CYCLOSPORINE capsule, liquid filled

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Strides Pharma Science Limited

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Cyclosporine capsules (modified) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules (modified) has been used in combination with azathioprine and corticosteroids. Cyclosporine capsules (modified) is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine capsules (modified) can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Cyclosporine capsules (modified) is 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 experience relapse with cyclosporine capsules (modified) as with other therapies upon cessation of treatment. Cyclosporine capsules (modified) is contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation. Rheumatoid arthritis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive cyclosporine capsules, (modified). Psoriasis patients who are treated with cyclosporine capsules (modified) should not receive concomitant PUVA or UVB therapy, methotrexate or other immunosuppressive agents, coal tar or radiation therapy. Psoriasis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive cyclosporine capsules, (modified).

Resumo do produto:

Cyclosporine capsules, USP (modified) (Soft Gelatin Capsules) 25 mg Blue gray colored opaque oval shaped soft gelatin capsule imprinted as 'S 25' in red color ink, containing clear to cloudy pale yellow colored oily liquid. Packages of 30 unit-dose blisters (NDC 64380-127-02). 50 mg White colored opaque oblong shaped soft gelatin capsule imprinted as 'S 50' in red color ink, containing clear to cloudy pale yellow colored oily liquid Packages of 30 unit-dose blisters (NDC 64380-128-02). 100 mg Blue gray colored opaque oblong shaped soft gelatin capsule imprinted as 'S 100' in red color ink, containing clear to cloudy pale yellow colored oily liquid. Packages of 30 unit-dose blisters (NDC 64380-129-02). Store and Dispense In the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C). Cyclosporine Capsules, USP (MODIFIED) (Soft Gelatin Capsules) All registered trademarks in this document are the property of their respective owners. Manufactured by: Strides Pharma Science Limited. Bengaluru – 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Revised: 12/2021

Status de autorização:

Abbreviated New Drug Application

Características técnicas

CYCLOSPORINE - CYCLOSPORINE CAPSULE, LIQUID FILLED
STRIDES PHARMA SCIENCE LIMITED
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CYCLOSPORINE, MODIFIED - CYCLOSPORINE CAPSULE, LIQUID FILLED
RX ONLY
PRESCRIBING INFORMATION
WARNING
Only physicians experienced in management of systemic
immunosuppressive therapy for the indicated disease
should prescribe cyclosporine capsules, (modified). At doses used in
solid organ transplantation, only physicians
experienced in immunosuppressive therapy and management of organ
transplant recipients should prescribe
cyclosporine capsules, (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, (modified), a systemic immunosuppressant, may
increase the susceptibility to infection and
the development of neoplasia. In kidney, liver, and heart transplant
patients cyclosporine capsules, (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, (modified) have increased bioavailability in
comparison to Sandimmune Soft Gelatin
Capsules (cyclosporine capsules, USP) [NON-MODIFIED]. Cyclosporine
capsules, (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, (modified) than with Sandimmune.
If a patient who is receiving exceptionally high doses of Sandimmune
is converted to cyclosporine capsules,
(modified), particular caution should be exercised. Cyclosporine blood
concentrations should be monitored in
transplant and rheumatoid arthritis patients taking cyclosporine
capsules, (modified) to avoid toxicity due to