Amoxicillin + Clavulanic Acid

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Generic Name: Amoxicillin + Clavulanic Acid Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: B

Uses

What is Amoxicillin + Clavulanic Acid used for?

Amoxicillin + Clavulanic Acid is used to treat certain infections caused by bacteria, including infections of the ears, lungs, sinus, skin, and urinary tract. Amoxicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria. Clavulanic acid is in a class of medications called beta-lactamase inhibitors. It works by preventing bacteria from destroying amoxicillin. Antibiotics will not work for colds, flu, or other viral infections.

How should I take Amoxicillin + Clavulanic Acid?

The combination of amoxicillin and clavulanic acid comes as a tablet, a chewable tablet, and a suspension (liquid) to take by mouth. It is usually taken with a meal or a snack every 8 hours (three times a day) or every 12 hours (twice a day). To help you remember to take amoxicillin and clavulanate, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take amoxicillin and clavulanic acid exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the liquid well before each use to mix the medication evenly.

The chewable tablets should be chewed thoroughly before they are swallowed. The other tablets should be taken with a full glass of water.

The 250 mg and 500 mg tablets of amoxicillin and clavulanic acid contain the same amount of clavulanic acid. Do not substitute two 250 mg tablets for one 500 mg tablet. The 250 mg regular tablet and the 250 mg chewable tablet contain different amounts of clavulanic acid. They also should not be substituted.

Take amoxicillin and clavulanic acid until you finish the prescription, even if you feel better. Stopping amoxicillin and clavulanic acid too soon may cause bacteria to become resistant to antibiotics.

How do I store Amoxicillin + Clavulanic Acid?

Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom). Keep liquid medication in the refrigerator, tightly closed, and dispose of any unused medication after 10 days. Do not freeze.

There may be different brands of Amoxicillin + Clavulanic Acid that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Amoxicillin + Clavulanic Acid down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Amoxicillin + Clavulanic Acid?

Before taking amoxicillin and clavulanic acid,

  • Tell your doctor and pharmacist if you are allergic to amoxicillin (Amoxil, Trimox, Wymox), clavulanic acid, penicillin, cephalosporins, or any other medications.
  • Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention either of the following: allopurinol (Lopurin, Zyloprim) and probenecid (Benemid). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • Tell your doctor if you have or have ever had kidney or liver disease, allergies, asthma, hay fever, hives, or mononucleosis.
  • You should know that amoxicillin and clavulanic acid may decrease the effectiveness of oral contraceptives (birth control pills). Plan to use another form of birth control while taking amoxicillin and clavulanic acid.
  • Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking amoxicillin and clavulanic acid, call your doctor.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Amoxicillin + Clavulanic Acid during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Amoxicillin + Clavulanic Acid. Amoxicillin + Clavulanic Acid is pregnancy risk category B according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Amoxicillin + Clavulanic Acid?

Tell your doctor if any of these symptoms are severe or do not go away:

  • Diarrhea
  • Upset stomach
  • Vomiting
  • Mild skin rash

If you experience any of the following symptoms, call your doctor immediately:

severe skin rash

  • Itching
  • Hives
  • Difficulty breathing or swallowing
  • Wheezing
  • Vaginal itching and discharge
  • Yellowing of the skin or eyes

Amoxicillin and clavulanic acid may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Amoxicillin + Clavulanic Acid?

Co-administration of probenecid, a drug used for treating gout, prevents the normal elimination of amoxicillin by the kidneys and can cause high, toxic blood levels of amoxicillin.

Amoxicillin + Clavulanic Acid may decrease the effectiveness of birth control pills, increasing the risk of unexpected pregnancies.

Combining Amoxicillin + Clavulanic Acid and allopurinol (Zyloprim, Aloprim) may increase the occurrence of skin rash.

Amoxicillin + Clavulanic Acid may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Amoxicillin + Clavulanic Acid?

Amoxicillin + Clavulanic Acid may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Amoxicillin + Clavulanic Acid?

Amoxicillin + Clavulanic Acid may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Amoxicillin + Clavulanic Acid.

What is the dose of Amoxicillin + Clavulanic Acid for an adult?

Usual Adult Dose for Aspiration Pneumonia

500 mg orally every 8 hours or 875 mg orally every 12 hours

Therapy should be continued until the infiltrate is cleared or a residual scar forms, sometimes for as long as 2 to 4 months, depending on the nature and severity of the infection.

Usual Adult Dose for Bronchitis

500 mg orally every 8 hours or 875 mg orally every 12 hours for 7 to 10 days

Usual Adult Dose for Febrile Neutropenia

Low-risk: 500 mg orally every 8 hours in combination with ciprofloxacin until the patient has been afebrile for at least 24 hours and the absolute neutrophil count is more than 500 cells/mm3

Usual Adult Dose for Otitis Media

250 mg orally every 8 hours or 500 mg orally every 12 hours for 10 to 14 days

For more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered.

Usual Adult Dose for Pneumonia

Immediate release tablets: 500 mg orally every 8 hours or 875 mg orally every 12 hours

The duration of therapy for pneumococcal pneumonia is 7 to 10 days. Pneumonia caused by other organisms may require up to 21 days of therapy.

Extended release tablets: 2 g (2 tablets) orally every 12 hours for 7 to 10 days for community-acquired pneumonia

Usual Adult Dose for Pyelonephritis

250 mg orally every 8 hours or 500 mg orally every 12 hours for 14 days

For more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered.

Usual Adult Dose for Sinusitis

Immediate release tablets: 250 mg orally every 8 hours or 500 mg orally every 12 hours for 10 to 14 days

For more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered. Longer courses of therapy, sometimes 3 or 4 weeks, may be required for refractory or recurrent cases.

Extended release tablets: 2 g (2 tablets) orally every 12 hours for 10 days

Usual Adult Dose for Skin or Soft Tissue Infection

250 mg orally every 8 hours or 500 mg orally every 12 hours for 7 days, or for 3 days following resolution of acute inflammation

For more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered. For more severe infections, such as diabetic soft tissue infections, 14 to 21 days of therapy may be required.

Usual Adult Dose for Upper Respiratory Tract Infection

250 mg orally every 8 hours or 500 mg orally every 12 hours for 10 days

For more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered.

Usual Adult Dose for Urinary Tract Infection

250 mg orally every 8 hours or 500 mg orally every 12 hours for 3 to 7 days

For more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered.

Renal Dose Adjustments

Adults and pediatric patients weighing 40 kg or more:

Immediate release tablets:

CrCl less than 30 mL/min: The 875 mg tablet should not be used.

CrCl 10 to 30 mL/min: 250 to 500 mg orally every 12 hours

CrCl less than 10 mL/min: 250 to 500 mg orally every 24 hours

Extended release tablets:

CrCl less than 30 mL/min: Contraindicated

Liver Dose Adjustments

Caution and regular hepatic function monitoring is recommended for patients with hepatic impairment.

Precautions

This drug is contraindicated in patients with a previous history of amoxicillin-clavulanate-associated cholestatic jaundice or hepatic dysfunction.

Serious and occasionally fatal hypersensitivity reactions have been reported. The drug should be discontinued immediately at the first appearance of a skin rash or other signs of hypersensitivity. Severe, acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures including oxygen, intravenous fluids, antihistamines, corticosteroids, cardiovascular support and airway management as clinically indicated.

Clostridium difficile associated diarrhea (CDAD) has been reported with almost all antibiotics and may potentially be life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea following amoxicillin-clavulanate therapy. Mild cases generally improve with discontinuation of the drug, while severe cases may require supportive therapy and treatment with an antimicrobial agent effective against Clostridium difficile. Hypertoxin producing strains of C difficile cause increased morbidity and mortality; these infections can be resistant to antimicrobial treatment and may necessitate colectomy.

Superinfection with nonsusceptible organisms (i.e., yeasts, Pseudomonas) may occur during therapy. Amoxicillin-clavulanate should be discontinued and/or appropriate treatment should be started if superinfection occurs.

Periodic monitoring of organ system functions (including renal, hepatic, and hematopoietic function) is recommended during prolonged therapy.

It may be advisable to monitor renal function in elderly patients.

The extended release tablets are not interchangeable with other amoxicillin-clavulanate tablets, due to differences in pharmacokinetics and clavulanic acid content. Amoxicillin-clavulanate 125 mg, 250 mg, and 500 mg tablets and chewable tablets are also not interchangeable with each other due to their clavulanic acid content. Amoxicillin-clavulanate 600 mg/5 mL oral suspension is not interchangeable with other oral suspension strengths, due to differences in clavulanic acid content.

Patients with phenylketonuria should be aware that some formulations contain aspartame: Each 200 mg chewable tablet contains 2.1 mg phenylalanine, each 400 mg chewable tablet contains 4.2 mg phenylalanine, each 5 mL of the 200 mg/5 mL, 400 mg/5 mL, and 600 mg/5 mL oral suspensions contain 7 mg phenylalanine.

To reduce the risk of development of drug resistant organisms, antibiotics should only be used to treat or prevent proven or suspected infections caused by bacteria. Culture and susceptibility information should be considered when selecting treatment or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy. Patients should be advised to avoid missing doses and to complete the entire course of therapy.

Dialysis

The drug is moderately dialyzable by hemodialysis and peritoneal dialysis (20% to 50%).

Adults and pediatric patients weighing 40 kg or more:

Hemodialysis:

Immediate release tablets: 250 to 500 mg orally every 24 hours; an additional dose is recommended both during and at the end of dialysis

Extended release tablets: Contraindicated

Other Comments

Dosages expressed reflect the amoxicillin component of the medication.

Ampicillin antibiotics (including amoxicillin) should not be used to treat mononucleosis due to a high incidence of erythematous skin rashes.

The extended release tablets and 600 mg/5 mL oral suspension are not indicated for the treatment of infections due to Streptococcus pneumoniae with penicillin MICs 4 mcg/mL or more.

The extended release tablets may be broken in half for ease of swallowing, but both halves should be taken. The tablets should not be crushed or chewed.

The every 12-hour dosage interval is associated with significantly less diarrhea than the every 8-hour dosage interval.

Doses may be taken at the start of meals to minimize gastrointestinal intolerance and improve clavulanate absorption.

The reconstituted oral suspension should be stored in the refrigerator and shaken well before use. Any unused portion should be discarded after 10 days.

Patients who have difficulty swallowing amoxicillin-clavulanate tablets may be given the 125 mg/5 mL or 250 mg/5 mL oral suspension in place of the 500 mg tablets or the 200 mg/5 mL or 400 mg/5 mL oral suspension in place of the 875 mg tablets.

What is the dose of Amoxicillin + Clavulanic Acid for a child?

Usual Pediatric Dose for Otitis Media

Less than 12 weeks:

125 mg/5 mL oral suspension: 15 mg/kg orally every 12 hours for 10 days

3 months (12 weeks) or older:

Less than 40 kg:

125 mg/5 mL or 250 mg/5 mL oral suspension: 6.67 to 13.33 mg/kg orally every 8 hours for 10 days

200 mg/5 mL or 400 mg/5 mL oral suspension or chewable tablets: 12.5 to 22.5 mg/kg orally every 12 hours for 10 days

40 kg or more:

Immediate release tablets: 250 mg orally every 8 hours or 500 mg orally every 12 hours; for more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered

Recurrent or persistent acute otitis media:

600 mg/5 mL oral suspension:

3 months or older:

Less than 40 kg: 45 mg/kg orally every 12 hours for 10 days

40 kg or more: Data not available; other formulations are recommended

Usual Pediatric Dose for Pneumonia

Less than 12 weeks:

125 mg/5 mL oral suspension: 15 mg/kg orally every 12 hours

3 months (12 weeks) or older:

Less than 40 kg:

125 mg/5 mL or 250 mg/5 mL oral suspension: 6.67 to 13.33 mg/kg orally every 8 hours

200 mg/5 mL or 400 mg/5 mL oral suspension or chewable tablets: 12.5 to 22.5 mg/kg orally every 12 hours

40 kg or more:

Immediate release tablets: 500 mg orally every 8 hours or 875 mg orally every 12 hours

Extended release tablets: 2 g (2 tablets) orally every 12 hours for 7 to 10 days for community-acquired pneumonia

Usual Pediatric Dose for Sinusitis

Less than 12 weeks:

125 mg/5 mL oral suspension: 15 mg/kg orally every 12 hours

3 months (12 weeks) or older:

Less than 40 kg:

125 mg/5 mL or 250 mg/5 mL oral suspension: 6.67 to 13.33 mg/kg orally every 8 hours

200 mg/5 mL or 400 mg/5 mL oral suspension or chewable tablets: 12.5 to 22.5 mg/kg orally every 12 hours

600 mg/5 mL oral suspension: 45 mg/kg orally every 12 hours

40 kg or more:

Immediate release tablets: 250 mg orally every 8 hours or 500 mg orally every 12 hours; for more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered

Extended release tablets: 2 g (2 tablets) orally every 12 hours for 10 days

Usual Pediatric Dose for Bacterial Infection

Less than 12 weeks:

125 mg/5 mL oral suspension: 15 mg/kg orally every 12 hours

3 months (12 weeks) or older:

Less than 40 kg:

125 mg/5 mL or 250 mg/5 mL oral suspension: 6.67 to 13.33 mg/kg orally every 8 hours

200 mg/5 mL or 400 mg/5 mL oral suspension or chewable tablets: 12.5 to 22.5 mg/kg orally every 12 hours

40 kg or more:

Immediate release tablets: 250 mg orally every 8 hours or 500 mg orally every 12 hours; for more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered

Usual Pediatric Dose for Urinary Tract Infection

Less than 12 weeks:

125 mg/5 mL oral suspension: 15 mg/kg orally every 12 hours

3 months (12 weeks) or older:

Less than 40 kg:

125 mg/5 mL or 250 mg/5 mL oral suspension: 6.67 to 13.33 mg/kg orally every 8 hours

200 mg/5 mL or 400 mg/5 mL oral suspension or chewable tablets: 12.5 to 22.5 mg/kg orally every 12 hours

40 kg or more:

Immediate release tablets: 250 mg orally every 8 hours or 500 mg orally every 12 hours; for more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered

Usual Pediatric Dose for Skin and Structure Infection

Less than 12 weeks:

125 mg/5 mL oral suspension: 15 mg/kg orally every 12 hours

3 months (12 weeks) or older:

Less than 40 kg:

125 mg/5 mL or 250 mg/5 mL oral suspension: 6.67 to 13.33 mg/kg orally every 8 hours

200 mg/5 mL or 400 mg/5 mL oral suspension or chewable tablets: 12.5 to 22.5 mg/kg orally every 12 hours

40 kg or more:

Immediate release tablets: 250 mg orally every 8 hours or 500 mg orally every 12 hours; for more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered

Usual Pediatric Dose for Melioidosis

8 years or younger: Amoxicillin-clavulanate 30 mg/kg-15 mg/kg per day plus amoxicillin 30 mg/kg/day are recommended after an initial 10 days of parenteral antibiotic therapy

Duration: 20 weeks

Precautions

The amoxicillin-clavulanate 250 mg tablet should not be used in pediatric patients until they weigh at least 40 kg and more.

Safety and efficacy of the amoxicillin-clavulanate 600 mg/5 mL oral suspension have not been established in pediatric patients less than 3 months of age or in pediatric patients weighing 40 kg or more. This oral suspension is not recommended for adults.

Safety and efficacy of the extended release tablets have not been established in pediatric patients weighing less than 40 kg.

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Amoxicillin + Clavulanic Acid available?

Amoxicillin + Clavulanic Acid is available in the following dosage forms and strengths:

  • Oral tablet, chewable,
  • Oral tablet,
  • Oral powder for reconstitution,
  • Oral tablet, extended release.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Amoxicillin + Clavulanic Acid, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 29, 2018 | Last Modified: August 29, 2018

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