Amoxicillin and clavulanate

Your doctor will check the progress of you or your child while you are using amoxicillin and clavulanate. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

amoxicillin and clavulanate may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after taking amoxicillin and clavulanate.

Amoxicillin and clavulanate combination may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using amoxicillin and clavulanate. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

In some young patients, tooth discoloration may occur while using amoxicillin and clavulanate. The teeth may appear to have brown, yellow, or gray stains. To help prevent this, brush and floss your teeth regularly or have a dentist clean your teeth.

Amoxicillin and clavulanate combination may decrease the effects of some oral contraceptives (birth control pills). Use another form of birth control to avoid getting pregnant. Other forms include condoms, a diaphragm, contraceptive foam, or jelly.

Before you or your child have any medical tests, tell the doctor in charge that you are taking amoxicillin and clavulanate. The results of some tests may be affected by amoxicillin and clavulanate.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Pneumonia, community-acquired: Extended-release tablets only: Treatment of patients with community-acquired pneumonia (CAP) caused by confirmed or suspected beta-lactamase-producing pathogens (ie, Haemophilus influenzae, Moraxella catarrhalis, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus) and Streptococcus pneumoniae with reduced susceptibility to penicillin (penicillin minimum inhibitory concentration [MIC] = 2 mcg/mL).

Limitations of use: Augmentin XR is not indicated for the treatment of infections caused by S. pneumoniae with penicillin MIC of 4 mcg/mL or greater (limited data).

Otitis media, acute:

Immediate-release tablets, chewable tablets, oral suspension (400/57 mg per 5 mL, 250/62.5 mg per 5 mL, 200/28.5 mg per 5 mL, and 125/31.25 mg per 5 mL only): Treatment of otitis media caused by beta-lactamase-producing strains of H. influenzae and M. catarrhalis.

Oral suspension (600/42.9 mg per 5 mL concentration): Treatment of acute otitis media, recurrent or persistent, caused by S. pneumoniae (penicillin MIC = 2 mcg/mL or less), H. influenzae (including beta-lactamase-producing strains), and M. catarrhalis (including beta-lactamase-producing strains) in pediatric patients with a history of antibiotic exposure for acute otitis media in the preceding 3 months and who are either 2 years or younger or attend day care; treatment of otitis media caused by beta-lactamase-producing strains of H. influenzae and M. catarrhalis.

Respiratory tract infections, lower: Immediate-release tablets, chewable tablets, oral suspension (400/57 mg per 5 mL, 250/62.5 mg per 5 mL, 200/28.5 mg per 5 mL, and 125/31.25 mg per 5 mL only): Treatment of lower respiratory tract infection caused by beta-lactamase-producing strains of H. influenzae and M. catarrhalis.

Sinusitis, acute bacterial:

Extended-release tablets: Treatment of patients with acute bacterial sinusitis caused by confirmed or suspected beta-lactamase-producing pathogens (ie, H. influenzae, M. catarrhalis, H. parainfluenzae, K. pneumoniae, methicillin-susceptible S. aureus) and S. pneumoniae with reduced susceptibility to penicillin (penicillin MIC = 2 mcg/mL).

Limitations of use: Augmentin XR is not indicated for the treatment of infections caused by S. pneumoniae with penicillin MIC of 4 mcg/mL or greater (limited data).

Immediate-release tablets, chewable tablets, oral suspension (400/57 mg per 5 mL, 250/62.5 mg per 5 mL, 200/28.5 mg per 5 mL, and 125/31.25 mg per 5 mL only): Treatment of sinusitis caused by beta-lactamase-producing strains of H. influenzae and M. catarrhalis.

Skin and skin structure infections: Immediate-release tablets, chewable tablets, oral suspension (400/57 mg per 5 mL, 250/62.5 mg per 5 mL, 200/28.5 mg per 5 mL, and 125/31.25 mg per 5 mL only): Treatment of skin and skin structure infections caused by beta-lactamase-producing strains of S. aureus, Escherichia coli, and Klebsiella spp.

Urinary tract infections: Immediate-release tablets, chewable tablets, oral suspension (400/57 mg per 5 mL, 250/62.5 mg per 5 mL, 200/28.5 mg per 5 mL, and 125/31.25 mg per 5 mL only): Treatment of urinary tract infections caused by beta-lactamase-producing strains of E. coli, Klebsiella spp, and Enterobacter spp.

Note: Dose is based on the amoxicillin component. Dose and frequency are product specific; not all products are interchangeable. Using a product with the incorrect amoxicillin:clavulanate ratio could result in subtherapeutic clavulanic acid concentrations or severe diarrhea. For adults who have difficulty swallowing the tablets, the 125 mg/5 mL or 250 mg/5 mL suspension may be given in place of the 500 mg/125 mg tablet; the 200 mg/5 mL or 400 mg/5 mL suspension may be given in place of the 875 mg/125 mg tablet.

Susceptible infections: Oral: 250 mg every 8 hours or 500 mg every 8 to 12 hours or 875 mg every 12 hours or 2,000 mg every 12 hours

Bite wounds (animal/human) (off-label use): Oral: Immediate release: 875 mg every 12 hours (IDSA [Stevens 2014])

Chronic obstructive pulmonary disease (COPD) (off-label use): Oral: Immediate release: 500 mg every 8 hours (Llor 2012)

Cystitis, acute uncomplicated: Oral: Immediate release:

Manufacturer’s labeling: 500 mg every 12 hours or 250 mg every 8 hours

Alternate dosing: 500 mg every 12 hours for 7 days (Colgan 2011; IDSA [Gupta 2011])

Impetigo (off-label use): Oral: Immediate release: 875 mg every 12 hours for 7 days, depending on response (IDSA [Stevens 2014])

Febrile neutropenia, empiric therapy in low-risk cancer patients (off-label use): Oral: Immediate release: 500 mg every 8 hours until resolution of neutropenia; use in combination with oral ciprofloxacin (Freifeld 1999; Pherwani 2015)

Group A streptococci chronic carrier, treatment (off-label use): Oral: Immediate release: Amoxicillin 40 mg/kg/day divided every 8 hours (maximum: Amoxicillin 2,000 mg/day) for 10 days (IDSA [Shulman 2012])

Pneumonia, community-acquired (CAP): Oral:

Manufacturer’s labeling:

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

Extended release: 2,000 mg every 12 hours for 7 to 10 days

Alternate dosing:

Outpatient empiric therapy: Extended release: 2,000 mg every 12 hours for a minimum of 5 days (patients should be afebrile for ≥48 hours and clinically stable before discontinuation of therapy); use in combination with a macrolide (preferred) or doxycycline (Mandell 2007)

Meliodosis, treatment (eradication phase) and postexposure prophylaxis (off-label use) (HHS [Lipsitz 2012]): Oral: Immediate release: Note: Duration for eradication phase treatment is ≥12 weeks; duration for postexposure prophylaxis is 21 days.

>60 kg: 1,500 mg (three 500 mg tablets) every 8 hours

<60 kg: 1,000 mg (two 500 mg tablets) every 8 hours

Prosthetic joint infection, chronic antimicrobial suppression, oxacillin-susceptible Staphylococci (alternative to cephalexin or cefadroxil) (off-label use): Oral: Immediate release: 500 mg 3 times daily (IDSA [Osmon 2013])

Respiratory tract infections, lower: Oral:

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

Sinusitis, acute bacterial: Oral:

Manufacturer’s labeling:

Immediate release: 500 mg every 8 hours or amoxicillin 875 mg every 12 hours

Extended release: Amoxicillin 2,000 mg every 12 hours for 10 days

Alternate dosing: IDSA recommendations:

Standard dose: Immediate release: 500 mg every 8 hours or 875 mg every 12 hours for 5 to 7 days

High dose: Extended release: 2,000 mg every 12 hours for 10 days. Note: Recommended for patients with any of the following: If initial therapy fails (as second-line therapy), in areas with high endemic rates of penicillin-nonsusceptible S. pneumoniae, those with severe infections, age >65 years, recent hospitalization, antibiotic use within the past month, or who are immunocompromised (AAO-HNS [Rosenfeld 2015]; IDSA [Chow 2012]).

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution. Use contraindicated in patients with a history of amoxicillin and clavulanate-associated hepatic dysfunction.