Product Name
:
PANAMOXY
Chemical Name
:
Amoxicillin (Sodium)
Therapeutic Category
:
Antimicrobial
Pharmacologic Category
:
Antibiotic, Penicillin
Pharmaceutical Form
:
Vial
Composition
:
Amoxicillin (Sodium) 250mg / 500mg / 1000mg
Dosing
 
Dosing: Adult

By intramuscular injection: 500mg every eight hours.
By intravenous injection or infusion: 500mg every eight hours (or in severe infection 1g every six hours) may be given by slow iv injection over three to four minutes or by infusion over 30 to 60 minutes.

Dosing: Pediatric
Treatment of Infection in Children up to 10 years
By intramuscular or intravenous injection or infusion:     50-100mg per kg bodyweight daily in divided doses.

Dosing: Geriatric
Refer to adult dosing.

Dosing: Renal Impairment

It may be necessary to reduce the total daily dosage depending on the degree of renal impairment.
As amoxicillin is removed by haemodialysis, patients receiving haemodialysis may require another dose of amoxicillin at the end of their dialysis.
Use
 
Treatment of otitis media, sinusitis, and infections caused by susceptible organisms involving the upper and lower respiratory tract, skin, and urinary tract; prophylaxis of infective endocarditis in patients undergoing surgical or dental procedures; as part of a multidrug regimen for H. pylori eradication
Use - Unlabeled/Investigational
Postexposure prophylaxis for anthrax exposure with documented susceptible organisms
Adverse Reactions
 
Frequency not defined.
Central nervous system: Agitation, anxiety, behavioral changes, confusion, dizziness, headache, hyperactivity (reversible), insomnia, seizure
Dermatologic: Acute exanthematous pustulosis, erythematous maculopapular rash, erythema multiforme, exfoliative dermatitis, hypersensitivity vasculitis, mucocutaneous candidiasis, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria
Gastrointestinal: Black hairy tongue, diarrhea, hemorrhagic colitis, nausea, pseudomembranous colitis, tooth discoloration (brown, yellow, or gray; rare), vomiting
Hematologic: Agranulocytosis, anemia, eosinophilia, hemolytic anemia, leukopenia,thrombocytopenia, thrombocytopenia purpura
Hepatic: Acute cytolytic hepatitis, ALT increased, AST increased, cholestatic jaundice, hepatic cholestasis
Renal: Crystalluria
Miscellaneous: Anaphylaxis, serum sickness-like reaction
Contraindications
 
Hypersensitivity to amoxicillin, penicillin, other beta-lactams, or any component of the formulation
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.
• 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:
• 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. In addition, use of certain dosage forms (eg, extended release 775 mg tablet and immediate release 875 mg tablet) should be avoided in patients with Clcr <30 mL/minute or patients requiring hemodialysis.
Dosage form specific issues:
• Phenylalanine: Chewable tablets 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 is classified as pregnancy category B. There is no documented increased risk of adverse pregnancy outcome or teratogenic effects caused by amoxicillin. It is the drug of choice for the treatment of chlamydial infections in pregnancy and for anthrax prophylaxis when penicillin susceptibility is documented.
Due to pregnancy-induced physiologic changes, amoxicillin clearance is increased during pregnancy resulting in lower concentrations and smaller AUCs. Oral ampicillin-class antibiotics are poorly-absorbed during labor.
Lactation
 
Enters breast milk/use caution (AAP rates “compatible”; AAP 2001 update pending)
Breast-Feeding Considerations
Very small amounts of amoxicillin are excreted in breast milk. The manufacturer recommends that caution be exercised when administering amoxicillin to nursing women. Nondose-related effects could include modification of bowel flora and allergic sensitization of the infant.
Monitoring Parameters
 
With prolonged therapy, monitor renal, hepatic, and hematologic function periodically; assess patient at beginning and throughout therapy for infection; monitor for signs of anaphylaxis during first dose
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
 
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
Excretion: Urine (60% as unchanged drug); lower in neonates