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Amoxycillin & Clavulanic acid

ANTIBIOTICS & ANTIINFECTIVES

PENICILLINS - [ ANTIBIOTICS & ANTIINFECTIVES ]

Amoxicillin is penicillinase-susceptible semi-synthetic penicillin. It causes cell wall synthesis inhibition. It is active against meningococci and L. monocytogenes are sensitive to this class of drugs. H. influenzae and the viridans group of streptococci exhibit varying degrees of resistance. Enterococci and most strains of N. gonorrhoeae, E. coli, P. mirabilis, Salmonella, and Shigella were highly susceptible but an increasing percentage of these species now are resistant. From 30% to 50% of E. coli, a significant number of P. mirabilis, and practically all species of Enterobacter presently are insensitive.1 Clavulanic acid is a beta-lactamase inhibitor. It has no significant antibacterial activity but in combination with Amoxycillin widens Amoxycillin’s spectrum of activity and allows its use against Amoxycillin-resistant strains of bacteria. It is used in respiratory-tract, genito-urinary and abdominal infections, cellulitis, animal bites and dental infections

Lower Respiratory Tract Infections – caused by β-lactamase–producing strains of H. influenzae and M. catarrhalis. Otitis Media – caused by β-lactamase–producing strains of H. influenzae and M. catarrhalis. Sinusitis – caused by β-lactamase–producing strains of H. influenzae and M. catarrhalis Skin and Skin Structure Infections – caused by β-lactamase–producing strains of S. aureus, E. coli, and Klebsiella spp. Urinary Tract Infections – caused by β-lactamase–producing strains of E. coli, Klebsiella spp. and Enterobacter spp. (2)

Combination is contraindicated in patients with a history of allergic reactions to any penicillin. It is also contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with combination. (2)

Diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment Skin rashes, pruritus, urticaria, angioedema, serum sickness–like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme (rarely Stevens-Johnson syndrome), acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and an occasional case of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported. These reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise. Serious and occasional fatal hypersensitivity (anaphylactic) reactions can occur with oral penicillin. A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted Interstitial nephritis and hematuria have been reported rarely. Crystalluria has also been reported Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported rarely. Tooth discoloration (brown, yellow, or gray staining) has been rarely reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases. (2)

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with combination may result in increased and prolonged blood levels of amoxicillin. Coadministration of probenecid cannot be recommended. The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with combination and allopurinol administered concurrently. In common with other broad-spectrum antibiotics, it may reduce the efficacy of oral contraceptives (2)

Oral ampicillin-class antibiotics are poorly absorbed during labor Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed (2)

Neonates and infants aged <12 weeks (3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of combination is 30 mg/kg/day divided q12h, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group. Experience with the 200 mg/5 mL formulation in this age group is limited and, thus, use of the 125 mg/5 mL oral suspension is recommended Pediatric Patients Weighing 40 kg and More: Should be dosed according to the following adult recommendations: The usual adult dose is one 500-mg tablet every 12 hours or one 250-mg tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet every 12 hours or one 500-mg tablet every 8 hours. Among adults treated with 875 mg every 12 hours, significantly fewer experienced severe diarrhea or withdrawals with diarrhea versusadults treated with 500 mg every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet. For Otitis media , sinusitis, lower respiratory tract infections, and more severe infections: 45 mg/kg/day q12h and 40 mg/kg/day q8h For other Less severe infections: 25 mg/kg/day q12h 20 mg/kg/day q8h (2)

1. William A. Petri Jr. Penicillins, Cephalosporins and Other β-Lactam Antibiotics. In: Brunton L, Chabner B, Knollmann B eds. Goodman & Gilman’s The Pharmacological basis of Therapeutics. 12th ed. China: McGraw Hill; 2011. p1477-1503. 2. AMOXIL [Internet]. [cited 2013 Aug 27]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725s025050726s019lbl.pdf 3. National Formulary of India. 4 th ed. Government of India, Ministry of Health and Family Welfare. India: Indian Pharmacopoeia Commission; 2011