amoxicillin/clavulanate, Augmentin, Augmentin ES, Augmentin XR, Clavulin

 Indications

Treatment of a variety of infections including: Skin and

skin structure infections, Otitis media, Sinusitis, Respiratory

tract infections, Genitourinary tract infections.

Action

Binds to bacterial cell wall, causing cell death; spectrum

of amoxicillin is broader than penicillin. Clavulanate

resists action of beta-lactamase, an enzyme produced

by bacteria that is capable of inactivating some

penicillins. Therapeutic Effects: Bactericidal action

against susceptible bacteria. Spectrum: Active

against: Streptococci, Pneumococci, Enterococci, Haemophilus

influenzae, Escherichia coli, Proteus mirabilis,

Neisseria meningitidis, N. gonorrhoeae,

Staphylococcus aureus, Klebsiella pneumoniae, Shigella,

Salmonella, Moraxella catarrhalis.

Pharmacokinetics

Absorption: Well absorbed from the duodenum

(75–90%). More resistant to acid inactivation than

other penicillins.

Distribution: Diffuses readily into most body tissues

and fluids. Does not readily enter brain/CSF; CSF penetration

isqin the presence of inflamed meninges.

Crosses the placenta and enters breast milk in small

amounts.

Metabolism and Excretion: 70% excreted unchanged

in the urine; 30% metabolized by the liver.

Half-life: 1–1.3 hr.

TIME/ACTION PROFILE (peak blood levels)

ROUTE ONSET PEAK DURATION

PO 30 min 1–2 hr 8–12 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity to penicillins

or clavulanate; Suspension and chewable tablets contain

aspartame and should be avoided in phenylketonurics;

History of amoxicillin/clavulanate-associated

cholestatic jaundice.

Use Cautiously in: Severe renal insufficiency (dose

pnecessary); Infectious mononucleosis (qrisk of

rash); Hepatic impairment (dose cautiously, monitor

liver function).

Adverse Reactions/Side Effects

CNS: SEIZURES (high doses). GI: CLOSTRIDIUM DIFFICILE-

ASSOCIATED DIARRHEA (CDAD), diarrhea, hepatic

dysfunction, nausea, vomiting. GU: vaginal candidiasis. A

Derm: rash, urticaria. Hemat: blood dyscrasias.

Misc: allergic reactions including ANAPHYLAXIS and SERUM

SICKNESS, superinfection.

Interactions

Drug-Drug: Probenecidprenal excretion andq

blood levels of amoxicillin—therapy may be combined

for this purpose. Mayqthe effect of warfarin. Concurrent

allopurinol therapyqrisk of rash. Maypthe effectiveness

of hormonal contraceptives.

Drug-Food: Clavulanate absorption ispby a high

fat meal.

Route/Dosage

Most Infections (Dosing based on amoxicillin

component)

PO (Adults and Children 40 kg): 250 mg q 8 hr or

500 mg q 12 hr.

Serious Infections and Respiratory Tract

Infections

PO (Adults and Children 40 kg): 875 mg q 12 hr

or 500 mg q 8 hr; Acute bacterial sinusitis—2000

mg q 12 hr for 10 days as extended release (XR) product;

Community-acquired pneumonia—2000 mg

every 12 hr for 7–10 days as extended release (XR)

product.

Recurrent/persistent acute otitis media

due to Multidrug-resistant Streptococcus

pneumonia, H. influenzae, or M. catarrhalis

PO (Children 40 kg): 80–90 mg/kg/day in divided

doses q 12 hr for 10 days (as ES formulation only).

Renal Impairment

PO (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.

Otitis Media, Sinusitis, Lower Respiratory

Tract Infections, Serious Infections

PO (Children 3 mo): 200 mg/5 mL or 400 mg/5

mL suspension—45 mg/kg/day divided q 12 hr; 125

mg/5 mL or 250 mg/5 mL suspension—40 mg/kg/

day divided q 8 hr.

Less Serious Infections

PO (Children 3 mo): 200 mg/5 mL or 400 mg/5

mL suspension—25 mg/kg/day divided q 12 hr or 20

mg/kg/day divided q 8 hr (as 125 mg/5mL or 250 mg/

5 mL suspension).

PO (Children 3 mo): 15 mg/kg q 12 hr (125 mg/

mL suspension recommended).

Availability (generic available)

Tablets: 250 mg amoxicillin with 125 mg clavulanate,

500 mg amoxicillin with 125 mg clavulanate, 875 mg

amoxicillin with 125 mg clavulanate. Cost: Generic—

500 mg $18.98/20, 875 mg $23.46/30. Chewable

tablets (cherry-banana flavor): 200 mg amoxicillin

with 28.5 mg clavulanate, 400 mg amoxicillin with 57

mg clavulanate. Cost: Generic—200 mg $36.17/20,

400 mg $68.93/20. Extended-release tablets

(scored): 1000 mg amoxicillin with 62.5 mg clavulanate.

Cost: Generic—$108.62/28. Powder for oral

suspension (125 mg/5 mL is banana flavor; 200

mg/5mL is fruit flavor; 250 mg/5 mL is orange

flavor; 400 mg/5 mL is fruit flavor; 600 mg/5 mL

is orange or strawberry-creme flavor): 125 mg

amoxicillin with 31.25 mg clavulanate/5 mL, 200 mg

amoxicillin with 28.5 mg clavulanate/5 mL, 250 mg

amoxicillin with 62.5 mg clavulanate/5 mL, 400 mg

amoxicillin with 57 mg clavulanate/5 mL, 600 mg

amoxicillin with 42.9 mg clavulanate/5 mL (ES formulation).

Cost: Generic—200 mg $36.17/100 mL, 250

mg $86.43/100 mL, 400 mg $68.93/100 mL, 600 mg

$83.03/125 mL.