September 30, 2014
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Clavulin

(amoxicillin - clavulanic acid)

DIN (Drug Identification Number)

01916882 CLAVULIN-125F 125MG/31.25MG PER 5 ML SUSPENSION
01916874 CLAVULIN-250 250MG/62.5MG PER 5ML SUSPENSION
02238831 CLAVULIN-200 200MG/28.5MG PER 5ML SUSPENSION
02238830 CLAVULIN-400 400MG/57MG PER 5ML SUSPENSION
01916858 CLAVULIN-500F 500MG/125MG TABLET
02238829 CLAVULIN-875 875MG/125MG TABLET

What side effects are possible with Clavulin?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal and stomach cramps
  • bad taste in mouth
  • constipation
  • diaper rash (infant)
  • diarrhea (mild)
  • gas
  • headache
  • loss of appetite
  • nausea
  • unusual tiredness or weakness
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • vaginal itching and discharge
  • white patches in the mouth or on the tongue

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • diarrhea (watery and severe; may also be bloody)
  • fever that appears after starting the antibiotic
  • symptoms of a severe allergic reaction (severe skin rash; itching; hives; difficulty breathing; swelling of the mouth, throat, or tongue)
  • signs of a severe skin reaction (such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)
  • wheezing, difficulty breathing, or shortness of breath

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Clavulin?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergy: Amoxicillin, one of the ingredients in this medication, is a penicillin. If you have previously had an allergic reaction to antibiotics such as penicillin or cephalosporins (e.g., cephalexin, ceftriaxone), you should not take this medication. Before you take amoxicillin - clavulanic acid, inform your doctor about any previous adverse reactions you have had to medications, especially cephalosporins and penicillins.

Get immediate medical attention if you experience symptoms of a severe allergic reaction (e.g., hives; swelling of the face, tongue, or throat; trouble breathing).

Antibiotic-associated colitis: This medication, like other antibiotics, may cause a potentially dangerous condition called antibiotic-associated, or pseudomembranous, colitis. Symptoms include severe, watery diarrhea that may be bloody. If you notice these symptoms, stop taking amoxicillin - clavulanic acid and contact your doctor as soon as possible.

Aspartame: The suspension forms of this medication contain aspartame. If you have phenylketonuria, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney Function: This medication is eliminated from the body mostly by the kidneys. If you have kidney disease or reduced kidney function, this medication may build up in your body and cause unwanted effects.

If you have kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver Function: If you have liver disease or reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Clavulanic acid may cause a decrease in liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Mononucleosis: When amoxicillin - clavulanic acid is used by a person who has mononucleosis, a widespread rash may occur. If you have or suspect you have mononucleosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

This medication should not be used by anyone who has or is suspected to have mononucleosis.

Overgrowth of organisms (super-infection): Prolonged or repeated use of this antibiotic may allow normal fungus or certain types of bacteria not killed by the antibiotic to overgrow, causing unwanted infections such as yeast infections. Contact your doctor if you notice white patches in the mouth (thrush), abnormal vaginal discharge, or itching.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Amoxicillin passes into breast milk. It is not known if clavulanic acid passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

What other drugs could interact with Clavulin?

There may be an interaction between amoxicillin - clavulanic acid and any of the following:

  • allopurinol
  • anticoagulants (e.g., warfarin)
  • birth control pills
  • methotrexate
  • mycophenolate
  • probenecid
  • sodium picosulfate
  • tetracyclines (e.g., tetracycline, minocycline, doxycycline)
  • tuberculosis vaccine
  • typhoid vaccine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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