CYCLOSPORINE- cyclosporine capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Eon Labs, Inc.

INN (International Name):

CYCLOSPORINE

Composition:

CYCLOSPORINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyclosporine Capsules USP (Modified) are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine Capsules USP (Modified) have been used in combination with azathioprine and corticosteroids. Cyclosporine Capsules USP (Modified) are indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine Capsules USP (Modified) can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Cyclosporine Capsules USP (Modified) are indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., PUVA, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated, or cannot be tolerated. While rebound rarely occurs, most patie

Product summary:

CycloSPORINE Capsules USP (Modified), for oral administration, are available as 25 mg Clear, oblong soft gelatin capsules, imprinted “E 0932”, filled with clear yellowish oil-like liquid and supplied as: NDC 0185-0932-86 unit-dose blister card of 5 capsules NDC 0185-0932-30 carton of 6 blister cards 100 mg Clear, oblong soft gelatin capsules, imprinted “E 0933”, filled with clear yellowish oil-like liquid and supplied as: NDC 0185-0933-86 unit-dose blister card of 5 capsules NDC 0185-0933-30 carton of 6 blister cards *Sandimmune® is a registered trademark of Novartis Pharmaceuticals Corporation. Storage: Store at 20° to 25°C (68°to 77°F) [See USP Controlled Room Temperature]. Dispense contents in the original unit-dose container. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Made in Switzerland for: Sandoz Inc. Princeton, NJ 08540 OS8443 Rev. October 2015 MF0933REV10/15

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOSPORINE- CYCLOSPORINE CAPSULE
EON LABS, INC.
----------
CYCLOSPORINE CAPSULES USP (MODIFIED)
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) and Cyclosporine Oral Solution
USP (Modified) have
increased bioavailability in comparison to Sandimmune® Soft Gelatin
Capsules (cyclosporine
capsules, USP). Cyclosporine Capsules USP (Modified) and Sandimmune®
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®. If a patient who is receiving
exceptionally high doses of
Sandimmune® 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 toxicity due
to high concentrations.