CYCLOSPORINE capsule, gelatin coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Apotex Corp.

INN (International Name):

CYCLOSPORINE

Composition:

CYCLOSPORINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyclosporine capsules, (NON-MODIFIED) are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is always to be used with adrenal corticosteroids. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.    Cyclosporine capsules are contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation.

Product summary:

Cyclosporine capsules, USP (NON-MODIFIED ) 25 mg Pale reddish brown opaque body, pale reddish brown opaque cap, hard gelatin capsule, imprinted " APO" over "133" and "25" in black ink; supplied in bottles of 30 (NDC 60505-0133-0), in bottles of 500 (NDC 60505-0133-2), and in bottles of 1,000 (NDC 60505-0133-1). 100 mg Reddish brown opaque body, reddish brown opaque cap, hard gelatin capsule, imprinted "APO" over "134" and "100" in black ink; supplied in bottles of 30 (NDC 60505-0134-0), in bottles of 500 (NDC 60505-0134-2), and in bottles of 1,000 (NDC 60505-0134-1). Store and Dispense Store at 20°C to 25°C (66°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. APOTEX INC. CYCLOSPORINE CAPSULES, USP 25 mg and 100 mg Manufactured by             Manufactured for Apotex Inc.                               Apotex Corp. Toronto, Ontario                       Weston, Florida Canada M9L 1T9                     USA 33326 Revised: November 2023 Rev. 11 *Neoral® (cyclosporine capsules, USP) MODIFIED manufactured by Novartis.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOSPORINE- CYCLOSPORINE CAPSULE, GELATIN COATED
APOTEX CORP.
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CYCLOSPORINE CAPSULES, USP
25 MG AND 100 MG
RX ONLY
PRESCRIBING INFORMATION
WARNING
ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND
MANAGEMENT OF ORGAN TRANSPLANT PATIENTS SHOULD PRESCRIBE CYCLOSPORINE
CAPSULES, (NON-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, (NON-MODIFIED) SHOULD BE ADMINISTERED WITH
ADRENAL CORTICOSTEROIDS BUT NOT WITH OTHER IMMUNOSUPPRESSIVE AGENTS.
INCREASED SUSCEPTIBILITY TO INFECTION AND THE POSSIBLE DEVELOPMENT OF
LYMPHOMA MAY RESULT FROM IMMUNOSUPPRESSION.
CYCLOSPORINE CAPSULES, (NON-MODIFIED) HAVE DECREASED BIOAVAILABILITY
IN
COMPARISON TO NEORAL
* (CYCLOSPORINE CAPSULES, USP) MODIFIED.
CYCLOSPORINE CAPSULES, (NON-MODIFIED) AND NEORAL
* (CYCLOSPORINE
CAPSULES, USP) MODIFIED ARE NOT BIOEQUIVALENT AND CANNOT BE USED
INTERCHANGEABLY WITHOUT PHYSICIAN SUPERVISION.
THE ABSORPTION OF CYCLOSPORINE DURING CHRONIC ADMINISTRATION OF
CYCLOSPORINE CAPSULES, (NON-MODIFIED) WAS FOUND TO BE ERRATIC. IT IS
RECOMMENDED THAT PATIENTS TAKING CYCLOSPORINE CAPSULES, (NON-
MODIFIED) OVER A PERIOD OF TIME BE MONITORED AT REPEATED INTERVALS FOR
CYCLOSPORINE BLOOD CONCENTRATIONS AND SUBSEQUENT DOSE ADJUSTMENTS BE
MADE IN ORDER TO AVOID TOXICITY DUE TO HIGH CONCENTRATIONS AND
POSSIBLE
ORGAN REJECTION DUE TO LOW ABSORPTION OF CYCLOSPORINE. THIS IS OF
SPECIAL
IMPORTANCE IN LIVER TRANSPLANTS. NUMEROUS ASSAYS ARE BEING DEVELOPED
TO
MEASURE BLOOD CONCENTRATIONS OF CYCLOSPORINE. COMPARISON OF
CONCENTRATIONS IN PUBLISHED LITERATURE TO PATIENT CONCENTRATIONS USING
CURRENT ASSAYS MUST BE DONE WITH DETAILED KNOWLEDGE OF THE ASSAY
METHODS EMPLOYED (SEE DOSAGE AND ADMINISTRATION, Blood Concentration
Monitoring).
DESCRIPTION
Cyclosporine, USP, the active principle in cyclosporine capsul