CYCLOSPORINE capsule, liquid filled

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Physicians Total Care, Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 patients will

Dettagli prodotto:

“100 mg” in blue ink, containing 100 mg Cyclosporine USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in two (2) unit-dose cartons of 30 capsules = 60 capsules  (NDC 54868-6232-0). PHARMACIST: Dispense in original unit-dose container. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Sandimmune® is a registered trademark of Novartis. Manufactured In Czech Republic By: TEVA CZECH INDUSTRIES s.r.o. Opava-Komarov, Czech Republic Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. C 4/2010 CYCLOSPORINE CAPSULES USP MODIFIED (Soft Gelatin Capsules) Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK       74146

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

CYCLOSPORINE - CYCLOSPORINE CAPSULE, LIQUID FILLED
PHYSICIANS TOTAL CARE, INC.
----------
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