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Neoral, cyclosporinChemical Names
Cyclosporin
Ingredients
Active Ingredients: Cyclosporin
Non-Active Ingredients: Corn oil-mono-di-triglycerides, polyoxyl 40 hydrogenated castor oil NF, DL-α tocopherol USP, gelatin NF, glycerol, iron oxide black, propylene glycol USP, titanium dioxide USP, carmine, and other ingredients.
Indications
Neoral is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Neoral has been used in combination with azathioprine and corticosteroids.
Neoral is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate
Neoral is a indicated for the treatment of adult, non-immunocompromised patients with severe psoriasis who have failed to respond to at least one systemic therapy.
How It Works
The exact mechanism of action is unknown at this time but seems to be related to the inhibition of production and release of interleukin-2, which is a proliferative factor necessary for the induction of cytotoxic T lymphocytes in response to alloantigenic challenge, and which plays a major role in both cellular and hormornal immune responses.
Dosage
Tablet (25 mg, 50 mg, 100 mg)
Organ Transplant: The initial oral dose of Neoral can be given 4-12 hours prior to transplantation or be given post operatively. The initial dose of Neoral varies depending on the transplanted organ and the other immunosuppressive agents included in the immunosuppressive protocol.The mean ± SD initial doses were 9 ± 3 mg/kg/day for renal transplant patients, 8 ± 4 mg/kg/day for liver transplant patients, and 7 ± 3 mg/kg/day for heart transplant patients (24 centers). Total daily doses were divided into two equal daily doses.
In transplanted patients who are considered for conversion to Neoral from Sandimmune, Neoral should be started with the same daily dose as was previously used with Sandimmune (1:1 dose conversion) Due to the increase in bioavailability of cyclosporine following conversion to Neoral, the cyclosporine blood trough concentration may exceed the target range. Particular caution should be exercised when converting patients to Neoral at doses greater than 10 mg/kg/day.
Rheumatoid Arthritis:
The initial dose of Neoral is 2.5 mg/kg/day, taken twice daily as a divided dose. Salicylates, nonsteroidal anti-inflammatory agents, and oral corticosteroids may be continued. Onset of action generally occurs between 4 and 8 weeks. If insufficient clinical benefit is seen and tolerability is good (including serum creatinine less than 30% above baseline), the dose may be increased by 0.5-0.75 mg/kg/day after 8 weeks and again after 12 weeks to a maximum of 4 mg/kg/day. If no benefit is seen by 16 weeks of therapy, Neoral therapy should be discontinued. Most patients can be treated with Neoral doses of 3 mg/kg/day or below when combined with methotrexate doses of up to 15 mg/week.
Psoriasis:
The initial dose of Neoral should be 2.5 mg/kg/day. Neoral should be taken twice daily, as a divided dose (1.25 mg/kg twice daily). Patients should be kept at that dose for at least 4 weeks, barring adverse events. If significant clinical improvement has not occurred in patients by that time, the patient's dosage should be increased at 2 week intervals. Based on patient response, dose increases of approximately 0.5 mg/kg/day should be made to a maximum of 4.0 mg/kg/day.
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Precautions
General: Before taking Cyclosporine, tell your doctor or pharmacist if you are allergic to it or if you have certain medical conditions. or have a history of chickenpox/shingles, uncontrolled high blood pressure, cancer, skin lesions of unknown cause, current use of radiation therapy, kidney problems (for arthritis or psoriasis patients only).
Before using this medication, tell your doctor or pharmacist about your medical history, especially in instances of: kidney disease, liver disease, any recent/current infections, seizures, untreated mineral imbalance (e.g., low magnesium or high potassium), blood disorders, diabetes, a certain gut problem (malabsorption), and high blood fats (cholesterol or triglycerides).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.This drug may reduce the magnesium levels in your blood. Ask your doctor about adding magnesium to your diet. Your doctor may prescribe a magnesium supplement. Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with those that have recently received oral polio vaccine or nasal flu vaccine. Avoid contact with people who have had any contagious illnesses.
This drug may increase your risk for developing skin cancer. Avoid long term exposure to the sun or going to the tanning salon.
This medication may cause swelling and growth of the gums (gingival hyperplasia). Brush your teeth and floss daily to minimize this problem. See your dentist regularly.The elderly may be at greater risk for the effects on blood pressure and kidneys while using this drug. This medication should be used only when clearly needed during pregnancy.
Cyclosporine used during pregnancy has resulted in newborns with problems such as low birth weight and being born too early (premature). Other more serious problems have also been reported, including death of the unborn baby. Discuss the risks and benefits with your doctor. This medication passes into breast milk. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
Blood pressure should be evaluated every 2 weeks during the initial 3 months of therapy and then monthly if the patient is stable, or more frequently when dosage adjustments are made.
CBC, uric acid, potassium, lipids, and magnesium levels ought to be monitored every 2 weeks during the initial 3 months.
The risk of Cyclosporine nephropathy is reduced when the starting dose is low (2.5 mg/kg/day), the maximum dose should not exceed 4.0 mg/kg/day. There has been one reported death associated with the use of Cyclosporine in psoriasis, take special precautions by keeping your doctor informed on your condition.
Renal dysfunction including structural kidney damage is a potential consequence of Neoral and therefore renal function must be monitored during therapy.
Elderly patients should be monitored with particular care, since decreases in renal function also occur with age. The kidneys are the organ that filters the drug
In kidney liver transplant: Kidney, Liver, and Heart Transplant. Cyclosporine can cause nephrotoxicity and hepatotoxicity when used in high doses. Nephrotoxicity associated with cyclosporine had been noted in 25% of cases of renal transplantation, 38% of cases of cardiac transplantation, and 37% of cases of liver transplantation.
A form of a cyclosporine-associated nephropathy is characterized by serial deterioration in renal function and morphologic changes in the kidneys. Significant electrolyte potassium elevation and elevated uric acid have been seen occasionally in individual patients.
Because of the danger of oversuppression of the immune system that will result in increased risk of infections or malignancy, a treatment regimen containing multiple immunosuppressants should be used with caution. Some malignancies may be fatal.
There have been reports of convulsions in adult and pediatric patients receiving cyclosporine, particularly in combination with high dose methylprednisolone. It appears that patients receiving liver transplants are more likely to have encephalopathy than those receiving kidney transplant. Another rare manifestation of Cyclosporine-induced neurotoxicity, occurring in transplant patients more frequently than in other indications, is optic disc edema including papilloedema, with possible visual impairment, secondary to benign intracranial hypertension.
There is also the possibility of experiencing some of the post market problems: loss of motor function, movement disorders and psychiatric disturbances. In many cases, changes in the white matter have been detected using imaging techniques and pathologic specimens. Predisposing factors such as hypertension, hypomagnesemia, hypocholesterolemia, high-dose corticosteroids, high cyclosporine blood concentrations, and graft-versus-host disease have been noted in many but not all of the reported cases. The changes in most cases have been reversible upon discontinuation of cyclosporine, and in some cases improvement was noted after reduction of dose. It appears that patients receiving liver transplant are more susceptible to encephalopathy than those receiving kidney.
Rhematoid Arthritis: Cyclosporine nephropathy was detected in renal biopsies of 6 out of 60. There is a potential, as with other immunosuppressive agents, for an increase in the occurrence of malignancies with Cyclosporine. Patients should be thoroughly evaluated before and during Neoral treatment for the development of malignancies.
Psoriasis: Cyclosporine, the active ingredient in Neoral, can cause nephrotoxicity and hypertension.
Renal dysfunction is a potential consequence of Neoral therefore renal function must be monitored during therapy. Patients receiving Neoral will require constant monitoring of serum creatinine. Kidney biopsies from 86 psoriasis patients treated for a mean duration of 23 months with 1.2-7.6 mg/kg/day of Cyclosporine showed evidence of Cyclosporine Nephropathy.
Blood pressure should be evaluated every 2 weeks during the initial 3 months of therapy and then monthly if the patient is stable, or more frequently when dosage adjustments are made.
CBC, uric acid, potassium, lipids, and magnesium should also be monitored every 2 weeks for the first 3 months of therapy,
Drug Interactions
This drug should not be used with the following medications because very serious interactions may occur: aliskiren, bosentan, coal tar, live vaccines, rosuvastatin, or tacrolimus. If you are currently using any of these medications, tell your doctor or pharmacist before starting cyclosporine.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially if yo u are taking the following: birth control pills, carvedilol, caspofungin, digoxin, etoposide, ezetimibe, other immunosuppressants (azathioprine, methotrexate, sirolimus), drugs that worsen kidney problems (acyclovir, aminoglycoside antibiotics including tobramycin; amphotericin B; colchicine; fibrates iincluding fenofibrate; melphalan; NSAIDs including diclofenac and sulindac; ranitidine; sulfa drugs including sulfamethoxazole; vancomycin), drugs affecting liver enzymes that remove cyclosporine from your system (such as allopurinol;allopurinol; amidarone; azole antifungals including fluconazole and ketonconzole ; barbiturates including phenobarbital; bromocriptine; calcium channel blockers: diltiazem, nicardipine, and verapamil, cimetidine HIV protease inhibitors including indinavir; imatinib; macrolide antibiotics including erythromycin; certain man-made male hormones such as danazol and methyltestosterone; methylprednisolone; metoclopramide; metronidazole; nafcillin; nefazodone ; octreotide; quinupristin/dalfopristin; rifamycins including rifampin; certain anti-seizure drugs including carbamazepine and phenytoin; St. Johns wort; ticlopine, nifedipine, orlistat, certain quinolones ( ciprofloxacin, norfloxacin), repaglinide, other statins ( atrovastatin) sulfinpyrazone, temsirolimus, terbinafine, tolterodine, ACE inhibitors including lisinopril, ARBs including losartan, potassium supplements, "water pill" including amiloride, spironolactone. Do not use potassium-containing salt substitutes while taking this medication.
Adverse/Side Effects
Most common side effects are not serious and should go away on their own, if they persist or become bothersome contact a doctor: acne, burning sensation, coughing, dizziness, flushing, headache, increased hair growth, nausea, runny nose, sleeplessness, stomach discomfort, vomiting, cramps, shaking fingers/hands (tremors), swollen/red/painful gums, and high blood pressure. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Your risk of bacterial infection may be higher while you are taking this medication.
The following is a list of symptoms of infection, if you experience any tell your doctor immediately: fever, sore throat, flu-like symptoms, or painful urination. Tell your doctor immediately if any of these unlikely but serious side effects occur: severe muscle spasms, fast/irregular heartbeat, muscle weakness, confusion, change in the amount/color of urine, unusual weight gain/loss, tingling of the hands/feet, hearing problems, easy bruising/bleeding, unusual tiredness. Tell your doctor immediately if any of these rare but very serious side effects occur: dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing of the skin/eyes, vomit that looks like coffee grounds, change in the appearance or size of skin moles/lesions, changes in skin color, loss of consciousness, mental/mood changes, vision changes, swollen glands, unusual lumps or night sweats.
Immediately seek medical attention right away if any of these severe side effects occur while using Neoral: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the urine; change in the appearance of a mole; chest pain; confusion; dark urine; diarrhea; fast or irregular heartbeat; gum disease or overgrowth; increased or decreased urination; loss of coordination; mental or mood changes; muscle cramps; numbness or tingling of the skin; seizures; severe or persistent headache or dizziness; shortness of breath; symptoms of infection (chills, cough, fever, painful urination, sore throat); tremors; unusual bleeding or bruising; unusual lumps; unusual thickening or growth on the skin; unusual tiredness or weakness; vision changes; wheezing; yellowing of the skin or eyes.
This is not a complete list there might e be other side effects if you experience any bothersome worrisome side effects please contact a doctor.
Overdose
In case of overdose immediately contact your local emergency room or poison control center.
Storage Instructions
Store in a controlled room temperature 68°-77°F (20°-25°C). Keep away from moisture and light and always store out of the reach of children.
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Home / Antibiotics / Neoral, cyclosporin
Buy Neoral (Cyclosporin) for the treatment of: prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants, rheumatoid arthritis and severe psoriasis in adult patients. Initial dosage will depend on condition and patient see product information for details.