Ecvoral (cyclosporine) capsules 50 mg. №50

Description

Ecvoral 50 mg Composition
active substance: cyclosporine;

1 capsule contains 100 mg cyclosporine;

Ecvoral 50 mg excipients: ethanol, macrogolglyceryl hydroxystearate, polyglycerol (3) monooleate, polyglycerol (10) monooleate, alpha-tocopherol, gelatin, glycerin (85%), glycine, sorbitol solution that does not crystallize (E 420), titanium dioxide (E 171 ), iron oxide brown (E 172).

Ecvoral 50 mg Dosage form
Soft capsules.

Basic physical and chemical properties: brown soft gelatin capsules (Oblong 20) containing yellowish to yellowish brown oily liquid. Each capsule is identified by the inscription with the hourglass logo and the text “100 mg”.

Pharmacotherapeutic group
Antineoplastic and immunomodulating drugs. Immunosuppressants. ATX code L04A D01.

Pharmacodynamics
Cyclosporin (known as cyclosporin A) is a cyclic polypeptide of 11 amino acids. Cyclosporin is a potent immunosuppressive drug that in animals increases the life span of allogeneic transplants of skin, heart, kidney, pancreas, bone marrow, small intestine, and lungs. Cyclosporine suppresses the development of cell-type reactions, including immunity to allograft, delayed-type skin sensitivity, experimental allergic encephalomyelitis, Freund’s adjuvant arthritis, graft-versus-host disease (GVHD), and T-lymphocyte-dependent antibody formation. At the cellular level, it inhibits the formation and release of lymphokines, including interleukin 2 (T-lymphocyte growth factor). Cyclosporine blocks resting lymphocytes in the G0 or G1 phase of the cell cycle and inhibits the antigenic release of lymphokines by activated T-lymphocytes. All the data obtained indicate that cyclosporine acts specifically and reversibly on lymphocytes. Unlike cytostatics, it does not suppress hematopoiesis and does not affect the function of phagocytes. Patients receiving cyclosporine are less susceptible to infections than patients receiving other immunosuppressive drugs.

There have been successful bone marrow and solid organ transplants in humans using cyclosporine to prevent and treat rejection and GVHD. Cyclosporine has been used in both hepatitis C virus (HVC) positive and HVC negative liver transplant recipients. The beneficial effects of cyclosporine have also been demonstrated in the treatment of various conditions that are autoimmune in nature or can be considered as such.

Cyclosporine has been shown to be effective in steroid-dependent nephrotic syndrome in children.

Indications
Indications for transplantation

Solid organ transplant:

preventing the rejection of solid organ transplants;
treatment of graft rejection in patients previously treated with other immunosuppressive drugs.
Bone marrow transplant:

preventing rejection of allogeneic bone marrow transplant and stem cell transplant;
preventing and treating graft versus host disease.
Indications not related to transplantation

Endogenous uveitis:

active middle or posterior uveitis, threatening loss of vision, of non-infectious etiology in cases where alternative treatment was ineffective or unacceptable due to adverse reactions;
uveitis in Behcet’s disease with repeated exacerbations of inflammation involving the retina of the eye without neurological symptoms.
Nephrotic syndrome:

steroid-dependent or steroid-resistant nephrotic syndrome due to minimal changes in primary glomerulonephritis, focal segmental glomerulosclerosis or membranous glomerulonephritis;
induction or maintenance of remission;
maintaining remission caused by corticosteroids, making them withdrawn.
Rheumatoid arthritis:

treatment of severe forms of active rheumatoid arthritis.
Psoriasis:

severe psoriasis, when standard treatment is ineffective or unacceptable.
Atopic dermatitis:

treatment of severe forms of atopic dermatitis, if necessary, systemic therapy.

Contraindications
Hypersensitivity to cyclosporine or other components of the drug.

Simultaneous use with medicines containing St. John’s wort (Hypericum perforatum).

Concomitant use with drugs, are substrates of the multilicar reflux transporter P-glycoprotein (Pgp) or organic anions of transport proteins (OATB), for which an increase in plasma concentration is associated with the development of serious adverse reactions and / or life-threatening adverse reactions, for example, bosentan, dabigatran etexilate and aliskiren.

Renal failure, with the exception of patients with nephrotic syndrome and moderately elevated baseline creatinine concentrations up to a maximum of 200 μmol / L in adults and 140 μmol / L in children. In nephrotic syndrome, cautious use is allowed in doses not exceeding 2.5 mg / kg / day, only if the use of cyclosporine contributes to the normalization of creatinine levels increased as a result of the disease.