AMOXICILLIN tablet, chewable

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Physicians Total Care, Inc.

INN (Tarptautinis Pavadinimas):

AMOXICILLIN

Sudėtis:

AMOXICILLIN ANHYDROUS 250 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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/lansoprazole Amoxicillin, in combination with cl

Produkto santrauka:

Amoxicillin Chewable Tablets, USP: Each chewable tablet contains 250 mg amoxicillin as the trihydrate. 250 mg Tablet 250 mg pink colored, strawberry flavored, circular, flat faced, beveled edge tablets, with mottled appearance; debossed with “RX515” on one side. NDC 54868-3105-2 bottles of 20 NDC 54868-3105-0 bottles of 30 NDC 54868-3105-3 bottles of 40 Dispense in a tight container. Store amoxicillin chewable tablets 250 mg and 400 mg at controlled room temperature 15° – 30° C (59° – 86° F) (see USP).

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

AMOXICILLIN - AMOXICILLIN TABLET, CHEWABLE
PHYSICIANS TOTAL CARE, INC.
----------
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin
capsules, amoxicillin tablets, amoxicillin tablets (chewable) and
amoxicillin for oral suspension and
other antibacterial drugs, amoxicillin capsules, amoxicillin tablets,
amoxicillin tablets (chewable) and
amoxicillin for oral suspension should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION
Amoxicillin formulations 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. It may
be represented structurally as:
The amoxicillin molecular formula is C
H N O S•3H O, and the molecular weight is 419.45.
Amoxicillin capsules, tablets, and oral suspension are intended for
oral administration.
CAPSULES: Each amoxicillin capsule contains amoxicillin trihydrate
equivalent to amoxicillin anhydrous
250 mg or 500 mg. Inactive ingredients: black iron oxide, colloidal
silicon dioxide, croscarmellose
sodium, D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, magnesium
stearate, microcrystalline
cellulose, shellac, sodium lauryl sulfate and titanium dioxide. In
addition 250 mg capsule contains
FD&C Red No. 40 and 500 mg capsule contains D&C Red No. 28 and FD&C
Blue No. 1.
TABLETS: Each amoxicillin tablet contains amoxicillin trihydrate
equivalent to amoxicillin anhydrous 500
mg or 875 mg. Inactive ingredients: colloidal silicon dioxide,
crospovidone, D&C Red No. 30
aluminum lake, hypromellose, magnesium stearate, microcrystalline
cellulose, polyethylene glycol,
sodium starch glycolate, and titanium dioxide.
CHEWABLE TABLETS 125 MG AND 250 MG: Each amoxicillin chewable tablet
contains