amoxicillin and clavulanate potassium
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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
☞ 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
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.
☞ 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.