国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
AMPICILLIN SODIUM (UNII: JFN36L5S8K) (AMPICILLIN - UNII:7C782967RD)
GC Hanford Manufacturing Company
AMPICILLIN SODIUM
AMPICILLIN 250 mg
INTRAMUSCULAR
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP 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 antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: Respiratory Tract Infections caused by S. pneumoniae (formerly D. pneumoniae), Staphylococcus aureus (penicillinase and non penicillinase-producing), H. influenzae and Group A beta-hemolytic Streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negati
Ampicillin for Injection, USP equivalent to 125, 250, 500 mg, 1 or 2 grams ampicillin as the sodium salt per vial is supplied as follows: NDC10515-143-00 125 mg vial (Tray of 10) NDC10515-145-00 250 mg vial (Tray of 10) NDC10515-146-00 500 mg vial (Tray of 10) NDC10515-772-00 1 gram vial (Tray of 10) NDC10515-140-00 2 gram vial (Tray of 10) NDC10515-147-00 500 mg “piggyback” vial (Tray of 10) NDC10515-139-00 1 gram “piggyback” vial (Tray of 10) NDC10515-141-00 2 gram “piggyback” vial (Tray of 10) Also available: Ampicillin for Injection, USP, Pharmacy Bulk Package bottle, contains ampicillin sodium equivalent to 10 grams ampicillin per bottle. NDC10515-142-00 10 gram Pharmacy Bulk Package (Tray of 10) Ampicillin for Injection, USP dry powder should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Rx only CLINITEST® is a registered trademark of Siemans Medical Solutions Diagnostics. CLINISTIX® is a registered trademark of Bayer Healthcare LLC. MANUFACTURED BY: G. C. Hanford Mfg. Co. Syracuse, New York 13201 USA INS11080 12 06/2013
Abbreviated New Drug Application
AMPICILLIN- AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION GC HANFORD MANUFACTURING COMPANY ---------- AMPICILLIN FOR INJECTION, USP FOR INTRAMUSCULAR OR INTRAVENOUS INJECTION To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Ampicillin for Injection, USP, the monosodium salt of [2S-[2α, 5 α, 6β(S*)]]-6- [(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. It has the following chemical structure: The molecular formula is C H N NaO S, and the molecular weight is 371.39. Ampicillin for Injection, USP contains 2.9 milliequivalents of sodium per 1 gram of drug. Ampicillin for Injection, USP is supplied in vials equivalent to 125 mg, 250 mg, 500 mg, 1 gram or 2 grams of ampicillin. It is to be administered by intravenous or intramuscular routes. CLINICAL PHARMACOLOGY Ampicillin for Injection, USP diffuses readily into most body tissues and fluids. However, penetration into the cerebrospinal fluid and brain occurs only when the meninges are inflamed. Ampicillin is excreted largely unchanged in the urine and its excretion can be delayed by concurrent administration of probenecid. The active form appears in the bile in higher concentrations than those found in serum. Ampicillin is the least serum-bound of all the penicillins, averaging about 20% compared to approximately 60 to 90% for other penicillins. Ampicillin for Injection, USP is well tolerated by most patients and has been given in doses of 2 grams daily for many weeks without adverse reactions. MICROBIOLOGY: While _in vitro_ studies have demonstrated the susceptibility of most st 阅读完整的文件