillin
Pharmaceutical Form
:
Vial
Composition
:
Clavulanic Acid 100mg+Amoxicillin 500mg / Clavulanic Acid 200mg+Amoxicillin 1000mg
Monitoring Parameters
Dosing
 
Dosing: Adult
Note: Dose is based on the amoxicillin component
Susceptible infections: Children >40 kg and Adults: Oral: 250-500 mg every 8 hours or 875 mg every 12 hours
Bite wounds (animal/human): Oral: 875 mg every 12 hours or 500 mg every 8 hours
Chronic obstructive pulmonary disease: Oral: 875 mg every 12 hours or 500 mg every 8 hours
Erysipelas: Oral: 875 mg every 12 hours or 500 mg every 8 hours
Febrile neutropenia: Oral: 875 mg every 12 hours
Pneumonia:
Aspiration: Oral: 875 mg every 12 hours
Community-acquired: Oral: Extended release tablet: Two 1000 mg tablets every 12 hours for 7-10 days
Pyelonephritis (acute, uncomplicated): Oral: 875 mg every 12 hours or 500 mg every 8 hours
Skin abscess: Oral: 875 mg every 12 hours

Dosing: Pediatric
Note: Dose is based on the amoxicillin component
Susceptible infections: Infants <3 months: Oral: 30 mg/kg/day divided every 12 hours using the 125 mg/5 mL suspension
Lower respiratory tract infections, severe infections, sinusitis: Children ≥3 months and <40 kg: Oral: 45 mg/kg/day divided every 12 hours or 40 mg/kg/day divided every 8 hours
Mild-to-moderate infections: Children ≥3 months and <40 kg: Oral: 25 mg/kg/day divided every 12 hours or 20 mg/kg/day divided every 8 hours
Otitis media: Children ≥3 months and <40 kg: Oral: 90 mg/kg/day divided every 12 hours for 10 days in children with severe illness and when coverage for β-lactamase positive H. influenzae and M. catarrhalis is needed.
Children >40 kg: Refer to adult dosing.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

Clcr <30 mL/minute: Do not use 875 mg tablet or extended release tablets.
Clcr 10-30 mL/minute: 250-500 mg every 12 hours
Clcr <10 mL/minute: 250-500 every 24 hours
Use
 
Treatment of otitis media, sinusitis, and infections caused by susceptible organisms involving the lower respiratory tract, skin and skin structure, and urinary tract; spectrum same as amoxicillin with additional coverage of beta-lactamase producing B. catarrhalis, H. influenzae, N. gonorrhoeae, and S. aureus (not MRSA). The expanded coverage of this combination makes it a useful alternative when amoxicillin resistance is present and patients cannot tolerate alternative treatments.
Adverse Reactions
 
>10%: Gastrointestinal: Diarrhea (3% to 34%; incidence varies upon dose and regimen used)
1% to 10%:
Dermatologic: Diaper rash, skin rash, urticaria
Gastrointestinal: Abdominal discomfort, loose stools, nausea, vomiting
Genitourinary: Vaginitis, vaginal mycosis
Miscellaneous: Moniliasis
<1% (Limited to important or life-threatening): Alkaline phosphatase increased, cholestatic jaundice, flatulence, headache, hepatic dysfunction, hepatitis, liver function tests increased, prothrombin time increased, thrombocytosis, vasculitis (hypersensitivity)
Additional adverse reactions seen with ampicillin-class antibiotics: Agitation, agranulocytosis, alkaline phosphatase increased, anaphylaxis, anemia, angioedema, anxiety, behavioral changes, bilirubin increased, black “hairy” tongue, confusion, convulsions, crystalluria, dizziness, enterocolitis, eosinophilia, erythema multiforme, exanthematous pustulosis, exfoliative dermatitis, gastritis, glossitis, hematuria, hemolytic anemia, hemorrhagic colitis, indigestion, insomnia, hyperactivity, interstitial nephritis, leukopenia, mucocutaneous candidiasis, pruritus, pseudomembranous colitis, serum sickness-like reaction, Stevens-Johnson syndrome, stomatitis, transaminases increased, thrombocytopenia, thrombocytopenic purpura, tooth discoloration, toxic epidermal necrolysis
Contraindications
 
Hypersensitivity to amoxicillin, clavulanic acid, penicillin, or any component of the formulation; history of cholestatic jaundice or hepatic dysfunction with amoxicillin/clavulanate potassium therapy; Clavoxil XR™: severe renal impairment (Clcr <30 mL/minute) and hemodialysis patients
Warnings / Precautions Drug
 
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Serious and occasionally severe or fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy, especially with a history of beta-lactam hypersensitivity, history of sensitivity to multiple allergens, or previous IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria). Use with caution in asthmatic patients. Low incidence of cross-allergy with cephalosporins exists.
• Diarrhea: Incidence of diarrhea is higher than with amoxicillin alone.
• Hepatic effects: Although rare, hepatic dysfunction is more common in elderly and/or males, and occurs more frequently with prolonged treatment, and may occur after therapy is complete.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• Infectious mononucleosis: A high percentage of patients with infectious mononucleosis have developed rash during therapy; ampicillin-class antibiotics not recommended in these patients.
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment recommended.
Dosage form specific issues:
• Clavulanic acid content: Due to differing content of clavulanic acid, not all formulations are interchangeable.
• Phenylalanine: Some products contain phenylalanine.
Interactions
 
Allopurinol: May enhance the potential for allergic or hypersensitivity reactions to Amoxicillin. Risk C: Monitor therapy
BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination
Fusidic Acid: May diminish the therapeutic effect of Penicillins. Risk D: Consider therapy modification
Methotrexate: Penicillins may decrease the excretion of Methotrexate. Risk C: Monitor therapy
Mycophenolate: Penicillins may decrease serum concentrations of the active metabolite(s) of Mycophenolate. This effect appears to be the result of impaired enterohepatic recirculation. Risk C: Monitor therapy
Probenecid: May increase the serum concentration of Penicillins. Risk C: Monitor therapy
Tetracycline Derivatives: May diminish the therapeutic effect of Penicillins. Risk D: Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 24 hours after cessation of antibacterial agents. Risk D: Consider therapy modification
Pregnancy
 
B
Pregnancy Implications
Adverse events have not been observed in animal studies; therefore, amoxicillin/clavulanate is classified as pregnancy category B. Both amoxicillin and clavulanic acid cross the placenta. There is no documented increased risk of teratogenic effects caused by amoxicillin/clavulanate. A potential increased risk of necrotizing enterocolitis in the newborn has been noted after maternal use of amoxicillin/clavulanate for preterm labor or premature prolonged rupture of membranes. When used during pregnancy, pharmacokinetic changes have been observed with amoxicillin alone (refer to the Amoxicillin monograph for details).
Lactation
 
Enters breast milk/use caution
Breast-Feeding Considerations
Amoxicillin is found in breast milk. The manufacturer recommends that caution be used if administered to breast-feeding women. The use of amoxicillin/clavulanate may be safe while breast-feeding; however, the risk of adverse events in the infant may be increased when compared to the use of amoxicillin alone. The risk of adverse events may be related to maternal dose. Nondose-related effects could include modification of bowel flora and allergic sensitization of the infant.
Mechanism of Action
 
Clavulanic acid binds and inhibits beta-lactamases that inactivate amoxicillin resulting in amoxicillin having an expanded spectrum of activity. Amoxicillin 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
 
Amoxicillin pharmacokinetics are not affected by clavulanic acid.
Amoxicillin:
Absorption: Oral: Rapid and nearly complete; food does not interfere
Distribution: Widely to most body fluids and bone; poor penetration into cells, eyes, and across normal meninges
Pleural fluids, lungs, and peritoneal fluid; high urine concentrations are attained; also into synovial fluid, liver, prostate, muscle, and gallbladder; penetrates into middle ear effusions, maxillary sinus secretions, tonsils, sputum, and bronchial secretions
CSF:blood level ratio: Normal meninges: <1%; Inflamed meninges: 8% to 90%
Protein binding: 17% to 20%
Metabolism: Partially hepatic
Half-life elimination:
Neonates, full-term: 3.7 hours
Infants and Children: 1-2 hours
Adults: Normal renal function: 0.7-1.4 hours
Clcr <10 mL/minute: 7-21 hours
Time to peak: Capsule: 2 hours; Extended-release tablet: 3.1 hours; Suspension: 1 hour
Excretion: Urine (60% as unchanged drug); lower in neonates
Clavulanic acid:
Protein binding: ~25%
Metabolism: Hepatic
Half-life elimination: 1 hour
Time to peak: 1 hour
Excretion: Urine (30% to 40% as unchanged drug)
 
   
 
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