CYCLOSPORINE capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

CYCLOSPORINE

Composition:

CYCLOSPORINE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyclosporine Capsules, USP 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 100 mg Hard gelatin capsules with a reddish brown opaque body and a reddish brown opaque cap.  "APO" over "134" and "100" are imprinted on each capsule in black ink; supplied in bottles of 30 (NDC 54868-5522-0). Store and Dispense Store at 20° to 25°C (66° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. APOTEX INC. CYCLOSPORINE CAPSULES, USP 100 mg Manufactured by:             Manufactured for: Apotex Inc.                               Apotex Corp. Toronto, Ontario                       Weston, Florida Canada M9L 1T9                     33326 Revised: August 2010 Rev. 6 *Neoral® (cyclosporine capsules, USP) MODIFIED manufactured by Novartis. Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK       74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOSPORINE - CYCLOSPORINE CAPSULE, LIQUID FILLED
PHYSICIANS TOTAL CARE, INC.
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CYCLOSPORINE CAPSULES, USP
25 MG AND 100 MG
WARNING
Only physicians experienced in immunosuppressive therapy and
management of organ transplant
patients should prescribe Cyclosporine Capsules, USP 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, USP 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 Soft Gelatin Capsules, USP (NON-MODIFIED) have decreased
bioavailability in
comparison to Neoral
* (cyclosporine capsules, USP) MODIFIED.
Cyclosporine Capsules, USP (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, USP
NON-MODIFIED was found to be erratic. It is recommended that patients
taking Cyclosporine
Capsules, USP NON-MODIFIED over a period of time be monitored at
repeated intervals for
cyclosporine blood levels and subsequent dose adjustments be made in
order to avoid toxicity due
to high levels 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
levels of cyclosporine. Comparison of levels in published literature
to patient levels using
current assays must be done with detailed knowledge of the assay
methods employed. (See BLOOD
LEVEL MONITORING under DOSAGE AND ADMINISTRATION.)
DESCRIPTION
Cyclosporine, the active principle in Cyclosporine Capsules, USP is a
cyclic polypeptide
immu