CYCLOSPORINE MODIFIED- cyclosporine capsule, liquid filled

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Teva Pharmaceuticals USA, Inc.

INN (Међународно име):

CYCLOSPORINE

Састав:

CYCLOSPORINE 25 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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 experience relapse with Cyclosporine Capsules USP MODIFIED as with other therapies upon cessation of treatment. Cyclosporine Capsules USP MODIFIED are 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 USP MODIFIED. Psoriasis patients who are treated with Cyclosporine Capsules USP 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 USP MODIFIED.

Резиме производа:

Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, printed “Ivax hourglass logo” and “25 mg”, containing 25 mg Cyclosporine, USP MODIFIED and 15.8% v/v (12.4% wt./vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-9018-65). Cyclosporine Capsules USP MODIFIED are available as ochre-yellow soft gelatin (oblong 11) capsules, filled with yellowish to yellow-brown oily liquid, printed “Ivax hourglass logo” and “50 mg”, containing 50 mg Cyclosporine, USP MODIFIED and 15.8% v/v (12.4% wt./vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-9019-65). Cyclosporine Capsules USP MODIFIED are available as brown soft gelatin (oblong 20) capsules, filled with yellowish to yellow-brown oily liquid, printed “Ivax hourglass logo” and “100 mg”, containing 100 mg Cyclosporine, USP MODIFIED and 15.8% v/v (12.4% wt./vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-9020-65). Store and Dispense PHARMACIST: Dispense in original unit-dose container. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep this and all medications out of the reach of children. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA. Manufactured In Czech Republic By: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. L 3/2024

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

CYCLOSPORINE MODIFIED- CYCLOSPORINE CAPSULE, LIQUID FILLED
TEVA PHARMACEUTICALS USA, 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 have 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