Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
AMPICILLIN TRIHYDRATE (UNII: HXQ6A1N7R6) (AMPICILLIN - UNII:7C782967RD)
NuCare Pharmaceuticals, 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 nonpenicillinase producing 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 bact
500 mg: white, opaque, hard gelatin capsules, imprinted in black ink GG 851/GG 851. NDC 68071-1981-8 bottles of 28 NDC 68071-1981-3 bottles of 30 NDC 68071-1981-1 bottles of 21 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.
Abbreviated New Drug Application
AMPICILLIN- AMPICILLIN CAPSULE NUCARE PHARMACEUTICALS, 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, 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 Action Ampicillin is similar to penicillin in its b Aqra d-dokument sħiħ