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Augmentin Chewable Tablets

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Augmentin Chewable Tablets

AUGMENTIN®
(amoxicillin/clavulanate potassium)

Powder for Oral Suspension and Chewable 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.

Augmentin Chewable Tablets

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:

AUGMENTIN® (amoxicillin/clavulanate potassium)  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:

AUGMENTIN® (amoxicillin/clavulanate potassium)  Structural Formula Illustration

Inactive Ingredients: Powder for Oral Suspension-Colloidal silicon dioxide, flavorings (see HOW SUPPLIED), xanthan gum, and 1 or more of the following: Aspartame•, hypromellose, mannitol, silica gel, silicon dioxide, and sodium saccharin. Chewable Tablets-Colloidal silicon dioxide, flavorings (see HOW SUPPLIED), magnesium stearate, mannitol, and 1 or more of the following: Aspartame•, D&C Yellow No. 10, FD&C Red No. 40, glycine, sodium saccharin and succinic acid.

Each 125-mg chewable tablet and each 5 mL of reconstituted 125 mg/5 mL oral suspension of AUGMENTIN contains 0.16 mEq potassium. Each 250-mg chewable tablet and each 5 mL of reconstituted 250 mg/5 mL oral suspension of AUGMENTIN contains 0.32 mEq potassium. Each 200-mg chewable tablet and each 5 mL of reconstituted 200 mg/5 mL oral suspension of AUGMENTIN contains 0.14 mEq potassium. Each 400-mg chewable tablet and each 5 mL of reconstituted 400 mg/5 mL oral suspension of AUGMENTIN contains 0.29 mEq of 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 medicine and call your doctor at once if you have a serious side effect such as:

  • 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 tingling, numbness, pain, muscle weakness;
  • agitation,...

Read All Potential Side Effects and See Pictures of Augmentin Chewable Tablets »

What are the precautions when taking amoxicillin clavulanate potassium (Augmentin Chewable Tablets)?

Before taking this product, tell your doctor or pharmacist if you are allergic to amoxicillin or clavulanic acid; or to penicillin or cephalosporin antibiotics; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell the doctor or pharmacist your medical history, especially of: liver disease (including liver problems caused by previous use of amoxicillin/clavulanic acid), kidney disease, a certain type of viral infection (infectious mononucleosis).

This medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet,...

Read All Potential Precautions of Augmentin Chewable Tablets »

•See PRECAUTIONS - Information for the Patient.

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 medicine and call your doctor at once if you have a serious side effect such as:

  • 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 tingling, numbness, pain, muscle weakness;
  • agitation,...

Read All Potential Side Effects and See Pictures of Augmentin Chewable Tablets »

What are the precautions when taking amoxicillin clavulanate potassium (Augmentin Chewable Tablets)?

Before taking this product, tell your doctor or pharmacist if you are allergic to amoxicillin or clavulanic acid; or to penicillin or cephalosporin antibiotics; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell the doctor or pharmacist your medical history, especially of: liver disease (including liver problems caused by previous use of amoxicillin/clavulanic acid), kidney disease, a certain type of viral infection (infectious mononucleosis).

This medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet,...

Read All Potential Precautions of Augmentin Chewable Tablets »

Last reviewed on RxList: 9/4/2008
This monograph has been modified to include the generic and brand name in many instances.

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Augmentin Chewable Tablets - User Reviews

Augmentin Chewable Tablets User Reviews

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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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