History of allergy especially to cephalosporins, infectious mononucleosis, severe renal impairment.
Lactation: Drug excreted in breast milk; use caution
>10%
Diarrhea (3-34%; varies upon dose and regimen)
1-10%
Diaper rash (3.5%),Mycosis (3.3%),Nausea (2-3%),Rash (1-3%),Vomiting (1-2.2%),Loose stool (1.6%),Candidiasis (1.4%),Vaginitis (1%)
<1%
Hypersensitivity reactions,Anaphylaxis,Anemia,Thrombocytopenia,Leukopenia,Agranulocytosis,Hepatoxicity,AST/ALT elevation,Pseudomembranous colitis,Serum sickness,Abdominal discomfort,Cholestatic jaundice,Flatulence
Potentially Fatal: Anaphylactic reaction with CV collapse esp with parenteral use.
Pregnancy Category
Name :
B
Description
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Mode of Action
Clavulanic acid has a high affinity for and binds to certain ?-lactamases that generally inactivate amoxicillin by hydrolyzing its ?-lactam ring. Combining clavulanate potassium with amoxicillin extends the antibacterial spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and other penicillins and cephalosporins.
Interaction
Allopurinol may reduce renal tubular secretion of amoxicillin thus increasing the serum levels of amoxicillin. Concurrent use may reduce the efficacy of oral contraceptives.
Pregnancy Category Note
Pregnancy category: B
Lactation: Drug excreted in breast milk; use caution
Adult Dose
Adults: PO: One 375 mg tablet 3 times a day. In severe infection one 625mg tablet 3 times a day or one 1gm tablet two times a day.
IV Injection: 1.2 g every 6-8 hours
Hepatic impairment: Dose with caution; monitor hepatic function regularly
Child Dose
Children: 125/31.25-, 250/62.5-mg/5-mL susp: 20?40 mg amoxicillin component/kg/day (max 1,500 mg/day) q8h
200/28.5-, 400/57-mg/5-mL susp: 25-45 mg amoxicillin component/kg/day (max 1,750 mg/day) q12h
Children of 6-12 years: 2 teaspoonful Powder for Suspension every 8 hours.
Children of 1-6 years: 1 teaspoonful Powder for Suspension every 8 hours.
Children below 1 year: 25 mg/kg/day in divided doses every 8 hours.
Children over 12 years: IV Injection: 1.2 g every 6-8 hours,
Children up to 3 months: 30 mg/kg every 8 hours (every 12 hours in the perinatal period and in premature infants);
Child 3 months-12 years, 30 mg/kg every 6-8 hours.
Renal Dose
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
Administration
Take with meals to avoid GI upset
Take suspension at start of meal to enhance absorption
Reconstitution: Powd for inj: Dissolve amoxicillin/clavulanic acid 500/100 mg in 10 mL solvent and 1,000/200 mg in 20 mL solvent. May further dilute to infusion soln containing either water for inj or NaCl 0.9%.
Disclaimer
The information provided herein are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please note that this information should not be treated as a replacement for physical medical consultation or advice. Great effort has been placed to provide accurate and comprehensive data. However, Medicart along with its authors and editors make no representations or warranties and specifically disclaim all liability for any medical information provided on the site. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company.