Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
AMPICILLIN TRIHYDRATE (UNII: HXQ6A1N7R6) (AMPICILLIN - UNII:7C782967RD)
PD-Rx Pharmaceuticals, Inc.
AMPICILLIN TRIHYDRATE
AMPICILLIN 500 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
AMPICILLIN- AMPICILLIN CAPSULE PD-RX PHARMACEUTICALS, INC. REFERENCE LABEL SET ID: 4DD38D9B-C5CF-450A-8C78-0BA312BDBF6F ---------- AMPICILLIN CAPSULES, USP 500 MG RX ONLY 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. DESCRIPTION Ampicillin trihydrate is a semisynthetic penicillin derived from the basic penicillin nucleus, 6- aminopenicillanic acid. Ampicillin is designated chemically as (2S, 5R, 6R)-6-[(R)-2-Amino-2- phenylacetamido]-3, 3-dimethyl-7-oxo-4-thia-l-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It has the following chemical structure: The molecular formula is C H N O S.3H O, and the molecular weight is 403.45. Ampicillin Capsules, USP for oral administration provide ampicillin trihydrate equivalent to 250 mg and 500 mg ampicillin. Ampicillin Capsules also contain magnesium stearate. The capsule shell contains black iron oxide, D&C red No. 28, FD&C blue No. 1, gelatin, silicon dioxide, sodium lauryl sulfate, and titanium dioxide. Ampicillin for Oral Suspension, USP provides ampicillin trihydrate equivalent to 125 mg/5 mL and 250 mg/5 mL ampicillin. Ampicillin for Oral Suspension also contains carboxymethylcellulose sodium, colloidal silicon dioxide, flavors, microcrystalline cellulose, sodium citrate, sodium propionate, and sucrose. 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 inf Přečtěte si celý dokument