AMOXICILLIN- amoxicillin tablet, coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Proficient Rx LP

INN (nume internaţional):

AMOXICILLIN

Compoziție:

AMOXICILLIN ANHYDROUS 875 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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-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/lansoprazole Amoxicillin, in combination with clarithromycin

Rezumat produs:

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 20. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

AMOXICILLIN- AMOXICILLIN TABLET, COATED
PROFICIENT RX LP
----------
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 61.3