Augmentin XR

DRUG DESCRIPTION

AUGMENTIN XR is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin (present as amoxicillin trihydrate and amoxicillin sodium) and the ?-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 trihydrate molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Chemically, amoxicillin trihydrate is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(phydroxyphenyl)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 trihydrate Structural Formula Illustration

The amoxicillin sodium molecular formula is C16H18N3NaO5S, and the molecular weight is 387.39. Chemically, amoxicillin sodium is [2S-[2?,5?,6?(S*)]]-6-[[Amino(4hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2carboxylic acid monosodium salt and may be represented structurally as:

Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a ?-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of ?-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated ?-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:

Inactive Ingredients: Citric acid, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and xanthan gum.

Each tablet of AUGMENTIN XR contains 12.6 mg (0.32 mEq) of potassium and 29.3 mg (1.27 mEq) of sodium.

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 XR

What are the precautions when taking amoxicillin clavulanic potassium (Augmentin XR)?

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 (such as requiring dialysis), a certain type of viral infection (infectious mononucleosis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and...

Read All Potential Precautions of Augmentin XR


Augmentin XR Consumer (continued)

SIDE EFFECTS: Diarrhea, nausea, or vomiting may occur. If any of these effects persist or worsen, tell the doctor or pharmacist promptly. Taking this medication with food will help to reduce stomach upset.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell the doctor right away if any of these rare but serious side effects occur: dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin, easy bruising/bleeding, new signs of infection (such as fever, persistent sore throat), unusual tiredness.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell the doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact the doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Amoxicillin can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 (such as requiring dialysis), a certain type of viral infection (infectious mononucleosis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This product may cause live bacterial vaccines (such as typhoid vaccine) not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.


Augmentin XR Patient Information Including Side Effects

Brand Names: Augmentin, Augmentin ES-600, Augmentin XR

Generic Name: amoxicillin and clavulanate potassium (Pronunciation: am OKS i sil in KLAV yoo la nate po TAS ee um)

  • What is amoxicillin and clavulanate potassium (Augmentin XR)?
  • What are the possible side effects of amoxicillin and clavulanate potassium (Augmentin XR)?
  • What is the most important information I should know about amoxicillin and clavulanate potassium (Augmentin XR)?
  • What should I discuss with my healthcare provider before taking amoxicillin and clavulanate potassium (Augmentin XR)?
  • How should I take amoxicillin and clavulanate potassium (Augmentin XR)?
  • What happens if I miss a dose (Augmentin XR)?
  • What happens if I overdose (Augmentin XR)?
  • What should I avoid while taking amoxicillin and clavulanate potassium (Augmentin XR)?
  • What other drugs will affect amoxicillin and clavulanate potassium (Augmentin XR)?
  • Where can I get more information?

What is amoxicillin and clavulanate potassium (Augmentin XR)?

Amoxicillin is an antibiotic in a group of drugs called penicillins. Amoxicillin fights bacteria in the body.

Clavulanate potassium is a form of clavulanic acid, which is similar to penicillin. Clavulanate potassium fights bacteria that is often resistant to penicillins and other antibiotics.

The combination of 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 other purposes not listed in this medication guide.

What are the possible side effects of amoxicillin and clavulanate potassium (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 tingling, numbness, pain, muscle weakness;
  • agitation, confusion, unusual thoughts or behavior, seizure (convulsions);
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • fever, sore throat, and headache with severe blistering, peeling, or red skin rash.

Less serious side effects may include:

  • 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).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about amoxicillin and clavulanate potassium (Augmentin XR)?

Do not use this medication if you are allergic to amoxicillin or clavulanate potassium, or if you have ever had liver problems caused by this medication.

Do not use if you are allergic to any other penicillin antibiotic, such as ampicillin (Omnipen, Principen), carbenicillin (Geocillin), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids), and others.

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, or if you are allergic to a cephalosporin antibiotic, such as cefdinir (Omnicef), cefprozil (Cefzil), cefuroxime (Ceftin), cephalexin (Keflex), and others.

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. This medicine may not be as effective or could be harmful if you do not use the exact tablet form your doctor has prescribed.

Amoxicillin and clavulanate potassium can pass into breast milk and may harm 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. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking amoxicillin and clavulanate potassium.

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