drug-information.ru

|Sandimmune Sandimmune

Sandimmune

Generic name:
Brand names: Sandimmune, Neoral

Why is Sandimmune prescribed?

Sandimmune is given after organ transplant surgery to help prevent rejection of organs (kidney, heart, or liver) by holding down the body"s immune system. It is also used to avoid long-term rejection in people previously treated with other immunosuppressant drugs, such as Imuran.

Neoral is a newer formulation of Sandimmune"s active ingredient, cyclosporine. In addition to prevention of organ rejection, it is prescribed for certain severe cases of rheumatoid arthritis and psoriasis.

Some doctors also prescribe Sandimmune to treat alopecia areata (localized areas of hair loss), aplastic anemia (shortage of red and white blood cells and platelets), Crohn"s disease (chronic inflammation of the digestive tract), and nephropathy (kidney disease). Sandimmune is sometimes used in the treatment of severe skin disorders, including psoriasis and dermatomyositis (inflammation of the skin and muscles causing weakness and rash). The drug is also used in procedures involving bone marrow, the pancreas, and the lungs.

Sandimmune is always given with prednisone or a similar steroid. It is available in capsules and liquid, or as an injection.

Most important fact about Sandimmune

If you take Sandimmune orally over a period of time, your doctor will monitor your blood levels of cyclosporine to make sure your body is receiving the correct amount of Sandimmune. The reason for this repeated testing is that the absorption of Sandimmune in the body is erratic. Constant monitoring is necessary to prevent toxicity due to overdosing or to prevent possible organ rejection due to underdosing. It is important to note that Sandimmune may need to be taken by mouth for an indefinite period following surgery.

How should you take Sandimmune?

Take the Sandimmune capsule or oral liquid at the same time every day. You may take the medication either with a meal or between meals, but be consistent.

To make Sandimmune oral liquid more palatable, you may mix it with room-temperature milk, chocolate milk, or orange juice. Try to use the same beverage as often as possible. Neoral oral solution may be mixed with room-temperature orange or apple juice. It does not taste good in milk. Use a container made of glass, not plastic. Never let the mixture stand; drink it as soon as you prepare it. To make sure you get your full dose, rinse the glass with a little more liquid and drink that too.

You should maintain good dental hygiene and see your dentist frequently for cleaning to prevent tenderness, bleeding, and gum enlargement.

After you use the dosage syringe to transfer the oral solution to a glass, dry the outside of the syringe with a clean towel and put it away. Do not rinse or wash it. If you do have to clean it, make sure it is thoroughly dry before you use it again.

You may notice an odor when you open the capsule container; this is nothing to worry about and will soon dissipate.

Neoral should start to work on rheumatoid arthritis in 4 to 8 weeks, and on psoriasis in 2 weeks. Psoriasis is usually controlled within 12 to 16 weeks; you should not take the drug for more than a year.

--If you miss a dose...

If fewer than 12 hours have passed, take it as soon as you remember. If it is almost time for the next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at once.

--Storage instructions...

Store both the capsules and the oral solution at room temperature. Do not store the liquid in the refrigerator. Keep the liquid from freezing. Sandimmune liquid, once opened, must be used within 2 months.

What side effects may occur?

Side effects cannot be anticipated. If any appear or change in intensity, inform your doctor immediately. Only your doctor can determine if it is safe for you to continue taking Sandimmune. The principal side effects of Sandimmune are high blood pressure, hirsutism (unusual growth of hair), kidney damage, excessive growth of the gums, and tremor.

• Other side effects may include:
  Abdominal discomfort, acne, breathing difficulty, convulsions, coughing, cramps, diarrhea, flu-like symptoms, flushing, headache, liver damage, lymph system tumor, muscle, bone, or joint pain, nasal inflammation, nausea, numbness or tingling, sinus inflammation, vomiting, wheezing

Why should Sandimmune not be prescribed?

Do not take these products if you have ever had an allergic reaction to them. Avoid Sandimmune by injection if you have ever had an allergic reaction to an injection of the drug or you are especially sensitive to castor oil.

Avoid taking Neoral for arthritis or psoriasis if you have a kidney condition, high blood pressure, or cancer. While taking the drug, you should avoid most other psoriasis treatment, including ultraviolet light, coal tar, methotrexate, and radiation.

Special warnings about Sandimmune

When your immune system is suppressed by Sandimmune, you are at increased risk of infection and of certain malignancies, including skin cancer and lymph system cancer.

High-dose Sandimmune is toxic to the liver and kidneys and may cause serious kidney damage. Because this toxicity has symptoms similar to those of transplant rejection, you must be monitored closely. If your body is trying hard to reject a transplanted organ, your doctor will probably allow the rejection to occur rather than give you a very high dose of Sandimmune.

This drug can raise blood pressure, especially in older people. If high blood pressure develops while you are taking Neoral for transplant rejection, the doctor will prescribe blood pressure medication. If it develops while you are taking the drug for arthritis or psoriasis, the doctor may lower your dose.

Sandimmune and Neoral are not directly interchangeable. Your doctor may need to adjust the dosage if you switch.

Brain disorders have developed in patients taking Sandimmune, sometimes leading to convulsions, loss of movement, vision problems, impaired consciousness, and psychiatric disturbances. The chance of convulsions is greater if you are taking high doses of steroid drugs, particularly methylprednisolone (Medrol). Brain-related disorders usually clear up once Sandimmune is discontinued.

Use a barrier method of contraception, such as diaphragms or condoms, during Sandimmune therapy. Do not use oral contraceptive pills without your doctor"s approval.

Do not try to change dosage forms without consulting your doctor.

If you take Neoral for arthritis or psoriasis, the condition will eventually return when you stop taking the drug, generally within 1 or 2 months. Neoral treatments for psoriasis should be replaced with other types of therapy after 1 year.

Possible food and drug interactions when taking Sandimmune

Avoid getting immunizations while you are taking Sandimmune. The drug may make vaccinations less effective or increase your risk of contracting an illness from a live vaccine.

If taking Neoral for psoriasis, remember to avoid other psoriasis treatments.

Avoid grapefruit and grapefruit juice while taking Sandimmune. Also avoid the antidepressant herb St. John"s wort. This over-the-counter herbal remedy reduces the effect of Sandimmune and Neoral, and can lead to organ rejection.

If Sandimmune is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Sandimmune with the following:

Allopurinol (Zyloprim)
Amiodarone (Cordarone)
Amphotericin B (Fungizone, Abelcet)
Atorvastatin (Lipitor)
Bromocriptine (Parlodel)
Calcium-blocking heart and blood pressure medications such as Adalat, Calan, Cardene, Cardizem, and Procardia
Carbamazepine (Tegretol)
Cimetidine (Tagamet)
Clarithromycin (Biaxin)
Colchicine
Danazol (Danocrine)
Diclofenac (Voltaren, Cataflam)
Digoxin (Lanoxin, Lanoxicaps)
Erythromycin (E.E.S., Erythrocin, others)
Fluconazole (Diflucan)
Fluvastatin (Lescol)
Gentamicin (Garamycin)
Indinavir (Crixivan)
Itraconazole (Sporanox)
Ketoconazole (Nizoral)
Lovastatin (Mevacor)
Melphalan (Alkeran)
Methotrexate
Methylprednisolone (Depo-Medrol, Medrol, Solu-Medrol)
Metoclopramide (Reglan)
Nafcillin (Unipen)
Nelfinavir (Viracept)
Nonsteroidal anti-inflammatory drugs such as Clinoril and Naprosyn
Octreotide (Sandostatin)
Orlistat (Xenical)
Phenobarbital
Phenytoin (Dilantin)
Potassium-sparing diuretics (Dyrenium, Midamor, Aldactone)
Pravastatin (Pravachol)
Prednisolone (Delta-Cortef, Prelone)
Quinupristin (Synercid)
Ranitidine (Zantac)
Rifampin (Rifadin, Rifamate, Rimactane)
Ritonavir (Norvir)
Saquinavir (Fortovase)
Simvastatin (Zocor)
Ticlopidine (Ticlid)
Tacrolimus (Prograf)
Tobramycin (Nebcin)
Trimethoprim/sulfamethoxazole (Bactrim, Septra)
Vancomycin (Vancocin)

Special information if you are pregnant or breastfeeding

The effects of Sandimmune in pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. Sandimmune should be used during pregnancy only if the benefit justifies the potential risk to the unborn child. Since Sandimmune appears in breast milk, it should not be used during breastfeeding. If you are a new mother, you may need to choose between taking Sandimmune and breastfeeding your baby.

Recommended dosage

ADULTS

Transplant Rejection

Your doctor will tailor your dosage of Sandimmune in accordance with your body"s response. Expect a single dose of 15 milligrams per 2.2 pounds of body weight 4 to 12 hours before a transplant and 1 dose daily for 1 to 2 weeks after the operation. After that, the doctor may keep you on a daily dose of 5 to 10 milligrams per 2.2 pounds of body weight.

The dosage of Neoral depends on the type of transplant and the other drugs you are taking. It is always taken twice a day.

Psoriasis or Rheumatoid Arthritis

The starting dosage is 2.5 milligrams of Neoral per 2.2 pounds of body weight divided into 2 doses per day. Your doctor may gradually increase the daily dose to a maximum of 4 milligrams per 2.2 pounds.

CHILDREN

Dosage is generally the same for children as for adults, though somewhat higher doses are sometimes needed. Both drugs have been used to prevent transplant rejection in small children. Neoral has not been tested for arthritis or psoriasis in children under 18.

Overdosage

Although no specific information is available, an overdose of Sandimmune would be expected to cause liver and kidney problems. Any medication taken in excess can have serious consequences. If you suspect an overdose of Sandimmune, seek medical attention immediately.