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Augmentin

Ear infection or inflammation (otitis media) facts

  • Otitis media (ear infection or inflammation) is the most common diagnosis in sick children in the U.S.
  • Otitis media features fever, ear pain, and a feeling of fullness in the ear; as well as fussiness and feeding problems in young children.
  • Otitis media is usually an infection and/or inflammation of the middle ear.
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  • Bottlefeeding increases the risk of ear infection or inflammation in babies.
  • Middle ear pus causes pain and temporary hearing loss.
  • Rupture of the eardrum allows the pus to drain into the ear canal.
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Augmentin

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AUGMENTIN®
(amoxicillin/clavulanate potassium) Tablets

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN (amoxicillin/clavulanate potassium) and other antibacterial drugs, AUGMENTIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DRUG DESCRIPTION

AUGMENTIN is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S•3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2- (p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2- carboxylic acid trihydrate and may be represented structurally as:

Amoxicillin Structural Formula Illustration

Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1- azabicyclo[3.2.0]-heptane-2-carboxylate, and may be represented structurally as:

Clavulanate potassium Structural Formula Illustration

Inactive Ingredients: Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide.

Each tablet of AUGMENTIN contains 0.63 mEq potassium.

What are the possible side effects of amoxicillin and clavulanate potassium (Augmentin, Augmentin ES-600, Augmentin XR)?

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 any of these serious side effects:

  • diarrhea that is watery or has blood in it;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • easy bruising or bleeding;
  • skin rash, bruising, severe...

Read All Potential Side Effects and See Pictures of Augmentin »

Last reviewed on RxList: 10/13/2011
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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