Amoxicillin/Clavulanate

Amoxicillin/Clavulanate is a prescription medication used to treat the symptoms of bacterial infections such as sinusitis, pneumonia, ear infections, bronchitis, urinary tract infections, and infections of the skin.

• Amoxicillin/Clavulanate is available under the following different brand names: Augmentin, Augmentin XR, and Augmentin ES-600.

• Common side effects of Amoxicillin/Clavulanate include:
  • nausea, 
  • vomiting, 
  • diarrhea, 
  • rash, 
  • itching, 
  • vaginal itching or discharge, and
  • diaper rash
• Serious side effects of Amoxicillin/Clavulanate include:
  • hives, 
  • difficult breathing, 
  • swelling in your face or throat, 
  • fever, 
  • sore throat, 
  • burning eyes, 
  • skin pain, 
  • red or purple skin rash with blistering and peeling, 
  • severe stomach pain, 
  • diarrhea that is watery or bloody (even if it occurs months after your last dose), 
  • pale or yellowed skin, 
  • dark-colored urine, 
  • fever, 
  • confusion, 
  • weakness, 
  • loss of appetite, 
  • upper stomach pain, 
  • little or no urination, 
  • easy bruising, and 
  • unusual bleeding 
• Rare side effects of Amoxicillin/Clavulanate include:
  • none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088

Adult Dosages:

Oral Suspension

• (125mg/31.25mg)/5mL
• (200mg/28.5mg)/5mL
• (250mg/62.5mg)/5mL
• (400mg/57mg)/5mL
• (600mg/42.9mg)/5mL

Tablet

• 250mg/125mg
• 500mg/125mg
• 875mg/125mg

Tablet, Extended Release

• 1000mg/62.5mg

Tablet, Chewable

• 200mg/28.5mg
• 400mg/57mg

Pediatric Dosages

Oral Suspension

• (125mg/31.25mg)/5mL
• (200mg/28.5mg)/5mL
• (250mg/62.5mg)/5mL
• (400mg/57mg)/5mL
• (600mg/42.9mg)/5mL

Tablets

• 200mg/28.5mg
• 250mg/125mg
• 500mg/125mg
• 875mg/125mg
• 1000mg/62.5mg

Tablets, Chewable

• 200mg/28.5mg
• 400mg/57mg

Children Weighing Less than 88 Pounds (40 kgs):

Dosages Based on Amoxicillin

Younger than 3 Months of Age:

• 30mg (125mg/5mL) orally divided twice daily

• 20 mg (125mg/5mL) orally divided every 8 hours, or 25 mg (200 mg or 400 mg chewable tablets, 200 mg/5mL or 400mg/5mL) orally divided every 12 hours

Severe Infections, Lower Respiratory Tract Infections, Sinusitis, Ear Infections (Otitis Media)

• 40 mg (125mg/5mL or 250mg/mL) orally divided every 8 hours or 45 mg (200mg or 400 mg/5mL) orally divided every 12 hours

Acute ear infection (Otitis media) (S pneumoniae, nontypeable H influenzae, M catarrhalis) 

• 80-90 mg orally divided every 12 hours for 10 days (maybe 5-7 days for children older than 6 years of age with mild-to-moderate disease)

Community-acquired Pneumonia

• Mild to moderate infection: 90 mg orally divided every 12 hours, not to exceed 4000 mg per day
• H. influenzae: 45 mg orally divided every 8 hours or 90 mg each day orally divided every 12 hours

Dosage Considerations – Should be Given as Follows: 

• See "Dosages".
• The safety and efficacy of extended-release tablets in children younger than 16 years of age have not been established

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Amoxicillin/Clavulanate has no known severe interactions with other drugs.
• Amoxicillin/Clavulanate has serious interactions with at least 13 other drugs.
• Amoxicillin/Clavulanate has moderate interactions with at least 21 other drugs. 
• Amoxicillin/Clavulanate has mild interactions with at least 10 other drugs.

This information does not contain all possible interactions or adverse effects.  Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use.  Keep a list of all your medications with you, and share this information with your doctor and pharmacist.  Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• Allergy to penicillins
• Previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate
• Extended-release: hemodialysis patients and severe renal impairment (kidney values [creatinine clearance] less than 30mL/min)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Amoxicillin/Clavulanate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Amoxicillin/Clavulanate?”

Cautions

• Allergy to cephalosporins, carbapenems
• Different tablets are not interchangeable, because ratios of amoxicillin to clavulanate are different
• Extended-release tablets are not for use in renal impairment (kidney function values  less than 30 mL/min)
• Incidence of diarrhea is higher than with amoxicillin alone
• Unknown safety and efficacy of extended-release tablets in patients younger than 16 years old
• Risk of Clostridium difficile-associated diarrhea (CDAD); consider in patients who present with diarrhea after antibiotic use; CDAD has been known to occur over 2 months after antibiotic therapy; if suspected, discontinue the drug immediately and administer appropriate fluid/electrolyte therapy, protein supplementation, and C difficile antibiotic treatment
• Risk of bacterial or fungal superinfections; if suspected, discontinue the drug immediately and administer appropriate therapy
• A high percentage of patients with mononucleosis reported developing rash during therapy; ampicillin-class antibiotics are not recommended in these patients
• Use caution in hepatic impairment; hepatic dysfunction (rare) is more common in elderly and/or males and prolonged therapy may increase the risk; may occur after completing therapy

Pregnancy and Lactation

• Therapy may be acceptable during pregnancy. Studies show minor risk or no risk. 
• The drug is excreted in breast milk; use with caution