AMOXICILLIN tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN - UNII:804826J2HU)

Disponível em:

Rebel Distributors Corp.

DCI (Denominação Comum Internacional):

AMOXICILLIN

Composição:

AMOXICILLIN 250 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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. Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the

Resumo do produto:

Amoxicillin capsules USP: Caramel and buff colored capsules are imprinted “93” - “3107” and contain 250 mg amoxicillin as the trihydrate; buff colored capsules are imprinted “93” - “3109” and contain 500 mg amoxicillin as the trihydrate. 250 mg available in bottles of 100, 500, and in unit dose cartons of 100 (10 x 10). 500 mg available in bottles of 50, 500, and in unit dose cartons of 100 (10 x 10). Amoxicillin for oral suspension USP: Each 5 mL of reconstituted suspension, when reconstituted according to directions on the container label, contains 125 mg or 250 mg amoxicillin as the trihydrate. 125 mg/5 mL available in bottles of 80 mL, 100 mL, and 150 mL. 250 mg/5 mL available in bottles of 80 mL, 100 mL, and 150 mL. Amoxicillin tablets USP (chewable): White to off-white, capsule-shaped tablets, debossed “93” on one side and “2267” on the other side, contain 125 mg amoxicillin as the trihydrate; white to off-white, capsule-shaped tablets, partial bisect and debossed “93” on one side and “2268” on the other side, contain 250 mg amoxicillin as the trihydrate. 125 mg available in bottles of 100. 250 mg available in bottles of 100 and 500. Store at 20 ° to 25 ° C (68 ° to 77 ° F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Status de autorização:

Abbreviated New Drug Application

Características técnicas

AMOXICILLIN- AMOXICILLIN TABLET
REBEL DISTRIBUTORS CORP.
----------
AMOXICILLIN CAPSULES USP, 250 MG AND 500 MG/ AMOXICILLIN FOR ORAL
SUSPENSION USP, 125 MG PER 5 ML AND 250 MG PER 5 ML/AMOXICILLIN
TABLETS USP
(CHEWABLE), 125 MG AND 250 MG
3107
3109
2267
2268
4150
4155
RX ONLY
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.
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 (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:
C
H N O S•3H O 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 gu