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Augmentin Chewable Tablets

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Augmentin Chewable Tablets

Indications
Dosage
How Supplied

INDICATIONS

AUGMENTIN is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:

Lower Respiratory Tract Infections - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis.

Otitis Media - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis.

Sinusitis - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis.

Skin and Skin Structure Infections - caused by β-lactamase-producing strains of S. aureus, E. coli, and Klebsiella spp.

Urinary Tract Infections - caused by β-lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter spp.

While AUGMENTIN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with AUGMENTIN due to its amoxicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to AUGMENTIN should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and AUGMENTIN. (See Microbiology.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN 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.

Bacteriological studies, to determine the causative organisms and their susceptibility to AUGMENTIN, should be performed together with any indicated surgical procedures.

DOSAGE AND ADMINISTRATION

Dosage

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

Neonates and infants aged < 12 weeks (3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of AUGMENTIN is 30 mg/kg/day divided q12h, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group. 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

INFECTIONS DOSING REGIMEN
q12h* q8h
  200 mg/5 mL or 400 mg/5 mL oral suspension† 125 mg/5 mL or 250 mg/5 mL oral suspension
Otitis media‡, sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day q12h 40 mg/kg/day q8h
Less severe infections 25 mg/kg/day q12h 20 mg/kg/day q8h
* The q12h regimen is recommended as it is associated with significantly less diarrhea. (See Clinical Studies.) However, the q12h formulations (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics.
Each strength of suspension of AUGMENTIN is available as a chewable tablet for use by older children.
‡Duration of therapy studied and recommended for acute otitis media is 10 days.

Pediatric Patients Weighing 40 kg and More: Should be dosed according to the following adult recommendations: 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. Among adults treated with 875 mg every 12 hours, significantly fewer experienced severe diarrhea or withdrawals with diarrhea versus adults treated with 500 mg every 8 hours. For detailed adult dosage recommendations, please see complete prescribing information for tablets of AUGMENTIN.

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

Adults: 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. See dosage recommendations above for children weighing 40 kg or more.

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. Therefore, the 250-mg tablet of AUGMENTIN and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable.

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), the 250-mg tablet of AUGMENTIN should not be used until the child weighs at least 40 kg and more.

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 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.

AUGMENTIN 125 mg/5 mL Suspension

Bottle Size Amount of Water Required for Reconstitution
75 mL 67 mL
100 mL 90 mL
150 mL 134 mL

Each teaspoonful (5 mL) will contain 125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt.

AUGMENTIN 200 mg/5 mL Suspension

Bottle Size Amount of Water Required for Reconstitution
50 mL 50 mL
75 mL 75 mL
100 mL 95 mL

Each teaspoonful (5 mL) will contain 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt.

AUGMENTIN 250 mg/5 mL Suspension

Bottle Size Amount of Water Required for Reconstitution
75 mL 65 mL
100 mL 87 mL
150 mL 130 mL

Each teaspoonful (5 mL) will contain 250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt.

AUGMENTIN 400 mg/5 mL Suspension

Bottle Size Amount of Water Required for Reconstitution
50 mL 50 mL
75 mL 70 mL
100 mL 90 mL

Each teaspoonful (5 mL) will contain 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.

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.

HOW SUPPLIED

AUGMENTIN 125 mg/5 mL for Oral Suspension: Each 5 mL of reconstituted banana-flavored suspension contains 125 mg amoxicillin and 31.25 mg clavulanic acid as the potassium salt.

NDC 0029-6085-39..................75 mL bottle
NDC 0029-6085-22.............150 mL bottle
NDC 0029-6085-23................100 mL bottle

AUGMENTIN 200 mg/5 mL for Oral Suspension: Each 5 mL of reconstituted orange-flavored suspension contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt.

NDC 0029-6087-29..................50 mL bottle
NDC 0029-6087-51.............100 mL bottle
NDC 0029-6087-39..................75 mL bottle

AUGMENTIN 250 mg/5 mL for Oral Suspension: Each 5 mL of reconstituted orange-flavored suspension contains 250 mg amoxicillin and 62.5 mg clavulanic acid as the potassium salt.

NDC 0029-6090-39..................75 mL bottle
NDC 0029-6090-22.............150 mL bottle
NDC 0029-6090-23................100 mL bottle

AUGMENTIN 400 mg/5 mL for Oral Suspension: Each 5 mL of reconstituted orange-flavored suspension contains 400 mg amoxicillin and 57 mg clavulanic acid as the potassium salt.

NDC 0029-6092-29..................50 mL bottle
NDC 0029-6092-51.............100 mL bottle
NDC 0029-6092-39..................75 mL bottle

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

NDC 0029-6073-47 carton of 30 tablets

AUGMENTIN 200-mg Chewable Tablets: Each mottled pink, round, biconvex, cherry-banana-flavored tablet contains 200 mg amoxicillin as the trihydrate and 28.5 mg clavulanic acid as the potassium salt.

NDC 0029-6071-12 carton of 20 tablets

AUGMENTIN 250-mg Chewable Tablets: Each mottled yellow, round, lemon-lime-flavored tablet, debossed with BMP 190, contains 250 mg amoxicillin as the trihydrate and 62.5 mg clavulanic acid as the potassium salt. DC 0029-6074-47 carton of 30 tablets

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

NDC 0029-6072-12 carton of 20 tablets

AUGMENTIN is Also Supplied as:

AUGMENTIN 250-mg Tablets (250 mg amoxicillin/125 mg clavulanic acid):

NDC 0029-6075-27 bottles of 30
NDC 0029-6075-31 100 Unit Dose tablets

AUGMENTIN 500-mg Tablets (500 mg amoxicillin/125 mg clavulanic acid):

NDC 0029-6080-12 bottles of 20
NDC 0029-6080-31 100 Unit Dose tablets

AUGMENTIN 875-mg Tablets (875 mg amoxicillin/125 mg clavulanic acid):

NDC 0029-6086-12 bottles of 20
NDC 0029-6086-21 100 Unit Dose tablets

Store tablets and dry powder at or below 25°C (77°F). Dispense in original containers. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days.

AUGMENTIN is a registered trademark of GlaxoSmithKline. CLINITEST is a registered trademark of Miles, Inc. CLINISTIX is a registered trademark of Bayer Corporation. GlaxoSmithKline, Research Triangle Park, NC 27709, ©2006, GlaxoSmithKline All rights reserved., December 2006 AG:PL17

Last reviewed on RxList: 9/4/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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