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RX ITEM-Cyclosporine Modified 100Mg Cap 30 By Actavis Pharma

NDC 00591-2223-15 UPC/GTIN No.3-05912-22315-9 Mfg.Part No.222315BRAND: CYCLOSPORINE NDC: 00591-2223-15,591222315 UPC: 3-05912-22315-9,305912223159 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Cyclosporine Modified 100Mg Cap 30 By Actavis Pharma

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item No.:RX763201 NDC No.591222315 UPC No.:305912223159 NDC No. 00591-2223-15 UPC/GTIN No. 3-05912-22315-9 MPN 222315 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No. Rx763201 Cyclosporine Modified 100mg Cap 30 by Actavis Pharma Item No. 3763201 NDC No. 00591222315 UPC No. 305912223159 Other Name

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SANDIMMUNE- cyclosporine capsule, liquid filled
SANDIMMUNE- cyclosporine injection
SANDIMMUNE- cyclosporine solution
Novartis Pharmaceuticals Corporation
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, USP) MODIFIED and Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIED.

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 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 Blood Concentration Monitoring under DOSAGE AND ADMINISTRATION)
DESCRIPTION

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 nivea.

Chemically, cyclosporine is designated as [R -[R *,R *-(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-?-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 and 100 mg strengths.

Each 25 mg capsule contains:

cyclosporine, USP����������������������������������25 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, iron oxide red, linoleoyl macrogolglycerides, sorbitol, and titanium dioxide. May also contain glycerol. 100 mg capsules may contain iron oxide yellow.

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 injection, USP) is available in a 5 mL sterile ampul for intravenous (IV) 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.
CLINICAL PHARMACOLOGY

Cyclosporine is a potent immunosuppressive agent which in animals prolongs survival of allogeneic transplants involving skin, heart, kidney, pancreas, bone marrow, small intestine, and lung. Cyclosporine has been demonstrated to suppress some humoral immunity and to a greater extent, cell-mediated reactions such as allograft rejection, delayed hypersensitivity, experimental allergic encephalomyelitis, Freund�s adjuvant arthritis, and graft vs. host disease in many animal species for a variety of organs.

Successful kidney, liver, and heart allogeneic transplants have been performed in man using cyclosporine.

The exact mechanism of action of cyclosporine is not known. Experimental evidence suggests that the effectiveness of cyclosporine is due to specific and reversible inhibition of immunocompetent lymphocytes in the G0 � or G1 -phase of the cell cycle. T-lymphocytes are preferentially inhibited. The T-helper cell is the main target, although the T-suppressor cell may also be suppressed. Cyclosporine also inhibits lymphokine production and release including interleukin-2 or T-cell growth factor (TCGF).

NDC 00591-2223-15 UPC/GTIN No.3-05912-22315-9 Mfg.Part No.222315
RX ITEM-Cyclosporine Modified 100Mg Cap
NDC 00591-2223-15 UPC/GTIN No.3-05912-22315-9 Mfg.Part No.222315

BRAND: CYCLOSPORINE NDC: 00591-2223-15,591222315 UPC: 3-05912-22315-9,305912223159
Actavis Pharma
BRAND: CYCLOSPORINE NDC: 00591-2223-15,591222315 UPC: 3-05912-22315-9,305912223159

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
Click above for Neoral
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.