Clinical Information
Gen. Code and Des.
23883 cyclosporine, modified ORAL SOLUTION 100 MG/ML
GCN and Des.
13917 cyclosporine, modified ORAL SOLUTION 100 MG/ML
Strength
Dose Form
SOLUTION, ORAL
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
92440000 IMMUNOSUPPRESSIVE AGENTS
92200000 IMMUNOMODULATORY AGENTS
92360000 DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
Active Ingredients
5038 cyclosporine, modified 59865133
Inactive Ingredients
1539 ethyl alcohol 64175
2468 propylene glycol 57556
9290 cremophor el (polyethoxlated castor oil)
BOXED WARNING (What is this?)
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 (see DOSAGE AND ADMINISTRATION).
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BOXED WARNING (What is this?)
For Psoriasis Patients (see also BOXED WARNING 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.
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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 ...
CLINICAL PHARMACOLOGY
Cyclosporine is a potent immunosuppressive agent that in animals prolongs survival of allogeneic transplants involving skin, kidney, liver, heart, pancreas, bone marrow, small intestine, and lung ...
CLINICAL TRIALS
Rheumatoid Arthritis - The effectiveness of Sandimmune and Neoral in the treatment of severe rheumatoid arthritis was evaluated in 5 clinical studies involving a total of 728 cyclosporine ...
INDICATIONS AND USAGE
Kidney, Liver, and Heart Transplantation - Neoral is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Neoral has been used in combination ...
CONTRAINDICATIONS
General - Neoral is contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation. Rheumatoid Arthritis - Rheumatoid arthritis ...
WARNINGS
(See also BOXED WARNING.) All Patients - Cyclosporine, the active ingredient of Neoral, can cause nephrotoxicity and hepatotoxicity. The risk increases with increasing doses of cyclosporine ...
PRECAUTIONS
General - Hypertension - Cyclosporine is the active ingredient of Neoral. Hypertension is a common side effect of cyclosporine therapy which may persist (see ADVERSE REACTIONS and DOSAGE AND ...
LABORATORY TESTS
Laboratory Tests - In all patients treated with cyclosporine, renal and liver functions should be assessed repeatedly by measurement of serum creatinine, BUN, serum bilirubin, and liver enzymes ...
Drug Interactions
A. Effect of Drugs and Other Agents on Cyclosporine Pharmacokinetics and/or Safety - All of the individual drugs cited below are well substantiated to interact with cyclosporine. In addition ...
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Carcinogenicity studies were carried out in male and female rats and mice. In the 78-week mouse study, evidence of a statistically significant trend was found for lymphocytic lymphomas in females ...
Pregnancy
Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to cyclosporine, including Neoral, during pregnancy. Encourage women who are ...
Nursing Mothers
Risk Summary - Cyclosporine and its metabolites are present in human milk following oral and intravenous administration. Adverse effects on the breastfed infant have not been reported. There are ...
Pediatric Use
Although no adequate and well-controlled studies have been completed in children, transplant recipients as young as one year of age have received Neoral with no unusual adverse effects. The safety ...
Geriatric Use
In rheumatoid arthritis clinical trials with cyclosporine, 17.5% of patients were age 65 or older. These patients were more likely to develop systolic hypertension on therapy, and more likely to ...
ADVERSE REACTIONS
Kidney, Liver, and Heart Transplantation - The principal adverse reactions of cyclosporine therapy are renal dysfunction, tremor, hirsutism, hypertension, and gum ...
OVERDOSAGE
There is a minimal experience with cyclosporine overdosage. Forced emesis and gastric lavage can be of value up to 2 hours after administration of Neoral. Transient hepatotoxicity and ...
DOSAGE AND ADMINISTRATION
Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED and Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIED - Neoral has increased bioavailability in comparison to ...
HOW SUPPLIED
Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED - 25 mg - Oval, blue-gray imprinted in red, “Neoral” over “25 mg.” Packages of 30 unit-dose blisters (NDC 0078-0246-15). 100 ...
PRINCIPAL DISPLAY PANEL
NOVARTIS - NDC 0078-0246-15 - NEORAL® Soft Gelatin Capsules - (cyclosporine capsules, USP) MODIFIED - WARNING: Neoral® (cyclosporine capsules, USP) MODIFIED is NOT BIOEQUIVALENT to - Sandimmune ...
PRINCIPAL DISPLAY PANEL
NOVARTIS - NDC 0078-0248-15 - NEORAL® Soft Gelatin Capsules - (cyclosporine capsules, USP) MODIFIED - WARNING: Neoral® (cyclosporine capsules, USP) MODIFIED is NOT BIOEQUIVALENT to - Sandimmune ...
PRINCIPAL DISPLAY PANEL
NOVARTIS - 50 mL Size - NDC 0078-0274-22 - NEORAL® Oral Solution - (cyclosporine oral solution, USP) MODIFIED - WARNING: Neoral® (cyclosporine oral solution, USP) MODIFIED is NOT - BIOEQUIVALINET to ...
INGREDIENTS AND APPEARANCE
Product Information
