Indications
- Skin and Soft Tissue Infections.
- Uncomplicated Cellulitis.
- Erysipelas.
- Polymicrobial infections.
- Animal or human bites infected by combined aerobic and Anaerobic pathogens.
Dosage
- Pediatric oral dosage : 20–40 mg/kg/day (of amoxicillin) divided q8h or q12h.
- Adult oral dosage : 500–875 mg BID.
- Skin and Soft Tissue Infections :
- 875/125 mg 2 times per day PO for Adults.
- 25 mg/kg/day of amoxicillin component in 2 divided doses PO for Children.
- Animal or human bites : 500-875 mg po twice per day.
Renal impairment
- CrCl <30 mL/min: Do not use 875/125 mg tablet or extended-release tablets.
- CrCl 10-30 mL/min: 250-500/125 mg PO q12hr.
- CrCl <10 mL/min: 250-500/125 mg PO q24hr.
- Hemodialysis: 250-500/125 mg PO q24hr; administer additional dose both during and at end of dialysis.
- Hepatic impairment.
- Dose with caution; monitor hepatic function regularly.
Side effects
- GI complaints, most commonly diarrhea.
- Diarrhea appears to occur less frequently when Amox/Clav is administered with food.
- Hypersensitivity reactions.
- Cholestatic injury.
- Clostridium Difficile Associated Diarrhea.
- Skin Rash In Patients With Mononucleosis.
Contraindications
- Allergy to penicillins.
- Previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate.
- Extended release: Hemodialysis patients and severe renal impairment (CrCl <30 mL/min).
Interactions
- Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid. Concurrent use may result in increased and prolonged blood concentrations of amoxicillin. Coadministration of probenecid is not recommended.
- Oral Anticoagulants : Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently with AUGMENTIN. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
- Allopurinol :The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.
- Oral Contraceptives : It may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy &Lactation
- Pregnancy category: B.
- Lactation: Drug excreted in breast milk; use caution.
Precautions
- Allergy to cephalosporins, carbapenems.
- Different tablets are not interchangeable, because ratios of amoxicillin to clavulanate are different.
- Extended release tablets not for use in renal impairment (CrCl <30 mL/min) .
- Incidence of diarrhea is higher than with amoxicillin alone.
- Unknown safety and efficacy of extended-release tablets in patients <16 years old.
- Risk of Clostridium difficile-associated diarrhea (CDAD); consider in patients who present with diarrhea after antibiotic use; CDAD has been known to occur over 2 months after antibiotic therapy; if suspected, discontinue drug immediately and administer appropriate fluid/electrolyte therapy, protein supplementation, and C difficile antibiotic treatment.
- Risk of bacterial or fungal superinfections; if suspected, discontinue drug immediately and administer appropriate therapy.
- High percentage of patients with mononucleosis reported to develop rash during therapy; ampicillin-class antibiotics not recommended in these patients.
- Use caution in hepatic impairment; hypatic dysfunction (rare) is more common in elderly and/or males and prolonged therapy may increase risk; may occur after completing therapy.
Drug Info
- Take with meals to avoid GI upset.
- Take suspension at start of meal to enhance absorption.