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amoxicillin and clavulanate potassium
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
• Severe renal impairment
• 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.
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
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
• 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.
☞ 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.
amoxicillin/clavulanate(a-mox-i-sill-in/klav-yoo-lan -ate) ,
Augmentin ES(trade name),
Augmentin XR(trade name),
ClassificationTherapeutic: anti infectives
Pharmacologic: aminopenicillins beta lactamase inhibitors
- Skin and skin structure infections,
- Otitis media,
- Respiratory tract infections,
- Genitourinary tract infections.
- Haemophilus influenzae,
- Escherichia coli,
- Proteus mirabilis,
- Neisseria meningitidis,
- N. gonorrhoeae,
- Staphylococcus aureus,
- Klebsiella pneumoniae,
- Moraxella catarrhalis.
Time/action profile (peak blood levels)
|PO||30 min||1–2 hr||8–12 hr|
Adverse Reactions/Side Effects
Central nervous system
- seizures (high doses) (life-threatening)
- pseudomembranous colitis (life-threatening)
- diarrhea (most frequent)
- hepatic dysfunction
- vaginal candidiasis
- rash (most frequent)
- blood dyscrasias
- allergic reactions including anaphylaxis and serum sickness (life-threatening)
Drug-Drug interactionProbenecid ↓ renal excretion and ↑ blood levels of amoxicillin—therapy may be combined for this purpose.May ↑ the effect of warfarin.Concurrent allopurinol therapy ↑ risk of rash.May ↓ the effectiveness of hormonal contraceptives.Clavulanate absorption is ↓ by a high fat meal.
Route/DosageMost Infections (Dosing based on amoxicillin component)
Renal ImpairmentOral (Adults) CCr 10–30 mL/min—250–500 mg q 12 hr (do not use 875 mg tablet); CCr <10 mL/min—250–500 mg q 24 hr.
Availability (generic available)
- Assess for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC) at beginning of and throughout therapy.
- Obtain a history before initiating therapy to determine previous use of and reactions to penicillins or cephalosporins. Persons with a negative history of penicillin sensitivity may still have an allergic response.
- Observe for signs and symptoms of anaphylaxis (rash, pruritus, laryngeal edema, wheezing). Notify health care professional immediately if these occur.
- Obtain specimens for culture and sensitivity prior to therapy. First dose may be given before receiving results.
- Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of pseudomembranous colitis. May begin up to several weeks following cessation of therapy.
- Lab Test Considerations: May cause ↑ serum alkaline phosphatase, LDH, AST, and ALT concentrations. Elderly men and patients receiving prolonged treatment are at ↑ risk for hepatic dysfunction.
- May cause false-positive direct Coombs’ test result.
Potential Nursing DiagnosesRisk for infection (Indications, Side Effects)
Noncompliance (Patient/Family Teaching)
- Oral: Administer around the clock. Administer at the start of a meal to enhance absorption and to decrease GI side effects. Do not administer with high fat meals; clavulanate absorption is decreased. XR tablet is scored and can be broken for ease of administration. Capsule contents may be emptied and swallowed with liquids. Chewable tablets should be crushed or chewed before swallowing with liquids. Shake oral suspension before administering. Refrigerated reconstituted suspension should be discarded after 10 days.
- Two 250-mg tablets are not bioequivalent to one 500-mg tablet; 250-mg tablets and 250-mg chewable tablets are also not interchangeable. Two 500-mg tablets are not interchangeable with one 1000-mg XR tablet; amounts of clavulanic acid and durations of action are different. Augmentin ES 600 (600 mg/5 mL) does not contain the same amount of clavulanic acid as any of the other Augmentin suspensions. Suspensions are not interchangeable.
- Pediatric: Do not administer 250-mg chewable tablets to children <40 kg due to clavulanate content. Children <3 mo should receive the 125-mg/5 mL oral solution.
- Instruct patients to take medication around the clock and to finish the drug completely as directed, even if feeling better. Advise patients that sharing of this medication may be dangerous.
- Pediatric: Teach parents or caregivers to calculate and measure doses accurately. Reinforce importance of using measuring device supplied by pharmacy or with product, not household items.
- Advise patient to report the signs of superinfection (furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools) and allergy.
- Instruct patient to notify health care professional immediately if diarrhea, abdominal cramping, fever, or bloody stools occur and not to treat with antidiarrheals without consulting health care professionals.
- Instruct the patient to notify health care professional if symptoms do not improve or if nausea or diarrhea persists when drug is administered with food.
- Instruct female patients taking oral contraceptives to use an alternate or additional method of contraception during therapy and until next menstrual period; may decrease effectiveness of hormonal contraceptives.
- Resolution of the signs and symptoms of infection. Length of time for complete resolution depends on the organism and site of infection.