LIPODOX doxorubicin hydrochloride injectable liposomal

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

DOXORUBICIN HYDROCHLORIDE (UNII: 82F2G7BL4E) (DOXORUBICIN - UNII:80168379AG)

Disponible depuis:

Sun Pharma Global FZE

DCI (Dénomination commune internationale):

DOXORUBICIN HYDROCHLORIDE

Composition:

DOXORUBICIN HYDROCHLORIDE 2 mg in 1 mL

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

Unapproved drug for use in drug shortage

Résumé des caractéristiques du produit

LIPODOX - DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL
LIPODOX 50 - DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL
SUN PHARMA GLOBAL FZE
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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FOR THE USE OF AN ONCOLOGIST OR A CANCER HOSPITAL OR A LABORATORY
ONLY.
DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION
LIPODOX LIPODOX 50
(PEGYLATED LIPOSOMAL)
DOSAGE FORM:
Concentrate for Intravenous infusion
COMPOS ITION:
Each ml contains:
Doxorubicin Hydrochloride IP 2 mg
(as pegylated liposomal)
Water for Injection IP q.s.
LIPODOX is provided as a sterile, transluscent, red dispersion in
single use vials.
DES CRIPTION:
LIPODOX is doxorubicin hydrochloride encapsulated in long circulating
pegylated Liposomes.
Liposomes are microscopic vesicles composed of a phospholipid bilayer
that are capable of
encapsulating active drugs. The pegylated Liposomes of doxorubicin are
formulated with surface
bound methoxypolyethylene glycol (MPEG), a process often referred to
as pegylation, to protect
liposomes from detection by the mononuclear phagocyte system (MPS) and
to increase blood
circulation time.
Pegylated liposomes have a half life of approximately 55 hours in
humans. They are stable in blood and
direct measurement of liposomal doxorubicin shows that atleast 90% of
the drug remains liposome
encapsulated during circulation.
It is hypothesized that because of their small size and persistence in
the circulation, the pegylated
doxorubicin liposomes are able to penetrate the altered and often
compromised vasculature of tumors.
Once the pegylated liposomes distribute to the tissue compartment, the
encapsulated doxorubicin HCL
becomes available. The exact mechanism of release is not understood.
CLINICAL PHARMACOLOGY
Doxorubicin is a cytotoxic anthracycline antibiotic isolated from
_Streptomyces peucetius _var. _caesius_. It
is indicated for the treatment of metastatic carcinoma of the ovary,
me