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Cyclosporine - Modified (Cyclosporine)

Trade Name : Cyclosporine

Teva Pharmaceuticals USA, Inc.

CAPSULE, LIQUID FILLED

Strength 25 mg/1

CYCLOSPORINE Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Cyclosporine - Modified (Cyclosporine) which is also known as Cyclosporine and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 25 mg/1 per ml. Read more

Cyclosporine - Modified (Cyclosporine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • Cyclosporine Capsules USP MODIFIED are an oral formulation of cyclosporine, USP that immediately forms an emulsion in an aqueous environment.
  • Cyclosporine, USP, the active principle in Cyclosporine Capsules USP MODIFIED, is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species .
  • Chemically, cyclosporine, USP is designated as [-[*,*-()]]-cyclic-(L-alanyl-D-alanyl--methyl-L-leucyl--methyl-L-leucyl--methyl-L-valyl-3-hydroxy-,4-dimethyl-L-2-amino-6-octenoyl-L-u03b1-amino-butyryl--methylglycyl--methyl-L-leucyl-L-valyl--methyl-L-leucyl) and has the following structural formula:
  • Each soft gelatin capsule for oral administration contains either 25 mg, 50 mg or 100 mg of Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol and has the following inactive ingredients: DL-alpha-tocopherol, gelatin, glycine, glycerol 85%, polyoxyl 40 hydrogenated castor oil, polyglycerol (3) oleate, polyglycerol (10) oleate, sorbitol solution and titanium dioxide. In addition, the 25 mg and 50 mg contain ferric oxide (yellow) and the 100 mg contains ferric oxide (brown).
  • Cyclosporine is a potent immunosuppressive agent that in animals prolongs survival of allogeneic transplants involving skin, kidney, liver, heart, pancreas, bone marrow, small intestine, and lung. Cyclosporine has been demonstrated to suppress some humoral immunity and to a greater extent, cell-mediated immune reactions such as allograft rejection, delayed hypersensitivity, experimental allergic encephalomyelitis, Freundu2019s adjuvant arthritis, and graft versus host disease in many animal species for a variety of organs.
  • The effectiveness of cyclosporine results from specific and reversible inhibition of immunocompetent lymphocytes in the G- and G-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.
  • No effects on phagocytic function (changes in enzyme secretions, chemotactic migration of granulocytes, macrophage migration, carbon clearance ) have been detected in animals. Cyclosporine does not cause bone marrow suppression in animal models or man.
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  • There is a minimal experience with cyclosporine overdosage. Forced emesis and gastric lavage can be of value up to 2 hours after administration of Cyclosporine Capsules USP MODIFIED. Transient hepatotoxicity and nephrotoxicity may occur which should resolve following drug withdrawal. Oral doses of cyclosporine up to 10 g (about 150 mg/kg) have been tolerated with relatively minor clinical consequences, such as vomiting, drowsiness, headache, tachycardia and, in a few patients, moderately severe, reversible impairment of renal function. However, serious symptoms of intoxication have been reported following accidental parenteral overdosage with cyclosporine in premature neonates. General supportive measures and symptomatic treatment should be followed in all cases of overdosage. Cyclosporine is not dialyzable to any great extent, nor is it cleared well by charcoal hemoperfusion. The oral dosage at which half of experimental animals are estimated to die is 31 times, 39 times and > 54 times the human maintenance dose for transplant patients (6 mg/kg; corrections based on body surface area) in mice, rats, and rabbits.
  • Cyclosporine Capsules USP MODIFIED, soft gelatin capsules, has increased bioavailability in comparison to Sandimmune (Cyclosporine Capsules USP). Cyclosporine Capsules USP MODIFIED and Sandimmune (Cyclosporine Capsules USP) are not bioequivalent and cannot be used interchangeably without physician supervision.
  • The daily dose of Cyclosporine Capsules USP MODIFIED should always be given in two divided doses (BID). It is recommended that Cyclosporine Capsules USP MODIFIED be administered on a consistent schedule with regard to time of day and relation to meals. Grapefruit and grapefruit juice affect metabolism, increasing blood concentration of cyclosporine, thus should be avoided.
  • Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, imprinted u201cIvax hourglass logou201d u201c25 mgu201d in blue, containing 25 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5740-65).
  • Cyclosporine Capsules USP MODIFIED are available as ochre-yellow soft gelatin (oblong 11) capsules, filled with yellowish to yellow-brown oily liquid, imprinted u201cIvax hourglass logou201d u201c50 mgu201d in blue, containing 50 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5741-65).
  • Cyclosporine Capsules USP MODIFIED are available as brown soft gelatin (oblong 20) capsules, filled with yellowish to yellow-brown oily liquid, imprinted u201cIvax hourglass logou201d u201c100 mgu201d in blue, containing 100 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5742-65).
  • Store and Dispense
  • PHARMACIST: Dispense in original unit-dose container.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
  • Manufactured In Czech Republic By:
  • TEVA CZECH INDUSTRIES s.r.o.
  • Opava-Komarov, Czech Republic
  • Manufactured For:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. H 4/2015
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