AMPICILLIN- ampicillin sodium injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Ampicillin Sodium (UNII: JFN36L5S8K) (Ampicillin - UNII:7C782967RD)

Available from:

C.O. Truxton, Inc.

INN (International Name):

Ampicillin Sodium

Composition:

Ampicillin Sodium 1 g

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic Streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis ). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus sp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella sp. respond to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effe

Product summary:

Ampicillin for Injection, USP for I.M.or I.V. Injection. Each vial contains Ampicillin sodium equivalent to 1 gram ampicillin per vial. Store dry powder at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]. NDC 0463-1118-10 1 gram vial packaged in 10s

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMPICILLIN - AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION
C.O. TRUXTON, INC.
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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 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 bacteria.
DESCRIPTION
Ampicillin for Injection, USP the monosodium salt of
[2S-[2α,5α,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:
Ampicillin sodium is a white to off-white crystalline powder with the
molecular formula of
C
H N NaO S, and the molecular weight of 371.39. Each vial of Ampicillin
for Injection contains
ampicillin sodium equivalent to 1 gram ampicillin. Ampicillin for
Injection, USP contains 2.9
milliequivalents of sodium (66 mg of sodium) per 1 gram of drug.
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
strains