Neoral

Neoral is a prescription medication used to prevent transplant rejection in those who have received kidney, liver, and heart transplants. Neoral may also be used to treat psoriasis and symptoms of rheumatoid arthritis. Neoral belongs to a group of drugs called immunosuppressants. They work by decreasing the activity of the immune system.

Neoral comes as a capsule and an oral liquid solution. It is usually taken twice a day. This medication is available as a modified form of cyclosporine that has been slightly changed to be more easily absorbed by the body.

Common side effects of Neoral include high blood pressure, gum overgrowth, and tremors. 

Neoral is a prescription medication used to prevent transplant rejection in those who have received kidney, liver, and heart transplants.

Neoral may also be used to treat psoriasis  symptoms of rheumatoid arthritis.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novartis Pharmaceuticals Corporation

Common side effects of Neoral include:

• headache
• diarrhea
• nausea
• vomiting
• kidney dysfunction
• tremor
• hirsutism (excessive growth of hair in women in a male-like pattern)
• high blood pressure
• gum tissue overgrowth

Tell your doctor if any side effect is bothersome or does not go away. Neoral may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medications that decrease the functioning of the immune system such as azathioprine (Imuran), cancer chemotherapy, methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf)
• other medicines that can cause high blood pressure or kidney damage such as amphotericin B (Amphotec, Fungizone); cimetidine (Tagamet); ciprofloxacin (Cipro); colchicine; fenofibrate (Antara, Lipophen, Tricor); gemfibrozil (Lopid); gentamicin; ketoconazole (Nizoral); melphalan (Alkeran); nonsteroidal anti-inflammatory drugs such as diclofenac (Cataflam, Voltaren), naproxen (Aleve, Naprosyn), and sulindac (Clinoril); ranitidine (Zantac); tobramycin (Tobi); trimethoprim with sulfamethoxazole (Bactrim, Septra); and vancomycin (Vancocin)
• acyclovir (Zovirax)
• allopurinol (Zyloprim)
• amiodarone (Cordarone)
• angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik)
• angiotensin II receptor antagonists such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• certain antifungal medications such as fluconazole (Diflucan), and itraconazole (Sporanox); azithromycin (Zithromax)
• bromocriptine (Parlodel)
• calcium channel blockers such as diltiazem (Cardizem), nicardipine (Cardene), and verapamil (Calan); carbamazepine (Tegretol)
• cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor)
• clarithromycin (Biaxin)
• dalfopristin and quinupristin combination (Synercid)
• danazol
• digoxin (Lanoxin)
• certain diuretics ('water pills') including amiloride (Midamor), spironolactone (Aldactone), and triamterene (Dyazide)
• erythromycin
• HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase)
• imatinib (Gleevec)
• metoclopramide (Reglan)
• methylprednisolone (Medrol)
• nafcillin; octreotide (Sandostatin)
• oral contraceptives (birth control pills)
• orlistat (Xenical)
• phenobarbital
• phenytoin (Dilantin)
• potassium supplements
• prednisolone (Pediapred)
• repaglinide (Prandin)
• rifabutin (Mycobutin)
• rifampin (Rifadin, Rimactane)
• St. John's wort
• sulfinpyrazone (Anturane)
• terbinafine (Lamisil)
• ticlopidine (Ticlid)

This is not a complete list of Neoral drug interactions. Ask your doctor or pharmacist for more information.

Grapefruit and grapefruit juice may interact with Neoral and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Your doctor may tell you to limit the amount of potassium in your diet. Follow these instructions carefully. Talk to your doctor about the amount of potassium-rich foods such as bananas, prunes, raisins, and orange juice you may have in your diet. Many salt substitutes contain potassium, so talk to your doctor about using them during your treatment.

Before using Neoral, tell your doctor about all of your medical conditions including:

• if you are allergic to Neoral, any other medications, or any of the inactive ingredients in Neoral. Ask your pharmacist for a list of the inactive ingredients
• tell your doctor if you have or have ever had any of the conditions mentioned in the "Neoral Precautions" section
• tell your doctor if you have low cholesterol, low levels of magnesium in your blood, any condition that makes it difficult for your body to absorb nutrients, or liver disease
• tell your doctor if you have an eye infection, if you have a punctal plug (stopper inserted by a doctor in a tear duct to keep tears in the eye), and if you have or have ever had a herpes infection of the eye
• if you are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Do not have vaccinations without talking to your doctor.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Neoral falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Neoral is excreted in human breast milk or if it will harm your nursing baby.

Neoral comes as a capsule and a solution (liquid) to take by mouth. Neoral is usually taken twice a day. It is important to take Neoral on a regular schedule. Take Neoral at the same time(s) each day, and allow the same amount of time between doses and meals every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Neoral exactly as directed. Do not take more or less of the medication or take it more often than prescribed by your doctor.

You may notice an unusual smell when you open a blister card of Neoral capsules. This is normal and does not mean that the medication is damaged or unsafe to use.

Neoral oral solution may gel or become lumpy if it is exposed to temperatures below 68 °F (20 °C). You can use the solution even if it has gelled, or you can turn the solution back to a liquid by allowing it to warm to room temperature (77 °F [25 °C]).

Neoral oral solution must be mixed with a liquid before use. Neoral oral solution may be mixed with orange juice or apple juice but should not be mixed with milk. You should choose one drink from the appropriate list and always mix your medication with that drink.

To take either type of oral solution, follow these steps:

• Fill a glass (not plastic) cup with the drink you have chosen.
• Remove the protective cover from the top of the dosing syringe that came with your medication.
• Place the tip of the syringe into the bottle of solution and pull back on the plunger to fill the syringe with the amount of solution your doctor has prescribed.
• Hold the syringe over the liquid in your glass and press down on the plunger to place the medication in the glass.
• Stir the mixture well.
• Drink all of the liquid in the glass right away.
• Pour a little more of the drink you have chosen into the glass, swirl the glass around to rinse, and drink the liquid.
• Dry the outside of the syringe with a clean towel and replace the protective cover. Do not wash the syringe with water. If you do need to wash the syringe, be sure that it is completely dry before you use it to measure another dose.

If you take too much Neoral, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Neoral is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep this medication in the container it came in, tightly closed and out of reach of children.
• Store this medication at room temperature and away from excess heat and moisture (not in the bathroom).
• Do not store this medicine in the refrigerator and do not freeze it.
• Oral Neoral: throw away any medication that is outdated or no longer needed.
• Throw away any remaining oral solution 2 months after you first open the bottle. Talk to your pharmacist about the proper disposal of your medication.

Warning: 

Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe Neoral. At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe Neoral. 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.

Neoral, a systemic immunosuppressant, may increase the susceptibility to infection and the development of neoplasia. In kidney, liver, and heart transplant patients Neoral may be administered with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma and other neoplasms may result from the increase in the degree of immunosuppression in transplant patients.

Neoral Soft Gelatin Capsules MODIFIED and Neoral Oral Solution MODIFIED have increased bioavailability in comparison to Sandimmune Soft Gelatin Capsules and Sandimmune Oral Solution. Neoral and Sandimmune are not bioequivalent and cannot be used interchangeably without physician supervision. For a given trough concentration, cyclosporine exposure will be greater with Neoral than with Sandimmune. If a patient who is receiving exceptionally high doses of Sandimmune is converted to Neoral, particular caution should be exercised. Cyclosporine blood concentrations should be monitored in transplant and rheumatoid arthritis patients taking Neoral to avoid toxicity due to high concentrations. Dose adjustments should be made in transplant patients to minimize possible organ rejection due to low concentrations. Comparison of blood concentrations in the published literature with blood concentrations obtained using current assays must be done with detailed knowledge of the assay methods employed.

For Psoriasis Patients

Psoriasis patients previously treated with PUVA and to a lesser extent, methotrexate or other immunosuppressive agents, UVB, coal tar, or radiation therapy, are at an increased risk of developing skin malignancies when taking Neoral.

Cyclosporine, the active ingredient in Neoral, in recommended dosages, can cause systemic hypertension and nephrotoxicity. The risk increases with increasing dose and duration of cyclosporine therapy. Renal dysfunction, including structural kidney damage, is a potential consequence of cyclosporine, and therefore, renal function must be monitored during therapy.