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Augmentin

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Augmentin

Augmentin

INDICATIONS

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN (amoxicillin/clavulanate potassium) and other antibacterial drugs, AUGMENTIN 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. AUGMENTIN® is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:

Lower Respiratory Tract Infections – caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis.

Acute Bacterial Otitis Media – caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.

Sinusitis – caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.

Skin and Skin Structure Infections – caused by beta-lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.

Urinary Tract Infections – caused by beta-lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species.

Limitations of Use – When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, AUGMENTIN should not be used.

DOSAGE AND ADMINISTRATION

AUGMENTIN may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when AUGMENTIN is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, AUGMENTIN should be taken at the start of a meal.

Adults

The usual adult dose is one 500-mg tablet of AUGMENTIN every 12 hours or one 250 mg tablet of AUGMENTIN every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of AUGMENTIN every 12 hours or one 500-mg tablet of AUGMENTIN every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet. Two 250-mg tablets of AUGMENTIN should not be substituted for one 500-mg tablet of AUGMENTIN. Since both the 250-mg and 500-mg tablets of AUGMENTIN contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of AUGMENTIN.

The 250-mg tablet of AUGMENTIN and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of AUGMENTIN and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of AUGMENTIN contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.

Pediatric Patients

Based on the amoxicillin component, AUGMENTIN should be dosed as follows:

Neonates and Infants Aged < 12 weeks ( < 3 months)

The recommended dose of AUGMENTIN is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.

Patients Aged 12 weeks (3 months) and Older

See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [see WARNINGS AND PRECAUTIONS]

Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older

INFECTION DOSING REGIMEN
Every 12 hours Every 8 hours
  200 mg/5 mL or 400 mg/5 mL oral suspensiona 125 mg/5 mL or 250 mg/5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day every 12 hours 40 mg/kg/day every 8 hours
Less severe infections 25 mg/kg/day every 12 hours 20 mg/kg/day every 8 hours
aEach strength of suspension of AUGMENTIN is available as a chewable tablet for use by older children.
bDuration of therapy studied and recommended for acute otitis media is 10 days.

Patients Weighing 40 kg or More

Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.

The 250-mg tablet of AUGMENTIN should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of AUGMENTIN (250/125) versus the 250-mg chewable tablet of AUGMENTIN (250/62.5).

Patients with Renal Impairment

Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of < 30 mL/min should not receive the 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

Directions for Mixing Oral Suspension

Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.

Table 2: Amount of Water for Mixing Oral Suspension

Strength Bottle Size Amount of Water for Reconstitution Contents of Each Teaspoonful (5 mL)
125 mg/5 mL 75 mL 100 mL 150 mL 67 mL 90 mL 134 mL 125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt
200 mg/5 mL 50 mL 75 mL 100 mL 50 mL 75 mL 95 mL 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
250 mg/5 mL 75 mL 100 mL 150 mL 65 mL 87 mL 130 mL 250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt
400 mg/5 mL 50 mL 75 mL 100 mL 50 mL 70 mL 90 mL 400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium salt

Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.

HOW SUPPLIED

Dosage Forms And Strengths

Tablets
  • 250-mg/125-mg Tablets: Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 250/125 on the other side, contains 250 mg amoxicillin and 125 mg clavulanic acid as the potassium salt.
  • 500-mg/125-mg Tablets: Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 500/125 on the other side, contains 500 mg amoxicillin and 125 mg clavulanic acid as the potassium salt.
  • 875-mg/125-mg Tablets: Each scored white capsule-shaped tablet, debossed with AUGMENTIN 875 on one side and scored on the other side, contains 875 mg amoxicillin and 125 mg clavulanic acid as the potassium salt.
Powder for Oral Suspension
  • 125 mg/31.25 mg per 5 mL: Banana-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt).
  • 200 mg/28.5 mg per 5 mL: Orange-favored powder for oral suspension (each 5 mL of reconstituted suspension contains 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt).
  • 250 mg/62.5 mg per 5 mL: Orange-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt).
  • 400 mg/57 mg per 5 mL Orange-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium salt).
Chewable Tablets
  • 125-mg/31.25-mg Chewable Tablets: Each mottled yellow, round, lemon-lime-flavored tablet, debossed with BMP 189 contains 125 mg amoxicillin and 31.25 mg clavulanic acid as the potassium salt.
  • 200-mg/28.5 mg Chewable Tablets: Each mottled pink, round, biconvex cherrybanana-flavored tablet, debossed with AUGMENTIN 200 contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt.
  • 250-mg/62.5-mg Chewable Tablets: Each mottled yellow, round, lemon-lime-flavored tablet, debossed with BMP 190 contains 250 mg amoxicillin and 62.5 mg clavulanic acid as the potassium salt.
  • 400-mg/57-mg Chewable Tablets: Each mottled pink, round, biconvex cherry-bananaflavored tablet, debossed with AUGMENTIN 400 contains 400 mg amoxicillin and 57.0 mg clavulanic acid as the potassium salt.

The 250-mg tablet of AUGMENTIN and the 250-mg chewable tablet should NOT be substituted for each other, as they are not interchangeable and the 250-mg tablet should not be used in children weighing less than 40 kg. The 250-mg tablet of AUGMENTIN and the 250-mg chewable tablet do not contain the same amount of clavulanic acid. The 250-mg tablet of AUGMENTIN contains 125 mg of clavulanic acid whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.

Two 250 mg tablets of AUGMENTIN should NOT be substituted for one 500 mg tablet of AUGMENTIN. Since both the 250 mg and 500 mg tablets of AUGMENTIN contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg tablets of AUGMENTIN are not equivalent to one 500 mg tablet of AUGMENTIN.

Storage And Handling

Tablets

250-mg/125-mg Tablets: Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 250/125 on the other side, contains 250 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.

NDC 43598-018-30 bottles of 30
NDC 43598-018-78 Unit Dose (10x10) 100 tablets

500-mg/125-mg Tablets: Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 500/125 on the other side, contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.

NDC 43598-006-14 bottles of 20
NDC 43598-006-78 Unit Dose (10x10) 100 tablets

875-mg/125-mg Tablets: Each scored white capsule-shaped tablet, debossed with AUGMENTIN 875 on one side and scored on the other side, contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.

NDC 43598-021-14 bottles of 20
NDC 43598-021-78 Unit Dose (10x10) 100 tablets

Powder for Oral Suspension: 125 mg/31.25 mg per 5 mL: Banana-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt).

NDC 43598-012-51 75 mL bottle
NDC
43598-012-52 100 mL bottle
NDC 43598-012-53 150 mL bottle

200 mg/28.5 mg per 5 mL: Orange-favored powder for oral suspension (each 5 mL of reconstituted suspension contains 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt).

NDC 43598-013-50 50 mL bottle
NDC
43598-013-51 75 mL bottle
NDC
43598-013-52 100 mL bottle

250 mg/62.5 mg per 5 mL: Orange-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt).

NDC 43598-004-51 75 mL bottle
NDC 43598-004-52 100 mL bottle
NDC
43598-004-53 150 mL bottle

400 mg/57 mg per 5 mL Orange-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium salt).

NDC 43598-008-50 50 mL bottle
NDC
43598-008-51 75 mL bottle
NDC
43598-008-52 100 mL bottle

Chewable Tablets

125-mg/31.25-mg Chewable Tablets: Each mottled yellow, round, lemon-lime-flavored tablet, debossed with BMP 189, contains 125 mg amoxicillin and 31.25 mg clavulanic acid as the potassium salt.

NDC 43598-014-31 carton of 30 (5x6) tablets

200-mg/28.5 mg Chewable Tablets: Each mottled pink, round, biconvex, cherry-bananaflavored tablet, debossed with AUGMENTIN 200, contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt.

NDC 43598-015-14 carton of 20 tablets

250-mg/62.5-mg Chewable Tablets: Each mottled yellow, round, lemon-lime-flavored tablet, debossed with BMP 190, contains 250 mg amoxicillin and 62.5 mg clavulanic acid as the potassium salt.

NDC 43598-016-31 carton of 30 (5x6) tablets

400-mg/57-mg Chewable Tablets: Each mottled pink, round, biconvex, cherry-banana-flavored tablet, debossed with AUGMENTIN 400, contains 400 mg amoxicillin and 57.0 mg clavulanic acid as the potassium salt.

NDC 43598-017-14 carton of 20 tablets

Dispense in original container.

Store tablets and dry powder at or below 25°C (77°F).

Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days.

Keep out of the reach of children.

Distributed by: Dr. Reddy's Laboratories Inc., Bridgewater, NJ 08807. Revised: 01/2013

Last reviewed on RxList: 2/4/2013
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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