CYCLOSPORINE solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

Cyclosporine (UNII: 83HN0GTJ6D) (Cyclosporine - UNII:83HN0GTJ6D)

Saatavilla:

Morton Grove Pharmaceuticals, Inc.

INN (Kansainvälinen yleisnimi):

Cyclosporine

Koostumus:

Cyclosporine 100 mg in 1 mL

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

CYCLOSPORINE- CYCLOSPORINE SOLUTION
MORTON GROVE PHARMACEUTICALS, INC.
----------
CYCLOSPORINE
ORAL SOLUTION, USP
100 MG/ML
RX ONLY
PRESCRIBING INFORMATION
WARNING
Only physicians experienced in immunosuppressive therapy and
management of organ transplant
patients should prescribe cyclosporine. 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 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 Oral Solution, USP has decreased bioavailability in
comparison to Neoral
soft
gelatin capsules (cyclosporine capsules, USP) MODIFIED and Neoral
oral solution
(cyclosporine oral solution, USP) MODIFIED.
Cyclosporine and Neoral
(cyclosporine [MODIFIED]) are not bioequivalent and cannot be used
interchangeably without physician supervision.
The absorption of cyclosporine during chronic administration of oral
solution was found to be
erratic. It is recommended that patients taking the oral solution 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.)
1
DESCRIPTION
Cyclosporine, the active principle in Cyclosporine Oral Solution, USP
is a cyclic polypeptide
immunosuppressant agent consisting of 11 amino acids. It