CYCLOSPORINE capsule liquid filled

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Cyclosporine (UNII: 83HN0GTJ6D) (Cyclosporine - UNII:83HN0GTJ6D)

Tilgjengelig fra:

Cardinal Health

INN (International Name):

Cyclosporine

Sammensetning:

Cyclosporine 100 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CYCLOSPORINE- CYCLOSPORINE CAPSULE, LIQUID FILLED
CARDINAL HEALTH
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CYCLOSPORINE CAPSULES USP MODIFIED (SOFT GELATIN CAPSULES)
RX ONLY
WARNING
Only physicians experienced in management of systemic
immunosuppressive therapy for the
indicated disease should prescribe Cyclosporine Capsules USP MODIFIED.
At doses used in
solid organ transplantation, only physicians experienced in
immunosuppressive therapy and
management of organ transplant recipients should prescribe
Cyclosporine Capsules USP
MODIFIED. 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 Capsules USP MODIFIED, a systemic immunosuppressant, may
increase the
susceptibility to infection and the development of neoplasia. In
kidney, liver, and heart transplant
patients Cyclosporine Capsules USP MODIFIED may be administered with
other
immunosuppressive agents. Increased susceptibility to infection and
the possible development of
lymphoma and other neoplasms may result from the increase in the
degree of immunosuppression
in transplant patients.
Cyclosporine Capsules USP MODIFIED has increased bioavailability in
comparison to
Sandimmune
(Cyclosporine Capsules USP). Cyclosporine Capsules USP MODIFIED and
Sandimmune
(Cyclosporine Capsules USP) are not bioequivalent and cannot be used
interchangeably without physician supervision. For a given trough
concentration, cyclosporine
exposure will be greater with Cyclosporine Capsules USP MODIFIED than
with Sandimmune
(Cyclosporine Capsules USP). If a patient who is receiving
exceptionally high doses of
Sandimmune
(Cyclosporine Capsules USP) is converted to Cyclosporine Capsules USP
MODIFIED, particular caution should be exercised. Cyclosporine blood
concentrations should
be monitored in transplant and rheumatoid arthritis patients taking
Cyclosporine Capsules USP
MODIFIED to avoid toxi