Amoxicillin & Clavulanate

Amoxicillin/clavulanate is a prescription medication used to treat symptoms of infection in the ears, nose, airways, skin, and urinary tract. It is a single medication containing two drugs, amoxicillin and clavulanate. Amoxicillin/clavulanate belongs to a group of drugs called antibiotics, which help fight infections due to bacteria.

This medication comes in tablet and powder for suspension forms and may be taken 2-3 times a day, preferably with food.

Common side effects of amoxicillin/clavulanate include diarrhea, nausea, rash or urticaria (red, itchy spots), and vomiting.

Amoxicillin/clavulanate can cause dizziness or drowsiness. Do not drive or operate heavy machinery until you know how this medication will affect you.

Amoxicillin/clavulanate is a prescription medication used to treat symptoms of infection in the ears, nose, airways, skin, and urinary tract.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Amoxicillin & Clavulanate may be found in some form under the following brand names:

• Augmentin

Serious side effects have been reported with amoxicillin/clavulanate. See “Amoxicillin & Clavulanate Precautions” section.

Common side effects of amoxicillin/clavulanate include diarrhea, nausea, rash or urticaria (red, itchy spots), and vomiting.

This is not a complete list of amoxicillin/clavulanate side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• probenecid (Benemid)
• warfarin (Jantoven, Coumadin)
• allopurinol (Zyloprim)
• oral contraceptives (birth control pills)

This is not a complete list of amoxicillin/clavulanate drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with amoxicillin/clavulanate including:

• Hypersensitivity (allergic) reaction: Tell your healthcare provider right away if you have some or all of the following symptoms...
  • skin rash
  • itching
  • hives
  • difficulty breathing or swallowing
  • wheezing
• Liver dysfunction and jaundice: Tell your healthcare provider right away if you have some or all of the following symptoms...
  • loss of appetite
  • nausea and vomiting
  • diarrhea
  • dark-colored urine and pale bowel movements
  • stomach pain
  • yellow tinting of the skin and the eyes
• Mononucleosis (type of viral infection) and skin rash: Those who take amoxicillin/clavulanate can develop skin rash. Avoid amoxicillin/clavulanate use in these patients.
• Clostridium difficile associated diarrhea (CDAD): Tell your healthcare provider right away if you have some or all of the following symptoms...
  • diarrhea

Amoxicillin/clavulanate can cause dizziness or drowsiness. Do not drive or operate heavy machinery until you know how this medication will affect you.

Do not take amoxicillin/clavulanate if you:

• have had a serious hypersensitivity (allergic) reaction to amoxicillin/clavulanate or to other antibiotics such as penicillins or cephalosporins
• have a history of jaundice/liver dysfunction linked to amoxicillin/clavulanate use

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of amoxicillin/clavulanate, there are no specific foods that you must exclude from your diet when receiving amoxicillin/clavulanate.

Before taking amoxicillin/clavulanate, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to amoxicillin (Amoxil), clavulanic acid, cephalosporins, penicillins, or any other medications
• have or have had kidney or liver disease
• have allergies and asthma
• have or have had hay fever, hives, or mononucleosis (type of viral infection)
• have phenylketonuria (inability to process phenylalanine). The chewable tablets and powder for suspension forms contain aspartame (which contains phenylalanine)
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Amoxicillin/clavulanate falls into category B. Studies in animals have failed to demonstrate a risk to the unborn baby and there are no well-controlled studies in pregnant women. Or, animal studies have shown a harmful and undesired effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the unborn baby in any trimester.

It is not known if amoxicillin/clavulanate will harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

The active ingredient in amoxicillin/clavulanate is excreted in human breast milk. The effect of amoxicillin/clavulanate on the nursing infant is not known.

• Take amoxicillin/clavulanate exactly as prescribed.
• Amoxicillin/clavulanate comes as an immediate-release tablet, extended-release tablet, a chewable tablet, and as a powder for oral (by mouth) suspension.
• Amoxicillin/clavulanate is usually taken 2 to 3 times every day, preferably with food.
• Continue to take this medication even if you feel well. Do not stop taking amoxicillin/clavulanate without talking to your doctor.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of amoxicillin/clavulanate at the same time.

Chewable tablets:

• Amoxicillin chewable tablets should be chewed before swallowing.

Extended-release tablets:

• Swallow extended-release tablets whole. Do not chew or crush unless you are taking the chewable tablets form of amoxicillin/clavulanate.

Oral suspension:

• Tap bottle until all powder flows freely.
• Add approximately 1/3 of the total amount of water to the bottle and shake well to wet the powder. Refer to the instructions on your bottle or your pharmacist for the amount of water to add.
• Add remainder of the water and again shake well.
• After mixing the powder with water, shake the oral suspension well before use.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• your weight
• your age
• your renal function
• the severity of the infection

The usual adult dose is one amoxicillin/clavulanate tablet 500 mg/125 mg every 12 hours or one Amoxicillin/clavulanate tablet 250 mg/125 mg every 8 hours.

• For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin/clavulanate tablet 875 mg/125 mg every 12 hours or one amoxicillin/clavulanate tablet 500 mg/125 mg every 8 hours.

Pediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
 

• Store amoxicillin/clavulanate at room temperature (tablet forms) or in the refrigerator (suspension form once made).
• Discard the suspension form (once made) after 10 days of refrigeration.
• Keep this and all medicines out of the reach of children.