Manufacturer of Augmentin
GlaxoSmithKline
Also know under brand names: Augmentin,
Augmentin ES-600,
Augmentin XR
Active ingredient / generic name: amoxicillin and clavulanate potassium
Approximate US Retail Price for Augmentin 875-125 mg (20 ea): $145.99
500-125 mg (30 ea): $166.71
250-125 mg (30 ea): $118.99
Short leafletAugmentin is the British Approved Name, in the British Pharmacopoeia, for the combination antibiotic containing Amoxicillin (as either trihydate or the sodium salt) and Clavulanic acid (as Potassium clavulanate). This name, unlike co-trimoxazole, has not been widely adopted internationally and the combination product is usually referred to by various names such as amoxicillin with clavulanic acid or amoxicillin+clavulanate or simply by the trade name. Augmentin is currently marketed under various trade names including Augmentin (GlaxoSmithKline formerly Beecham). The combination of amoxicillin, a β-lactam antibiotic; with clavulanic acid, a β-lactamase inhibitor; results in an antibiotic with an increased spectrum of action and restored efficacy against β-lactamase producing amoxicillin-resistant bacteria.
The proportions of the two constituents are expressed as x/y where x and y are the strengths in milligrams of amoxicillin and clavulanic acid respectively. However, the branded products indicate their strengths as the quantity of amoxicillin, hence Augmentin 250/125 ≡ Augmentin 250 and contains 250 mg of amoxicillin with 125 mg of clavulanic acid.
Standard adult dosages for respiratory tract, urinary, abdominal and dental infections as well as cellulitis and animal bites is Augmentin 250/125 (one tablet Augmentin 250) taken every 8 hours, which may be doubled in severe infections (as a single tablet of Augmentin 500/125 ≡ Augmentin 500, but not as two Augmentin 250/125 tablets which would double the maximum recommended dose of clavulanic acid). In the US, Augmentin XR (Augmentin 1000/62.5) is marketed for use in community acquired pneumonia with two tablets taken twice a day (giving 4000 mg total daily dose of amoxicillin).
Dosages for children are also given three times a day using suspensions containing Augmentin 250/62 in each 5 mL (Augmentin '250/62 SF') for those between the ages of 6–12 years and Augmentin 125/31 (Augmentin '125/31 SF') for those between the ages of 1–6 years. A more concentrated solution, Augmentin 400/57 (Augmentin '400/57 SF'), may be administered more conveniently just twice daily to children from as young as 2 months of age; quantities are based on body weight with 2.5 mL from the age of 2 years and 5 mL after the age of 6 years.
An intravenous preparation of Augmentin has been available in the UK and Australia since 1985, but there is no parenteral preparation available in the US: the nearest equivalent is ampicillin-sulbactam.
Amongst the possible side-effects of this medication are diarrhea, vomiting and a few other conditions. These do not usually require medical attention. However, if the patient experiences an allergic reaction to the medication, jaundice, fever or severe diarrhea, it is necessary to contact a doctor immediately. As with all antimicrobial agents, pseudomembranous colitis has been associated with the use of amoxicillin-clavulanate. Amoxicillin is a member of the penicillin family of antibiotics, and therefore should not be taken by patients allergic to penicillin.
The amoxicillin/clavulanic acid combination is also used in the treatment of, amongst other infections, periodontitis in dogs and skin infections in cats. The preparation for veterinary use is commonly marketed under the trade names Clavaseptin, and Clavamox (or Synulox in Europe). Amoxicillin/clavulanic acid is banned from use in domestic food animals (cattle, swine, etc.) in both the US and Europe.
Liquid Augmentin must be refrigerated to maintain effectiveness.
Augmentin: Patient Education
If you have ever had an allergic reaction to penicillin or to a cephalosporin, you may
also be allergic to amoxicillin and clavulanate potassium. Tell your doctor about any past drug
allergies.
If you switch from one tablet form to another (regular, chewable, or extended-release
tablet), take only the new tablet form and strength prescribed for you. The strength of
clavulanate potassium is not the same among the different tablet forms, even though the amount
of amoxicillin may be the same as in the tablet you were using before. This medicine may not be
as effective or could be harmful if you do not use the exact tablet form your doctor has
prescribed.
Take this medication for the entire length of time prescribed by your doctor. Your
symptoms may get better before the infection is completely treated. Amoxicillin and clavulanate
potassium will not treat a viral infection such as the common cold or flu.
Amoxicillin and clavulanate potassium can pass into breast milk and may cause a
yeast infection, diarrhea, or allergic reaction in a nursing baby. Do not use this medication
without telling your doctor if you are breast-feeding a baby.
Amoxicillin and clavulanate potassium can make birth control pills less effective. Use a
second non-hormone method of birth control (such as a condom, diaphragm, spermicide) to
prevent pregnancy while taking amoxicillin and clavulanate potassium.
Amoxicillin and clavulanate potassium is an antibiotic in a group of drugs called
penicillins. Amoxicillin and clavulanate potassium fights bacteria in the body.
Amoxicillin and clavulanate potassium is used to treat many different infections caused
by bacteria, such as sinusitis, pneumonia, ear infections, bronchitis, urinary tract infections, and
infections of the skin.
Amoxicillin and clavulanate potassium may also be used for purposes other than those
listed in this medication guide.
If you have ever had an allergic reaction to penicillin or to a cephalosporin, you may
also be allergic to amoxicillin and clavulanate potassium. Tell your doctor about any past drug
allergies.
Before taking amoxicillin and clavulanate potassium, tell your doctor if you have:
liver disease (or a history of hepatitis or jaundice);
kidney disease; or
mononucleosis.
If you have any of these conditions, you may not be able to use
amoxicillin and clavulanate potassium, or you may need a dosage adjustment or special tests
during treatment.
Some forms of this medication contain as much as 7 mg of phenylalanine per dose. Tell
your doctor if you have phenylketonuria (PKU) or otherwise need to restrict your intake of
phenylalanine.
FDA pregnancy category B. This medication is not expected to be harmful to an
unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
Amoxicillin and clavulanate potassium can pass into breast milk and may cause a
yeast infection, diarrhea, or allergic reaction in a nursing baby. Do not use this medication
without telling your doctor if you are breast-feeding a baby.
Take this medication exactly as it was prescribed for you. Do not take the medication in
larger or smaller amounts, or take it for longer than recommended by your doctor.
If you switch from one tablet form to another (regular, chewable, or extended-release
tablet), take only the new tablet form and strength prescribed for you. The strength of
clavulanate potassium is not the same among the different tablet forms, even though the amount
of amoxicillin may be the same as in the tablet you were using before. This medicine may not be
as effective or could be harmful if you do not use the exact tablet form your doctor has
prescribed.
Take each dose with a full glass of water.
Take the medicine at the start of a meal to reduce stomach upset.
The Augmentin tablet should be swallowed whole.
The Augmentin Chewable tablet must be chewed before swallowing.
Do not swallow a chewable tablet whole.
Do not crush or chew the Augmentin XR (extended-release) tablet. Swallow the pill whole, or break the pill in half and take both halves one at a time. If
you have trouble swallowing a whole or half pill, talk with your doctor about using another form
of amoxicillin and clavulanate potassium.
Shake the liquid form of this medicine well just before you measure a dose. To be
sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine
cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your
pharmacist for one.
Amoxicillin and clavulanate potassium should be taken at evenly spaced intervals as
prescribed. It is important to take amoxicillin and clavulanate potassium regularly to get the most
benefit.
Take this medication for the entire length of time prescribed by your doctor. Your
symptoms may get better before the infection is completely treated. Amoxicillin and clavulanate
potassium will not treat a viral infection such as the common cold or flu.
This medication can cause you to have unusual results with certain medical tests. Tell any
doctor who treats you that you are using amoxicillin and clavulanate potassium.
Store the tablets at room temperature away from moisture and heat.
Store the liquid form of this medicine in the refrigerator. Throw away any unused
liquid after 10 days.
Take the missed dose as soon as you remember. If it is almost time for your next dose,
skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention if you think you have used too much of this
medicine.
Symptoms of an amoxicillin and clavulanate potassium overdose may include nausea,
vomiting, stomach pain, skin rash, drowsiness, or hyperactivity.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you
have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop
the diarrhea unless your doctor has told you to.
Get emergency medical help if you have any of these signs of an allergic
reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have diarrhea that is
severe or lasts longer than 3 days, or if you have nausea, stomach pain, low fever, loss of
appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
Keep taking the medication and talk with your doctor if you have any of these less serious
side effects:
mild diarrhea, gas, stomach pain;
nausea or vomiting;
headache;
skin rash or itching;
white patches in your mouth or throat; or
vaginal yeast infection (itching or discharge).
Side effects other than those listed here may also occur. Talk to your
doctor about any side effect that seems unusual or that is especially bothersome.
Before taking amoxicillin and clavulanate potassium, tell your doctor if you are using any
of the following drugs:
allopurinol (Zyloprim);
probenecid (Benemid); or
another antibiotic (for the same or for a different infection).
If you are using any of these drugs, you may not be able to use
amoxicillin and clavulanate potassium, or you may need dosage adjustments or special tests
during treatment.
Amoxicillin and clavulanate potassium can make birth control pills less effective. Use a
second non-hormone method of birth control (such as a condom, diaphragm, spermicide) to
prevent pregnancy while taking amoxicillin and clavulanate potassium.
There may be other drugs not listed that can affect amoxicillin and clavulanate potassium.
Tell your doctor about all the prescription and over-the-counter medications you use. This
includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start
using a new medication without telling your doctor.
Your pharmacist has additional information about amoxicillin and clavulanate potassium
written for health professionals that you may read.
Augmentin: Dosinginfections, bacterial: 500-875 mg PO q12h: Alt: 250-500 mg PO q8h; Info: give w/ food/milk to decrease GI effects
renal dosing: adjust dose frequency: CrCl 10-30: give q12h; CrCl <10: give q24h; HD: give usual dose as supplement both during and after dialysis; Info: do not use 875/125 mg tab for CrCl <30
hepatic dosing: see below: hepatic impairment: caution advised; amoxicillin/clavulanate-assoc. hepatic impairment hx: contraindicated
Augmentin: Drug Interactions
Augmentin vs typhoid vaccine, live oral: avoid combo; delay vaccine until >3 days after abx course complete or complete vaccine >3 days before 1st abx dose: combo may result in inadequate immunologic vaccine response and abx effect may inactivate vaccine
Augmentin vs chloroquine phosphate: caution advised w/ oral penicillins, separate admin by >2h: combo may decr. oral penicillin levels, efficacy and absorption decreased
Augmentin vs exenatide: give oral antibiotic >1h before exenatide: combo may decr. oral antibiotic levels, efficacy and absorption possibly delayed/reduced
Augmentin vs methotrexate: monitor CBC, signs of toxicity: combo may incr. methotrexate levels, risk of toxicity primarily w/ antineoplastic doses and renal excretion decreased
Augmentin vs warfarin: monitor INR: combo may incr. INR, risk of bleeding and possibly altered vitamin K production by gut flora
Augmentin vs aminoglycosides, parenteral: use for therapeutic advantage: combo may enhance efficacy and additive/synergistic effects. Aminoglycosides, parenteral: also know as amikacin, gentamicin, kanamycin, streptomycin, tobramycin
Augmentin vs probenecid: use for therapeutic advantage: probenecid may incr. penicillin levels, prolong duration of action and renal excretion decreased
Augmentin vs acetaminophen/tramadol: caution advised: combo w/ tramadol may incr. risk of seizures and additive effects
Augmentin vs allopurinol: caution advised: combo may incr. risk of amoxicillin/ampicillin rash and mechanism unknown
Augmentin vs bupropion: caution advised: combo may incr. risk of seizures and additive effects
Augmentin vs contraceptives, oral combo: caution advised: abx may decr. hormonal contraceptive efficacy; best evid. for tetracyclines, ampicillin and enterohepatic recirculation possibly altered. Contraceptives, oral combo: also know as desogestrel/ethinyl estradiol, drospirenone/ethinyl estradiol, ethinyl estradiol/ethynodiol, ethinyl estradiol/levonorgestrel, ethinyl estradiol/norethindrone, ethinyl estradiol/norgestimate, ethinyl estradiol/norgestrel, mestranol/norethindrone
Augmentin vs contraceptives, oral progestin: caution advised: abx may decr. hormonal contraceptive efficacy; best evid. for tetracyclines, ampicillin and enterohepatic recirculation possibly altered. Contraceptives, oral progestin: also know as norethindrone, norgestrel
Augmentin vs contraceptives, other combo: caution advised: abx may decr. hormonal contraceptive efficacy; best evid. for tetracyclines, ampicillin and enterohepatic recirculation possibly altered. Contraceptives, other combo: also know as ethinyl estradiol/norelgestromin transdermal, etonogestrel/ethinyl estradiol vaginal
Augmentin vs lindane topical: caution advised: combo may incr. risk of seizures and additive toxicity
Augmentin vs mycophenolate mofetil: caution advised: combo may decr. mycophenolate efficacy and enterohepatic recirculation decreased
Augmentin vs mycophenolic acid: caution advised: combo may decr. mycophenolic acid efficacy and enterohepatic recirculation decreased
Augmentin vs proton pump inhibitors: caution advised w/ oral penicillin, ampicillin, dicloxacillin: combo may decr. antimicrobial levels, efficacy and absorption decreased. Proton pump inhibitors: also know as esomeprazole, lansoprazole, lansoprazole/amoxicillin/clarithromycin, omeprazole, omeprazole/sodium bicarbonate, pantoprazole, rabeprazole
Augmentin vs sodium phenylacetate/sodium benzoate: caution advised: combo may incr. levels of active metabolites and renal excretion decr. by competition for active tubular transport
Augmentin vs sodium phosphate: caution advised: combo may incr. risk of seizures and additive effects
Augmentin vs tiagabine: caution advised, especially in non-epileptic pts: combo may incr. risk of seizures and additive effects
Augmentin vs tramadol: caution advised: combo may incr. risk of seizures and additive effects
Augmentin: Adverse Reactions
hypersensitivity rxn, severe
anaphylactic rxns
angioedema
serum sickness-like rxn
erythema multiforme
Stevens-Johnson syndrome (rare)
exfoliative dermatitis
pseudomembranous colitis
superinfection
anemia
leukopenia
thrombocytopenia
agranulocytosis
seizures
hepatotoxicity
cholestatic jaundice
interstitial nephritis (rare)
diarrhea
nausea/vomiting
loose stools
rash
urticaria
candidiasis, vulvovaginal
contact dermatitis
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