Buy Restasis eye drops 0.05%, 30 pcs
  • Buy Restasis eye drops 0.05%, 30 pcs


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Clinical Pharmacology

Cyclosporine is a substance that has an immunosuppressive effect after systemic administration.

When oppression products tears in patients with dry keratoconjunctivitis, cyclosporine, applied topically, has anti-inflammatory and immunomodulatory effects.


The concentration of cyclosporine after topical administration in adults at a concentration of 0.05%, 2 times a day, is lower than the determined value — 0.1 ng / ml.


Reduced tear production due to dry keratoconjunctivitis.


1 ml of eye drops contains:

Active substance

  • Cyclosporine 500 mcg.


Castor oil, glycerol, carbomer, polysorbate-80, sodium hydroxide, water.

Cyclosporine is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Restasis Allergan USA eye drops
Sandimmune Neoral solution Novartis Switzerland vials
Sandimmune neoral Novartis Switzerland capsules

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Dosage and Administration

Sandimmune Neoral is taken orally: for adults with a transplant of solid organs, treatment should be started 12 hours before the operation at a dose of 10-15 mg / kg, divided into 2 doses. Within 1-2 weeks after the operation - every day, in the same dose, after which the dose is gradually reduced (5% / week) until a maintenance dose is reached - 2-6 mg / kg / day. When administered in combination with corticosteroids or other immunosuppressants, use smaller doses (3-6 mg / kg / day in the initial phase of treatment). For bone marrow transplantation - on the day preceding the transplant, and during the transplantation period, for 2 weeks, in a daily dose of 12.5-15 mg / kg, then switch to maintenance therapy at a dose of about 12.5 mg / kg / day (with impaired absorption, require higher oral doses or a transition to / in the introduction). Maintenance treatment is continued for at least 3-6 months (preferably 6 months), after which the dose is gradually reduced, so that the treatment is stopped 1 year after transplantation. In some patients, after the cessation of treatment, the reaction of rejection develops, in which case the treatment should be resumed. With endogenous uveitis, for the induction of remission - in the initial daily dose of 5 mg / kg, in 1 or several doses, until inflammation subsides and improves visual acuity. In severe cases, the dose can be increased to 7 mg / kg / day for a limited period. During maintenance therapy, the dose should be slowly reduced until the lowest effective dose is reached, which should not exceed 5 mg / kg / day during the remission of the disease. With nephrotic syndrome, for the induction of remission - in a daily dose of 5 mg / kg for adults and 6 mg / kg - for children (in 2 doses), provided that there is no decrease in kidney function (except in cases of proteinuria). For patients with impaired renal function, the initial daily dose should not exceed 2.5 mg / kg. If cyclosporin monotherapy fails to achieve the desired effect, it may be combined with small doses of GCS, orally. If after 3 months of treatment there is no positive effect, treatment should be discontinued. For maintenance treatment, the dose should be slowly reduced to the minimum effective. In rheumatoid arthritis, during the first 6 weeks of treatment, the daily dose is 3 mg / kg in 2 divided doses. In case of insufficient effect, the daily dose can be gradually increased, provided satisfactory tolerability (no more than 5 mg / kg / day). The course of treatment is up to 12 weeks. For maintenance therapy, the dose should be selected individually depending on tolerability (can be administered in combination with small doses of GCS and / or NSAIDs). In psoriasis, for the induction of remission, the daily dose is 2.5 mg / kg in 2 doses. In severe cases of the disease, when rapid effect is required, the initial daily dose may be 5 mg / kg. If it was not possible to achieve an adequate effect when applied in a daily dose of 5 mg / kg for 6 weeks, the drug should be discontinued. The dose for maintenance treatment of psoriasis should be minimally effective (should not exceed 5 mg / kg / day). With atopic dermatitis - the initial dose of 2.5 mg / kg / day. In severe cases, the dose may be increased to 5 mg / kg / day. When a positive result is achieved, the dose should be gradually reduced to complete cancellation.

Adverse reactions

Many of the side effects associated with the use of cyclosporine, dose-dependent and reversible with decreasing dose. The spectrum of side effects is generally the same for different indications, although the frequency and severity of side effects may vary. In transplant patients, due to the higher dose and longer duration of treatment, side effects are more common and usually more pronounced than in patients with other indications.

Frequency of side effects: very often - ≥ 10%; often from ≥ 1% to <10%; sometimes from ≥ 0.1% to <1%; rarely from ≥ 0.01% to <0.1%; very rarely - <0.01%.

From the urinary system:

Very often - impaired renal function.

Since the cardiovascular system:

Very often - increase blood pressure.

From the side of the central nervous system and peripheral nervous system:

Very often - tremor, headache; often - Paresthesia; sometimes signs of encephalopathy, such as convulsions, lethargy, disorientation, slow reactions, agitation, sleep disturbances, visual disturbances, cortical blindness, coma, paresis, cerebellar Ataxia; rarely, motor polyneuropathy; very rarely - swelling of the optic nerve head (including the nipple of the optic nerve), secondary to benign intracranial hypertension.

From the digestive system:

Often - Anorexia, nausea, vomiting, abdominal pain, diarrhea, gingival hyperplasia, abnormal liver function; rarely - pancreatitis.


Very often - hyperlipidemia; often - hyperuricemia, hyperkalemia, hypomagnesemia; rarely - hyperglycemia.

From the musculoskeletal system

Often - muscle spasms, myalgia; rarely - muscle weakness, myopathy.

From the hemopoietic system:

Sometimes - anemia, thrombocytopenia; rarely - microangiopathic hemolytic anemia, hemolytic uremic syndrome.

Dermatological reactions:

Often - hypertrichosis; sometimes an allergic rash.

On the part of the body as a whole:

Often - fatigue; sometimes - swelling, weight gain.

On the part of the endocrine system:

Rarely - a violation of the menstrual cycle, gynecomastia.


Hypersensitivity (including to polyoxyethylated castor oil - for dosage forms containing it); malignant neoplasms, precancerous skin diseases; children's age (up to 1 year), lactation period, children's age (for use in the treatment of psoriasis and rheumatoid arthritis).

With caution. Varicella zoster (risk of process generalization) and other viral diseases, renal and / or liver failure, hyperkalemia, arterial hypertension, infections, malabsorption syndrome, varicella (currently or recently transferred, including recent contact with the patient).

Hypersensitivity; malignant neoplasms, precancerous skin diseases; children's age (up to 1 year), lactation period, children's age (for use in the treatment of psoriasis and rheumatoid arthritis) .C caution. Varicella zoster (risk of process generalization) and other viral diseases, renal and / or liver failure, hyperkalemia, arterial hypertension, infections, malabsorption syndrome, varicella (currently or recently transferred, including recent contact with the patient).

Drug interactions

Enhances the action of quinidine, theophylline, sodium valproate. When treating cyclosporin, excessive K + intake should be avoided (with food, with potassium-containing drugs), and potassium-saving diuretics, potassium-containing penicillins, heparin, ACE inhibitors, beta-adrenergic blockers, cardiac glycosides, suxametonium should not be prescribed. When using cyclosporine together with other immunosuppressive drugs (azathioprine, chlorambucil, GCS, cyclophosphamide, mercaptopurine) there is a risk of developing excessive immunodepression, which can lead to increased sensitivity to infections and the development of lymphoproliferative diseases. Increases the risk of nephrotoxicity of aminoglycosides, amphotericin B, fluoroquinolones, melphalan, colchicine, trimethoprim, NSAIDs (it is necessary to reduce the dose of both drugs). It reduces the clearance of prednisone, treatment with high doses of prednisone can increase the concentration of cyclosporine in the blood. Allopurinol, bromocriptine, cimetidine, clarithromycin, androgens, estrogens, danazol, diltiazem, some macrolide antibiotics (including erythromycin and josamycin), doxycycline, oral contraceptives, propafenone, some BCC (includingverapamil, diltiazem, nicardipine), miconazole, fluconazole, itraconazole, ketoconazole, HIV protease inhibitors, metoclopramide, immunosuppressants, grapefruit juice may increase the concentration of cyclosporine (inhibiting CYP3A isoenzyme), increasing the risk of hepatosyrosis, and you can have an organism. P450 inducers of CYP3A isoenzyme (barbiturates, carbamazepine, phenytoin, sodium metamizole, benzodiazepine derivatives, aminoglutetimid, estrogen-gestagenic drugs, progesterone, isoniazid, rifampicin, nafcillin, as well as sulfadimidine and trimetham, as well as sulfimetimine, and triacimer, as a part of the procedure for the production of steroids; Statins (lovastatin and simvastatin) increase the risk of rhabdomyolysis and acute renal failure. Colchicine increases the risk of developing myalgia and weakness; nifedipine - gum hyperplasia. NSAIDs (indomethacin, diclofenac, naproxen) increase the risk of renal failure and hyperkalemia. Activated carbon, methoxen, trioxalene, PUVA therapy (psoriasis) increase the risk of developing malignant skin tumors. NSAIDs can potentially reduce the size of the glomerular filtration, adding them or increasing the dose should be accompanied by strict control of the kidney function (especially in the initial stages of treatment). Vaccination may be less effective during treatment with cyclosporin (use of live attenuated vaccines should be avoided).

Pregnancy and Lactation

The experience of using Sandimmune Neoral in pregnant women is limited. Pregnant women who have undergone organ transplantation and receiving treatment with immunosuppressive drugs, increases the risk of premature birth. There are a limited number of observations of children (until they reach the age of 7 years), exposed to cyclosporine in the period of prenatal development. Kidney function and blood pressure in these children were normal. However, adequate and well-controlled studies in pregnant women have not been conducted; therefore, Sandimmune Neoral should not be used during pregnancy, unless the expected benefit to the mother justifies the potential risk to the fetus.

Experimental studies have shown the toxic effect of the drug on reproductive function.

Cyclosporine passes into breast milk. Mothers receiving Sandimmune Neoral should stop breastfeeding.

Special instructions

Sandimmune Neoral should be used only by doctors who have experience in immunosuppressive therapy and are able to provide adequate monitoring of the patient, including regular full physical examination, measurement of blood pressure and control of serum creatinine concentration. Surveillance of patients who have undergone transplantation and are receiving the drug should be carried out only in those institutions that are provided with trained medical personnel, adequate laboratory and other resources.

It should be borne in mind that the use of cyclosporine, as well as other immunosuppressants, increases the risk of developing lymphomas and other malignant neoplasms, often the skin. The increased risk of this complication is associated more with the degree and duration of immunosuppression than with the use of a particular drug. Thus, caution should be exercised when using combined immunosuppressive therapy regimens, bearing in mind the likelihood of developing lymphoproliferative diseases and solid organ tumors, sometimes resulting in death.

The use of cyclosporine, as well as other immunosuppressants, predisposes to the development of various bacterial, fungal, parasitic and viral infections, often with the participation of opportunistic pathogens.Given the potential danger of these infections for the life of the patient, an effective system of preventive and therapeutic measures should be applied, especially in cases of long-term use of combined immunosuppressive treatment.

During the first few weeks of treatment with Sandimmune Neoral, a frequent and potentially dangerous complication can occur - an increase in serum creatinine and urea levels. These functional changes are reversible and dose-dependent, normalized with decreasing dose. With long-term treatment in some patients, structural changes in the kidneys (for example, interstitial fibrosis) are possible, which in patients with renal transplants should be differentiated from changes in chronic rejection. Sandimmune Neoral can also cause a dose-dependent, reversible increase in serum bilirubin and, rarely, liver enzymes. In these cases, careful monitoring of renal and hepatic function is required. In case of deviations of these indicators from the norm, a dose reduction may be required.

To control the concentration of cyclosporine in the blood, it is preferable to use specific monoclonal antibodies (measurement of the amount of unchanged drug). You can use the HPLC method, which also measures the concentration of unchanged substance. If plasma or serum is used, then standard separation procedures (time and temperature) should be followed. For the initial determination of the concentration of cyclosporine in patients with liver transplants, specific monoclonal antibodies should be used. It is also possible to conduct parallel determinations using specific and nonspecific monoclonal antibodies in order to achieve a dose that provides adequate immunosuppression.

It should be remembered that the concentration of cyclosporine in the blood, plasma or serum is only one of many factors that characterize the clinical condition of the patient. The results of determining the concentration of cyclosporine are only one of the factors determining the dosing regimen, and are considered in conjunction with various clinical and laboratory parameters.

When treating Sandimmune Neoral, regular blood pressure monitoring is required. With an increase in blood pressure should be assigned appropriate antihypertensive therapy.

Influence on ability to drive motor transport and control mechanisms

There are currently no data on the effect of Sandimmune Neoral on the ability to drive a car and work with machinery.


Symptoms: Experience with overdose of Sandimmune Neoral is limited. Possible development of renal dysfunction, which is likely to be reversible with drug withdrawal When ingested cyclosporine in a dose of up to 10 g (about 150 mg / kg) in most cases there were slightly pronounced clinical manifestations, such as vomiting, dizziness, headache, tachycardia. In some cases, reversible impaired renal function of moderate degree was observed. However, in the case of an accidental parenteral overdose of cyclosporine in premature babies in the neonatal period, severe toxic complications were reported.
Treatment: symptomatic therapy, there is no specific antidote. During the first 2 hours after ingestion, the drug can be removed from the body by causing vomiting or by washing the stomach. Cyclosporine is practically not excreted by hemodialysis and hemoperfusion using activated carbon.

Studies and clinical trials of Cyclosporine (Click to expand)
  1. Refractory thrombotic thrombocytopenic purpura treated with cyclosporine
  2. Cyclic thrombocytopenia in a patient treated with cyclosporine for refractory idiopathic thrombocytopenic purpura
  3. Chronic relapsing thrombotic thrombocytopenic purpura: Role of therapy with cyclosporine
  4. Acquired pure megakaryocytic aplasia report of two cases with long-term responses to antithymocyte globulin and cyclosporine
  5. Salvage therapy and long-term remission with danazol and cyclosporine in refractory evan's syndrome
  6. Cyclosporine A therapy for multisystem Langerhans cell histiocytosis
  7. Assessment of systemic toxicity in children receiving chemotherapy with cyclosporine for sarcoma
  8. Foetal rat pancreatic transplantation: posttransplantation development of foetal pancreatic iso- and allografts and suppression of rejection with mycophenolate mofetil (MMF) and cyclosporine based immunesuppression
  9. De novo malignancies after liver transplantation using tacrolimus-based protocols or cyclosporine-based quadruple immunosuppression with an interleukin-2 receptor antibody or antithymocyte globulin
  10. Mitoxantrone, etoposide, and cytarabine plus cyclosporine for patients with relapsed or refractory acute myeloid leukemia : An Eastern Cooperative Oncology Group pilot study
  11. Non-immunosuppressive cyclosporine derivative PSC 833 abolishes resistance of human multidrug-resistant ovarian carcinoma cells in vitro to paclitaxel and paclitaxel-induced radiosensitization
  12. Muscle disorders associated with cyclosporine treatment
  13. Cyclosporine A inhibits lymphocyte migration into ovine peripheral nerve allografts
  14. Synergistic effect of rapamycin and cyclosporine in prevention of acute kidney allograft rejection in the mouse
  15. Multisystem Langerhans-cell histiocytosis with life-threatening pulmonary involvement—Good response to cyclosporine A
  16. Acral erythema secondary to high-dose cytosine arabinoside with pain worsened by cyclosporine infusions
  17. Cyclosporine treatment of refractory T-cell lymphomas
  18. The effects of cyclosporine on the pharmacokinetics of doxorubicin in patients with small cell lung cancer
  19. The effects of cyclosporine on the pharmacokinetics of doxorubicin in patients with small cell lung cancer
  20. Cyclosporine has a direct effect on the differentiation of a mucin-secreting cell line
  21. A potential mechanism of cyclosporine-associated bone pain: Comment on the radiologic vignette by Stone et al
  22. Frequency of recurrent lupus nephritis among ninety-seven renal transplant patients during the cyclosporine era
  23. Outcome of renal transplantation in ninety-seven cyclosporine-era patients with systemic lupus erythematosus and matched controls
  24. Long-term followup of patients receiving combined therapy with cyclosporine and methotrexate

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