AMOXICILLIN tablet, coated
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
01-07-2011
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Active ingredient:
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)
Available from:
RedPharm Drug Inc.
INN (International Name):
AMOXICILLIN
Composition:
AMOXICILLIN 875 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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. Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY α -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-ge
Product summary:
Tablets of Amoxicillin: Amoxicillin Tablets USP, 875 mg are available as film-coated, capsule-shaped, pink tablets scored on one side and imprinted WW951 on the other side. They are available in bottles of 100 and 20. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.
Authorization status:
Abbreviated New Drug Application
Summary of Product characteristics
AMOXICILLIN - AMOXICILLIN TABLET, COATED
REDPHARM DRUG INC.
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AMOXICILLIN TABLETS, USP 875 MG
RX ONLY
REVISED: AUGUST 2008
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
Formulation of amoxicillin tablets 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 (2_S_,5_R_,6_R_)-
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:
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.
TABLETS: Each film coated tablet contains 875 mg amoxicillin as the
trihydrate. Each film-coated,
capsule-shaped, pink tablet is scored on one side and imprinted WW951
on the other side. Inactive
ingredients: carmine, colloidal silicon dioxide, crospovidone, FD&C
Red #40 Lake, magnesium
stearate, microcrystalline cellulose, polyvinyl alcohol-partially
hydrolyzed, polyethylene glycol,
sodium starch glycolate, talc, 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
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