NEORAL- cyclosporine capsule, liquid filled NEORAL- cyclosporine solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Novartis Pharmaceuticals Corporation

INN (nemzetközi neve):

CYCLOSPORINE

Összetétel:

CYCLOSPORINE 25 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Neoral is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Neoral has been used in combination with azathioprine and corticosteroids. Neoral is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Neoral can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Neoral 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 Neoral as with other therapies upon cessation of treatment. Neoral 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 Neoral. Psoriasis patients who are treated with Neoral 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 Neoral. Although no adequate and well-controlled studies have been completed in children, transplant recipients as young as one year of age have received Neoral with no unusual adverse effects. The safety and efficacy of Neoral treatment in children with juvenile rheumatoid arthritis or psoriasis below the age of 18 have not been established. In rheumatoid arthritis clinical trials with cyclosporine, 17.5% of patients were age 65 or older. These patients were more likely to develop systolic hypertension on therapy, and more likely to show serum creatinine rises ≥ 50% above the baseline after 3 to 4 months of therapy. Clinical studies of Neoral in transplant and psoriasis patients did not include a sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experiences have not identified differences in response between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Termék összefoglaló:

Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED 25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.” Packages of 30 unit-dose blisters (NDC 0078-0246-15). 100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.” Packages of 30 unit-dose blisters (NDC 0078-0248-15). Store and Dispense In the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C). Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIED A clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22). Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes. Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIED Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 © Novartis Revised: September 2023 T2023-70

Engedélyezési státusz:

New Drug Application

Termékjellemzők

NEORAL- CYCLOSPORINE CAPSULE, LIQUID FILLED
NEORAL- CYCLOSPORINE SOLUTION
NOVARTIS PHARMACEUTICALS CORPORATION
----------
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