Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
AMPICILLIN TRIHYDRATE (UNII: HXQ6A1N7R6) (AMPICILLIN - UNII:7C782967RD)
Physicians Total Care, Inc.
AMPICILLIN TRIHYDRATE
AMPICILLIN 500 mg
ORAL
PRESCRIPTION DRUG
Ampicillin Capsules, USP are indicated in the treatment of infections caused by susceptible strains of the designated organism listed below: INFECTIONS OF THE GENITOURINARY TRACT INCLUDING GONORRHEA: E. coli, P. mirabilis, enterococci, Shigella, S. typhosa and other Salmonella , and nonpenicillinaseproducing N. gonorrhoeae . INFECTIONS OF THE RESPIRATORY TRACT: Nonpenicillinase- producing H. influenzae and staphylococci, and streptococci including streptococcus pneumoniae . INFECTIONS OF THE GASTROINTESTINAL TRACT: Shigella, S. typhosa and other Salmonella, E. coli, P. mirabilis, and enterococci. MENINGITIS: N. Meningitides . 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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying anti
Ampicillin Capsules, USP: Each capsule, for oral administration, contains ampicillin trihydrate equivalent to 250 mg or 500 mg ampicillin, and are supplied as: 500 mg: white, opaque, hard gelatin capsules, imprinted in black ink GG 851/GG 851. NDC 54868-3113-1 in bottles of 14 NDC 54868-3113-5 in bottles of 30 Store at 20°-25°C (68°- 77°F) (see USP Controlled Room Temperature). Dispense in a tight container. Rev. 11-2006 8077 399658 Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146
Abbreviated New Drug Application
AMPICILLIN - AMPICILLIN CAPSULE PHYSICIANS TOTAL CARE, INC. ---------- AMPICILLIN CAPSULES, USP 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: 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 and titanium dioxide. 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: While _in vitro _studies have demonstrated the susceptibility of most strains of the following organisms, clinical efficacy for infect Olvassa el a teljes dokumentumot