Amoxicillin and Clavulanate Potassium Extended Release

AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE- amoxicillin, amoxicillin sodium and clavulanate potassium tablet, film coated, extended release
Dr. Reddy’s Laboratories Inc

amoxicillin trihydrateClavulanateAmoxicillin sodiumACP 1000mg 28ctACP 1000mg 40ct

1 INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Extended Release Tablets should be used only to treat 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.

Amoxicillin and Clavulanate Potassium Extended Release Tablets is 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). Amoxicillin and Clavulanate Potassium Extended Release Tablet 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 (14)].

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 Amoxicillin and Clavulanate Potassium Extended Release Tablet 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 amoxicillin/clavulanate potassium product containing lower daily doses of amoxicillin (i.e., 500 mg every 8 hours or 875 mg every 12 hours). Acute bacterial sinusitis or community-acquired pneumonia due to S. pneumoniae alone can be treated with amoxicillin.

2 DOSAGE AND ADMINISTRATION

Amoxicillin and Clavulanate Potassium Extended Release Tablet should be taken at the start of a meal to enhance the absorption of amoxicillin and to minimize the potential for gastrointestinal intolerance. Amoxicillin and Clavulanate Potassium Extended Release Tablet is not recommended to be taken with a high‑fat meal, because clavulanate absorption is decreased. [see Clinical Pharmacology (12.3)].

2.1 Adults

The recommended dose of Amoxicillin and Clavulanate Potassium Extended Release Tablets 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 Amoxicillin and Clavulanate Potassium (250 mg or 500 mg) CANNOT be used to provide the same dosages as Amoxicillin and Clavulanate Potassium Extended Release Tablets. This is because Amoxicillin and Clavulanate Potassium Extended Release Tablets contain 62.5 mg of clavulanic acid, while the Amoxicillin and Clavulanate Potassium 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 Amoxicillin and Clavulanate Potassium 500-mg tablets are not equivalent to one Amoxicillin and Clavulanate Potassium Extended Release Tablet.

Scored Amoxicillin and Clavulanate Potassium Extended Release Tablets are available 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 Amoxicillin and Clavulanate Potassium Extended Release Tablet is two tablets twice a day (every 12 hours).

2.2 Renally Impaired Patients

The pharmacokinetics of Amoxicillin and Clavulanate Potassium Extended Release Tablets have not been studied in patients with renal impairment. Amoxicillin and Clavulanate Potassium Extended Release Tablet is contraindicated in patients with a creatinine clearance of < 30 mL/min and in hemodialysis patients [see Contraindications (4)].

2.3 Hepatically Impaired Patients

Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals [see Warnings and Precautions (5.2)].

2.4 Pediatric Use

Pediatric patients who weigh 40 kg or more and can swallow tablets should receive the adult dose [see Use in Specific Populations (8.4)].

2.5 Geriatric Use

No dosage adjustment is required for the elderly [see Use in Specific Populations (8.5)].

3 DOSAGE FORMS AND STRENGTHS

Amoxicillin and Clavulanate Potassium 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.

4 CONTRAINDICATIONS

4.1 Serious Hypersensitivity Reactions

Amoxicillin and Clavulanate Potassium Extended Release Tablet is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).

4.2 Cholestatic Jaundice/Hepatic Dysfunction

Amoxicillin and Clavulanate Potassium Extended Release Tablet is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with amoxicillin/clavulanate potassium.

4.3 Renal Impairment

Amoxicillin and Clavulanate Potassium Extended Release Tablet is contraindicated in patients with severe renal impairment (creatinine clearance < 30 mL/min) and in hemodialysis patients.

5 WARNINGS AND PRECAUTIONS

5.1 Serious Allergic Reactions, Including Anapslaxis

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving Amoxicillin and Clavulanate Potassium Extended Release Tablets. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with Amoxicillin and Clavulanate Potassium Extended Release Tablets, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, Amoxicillin and Clavulanate Potassium Extended Release Tablets should be discontinued and appropriate therapy instituted.

5.2 Hepatic Dysfunction

Amoxicillin and Clavulanate Potassium Extended Release Tablets should be used with caution in patients with evidence of hepatic dysfunction. Hepatic toxicity associated with the use of amoxicillin/clavulanate potassium is usually reversible. Deaths have been reported (fewer than 1 death reported per estimated 4 million prescriptions worldwide). These have generally been cases associated with serious underlying diseases or concomitant medications [see Contraindications (4.2) and Adverse Reactions (6.2)] .

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