Amoxicillin Clavulanate Potassium Drug Facts

Amoxicillin / Clavulanate Potassium

Trade Names:
Augmentin
- Tablets 250 mg amoxicillin and 125 mg clavulanic acid
- Tablets 500 mg amoxicillin and 125 mg clavulanic acid
- Tablets 875 mg amoxicillin and 125 mg clavulanic acid
- Chewable tablets 125 mg amoxicillin and 31.25 mg clavulanic acid
- Chewable tablets 200 mg amoxicillin and 28.5 mg clavulanic acid
- Chewable tablets 250 mg amoxicillin and 62.5 mg clavulanic acid
- Chewable tablets 400 mg amoxicillin and 57 mg clavulanic acid
- Powder for oral suspension 125 mg amoxicillin and 31.25 mg clavulanic acid per 5 mL
- Powder for oral suspension 200 mg amoxicillin and 28.5 mg clavulanic acid per 5 mL
- Powder for oral suspension 250 mg amoxicillin and 62.5 mg clavulanic acid per 5 mL
- Powder for oral suspension 400 mg amoxicillin and 57 mg clavulanic acid per 5 mL

Trade Names:
Augmentin ES-600
- Powder for oral suspension 600 mg amoxicillin (as trihydrate) and 42.9 mg clavulanic acid per 5 mL (as the potassium salt)

Trade Names:
Augmentin XR
- Tablets 1,000 mg amoxicillin and 62.5 mg clavulanic acid

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.

Indications and Usage

Treatment of infections of lower respiratory tract, otitis media, sinusitis, skin and skin structure infections, UTIs, and community-acquired pneumonia caused by susceptible microorganisms.

Contraindications

History of penicillin allergy; history of amoxicillin and clavulanate-associated cholestatic jaundice or liver disease. Augmentin XR : Severe renal function impairment (Ccr less than 30 mL/min); hemodialysis patients.

Dosage and Administration

Strengths listed below are based on amoxicillin content.

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

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

Because Augmentin XR contains 62.5 mg of clavulanate, Augmentin tablets cannot be used to provide the same dosages as Augmentin XR .

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

PO 2 tablets every 12 h for 10 days.

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

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

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

PO Should be dosed according to the adult recommendations.

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

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

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

Augmentin ES-600 (5 mL) does not contain the same amount of clavulanic acid as any of the other Augmentin suspensions (5 mL). Therefore, Augmentin ES-600 and Augmentin are not interchangeable.

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. Do not administer to patient with phenylketonuria without first discussing with health care provider.
• 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 (at or below 77°F). Store reconstituted suspension in refrigerator (36° to 46°F). Discard any unused suspension after 10 days.

Drug Interactions

May increase incidence of rash.

May reduce effectiveness of oral contraceptives.

May increase and prolong blood levels of amoxicillin.

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%); erythema multiforme; maculopapular to exfoliative dermatitis; pruritus; 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; pseudomembranous colitis; rectal bleeding.

Genitourinary

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

Hematologic

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

Hepatic

Cholestatic jaundice; transient hepatitis.

Metabolic

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

Miscellaneous

Hyperthermia; superinfection.

Precautions

Pregnancy

Category B .

Lactation

Secreted into breast milk.

Children

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

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

Safety and efficacy not established in children younger than 3 mo of age. Safety and efficacy has not been established for treatment of otitis media in infants and children 3 mo to 12 yr of age.

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 extended-release tablets are not used in patient with severe renal function impairment (eg, Ccr 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, 200 mg per 5 mL, 400 mg per 5 mL, and 600 mg per 5 mL oral suspensions.

Pseudomembranous colitis

Consider the possibility in patients who develop diarrhea.

Overdosage

Symptoms

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

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 nonscored extended-release tablet to swallow tablet whole. Caution patient not to break, crush, or chew the tablet.
• Advise patient using the scored extended-release 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 to discard any unused suspension at end of treatment period.
• Advise patient or caregiver using chewable tablets to swallow whole or 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 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.