AMPICILLIN injection, powder, for solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Mylan Institutional LLC

INN (International Name):

AMPICILLIN SODIUM

Sammensetning:

AMPICILLIN 250 mg

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 Streptococcus 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 spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of

Produkt oppsummering:

Ampicillin for Injection, USP for IM or IV Injection. Each vial of ampicillin for injection contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram, or 2 grams ampicillin. 67457-353-10 250 mg vial packaged in 10s 67457-350-10 500 mg vial packaged in 10s 67457-351-10 1 gram vial packaged in 10s 67457-352-10 2 grams vial packaged in 10s Store dry powder at 20o to 25o C (68o to 77o F). [See USP Controlled Room Temperature.] Protect the constituted solution from freezing. Clinitest is a registered trademark of Miles, Inc. Clinistix is a registered trademark of Bayer Corporation. Tes-Tape is a registered trademark of Eli Lilly Company. Manufactured for: Mylan Institutional LLC Rockford, IL 61103 U.S.A. Manufactured by: MITIM S.r.l. Via Cacciamali n°34-36-38 25125 Brescia, ITALY (premises) Via Rodi n° 27 Brescia, ITALY (headquarters) FEBRUARY 2018

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

AMPICILLIN- AMPICILLIN INJECTION, POWDER, FOR SOLUTION
MYLAN INSTITUTIONAL LLC
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AMPICILLIN FOR INJECTION, USP
(FOR INTRAMUSCULAR OR INTRAVENOUS INJECTION)
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.
Ampicillin for Injection, USP is a white to off-white crystalline
sterile powder and forms a clear
colorless solution upon reconstitution with sterile water for
injection, USP or Bacteriostatic water for
injection, USP.
Each vial of ampicillin for injection, USP contains ampicillin sodium
equivalent to 250 mg, 500 mg, 1
gram or 2 grams ampicillin. The sodium content is 16.46 mg (0.71 mEq)
per 250 mg, 32.91 mg (1.43
mEq) per 500 mg, 65.83 mg (2.86 mEq) per 1 g, 131.66 mg (5.72 mEq) per
2 g of ampicillin.
It has the following molecular structure:
The molecular formula is C
H N NaO S, and the molecular weight is 371.39. The pH range of the
reconstituted solution is 8 to 10.
CLINICAL PHARMACOLOGY
Ampicillin for injection 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. Due to maturational changes in renal function, ampicillin
half-life decreases as
postmenstrual age (a sum of gestational age and postnatal age)
increases for infants with postnatal age of
less than 28 days. The