amoxicillin and clavulanate potassium

(redirected from Novo-Clavamoxin)

amoxicillin and clavulanate potassium

Apo-Amoxi-Clav (CA), Augmentin, Augmentin-Duo (UK), Augmentin XR, Clavulin (CA), Novo-Clavamoxin (CA)

Pharmacologic class: Aminopenicillin

Therapeutic class: Anti-infective

Pregnancy risk category B


Amoxicillin inhibits transpeptidase, preventing cross-linking of bacterial cell wall and leading to cell death. Addition of clavulanate (a beta-lactam) increases drug's resistance to beta-lactamase (an enzyme produced by bacteria that may inactivate amoxicillin).


Oral suspension: 125 mg amoxicillin with 31.25 mg clavulanic acid/5 ml, 200 mg amoxicillin with 28.5 mg clavulanic acid/5 ml, 250 mg amoxicillin with 62.5 mg clavulanic acid/5 ml, 400 mg amoxicillin with 57 mg clavulanic acid/5 ml, 600 mg amoxicillin with 42.9 mg clavulanic acid/5 ml

Tablets (chewable): 200 mg amoxicillin with 28.5 mg clavulanate, 400 mg amoxicillin with 57 mg clavulanate

Tablets (extended-release): 1,000 mg amoxicillin with 62.5 mg clavulanate

Tablets (film-coated): 250 mg amoxicillin with 125 mg clavulanate, 500 mg amoxicillin with 125 mg clavulanate, 875 mg amoxicillin with 125 mg clavulanate

Indications and dosages

Lower respiratory tract infections, otitis media, sinusitis, skin and skin-structure infections, and urinary tract infections (UTIs) caused by susceptible strains of gram-negative and gram-positive organisms

Adults and children weighing more than 40 kg (88 lb): 500 mg q 12 hours or 250 mg P.O. q 8 hours (based on amoxicillin component). For severe infections, 875 mg P.O. q 12 hours or 500 mg P.O. q 8 hours.

Serious infections and community-acquired pneumonia

Adults and children weighing more than 40 kg (88 lb): 875 mg P.O. q 12 hours or 500 mg P.O. q 8 hours

Infants and children ages 3 months and older weighing less than 40 kg (88 lb): 20 to 45 mg/kg/day P.O. in divided doses q 12 hours or 20 or 25 to 40 mg/kg/day in divided doses q 8 hours, based on severity of infection and amoxicillin component (125 mg/5 ml or 250 mg/5 ml suspension)

Infants younger than 3 months: 30 mg/kg/day P.O. (based on amoxicillin component) divided q 12 hours. (125 mg/5 ml oral suspension is recommended.)

Recurrent or persistent acute otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis in children ages 2 and younger and in children who have received antibiotic therapy within last 3 months

Children ages 3 months to 12 years: 90 mg/kg/day of Augmentin ES-600 P.O. q 12 hours for 10 days

Dosage adjustment

• Severe renal impairment

• Hemodialysis

• Infants ages 3 months and younger


• Hypersensitivity to drug or any penicillin

• Phenylketonuria (some products)

• History of cholestatic jaundice or hepatic dysfunction associated with this drug


Use cautiously in:

• severe renal insufficiency, infectious mononucleosis

• pregnant patients.


Ask about history of penicillin allergy before giving.

• Give with or without food.

• Know that maximum dosage for infants ages 3 months and younger is 30 mg/kg/day divided q 12 hours.

• Be aware that 12-hour dosing is recommended to reduce diarrhea.

Adverse reactions

CNS: lethargy, hallucinations, anxiety, confusion, agitation, depression, dizziness, fatigue, hyperactivity, insomnia, behavioral changes, seizures (with high doses)

GI: nausea, vomiting, diarrhea, abdominal pain, stomatitis, glossitis, gastritis, black "hairy" tongue, furry tongue, enterocolitis, pseudomembranous colitis

GU: vaginitis, nephropathy, interstitial nephritis

Hematologic: anemia, thrombocytopenia, thrombocytopenic purpura, leukopenia, hemolytic anemia, agranulocytosis, bone narrow depression, eosinophilia

Hepatic: cholestatic hepatitis

Respiratory: wheezing

Skin: rash

Other: superinfections (oral and rectal candidiasis), fever, anaphylaxis


Drug-drug. Any food: enhanced clavulanate absorption

Chloramphenicol, macrolides, sulfonamides, tetracycline: decreased amoxicillin efficacy

Hormonal contraceptives: decreased contraceptive efficacy

Probenecid: decreased renal excretion and increased blood level of amoxicillin

Drug-food. Any food: enhanced clavulanate absorption

Drug-herbs. Khat: decreased antimicrobial effect

Patient monitoring

• Monitor patient carefully for signs and symptoms of hypersensitivity reaction.

Monitor for seizures when giving high doses.

• Check patient's temperature and watch for other signs and symptoms of superinfection, especially oral or rectal candidiasis.

Patient teaching

Instruct patient to immediately report signs or symptoms of hypersensitivity reaction, such as rash, fever, or chills.

• Tell patient he may take drug with or without food.

• Inform patient that drug lowers resistance to some types of infections. Instruct him to report new signs or symptoms of infection (especially of mouth or rectum).

• Advise patient to minimize GI upset by eating small, frequent servings of food and drinking plenty of fluids.

• Tell patient taking hormonal contraceptives that drug may reduce contraceptive efficacy. Suggest she use alternative birth control method.

• Inform parents that they may give liquid form of drug directly to child or may mix it with foods or beverages.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, foods, and herbs mentioned above.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved