NEORAL cyclosporine capsule liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health

INN (International Name):

CYCLOSPORINE

Composition:

CYCLOSPORINE 25 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

NEORAL- CYCLOSPORINE CAPSULE, LIQUID FILLED
CARDINAL HEALTH
----------
NEORAL SOFT GELATIN CAPSULES (CYCLOSPORINE CAPSULES, USP) MODIFIED
NEORAL ORAL SOLUTION (CYCLOSPORINE ORAL SOLUTION, USP) MODIFIED
RX ONLY
PRESCRIBING INFORMATION
WARNING
Only physicians experienced in management of systemic
immunosuppressive therapy for the
indicated disease should prescribe Neoral
. At doses used in solid organ transplantation, only
physicians experienced in immunosuppressive therapy and management of
organ transplant
recipients should prescribe Neoral
. 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.
Neoral
, a systemic immunosuppressant, may increase the susceptibility to
infection and the
development of neoplasia. In kidney, liver, and heart transplant
patients Neoral
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.
Neoral
Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED and Neoral
Oral
Solution (cyclosporine oral solution, USP) MODIFIED have increased
bioavailability in
comparison to Sandimmune
Soft Gelatin Capsules (cyclosporine capsules, USP) and
Sandimmune
Oral Solution (cyclosporine oral solution, USP). Neoral
and Sandimmune
are not
bioequivalent and cannot be used interchangeably without physician
supervision. For a given
trough concentration, cyclosporine exposure will be greater with
Neoral
than with
Sandimmune
. If a patient who is receiving exceptionally high doses of Sandimmune
is
converted to Neoral
, particular caution should be exercised. Cyclosporine blood
concentrations
should be monitored in transplant and rheumatoid arthritis patients
taking Neoral
to avoid toxicity
due to high concentr