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Amoxicillin/clavulanic Acid Chew Tabs Generic Name & Formulations
Legal Class
Rx
General Description
Amoxicillin, clavulanic acid (as potassium); 200mg/28.5mg cherry-banana flavor, contains phenylalanine; 400mg/57mg cherry-banana flavor, contains phenylalanine.
Pharmacological Class
Broad-spectrum penicillin + β-lactamase inhibitor.
See Also
How Supplied
Ext-rel tabs—contact supplier; Tabs 875mg—20; Susp 125mg/5mL, 250mg/5mL—75mL, 100mL, 150mL; Chew tabs—contact supplier; Susp ES-600 600mg/5mL—50mL, 75mL, 100mL, 125mL, 150mL, 200mL
Manufacturer
Amoxicillin/clavulanic Acid Chew Tabs Indications
Indications
Susceptible infections including sinusitis due to β-lactamase producing organisms, otitis media, lower respiratory or skin and skin structure infections, UTIs.
Amoxicillin/clavulanic Acid Chew Tabs Dosage and Administration
Adult
Take with meals. Base dose on amoxicillin component. Due to clavulanic acid component: two 250mg tabs are not equivalent to one 500mg tab. May use 125mg/5mL or 250mg/5mL susp in place of 500mg tab; or 200mg/5mL or 400mg/5mL susp in place of 875mg tab. Severe infections or respiratory tract infections: 875mg every 12 hrs or 500mg every 8 hrs. Others: 500mg every 12 hrs or 250mg every 8 hrs. Renal impairment: CrCl<30mL/min: do not use 875mg tabs. CrCl: 10–30mL/min: 250–500mg every 12 hrs. CrCl<10mL/min: 250mg–500mg every 24 hrs; hemodialysis: give additional doses during and after dialysis.
Children
Take with meals. Base dose on amoxicillin component. <12 weeks: 30mg/kg/day in 2 divided doses every 12 hrs (use 125mg/5mL). ≥12 weeks: Twice-daily regimen: use 200mg/5mL or 400mg/5mL. Three times daily regimen: use 125mg/5mL or 250mg/5mL. Less severe infections: 25mg/kg/day in 2 divided doses every 12 hrs or 20mg/kg/day in 3 divided doses every 8 hrs. Others: 45mg/kg/day in 2 divided doses every 12 hrs or 40mg/kg/day in 3 divided doses every 8 hrs. ≥40kg: see Adult dose.
Amoxicillin/clavulanic Acid Chew Tabs Contraindications
Contraindications
History of amoxicillin/clavulanic acid-associated cholestatic jaundice/hepatic dysfunction. Ext-rel: Severe renal impairment (CrCl <30mL/min) or hemodialysis.
Amoxicillin/clavulanic Acid Chew Tabs Boxed Warnings
Not Applicable
Amoxicillin/clavulanic Acid Chew Tabs Warnings/Precautions
Warnings/Precautions
Cephalosporin, imipenem, or other allergy: not recommended. Monitor blood, renal, and hepatic function in long-term use. Monitor closely if skin rash develops; discontinue if lesions progress. Hepatic dysfunction. Mononucleosis. Elderly (consider monitoring renal function). Labor & delivery. Pregnancy (Cat.B). Nursing mothers.
Amoxicillin/clavulanic Acid Chew Tabs Pharmacokinetics
See Literature
Amoxicillin/clavulanic Acid Chew Tabs Interactions
Interactions
May cause false (+) glucose test with Clinitest, Benedict's or Fehling's soln. Probenecid potentiates amoxicillin. May potentiate oral anticoagulants (monitor). May antagonize oral contraceptives.
Amoxicillin/clavulanic Acid Chew Tabs Adverse Reactions
Adverse Reactions
Diarrhea, nausea, abdominal pain, rash, urticaria, vomiting, vaginitis; anaphylaxis, severe cutaneous adverse reactions (eg, SJS, TEN, DRESS, AGEP).
Amoxicillin/clavulanic Acid Chew Tabs Clinical Trials
See Literature
Amoxicillin/clavulanic Acid Chew Tabs Note
Not Applicable
Amoxicillin/clavulanic Acid Chew Tabs Patient Counseling
See Literature
