This is my first word document, converted into pdf format! This document deals with AMOXICILLIN drug profile in brief. It includes significant pharmacological headings, including an additional heading, stating important catchpoints with respect to amoxicillin!

1. AMOXICILLIN DRUG PROFILE
BASIC FEATURES:
Class: Aminopenicillin, beta-lactam antibiotic
Mechanism of action: Drug  binds to PBPs (Penicillin-binding proteins) 
disrupts cell wall synthesis  death of susceptible organism (bactericidal effect)
Mechanisms of resistance:
1. Alteration of PBP  reduced drug binding affinity
2. Organism  produces beta-lactamase enzyme  hydrolysis of beta-
lactam ring  drug ineffective!
3. Organism  reduces porin production  reduced ability of antibiotic
to reach PBP  reduced drug concentration within cell.
Metabolic route: Amoxicillin  excreted unchanged in urine.
FDA-APPROVED INDICATIONS:
1. Infections of ear, nose and throat
2. Infections of genitourinary tract
3. Infections of skin and skin structure
4. Infections of lower respiratory tract
5. Gonorrhea
6. Acute uncomplicated ano-genital and urethral infections
7. H.pylori eradication:
 Triple therapy: Amoxicillin+clarithromycin+lansoprazole
 Dual therapy: Amoxicillin+lansoprazole

2. SIDE-EFFECTS/TOXICITY:
1. Clostridium difficile-associated diarrhea (CDAD)
2. Mucocutaneous candidiasis
3. N&V
4. Diarrhea
5. Black hairy tongue
6. Hypersensitivity reactions (rashes, erythema multiforme, SJS)
7. Rise in SGOT & SGPT
8. Crystalluria
9. Anemia
10.Thrombocytopenia
11.Eosinophilia
12.Leukopenia.
SIGNIFICANT DRUG INTERACTIONS/FOOD
INTERACTIONS:
1. Amoxicillin (capsules, chewable tablets and oral suspension)  may
be given without regard to meals
2. Amoxicillin + probenecid  increased & prolonged blood levels of
former
3. Amoxicillin + bacteriostatic antibiotics (chloramphenicol,
sulfonamides, tetracyclines, macrolides)  reduced bactericidal
effects of amoxicillin.
DOSAGE FORMS:
1. Each capsule of amoxicillin  contains 250/500 mg of drug
2. Each tablet of amoxicillin  contains 500/875 mg of drug
3. Each chewable tablet  contains 125/200/250/400 mg of drug
4. Oral suspension  contains (200 mg/5 ml) OR (400 mg/5 ml).

3. DOSING:
INFECTION DOSE
Ear/nose/throat
(mild/moderate)
500 mg q12h OR 250 mg q8h
Ear/nose/throat (severe) 875 mg q12h OR 500 mg q8h
Lower respiratory tract
infections
875 mg q12h OR 500 mg q8h
Skin/skin structure infections
(mild/moderate)
500 mg q12h OR 250 mg q8h
Skin/skin structure infections
(severe)
875 mg q12h OR 500 mg q8h
Genitourinary infections
(mild/moderate)
500 mg q12h OR 250 mg q8h
Genitourinary infections
(severe)
875 mg q12h OR 500 mg q8h
H.pylori eradication (1 g amoxicillin
+ 500 mg
clarithromycin
+ 30 mg
lansoprazole),
twice daily, for
14 days
OR
(1 g
amoxicillin +
+ 30 mg
lansoprazole)
, thrice daily,
for 14 days

4. DOSING IN SPECIAL POPULATIONS:
In renal impairment:
CREATININE CLEARANCE
(ml/min)
DOSE TO BE ADJUSTED
10-30 250-500 mg every 12 hours
<10 250-500 mg daily
Hemodialysis 250-500 mg, every 24 hours + an
ADDITIONAL DOSE after dialysis
CAPD 250 mg every 12 hours
CRRT N/A
In hepatic dysfunction: No dose adjustment necessary
Pediatrics:
1. For neonates & infants aged ≤ 12 weeks  30 mg/kg/day, divided
q12h.
2. For pediatrics > 3 months:
 25-45 mg/kg/day, in divided doses, every 12 hours
o OR
 20-40 mg/kg/day, in divided doses, every 8 hours (based on
infection severity).
IMPORTANT DRUG CATCHPOINTS:
1. Amoxicillin dose should be adjusted in case of renal dysfunction
2. If taken with clavulanic acid:
3. Preferably take drug with meals  helps improve drug absorption &
reduce GI ADRs
4. Avoid high fatty meals (since clavulanate absorption is hindered)
5. Avoid drug in patients with allergenicity to amoxicillin or any other
beta-lactam antibiotic (except aztreonam)

5. 6. In patients with MONONUCLEOSIS who receive amoxicillin 
erythematous skin rash may occur.
WORK WELL AND SMART!
DR. VISHNU R. NAIR