CYCLOSPORINE capsule, gelatin coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

CYCLOSPORINE

Composition:

CYCLOSPORINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyclosporine capsules, USP (NON-MODIFIED) are 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. Cyclosporine capsules are contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation.

Product summary:

Cyclosporine capsules, USP (NON-MODIFIED ) 25 mg Hard gelatin capsules with a pale reddish brown opaque body and a pale reddish brown opaque cap. "APO" over "133" and "25" are imprinted on each capsule in black ink; supplied in unit dose packages of 30 (5 × 6) NDC 68084-879-25. 100 mg Hard gelatin capsules with a reddish brown opaque body and a reddish brown opaque cap. "APO" over "134" and "100" are imprinted on each capsule in black ink; supplied in unit dose packages of 30 (5 x 6) NDC 68084-921-25. Store and Dispense Store at 20° to 25°C (66° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. *Neoral ® (cyclosporine capsules, USP) MODIFIED manufactured by Novartis.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOSPORINE- CYCLOSPORINE CAPSULE, GELATIN COATED
AMERICAN HEALTH PACKAGING
----------
CYCLOSPORINE CAPSULES, USP
8287925/0216OS
RX ONLY
PRESCRIBING INFORMATION
WARNING
Only physicians experienced in immunosuppressive therapy and
management of
organ transplant patients should prescribe cyclosporine capsules,
(NON-
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, (NON-MODIFIED) 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 capsules, (NON-MODIFIED) have decreased bioavailability
in
comparison to Neoral
* (cyclosporine capsules, USP) MODIFIED.
Cyclosporine capsules, (NON-MODIFIED) and Neoral
* (cyclosporine capsules,
USP) MODIFIED are not bioequivalent and cannot be used interchangeably
without
physician supervision.
The absorption of cyclosporine during chronic administration of
cyclosporine
capsules, USP (NON-MODIFIED) was found to be erratic. It is
recommended that
patients taking cyclosporine capsules, (NON-MODIFIED) over a period of
time be
monitored at repeated intervals for cyclosporine blood concentrations
and
subsequent dose adjustments be made in order to avoid toxicity due to
high
concentrations and possible organ rejection due to low absorption of
cyclosporine.
This is of special importance in liver transplants. Numerous assays
are being
developed to measure blood concentrations of cyclosporine. Comparison
of
concentrations in published literature to patient concentrations using
current
assays must be done with detailed knowledge of the assay methods
employed.
(See BLOOD CONCENTRATION MONITORING under DOSAGE AND
ADMINISTRATION.)
DESCRIPTION
Cyclosporine, the active principle in cyc