CYCLOSPORINE injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)

Disponible desde:

Bryant Ranch Prepack

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Cyclosporine is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is always to be used with adrenal corticosteroids. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents. Because of the risk of anaphylaxis, cyclosporine injection should be reserved for patients who are unable to take the soft gelatin capsules or oral solution. Cyclosporine injection is contraindicated in patients with a hypersensitivity to cyclosporine and/or Cremophor ® EL (polyoxyethylated castor oil).

Resumen del producto:

CycloSPORINE Injection USP, 50 mg/mL FOR INTRAVENOUS INFUSION Supplied as a 5 mL sterile ampule containing 50 mg of cyclosporine per mL, in boxes of 10 ampules. (NDC 63629-8640-1) Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. Discard unused portion. *Cremophor is the registered trademark of BASF Aktiengesellschaft. **Neoral is a registered trademark of Novartis Pharmaceutical Corporation.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

CYCLOSPORINE- CYCLOSPORINE INJECTION, SOLUTION
BRYANT RANCH PREPACK
----------
CYCLOSPORINE INJECTION, USP
_FOR INTRAVENOUS INFUSION ONLY_
RX ONLY
PRESCRIBING INFORMATION
BOXED WARNING
Only physicians experienced in immunosuppressive therapy and
management of
organ transplant patients should prescribe cyclosporine. Patients
receiving the
drug should be managed in facilities equipped and staffed with
adequate laboratory
and supportive medical resources. The physician responsible for
maintenance
therapy should have complete information requisite for the follow-up
of the patient.
Cyclosporine should be administered with adrenal corticosteroids but
not with
other immunosuppressive agents. Increased susceptibility to infection
and the
possible development of lymphoma may result from immunosuppression.
Cyclosporine and cyclosporine [MODIFIED] are not bioequivalent and
cannot be
used interchangeably without physician supervision.
DESCRIPTION
Cyclosporine, the active principle in cycloSPORINE injection, USP is a
cyclic polypeptide
immunosuppressant agent consisting of 11 amino acids. It is produced
as a metabolite
by the fungus species _Beauveria nivea_.
Chemically, cyclosporine is designated as [ _R_-[ _R_*, _R_*-(
_E_)]]-cyclic(L-alanyl-D-alanyl- _N_-
methyl-L-leucyl- _N-_methyl-L-leucyl- _N_-methyl-L-valyl-3-hydroxy-
_N_,4-dimethyl-L-2-amino-
6-octenoyl-L-α-amino-butyryl- _N-_methylglycyl-
_N_-methyl-L-leucyl-L-valyl- _N_-methyl-L-
leucyl).
CycloSPORINE injection, USP is available in a 5 mL sterile ampule for
intravenous
administration.
Each mL contains Cyclosporine USP, 50 mg; *Cremophor
EL (polyoxyethylated castor
oil), 650 mg; Absolute Alcohol, 32.9% (v/v). Cyclosporine injection,
USP must be diluted
further with 0.9% Sodium Chloride Injection or 5% Dextrose Injection
before use.
The chemical structure of cyclosporine (also known as cyclosporin A)
is:
®
CLINICAL PHARMACOLOGY
Cyclosporine is a potent immunosuppressive agent which in animals
prolongs survival of
allogeneic transplants involving skin, heart, kidney,