amoxicillin and clavulanate potassium
amoxicillin and clavulanate potassium
Pharmacologic class: Aminopenicillin
Therapeutic class: Anti-infective
Pregnancy risk category B
Action
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).
Availability
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
Contraindications
• Hypersensitivity to drug or any penicillin
• Phenylketonuria (some products)
• History of cholestatic jaundice or hepatic dysfunction associated with this drug
Precautions
Use cautiously in:
• severe renal insufficiency, infectious mononucleosis
• pregnant patients.
Administration
See 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.
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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
Interactions
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.
See 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
See 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.