AUGMENTIN Powder for suspension / Film coated-tablet Ref.[10549] Active ingredients: Amoxicillin Clavulanic acid

Source: FDA, National Drug Code (US) Revision Year: 2019

Product description

AUGMENTIN is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid).

Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C₁₆H₁₉N₃O₅S•3H₂O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)6[(R)()-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:

Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C₈H₈KNO₅, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)3(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:

Inactive Ingredients:

Tablets – Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of AUGMENTIN contains 0.63 mEq potassium.
Powder for Oral Suspension, 125 mg/5mL and 250 mg/5mL – Colloidal silicon dioxide, flavorings, xanthan gum, mannitol, succinic acid, silica gel and sodium saccharin.
Powder for Oral Suspension, 200 mg/5mL and 400 mg/5mL – Colloidal silicon dioxide, flavorings, xanthan gum, silica gel, hypromellose and aspartame [see Warnings and Precautions (5.6)]
Chewable Tablets, 125 mg and 250 mg – Colloidal silicon dioxide, flavorings, magnesium stearate, mannitol, sodium saccharin, glycine, and D&C Yellow No.10.
- Each 125 mg chewable tablet and each 5 mL of reconstituted 125/5 mL oral suspension of Amoxicillin and Clavulanate Potassium contains 0.16 mEq potassium
- Each 250 mg chewable tablet and each 5 mL of reconstituted 250/5 mL oral suspension of Amoxicillin and Clavulanate Potassium contains 0.32 mEq potassium
Chewable Tablets, 200 mg and 400 mg – Colloidal silicon dioxide, flavorings, magnesium stearate, mannitol, FD&C Red No. 40 and aspartame [see Warnings and Precautions (5.6)].
- Each 200 mg chewable tablet and each 5 mL of reconstituted 200/5 mL oral suspension of Amoxicillin and Clavulanate Potassium contains 0.14 mEq potassium
- Each 400 mg chewable tablet and each 5 mL of reconstituted 400/5 mL oral suspension of Amoxicillin and Clavulanate Potassium contains 0.29 mEq potassium

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 of 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 of 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-flavored 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 cherry-banana-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-banana-flavored 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.

How Supplied
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 250mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt. NDC 72508-018-30 bottles of 30 NDC 72508-018-78 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 500mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt. NDC 72508-006-14 bottles of 20 NDC 72508-006-78 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 875mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt. NDC 72508-021-14 bottles of 20 NDC 72508-021-78 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 72508-012-01 75 mL bottle NDC 72508-012-03 100 mL bottle NDC 72508-012-05 150 mL bottle 200 mg/28.5 mg per 5 mL: Orange-flavored 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 72508-013-50 50 mL bottle NDC 72508-013-51 75 mL bottle NDC 72508-013-52 100 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 72508-004-07 75 mL bottle NDC 72508-004-10 100 mL bottle NDC 72508-004-15 150 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 72508-008-50 50 mL bottle NDC 72508-008-51 75 mL bottle NDC 72508-008-52 100 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 72508-014-31 carton of 30 (5x6) tablets 200 mg/28.5 mg Chewable Tablets: Each mottled pink, round, biconvex, cherry-banana-flavored tablet, debossed with AUGMENTIN 200, contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt. NDC 72508-015-14 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 72508-016-31 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 72508-017-14 carton of 20 tablets Dispense in original container. AUGMENTIN is a registered trademark of GlaxoSmithKline and is licensed to Neopharma Inc. CLINITEST is a registered trademark of Miles, Inc. Manufactured By: Neopharma Tennessee LLC., Bristol, TN 37620 Manufactured for: Neopharma Inc., Princeton, NJ 08540

Drugs

Drug	Countries
AUGMENTIN	Austria, Australia, Cyprus, Ecuador, Estonia, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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