Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
AMPICILLIN TRIHYDRATE (UNII: HXQ6A1N7R6) (AMPICILLIN - UNII:7C782967RD)
Sandoz Inc
AMPICILLIN TRIHYDRATE
AMPICILLIN 250 mg
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin capsules, ampicillin for oral suspension and other antibacterial drugs, ampicillin capsules and ampicillin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting of modifying antimicrobial therapy, in the absence of such data, local epidemiology and susceptibility patterns contribute to the empiric selection of therapy. Ampicillin capsules and ampicillin for oral suspension are indicated in the treatment of infections caused by susceptible strains of the designated organisms listed below: Infections of the genitourinary tract including gonorrhea: E. coli, P. mirabilis, enterococci , Shigella, S. typhosa and other Salmonella , and nonpenicillinase producing N. gonorrhoeae . Infections of the respiratory tract: Nonpenicillinase- producing
Ampicillin capsules, USP: Each capsule, for oral administration, contains ampicillin trihydrate equivalent to 250 mg or 500 mg ampicillin, and are supplied as: 250 mg: white, opaque, hard gelatin capsules, imprinted in black ink GG 850/GG 850. NDC 0781-2144-01 in bottles of 100 NDC 0781-2144-05 in bottles of 500 500 mg: white, opaque, hard gelatin capsules, imprinted in black ink GG 851/GG 851. NDC 0781-2145-01 in bottles of 100 NDC 0781-2145-05 in bottles of 500 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Clinitest® is a registered trademark of Miles, Inc. Clinistix® is a registered trademark of Bayer Corporation. Tes-Tape® is a registered trademark of Eli Lilly Company. Revised: August 2020 46275512 Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540
Abbreviated New Drug Application
AMPICILLIN- AMPICILLIN CAPSULE SANDOZ INC ---------- AMPICILLIN CAPSULES, USP RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin and other antibacterial drugs, ampicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Ampicillin trihydrate is a semisynthetic penicillin derived from the basic penicillin nucleus, 6- aminopenicillanic acid. Ampicillin is designated chemically as (2S, 5_R_, 6_R_)-6-[(_R_)-2-Amino-2- phenylacetamido]-3,3- dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2- carboxylic acid. Its structural formula is: Molecular formula: C H N O S · 3 H O Molecular weight: 403.5 Ampicillin capsules, USP for oral administration provide ampicillin trihydrate equivalent to 250 mg and 500 mg ampicillin. Inactive ingredients: black iron oxide, gelatin, magnesium stearate, titanium dioxide, shellac, propylene glycol, ammonium hydroxide, and potassium hydroxide. CLINICAL PHARMACOLOGY Ampicillin is bactericidal at low concentrations and is clinically effective not only against the gram- positive organisms usually susceptible to penicillin G but also against a variety of gram-negative organisms. It is stable in the presence of gastric acid and is well absorbed from the gastrointestinal tract. It diffuses readily into most body tissues and fluids; however, penetration into the cerebrospinal fluid and brain occurs only with meningeal inflammation. Ampicillin is excreted largely unchanged in the urine; its excretion can be delayed by concurrent administration of probenecid which inhibits the renal tubular secretion of ampicillin. In blood serum, ampicillin is the least bound of all the penicillins; an average of about 20 percent of the drug is bound to plasma proteins as compared to 60 to 90 percent of the other penicillins. The administration of 500 mg dose of ampicillin capsules results in an average peak blood serum level of approximately 3.0 mcg/mL. MICROBIOLOGY Mechanism of A Olvassa el a teljes dokumentumot