CYCLOSPORINE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

CYCLOSPORINE

Composition:

CYCLOSPORINE 100 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyclosporine Oral Solution USP MODIFIED is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine Oral Solution USP MODIFIED has been used in combination with azathioprine and corticosteroids. Cyclosporine Oral Solution USP MODIFIED is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine Oral Solution USP MODIFIED can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Cyclosporine Oral Solution USP 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

Product summary:

Cyclosporine Oral Solution USP MODIFIED is available as a yellowish to yellow-brown oily liquid containing 100 mg/mL cyclosporine, USP in a 50 mL bottle (NDC 0172-7313-20). Store and Dispense PHARMACIST: Store and dispense in the original container at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 20°C (68°F) the solution may gel; light flocculation or the formation of a light sediment may also occur. This solution, when mixed with juice, may appear cloudy. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 25°C (77°F) to reverse these changes. 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. F 4/2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOSPORINE- CYCLOSPORINE SOLUTION
TEVA PHARMACEUTICALS USA, INC.
----------
CYCLOSPORINE ORAL SOLUTION USP MODIFIED
7313
RX ONLY
PRESCRIBING INFORMATION
WARNING
ONLY PHYSICIANS EXPERIENCED IN MANAGEMENT OF SYSTEMIC
IMMUNOSUPPRESSIVE THERAPY FOR
THE INDICATED DISEASE SHOULD PRESCRIBE CYCLOSPORINE ORAL SOLUTION USP
MODIFIED. AT
DOSES USED IN SOLID ORGAN TRANSPLANTATION, ONLY PHYSICIANS EXPERIENCED
IN
IMMUNOSUPPRESSIVE THERAPY AND MANAGEMENT OF ORGAN TRANSPLANT
RECIPIENTS SHOULD
PRESCRIBE CYCLOSPORINE ORAL SOLUTION 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 ORAL SOLUTION USP MODIFIED, A SYSTEMIC IMMUNOSUPPRESSANT,
MAY
INCREASE THE SUSCEPTIBILITY TO INFECTION AND THE DEVELOPMENT OF
NEOPLASIA. IN KIDNEY, LIVER,
AND HEART TRANSPLANT PATIENTS CYCLOSPORINE ORAL SOLUTION 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 ORAL SOLUTION USP MODIFIED HAS INCREASED BIOAVAILABILITY
IN COMPARISON TO
SANDIMMUNE (CYCLOSPORINE ORAL SOLUTION USP). CYCLOSPORINE ORAL SOLUTION USP
MODIFIED AND SANDIMMUNE (CYCLOSPORINE ORAL SOLUTION USP) ARE NOT
BIOEQUIVALENT AND
CANNOT BE USED INTERCHANGEABLY WITHOUT PHYSICIAN SUPERVISION. FOR A
GIVEN TROUGH
CONCENTRATION, CYCLOSPORINE EXPOSURE WILL BE GREATER WITH CYCLOSPORINE
ORAL SOLUTION USP
MODIFIED THAN WITH SANDIMMUNE (CYCLOSPORINE ORAL SOLUTION USP). IF A
PATIENT WHO IS
RECEIVING EXCEPTIONALLY HIGH DOSES OF SANDIMMUNE (CYCLOSPORINE ORAL
SOLUTION USP) IS
CONVERTED TO CYCLOSPORINE ORAL SOLUTION USP MODIFIED, PARTICULAR
CAUTION SHOULD BE
EXERCISED. CYCLOSPORINE BLOOD CONCENTRATIONS SHOULD BE MONITORED IN
TRANSPLANT AND
RHEUMATOID ART