AMPICILLIN- ampicillin sodium injection, powder, for solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

AMPICILLIN SODIUM (UNII: JFN36L5S8K) (AMPICILLIN - UNII:7C782967RD)

Disponível em:

GC Hanford Manufacturing Company

DCI (Denominação Comum Internacional):

AMPICILLIN SODIUM

Composição:

AMPICILLIN 250 mg

Via de administração:

INTRAMUSCULAR

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

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

Status de autorização:

Abbreviated New Drug Application

Características técnicas

AMPICILLIN- AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION
GC HANFORD MANUFACTURING COMPANY
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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