A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Sandimmune Online, Description, Chemistry, Ingredients - Cyclosporine
Sandimmune Online, Description, Chemistry, Ingredients - Cyclosporine
DESCRIPTION
Sandimmune® Soft Gelatin Capsules (cyclosporine capsules,
USP)
Sandimmune® Oral Solution (cyclosporine oral solution, USP)
Sandimmune® Injection (cyclosporine concentrate for injection, USP) FOR
INFUSION ONLY
| WARNING
Only physicians experienced in immunosuppressive therapy and management
of organ transplant patients should prescribe Sandimmune® (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.
Sandimmune® (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.
Sandimmune® soft gelatin capsules (cyclosporine capsules, USP)
and Sandimmune® oral solution (cyclosporine oral solution, USP)
have decreased bioavailability in comparison to Neoral® soft gelatin
capsules (cyclosporine capsules for microemulsion) and Neoral® oral
solution (cyclosporine oral solution for microemulsion).
Sandimmune® and Neoral® are not bioequivalent and cannot be used
interchangeably without physician supervision.
The absorption of cyclosporine during chronic administration of
Sandimmune® soft gelatin capsules and oral solution was found to
be erratic. It is recommended that patients taking the soft gelatin
capsules or 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)
|
Cyclosporine, the active principle in Sandimmune® (cyclosporine) is a
cyclic polypeptide immunosuppressant agent consisting of 11 amino acids.
It is produced as a metabolite by the fungus species Beauveria nlyea.
Chemically, cyclosporine is designated as [R-[RR*(E)}]
cyclic(L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl-3-hydroxy-N,4-dimethyl-L-2-amino-6-octenoyl-L-a-amino-butyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl).
Sandimmune® soft gelatin capsules (cyclosporine capsules, USP) are available
in 25 mg, 50 mg, and 100 mg strengths.
| Each 25 mg capsule contains: |
| cyclosporine, USP |
|
25 mg
|
| alcohol, USP dehydrated |
|
max 12.7% by volume
|
| Each 50 mg capsule contains: |
| cyclosporine, USP |
|
50 mg
|
| alcohol, USP dehydrated |
|
max 12.7% by volume
|
| Each 100 mg capsule contains: |
| cyclosporine, USP |
|
100 mg
|
| alcohol, USP dehydrated |
|
max 12.7% by volume
|
Inactive Ingredients: corn oil, gelatin, glycerol, Labrafil
M 2125 CS (polyoxyethylated glycolysed glycerides), red iron oxide (25
mg and 100 mg capsule only), sorbitol, titanium dioxide, yellow iron oxide
(50 mg capsule only), and other ingredients.
Sandimmune® oral solution (cyclosporine oral solution, USP) is available
in 50 mL bottles.
| Each mL contains: |
| cyclosporine, USP |
|
100 mg
|
| alcohol, Ph Helv |
|
12.5% by volume
|
dissolved in an olive oil, Ph. Helv./Labrafil M 1944 CS (polyoxyethylated
oleic glycerides) vehicle which must be further diluted with milk, chocolate
milk, or orange juice before oral administration.
Sandimmune® injection (cyclosporine concentrate for injection, USP) is
available in a 5 mL sterile ampul for I.V. administration.
| Each mL contains: |
| cyclosporine, USP |
|
50 mg |
| *Cremophor® EL (polyoxyethylated castor oil) |
|
650 mg |
| alcohol, Ph Helv |
|
32.9% by volume |
| nitrogen |
|
qs |
which must be diluted further with 0.9% Sodium Chloride Injection or 5%
Dextrose Injection before use.
It has molecular formular: C62H111N11O12
with a molecular weight of: 1202.63.
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