IMIPENEM AND CILASTATIN sodium injection powder for solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

Imipenem (UNII: 71OTZ9ZE0A) (IMIPENEM ANHYDROUS - UNII:Q20IM7HE75)

Dostupné s:

Cardinal Health

INN (Mezinárodní Name):

Imipenem

Složení:

IMIPENEM ANHYDROUS 500 mg

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

IMIPENEM AND CILASTATIN- IMIPENEM AND CILASTATIN SODIUM INJECTION,
POWDER, FOR SOLUTION
CARDINAL HEALTH
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IMIPENEM AND CILASTATIN FOR INJECTION, USP (I.V.)
451205B/Revised: September 2012
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of imipenem and
cilastatin for injection (I.V.) and other antibacterial drugs,
imipenem and cilastatin for injection (I.V.)
should be used only to treat or prevent infections that are proven or
strongly suspected to be caused by
bacteria.
FOR INTRAVENOUS INJECTION ONLY
DESCRIPTION
Imipenem and Cilastatin for Injection, USP (I.V.) is a sterile
formulation of imipenem (a thienamycin
antibiotic) and cilastatin sodium (the inhibitor of the renal
dipeptidase, dehydropeptidase I), with sodium
bicarbonate added as a buffer. Imipenem and Cilastatin for Injection,
USP (I.V.) is a potent broad
spectrum antibacterial agent for intravenous administration.
Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline
derivative of thienamycin, which is
produced by _Streptomyces cattleya_. Its chemical name is
(5_R_,6_S_)-3-[[2-(formimidoylamino)ethyl]thio]-6-
[(_R_)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic
acid monohydrate. It is an off-
white, nonhygroscopic crystalline compound with a molecular weight of
317.37. It is sparingly soluble
in water and slightly soluble in methanol. Its empirical formula is C
H N O S•H O, and its structural
formula is:
Cilastatin sodium is the sodium salt of a derivatized heptenoic acid.
Its chemical name is sodium (_Z_)-
7[[(_R_)-2-amino-2-carboxyethyl]thio]-2-[(_S_)-2,2-dimethylcyclopropanecarboxamido]-2-heptenoate.
It is
an off-white to yellowish-white, hygroscopic, amorphous compound with
a molecular weight of
380.43. It is very soluble in water and in methanol. Its empirical
formula is C
H N O SNa, and its
structural formula is:
Imipenem and Cilastatin for Injection, USP (I.V.) is buffered to
provide solutions in the pH range of 6.5
to 8.5. There is no significant change in pH when solu