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:

General Injectables & Vaccines, Inc

INN (International Name):

AMPICILLIN SODIUM

Composition:

AMPICILLIN 500 mg in 500 mg

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 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-negative bacteria (Listeria monocytogenes, N. meningitidis).

Product summary:

Ampicillin for Injection, USP, equivalent to 250 mg, 500 mg, 1 or 2 grams ampicillin as the sodium salt per vial, is supplied as follows: Ampicillin for Injection, USP, is also available as a Pharmacy Bulk Package, containing 10 grams ampicillin as the sodium salt per vial, and is supplied as follows: Storage Conditions Store dry powder at 20˚ to 25˚C (68˚ to 77˚F). [See USP Controlled Room Temperature.] LATEX-FREE Sterile, Nonpyrogenic, Preservative-free. SAGENT Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in USA ©2009 Sagent Pharmaceuticals, Inc. INS15831 01 October 2009

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMPICILLIN- AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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AMPICILLIN FOR INJECTION, USP
FOR INTRAMUSCULAR OR INTRAVENOUS INJECTION
SAGENT RX ONLY
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 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 structural formula:
The molecular formula is C16H18N3NaO4S, 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 g or 2 g of
ampicillin. It is to be administered by intravenous or intramuscular
routes.
CLINICAL PHARMACOLOGY
Ampicillin 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 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 of the
following organisms, clinical eff