Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN - UNII:804826J2HU)
Rebel Distributors Corp.
AMOXICILLIN
AMOXICILLIN 250 mg
ORAL
PRESCRIPTION DRUG
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
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).
Abbreviated New Drug Application
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 Przeczytaj cały dokument