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.

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

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.

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.

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.

Frequently asked questions

• Amoxicillin rash: When should I be concerned?
• What are the best antibiotics for pneumonia?
• Does AMOX-CLAV treat an abcessed tooth?
• Can Amox-Clav tablets be crushed?