Generic Name

Amoxicillin + Clavulanic Acid (Clavulanate)

Precaution

History of allergy especially to cephalosporins, infectious mononucleosis, severe renal impairment. Lactation: Drug excreted in breast milk; use caution

Indication

Bacterial infections, Acute otitis media, Acute bacterial sinusitis, Endocarditis, Dental abscess, Community-acquired pneumonia, Acute uncomplicated UTI, Uncomplicated gonorrhea, Severe or recurrent resp tract infections

Contra Indication

Penicillin allergy.

Dose

N/A

Side Effect

>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

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%.