Augmentin XR (Amoxicillin / Clavulanate Potassium) - Indications and Dosage

INDICATIONS AND USAGE

AUGMENTIN XR Extended Release Tablets are indicated for the treatment of patients with community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected β-lactamase−producing pathogens (i.e., H. influenzae, M. catarrhalis, H. parainfluenzae, K. pneumoniae , or methicillin-susceptible S. aureus ) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs = 2 mcg/mL). AUGMENTIN XR is not indicated for the treatment of infections due to S. pneumoniae with penicillin MICs ≥4 mcg/mL. Data are limited with regard to infections due to S. pneumoniae with penicillin MICs ≥4 mcg/mL (see CLINICAL STUDIES).

Of the common epidemiological risk factors for patients with resistant pneumococcal infections, only age >65 years was studied. Patients with other common risk factors for resistant pneumococcal infections (e.g., alcoholism, immune-suppressive illness, and presence of multiple co-morbid conditions) were not studied.

In patients with community-acquired pneumonia in whom penicillin-resistant S. pneumoniae is suspected, bacteriological studies should be performed to determine the causative organisms and their susceptibility when AUGMENTIN XR is prescribed.

Acute bacterial sinusitis or community-acquired pneumonia due to a penicillin-susceptible strain of S. pneumoniae plus a β-lactamase−producing pathogen can be treated with another AUGMENTIN^® (amoxicillin/clavulanate potassium) product containing lower daily doses of amoxicillin (i.e., 500 mg q8h or 875 mg q12h). Acute bacterial sinusitis or community-acquired pneumonia due to S. pneumoniae alone can be treated with amoxicillin.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN XR and other antibacterial drugs, AUGMENTIN XR should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

DOSAGE AND ADMINISTRATION

AUGMENTIN XR should be taken at the start of a meal to enhance the absorption of amoxicillin and to minimize the potential for gastrointestinal intolerance. Absorption of the amoxicillin component is decreased when AUGMENTIN XR is taken on an empty stomach (see CLINICAL PHARMACOLOGY).

The recommended dose of AUGMENTIN XR is 4,000 mg/250 mg daily according to the following table:

Indication	Dose	Duration
Acute bacterial sinusitis	2 tablets q12h	10 days
Community-acquired pneumonia	2 tablets q12h	7 - 10 days

Tablets of AUGMENTIN (250   mg or 500   mg) CANNOT be used to provide the same dosages as AUGMENTIN XR Extended Release Tablets. This is because AUGMENTIN XR contains 62.5   mg of clavulanic acid, while the AUGMENTIN 250-mg and 500-mg tablets each contain 125   mg of clavulanic acid. In addition, the Extended Release Tablet provides an extended time course of plasma amoxicillin concentrations compared to immediate-release Tablets. Thus, two AUGMENTIN 500-mg tablets are not equivalent to one AUGMENTIN XR tablet.

Scored AUGMENTIN XR Extended Release Tablets are available for greater convenience for adult patients who have difficulty swallowing. The scored tablet is not intended to reduce the dosage of medication taken; as stated in the table above, the recommended dose of AUGMENTIN XR is two tablets twice a day (q12h).

Renally Impaired Patients

The pharmacokinetics of AUGMENTIN XR have not been studied in patients with renal impairment. AUGMENTIN XR is contraindicated in patients with a creatinine clearance of <30 mL/min. and in hemodialysis patients (see CONTRAINDICATIONS).

Hepatically Impaired Patients

Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).

Pediatric Use

Safety and effectiveness in pediatric patients younger than 16 years have not been established.

Geriatric Use

No dosage adjustment is required for the elderly (see PRECAUTIONS, Geriatric Use).

HOW SUPPLIED

AUGMENTIN XR Extended Release Tablets

Each white, oval film-coated bilayer scored tablet, debossed with AUGMENTIN XR, contains amoxicillin trihydrate and amoxicillin sodium equivalent to a total of 1,000 mg of amoxicillin and clavulanate potassium equivalent to 62.5 mg of clavulanic acid.

NDC 0029-6096-48	Bottles of 28 (7 day XR pack)
NDC 0029-6096-60	Bottles of 40 (10 day XR pack)

STORAGE

Store tablets at or below 25°C (77°F). Dispense in original container.