AMOXICILLIN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)

Available from:

STAT RX USA LLC

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN 875 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) strains of the designated microorganisms in the conditions listed below:  Infections of the ear, nose, and throat – due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae , Staphylococcus spp., or H. influenzae . Infections of the genitourinary tract – due to E. coli, P. mirabilis , or E. faecalis . Infections of the skin and skin structure – due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli . Infections of the lower respiratory tract – due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae . Gonorrhea, acute uncomplicated (ano-genital and urethral infections) – due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence   Triple Therapy Amoxicillin/clarithromycin/lans

Product summary:

Amoxicillin Tablets, USP contains 875 mg amoxicillin as the trihydrate. 875 mg Tablet Pink colored, capsule shaped, film coated tablets debossed with “A” on one side and with a score line in between “6” and “7” on the other side.                  Bottles of 20                            NDC 59762-1050-2                Bottles of 100                          NDC 59762-1050-5 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN - AMOXICILLIN TABLET, FILM COATED
STAT RX USA LLC
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To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin and
other antibacterial drugs, amoxicillin should be used only to treat or
prevent infections that are proven
or strongly suspected to be caused by bacteria.
DESCRIPTION
Formulations of amoxicillin tablets, USP contain amoxicillin, 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. It may be represented
structural formula as:
The amoxicillin molecular formula is C
H N O S•3H O, and the molecular weight is 419.45.
Tablets of amoxicillin are intended for oral administration.
Each film coated tablet contains 875 mg amoxicillin as the trihydrate.
The 875 mg Pink colored, capsule
shaped, film coated tablets debossed with “A” on one side and with
a score line in between “6” and “7”
on the other side. Inactive ingredients: Colloidal silicon dioxide,
crospovidone, D and C Red No. 30
aluminum lake, hypromellose, magnesium stearate, microcrystalline
cellulose, polyethylene glycol,
sodium starch glycolate, and titanium dioxide.
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 the tablets
and suspension of amoxicillin 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 t