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USP, 125 mg per 5 mL and 250 mg per 5 mL/Amoxicillin TABLETS USP (CHEWABLE), 125 mg and 250 mg
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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin capsules, Amoxicillin for oral suspension, Amoxicillin tablets (chewable) and other antibacterial drugs, Amoxicillin capsules, Amoxicillin for oral suspension, and Amoxicillin tablets (chewable) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Amoxicillin Description


Amoxicillin is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically, it 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. The structural formula is:

C16H19N3O5S•3H2O M.W. 419.45

Each capsule, for oral administration, contains 250 mg or 500 mg Amoxicillin as the trihydrate.

Inactive Ingredients: CAPSULES-DRUG PRODUCT: magnesium stearate.

CAPSULE SHELL AND PRINT CONSTITUENTS: black iron oxide, D&C Yellow #10, FD&C Red #40, gelatin, propylene glycol, shellac, sodium lauryl sulfate, titanium dioxide, and may also contain D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, methylparaben, propylparaben, and silicon dioxide. In addition, the 250 mg capsule shell contains D&C Red #28 and FD&C Blue #1 and the 500 mg capsule shell may also contain FD&C Blue #1.

After mixing, each 5 mL of Amoxicillin suspension, for oral administration, will contain 125 mg or 250 mg of Amoxicillin as the trihydrate.

Inactive Ingredients: SUSPENSION: FD&C Red #40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum.

Each chewable tablet, for oral administration, contains 125 mg or 250 mg of Amoxicillin as the trihydrate.

Inactive Ingredients: CHEWABLE TABLETS: cherry flavor, lactose, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose.
Amoxicillin - Clinical Pharmacology

Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. The effect of food on the absorption of Amoxicillin from Amoxicillin tablets and Amoxicillin suspension has been partially investigated. The 400 mg and 875 mg formulations have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations. Amoxicillin diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. The half-life of Amoxicillin is 61.3 minutes. Most of the Amoxicillin is excreted unchanged in the urine; its excretion can be delayed by concurrent administration of probenecid. In blood serum, Amoxicillin is approximately 20% protein-bound.

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Orally administered doses of 250 mg and 500 mg Amoxicillin capsules result in average peak blood levels 1 to 2 hours after administration in the range of 3.5 mcg/mL to 5.0 mcg/mL and 5.5 mcg/mL to 7.5 mcg/mL, respectively.

Mean Amoxicillin pharmacokinetic parameters from an open, two-part, single-dose crossover bioequivalence study in 27 adults comparing 875 mg of Amoxicillin with 875 mg of Amoxicillin/clavulanate potassium showed that the 875 mg tablet of Amoxicillin produces an AUC0-∞ of 35.4 ± 8.1 mcg•hr/mL and a Cmax of 13.8 ± 4.1 mcg/mL. Dosing was at the start of a light meal following an overnight fast.

Orally administered doses of Amoxicillin suspension, 125 mg/5 mL and 250 mg/5 mL, result in average peak blood levels 1 to 2 hours after administration in the range of 1.5 mcg/mL to 3.0 mcg/mL and 3.5 mcg/mL to 5.0 mcg/mL, respectively.

Oral administration of single doses of 400 mg chewable tablets and 400 mg/5 mL suspension of Amoxicillin to 24 adult volunteers yielded comparable pharmacokinetic data:
Dose* AUC0-∞ (mcg•hr/mL) Cmax (mcg/mL)†
Amoxicillin Amoxicillin (± S.D.) Amoxicillin (± S.D.)
400 mg (5 mL of suspension) 17.1 (3.1) 5.92 (1.62)
400 mg (1 chewable tablet) 17.9 (2.4) 5.18 (1.64)
*
Administered at the start of a light meal.
†
Mean values of 24 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose.


Detectable serum levels are observed up to 8 hours after an orally administered dose of Amoxicillin. Following a 1 gram dose and utilizing a special skin window technique to determine levels of the antibiotic, it was noted that therapeutic levels were found in the interstitial fluid. Approximately 60% of an orally administered dose of Amoxicillin is excreted in the urine within 6 to 8 hours.

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