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Neoral

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Neoral

NEORAL® Soft Gelatin Capsules
(cyclosporine) Capsules, USP Modified

NEORAL® Oral Solution
(cyclosporine) Oral Solution, USP Modified

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 (cyclosporine capsules, USP) MODIFIED and Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIED have increased bioavailability in comparison to Sandimmune® Soft Gelatin Capsules (cyclosporine capsules, USP) and Sandimmune® Oral Solution (cyclosporine oral solution, USP). 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 (See also BOXED WARNINGS above)

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.

DRUG DESCRIPTION

Neoral® is an oral formulation of cyclosporine that immediately forms a microemulsion in an aqueous environment.

Cyclosporine, the active principle in Neoral®, is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Beauveria nivea.

Chemically, cyclosporine is designated as [R-[R*,R*-(E)]]-cyclic-(L-alanyl-D-alanyl-N-methyl-L-leucylN-methyl-L-leucyl-N-methyl-L-valyl-3-hydroxy-N,4-dimethyl-L-2-amino-6-octenoyl-L-α -aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl).

Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED are available in 25 mg and 100 mg strengths.

Each 25 mg capsule contains:

cyclosporine………………………………25 mg
alcohol, USP dehydrated.............................11.9% v/v (9.5% wt/vol.)

Each 100 mg capsule contains:

cyclosporine……………………………...100 mg
alcohol, USP dehydrated............................11.9% v/v (9.5% wt/vol.)

Inactive Ingredients: Corn oil-mono-di-triglycerides, polyoxyl 40 hydrogenated castor oil NF, DL-αtocopherol USP, gelatin NF, glycerol, iron oxide black, propylene glycol USP, titanium dioxide USP, carmine, and other ingredients.

Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIED is available in 50 mL bottles.

Each mL contains:

cyclosporine…………………..................100 mg/mL
alcohol, USP dehydrated...........................11.9% v/v (9.5% wt/vol.)

Inactive Ingredients: Corn oil-mono-di-triglycerides, polyoxyl 40 hydrogenated castor oil NF, DL-α tocopherol USP, propylene glycol USP.

The chemical structure of cyclosporine (also known as cyclosporin A) is:

NEORAL® Soft Gelatin Capsules (cyclosporine) Structural Formula Illustration

What are the possible side effects of cyclosporine (Gengraf, Neoral, Sandimmune)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, sweating, chills, body aches, flu symptoms, sores in your mouth and throat, weight loss;
  • change in your mental state, problems with speech or walking, decreased vision (may start gradually and get worse quickly);
  • easy bruising or bleeding, pale skin, confusion or weakness;
  • feeling light-headed...

Read All Potential Side Effects and See Pictures of Neoral »

What are the precautions when taking cyclosporine (Neoral)?

Before taking cyclosporine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of chicken pox/shingles, uncontrolled high blood pressure, cancer, skin lesions of unknown cause, current use of radiation therapy (including phototherapy with PUVA or UVB), kidney problems (for arthritis or psoriasis patients only).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver...

Read All Potential Precautions of Neoral »

Last reviewed on RxList: 10/12/2012
This monograph has been modified to include the generic and brand name in many instances.

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