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Amoxicillin / Clavulanate Potassium

Pronunciation

Pronunciation: a-MOX-i-SIL-in/KLAV-ue-la-nate po-TAS-ee-um
Class: Aminopenicillin

Trade Names

Augmentin
- Tablets 250 mg/125 mg
- Tablets 500 mg/125 mg
- Tablets 875 mg/125 mg
- Chewable tablets 200 mg/28.5 mg
- Chewable tablets 400 mg/57 mg
- Powder for oral suspension 125 mg/31.25 mg per 5 mL
- Powder for oral suspension 200 mg/28.5 mg per 5 mL
- Powder for oral suspension 250 mg/62.5 mg per 5 mL
- Powder for oral suspension 400 mg/57 mg per 5 mL

Augmentin ES-600
- Powder for oral suspension 600 mg/42.9 mg per 5 mL

Augmentin XR
- Tablets, extended release 1,000 mg/62.5 mg

Apo-Amoxi-Clav (Canada)
Clavulin (Canada)
ratio-Aclavulanate (Canada)

Pharmacology

Amoxicillin inhibits bacterial cell wall mucopeptide synthesis. Clavulanic acid inactivates a wide range of beta-lactam enzymes found in bacteria resistant to penicillins and cephalosporins.

Slideshow: Flashback: FDA Drug Approvals 2013

Indications and Usage

Tablets, chewable tablets, oral suspension (other than 600 mg/42.9 mg per mL)

Treatment of infections of the lower respiratory tract, otitis media, sinusitis, skin and skin structures, and UTIs caused by susceptible microorganisms.

Extended-release (ER) tablets

Acute bacterial sinusitis or community-acquired pneumonia caused by confirmed or suspected beta-lactamase–producing pathogens and Streptococcus pneumoniae with reduced susceptibility to penicillin (MIC equal to 2 mcg/mL).

Oral suspension (600 mg/42.9 mg per 5 mL)

Treatment of children with recurrent or persistent acute otitis media due to S. pneumoniae , Haemophilus influenzae , or Moraxella catarrhalis characterized by antibiotic exposure for acute otitis media within the preceding 3 months and who are either 2 yr of age or younger or attend day care.

Contraindications

History of penicillin allergy; history of amoxicillin- and clavulanate-associated cholestatic jaundice or liver disease.

ER tablets

Severe renal function impairment (CrCl less than 30 mL/min); hemodialysis patients.

Dosage and Administration

Strengths listed in the following sections are based on amoxicillin content. Because the strengths listed are based on amoxicillin content and the amount of clavulanic acid may differ between products, the dose for various products or dosage forms may not be interchangeable and must be verified before administration.

Tablets

Because 250 and 500 mg tablets contain the same amount of clavulanate, two 250 mg tablets are not equivalent to one 500 mg tablet.

Adults and children weighing 40 kg or more

PO One 500 mg tablet every 12 h or one 250 mg tablet every 8 h. For more severe infections and infections of the respiratory tract, give one 875 mg tablet every 12 h or one 500 mg tablet every 8 h.

Adult patients with severe renal function impairment (glomerular filtration rate [GFR] 10 to 30 mL/min) should receive 500 or 250 mg every 12 h, depending on severity of infection. Patients with GFR less than 10 mL/min should receive 500 or 250 mg every 24 h, depending on severity of infection. Hemodialysis patients should receive 500 or 250 mg every 24 h, depending on severity of infection. They should receive an additional dose during and at the end of dialysis.

ER tablets

Because the ER tablets contain clavulanate 62.5 mg, other tablets cannot be used to provide the same dosages as the ER tablets.

Adults and children 16 yr of age and older

PO Recommended daily dose is amoxicillin 4,000 mg and clavulanate potassium 250 mg daily.

Acute Bacterial Sinusitis

PO 2 tablets every 12 h for 10 days.

Community-Acquired Pneumonia

PO 2 tablets every 12 h for 7 to 10 days.

Oral Suspension (other than 600 mg/42.9 mg per 5 mL) and Chewable Tablets

600 mg (5 mL) suspension does not contain the same amount of clavulanic acid as any of the other suspensions (5 mL). Therefore, the suspensions are not interchangeable. Because 250 mg chewable tablets and 250 mg tablets do not contain the same amount of clavulanic acid, they are not interchangeable and should not be substituted for each other.

Adults

PO See dose for tablets (listed previously). Adults who have trouble swallowing may be given 125 or 250 mg per 5 mL suspension in place of the 500 mg tablet. The 200 or 400 mg per 5 mL suspension may be used in place of the 875 mg tablet.

Children weighing 40 kg or more

PO Dose according to the adult recommendations.

Children 12 wk of age and older Otitis media, sinusitis, lower respiratory tract infections, and more severe infections

PO 40 mg/kg/day divided every 8 h or 45 mg/kg/day divided every 12 h.

Less severe infections

PO 20 mg/kg/day divided every 8 h or 25 mg/kg/day divided every 12 h.

Neonates and infants 12 wk of age and younger

PO 30 mg/kg/day divided every 12 h.

Oral Suspension (600 mg/42.9 mg per /5 mL)

This strength does not contain the same amount of clavulanic acid as any of the other suspensions (5 mL). Therefore, the suspensions are not interchangeable.

Children 3 mo of age and older

PO 90 mg/kg/day divided every 12 h for 10 days.

General Advice

  • The oral suspensions (200, 400, and 600 mg per 5 mL strengths) and the 200 and 400 mg strengths of chewable tablets contain phenylalanine.
  • Administer each dose at the start of a meal to minimize GI intolerance.
  • Shake suspension well before measuring dose. Measure and administer prescribed dose of suspension using dosing syringe, dosing spoon, or dosing cup.
  • Chewable tablets can be swallowed whole or crushed or chewed before swallowing. Supply water after each dose.

Storage/Stability

Store tablets, chewable tablets, and dry powder for suspension at controlled room temperature (68° to 77°F). Store reconstituted suspension in refrigerator (36° to 46°F). Discard any unused suspension after 10 days.

Drug Interactions

Allopurinol

May increase incidence of rash.

Contraceptives, oral

May reduce effectiveness of oral contraceptives.

Probenecid

May increase and prolong blood levels of amoxicillin.

Tetracyclines

May reduce antibacterial effectiveness of amoxicillin.

Laboratory Test Interactions

May cause false-positive urine glucose test results with Benedict solution, Fehling solution, or Clinitest tablets (enzyme-based tests [eg, Clinistix , Tes-Tape ] are recommended); false-positive direct Coombs test result in certain patient groups; false-positive protein reactions with sulfosalicylic acid and boiling test, acetic acid test, biuret reaction, and nitric acid test ( Bromphenol Blue Test , Multi-Stix is recommended).

Adverse Reactions

CNS

Agitation; anxiety; behavioral changes; confusion; convulsions; dizziness; fatigue; headache; insomnia; reversible hyperactivity.

Dermatologic

Skin rashes, urticaria (3%); acute generalized exanthematous rash; erythema multiforme; exanthematous pustulosis; maculopapular to exfoliative dermatitis; pruritus; Stevens-Johnson syndrome (rare); toxic epidermal necrolysis; vesicular eruptions.

EENT

Abnormal taste sensation; black, hairy tongue; glossitis; itchy eyes; laryngeal edema; laryngospasm; sore or dry mouth or tongue; stomatitis.

GI

Diarrhea/loose stools (9%); nausea (3%); vomiting (1%); abdominal pain or cramps; anorexia; bloody diarrhea; enterocolitis; epigastric distress; flatulence; gastritis; glossitis; indigestion; mucocutaneous candidiasis; pseudomembranous colitis; rectal bleeding; stomatitis; tooth discoloration.

Genitourinary

Vaginitis (1%); crystalluria; interstitial nephritis (eg, hematuria, hyaline casts, oliguria, proteinuria, pyuria); nephropathy.

Hematologic

Agranulocytosis; anemia; bone marrow depression; eosinophilia; granulocytopenia; hemolytic anemia; increased basophils; increased monocytes; increased platelets; increased or decreased lymphocyte count; leukopenia; neutropenia; prolonged bleeding and prothrombin time; reduced hemoglobin or hematocrit; thrombocytopenia; thrombocytopenic purpura.

Hepatic

Cholestatic jaundice; elevated LFTs; hepatitis; increased bilirubin and/or alkaline phosphatase; transient hepatitis.

Metabolic

Reduced albumin; elevated serum alkaline phosphatase and hypernatremia; reduced serum potassium; reduced total proteins and uric acid.

Miscellaneous

Anaphylaxis; angioedema; hypersensitivity vasculitis; hyperthermia; serum sickness–like reactions (including urticaria, rash, arthritis, arthralgia, myalgia, and fever); superinfection.

Precautions

Monitor

Periodically assess organ system function, including renal, hepatic, and hematopoietic function with long-term therapy.

Allergic reaction

Monitor patient for signs of anaphylaxis or severe allergic reaction. Discontinue therapy if noted. Be prepared to treat appropriately.

Liver enzymes

Ensure liver enzymes are determined before starting therapy and periodically thereafter in patients with hepatic function impairment. Be prepared to discontinue therapy.

Sensitivity testing

Review results of culture and sensitivity testing as appropriate. Ensure amoxicillin/clavulanate is discontinued and another antimicrobial agent is started if sensitivity tests indicate that the organism is resistant to amoxicillin/clavulanate.

Adverse reactions

Monitor patient for CNS, GI, dermatologic, and general body adverse reactions, and signs of superinfection.

Therapy response

Monitor patient's response to therapy.


Pregnancy

Category B .

Lactation

Secreted into breast milk.

Children

Tablets

Safety and efficacy of 250 mg tablet not established in children weighing less than 40 kg.

ER tablets

Safety and efficacy not established in children younger than 16 yr of age.

Oral suspension (600 mg/42.9 mg per 5 mL)

Safety and efficacy not established in children younger than 3 mo of age.

Oral suspension and chewable tablets

Modify dosage for children younger than 12 wk of age.

Hypersensitivity

Serious and sometimes fatal reactions have been reported in patients on penicillin therapy. Also, there are reports of severe reactions in patients treated with a cephalosporin who have a history of penicillin hypersensitivity.

Renal Function

Dose reduction or every 12 h recommended with severe impairment. Ensure 875 mg tablets and 1,000 mg ER tablets are not used in patient with severe renal function impairment (eg, CrCl less than 30 mL/min).

Hepatic Function

Use with caution.

Superinfection

May result in overgrowth of nonsusceptible bacterial or fungal organisms.

Adults

Safety and efficacy of Augmentin ES-600 not established.

Mononucleosis patients

Increased risk of skin rash. Use not recommended.

Phenylalanine

Contains phenylalanine in 200 and 400 mg chewable tablets, and 200, 400, and 600 mg per 5 mL oral suspensions.

Pseudomembranous colitis

Consider the possibility in patients who develop diarrhea.

Overdosage

Symptoms

Crystalluria, which may lead to renal failure; diarrhea; drowsiness; hyperactivity; interstitial nephritis, resulting in oliguric renal failure; rash; stomach and abdominal pain; vomiting.

Patient Information

  • Review dosing schedule (every 8 or 12 h) and prescribed length of therapy with patient or caregiver. Advise patient or caregiver that dose, dosing frequency, and duration of therapy are dependent on the site and cause of infection and strength of antibiotic being used.
  • Reinforce to patient or caregiver the need to take exactly as prescribed and to complete the entire course of therapy, even if symptoms of infection have disappeared. Caution patient or caregiver that skipping doses or not completing the full course of therapy may allow the infection to worsen and increase the possibility that the bacteria will become resistant to the antibiotic and may cause infections that will not be treatable in the future.
  • Instruct patient to take each dose at the start of a meal or snack to minimize intestinal adverse reactions.
  • Advise patient using the scored ER tablet that the tablet may be split and taken as 2 halves. Advise patient that ½ tablets should be swallowed whole. Caution patient not to crush, chew, or break ½ tablets.
  • Instruct patient or caregiver administering suspension to do the following: keep suspension refrigerated; shake well before each use; use dosing syringe, dosing spoon, or dosing cup when measuring and administering dose; and discard any unused suspension at end of treatment period (after 10 days).
  • Advise patient or caregiver using chewable tablets to swallow whole or to crush or chew before swallowing. Advise patient or caregiver to follow each dose with water.
  • Instruct patient to notify health care provider if infection does not appear to be improving or is worsening.
  • Advise patient or caregiver to notify health care provider if severe diarrhea or diarrhea lasting 2 or 3 days occurs.
  • Warn patient that diarrhea containing blood or pus may be a sign of a serious disorder and to seek medical care if noted and not to treat at home.
  • Advise patient or caregiver to report signs of superinfection to health care provider: black, “furry” tongue; white patches in mouth; foul-smelling stools; vaginal itching or discharge.
  • Advise patient, family, or caregiver to discontinue therapy and contact health care provider immediately if skin rash, hives, itching, or shortness of breath occurs.

Copyright © 2009 Wolters Kluwer Health.

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