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Neoral

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Overview

What is Neoral?

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

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



What does Neoral look like?



What are the available doses of Neoral?

Sorry No records found.

What should I talk to my health care provider before I take Neoral?

Sorry No records found

How should I use Neoral?

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 Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED and Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIED

Neoral has increased bioavailability in comparison to Sandimmune. Neoral and Sandimmune are not bioequivalent and cannot be used interchangeably without physician supervision.

The daily dose of Neoral should always be given in two divided doses (BID). It is recommended that Neoral be administered on a consistent schedule with regard to time of day and relation to meals. Grapefruit and grapefruit juice affect metabolism, increasing blood concentration of cyclosporine, thus should be avoided.

Specific Populations

Renal Impairment in Kidney, Liver, and Heart Transplantation

Cyclosporine undergoes minimal renal elimination and its pharmacokinetics do not appear to be significantly altered in patients with end-stage renal disease who receive routine hemodialysis treatments (). However, due to its nephrotoxic potential (), careful monitoring of renal function is recommended; cyclosporine dosage should be reduced if indicated. ()

Renal Impairment in Rheumatoid Arthritis and Psoriasis

Patients with impaired renal function should not receive cyclosporine. ()

Hepatic Impairment

The clearance of cyclosporine may be significantly reduced in severe liver disease patients (). Dose reduction may be necessary in patients with severe liver impairment to maintain blood concentrations within the recommended target range ().


What interacts with Neoral?

Sorry No Records found


What are the warnings of Neoral?

Sorry No Records found


What are the precautions of Neoral?

Sorry No Records found


What are the side effects of Neoral?

Sorry No records found


What should I look out for while using Neoral?

(See also BOXED WARNING)


What might happen if I take too much Neoral?

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 nephrotoxicity may occur which should resolve following drug withdrawal. Oral doses of cyclosporine up to 10 g (about 150 mg/kg) have been tolerated with relatively minor clinical consequences, such as vomiting, drowsiness, headache, tachycardia and, in a few patients, moderately severe, reversible impairment of renal function. However, serious symptoms of intoxication have been reported following accidental parenteral overdosage with cyclosporine in premature neonates. General supportive measures and symptomatic treatment should be followed in all cases of overdosage. Cyclosporine is not dialyzable to any great extent, nor is it cleared well by charcoal hemoperfusion. The oral dosage at which half of experimental animals are estimated to die is 31 times, 39 times, and >54 times the human maintenance dose for transplant patients (6mg/kg; corrections based on body surface area) in mice, rats, and rabbits.


How should I store and handle Neoral?

Storage and HandlingStore at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store blister pack in original carton to protect from light. FARYDAK capsules should not be opened, crushed, or chewed. Direct contact of the powder in FARYDAK capsules with the skin or mucous membranes should be avoided. If such contact occurs wash thoroughly. Personnel should avoid exposure to crushed and/or broken capsules.FARYDAK is a cytotoxic drug. Follow special handling and disposal procedures .Storage and HandlingStore at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store blister pack in original carton to protect from light. FARYDAK capsules should not be opened, crushed, or chewed. Direct contact of the powder in FARYDAK capsules with the skin or mucous membranes should be avoided. If such contact occurs wash thoroughly. Personnel should avoid exposure to crushed and/or broken capsules.FARYDAK is a cytotoxic drug. Follow special handling and disposal procedures .Storage and HandlingStore at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store blister pack in original carton to protect from light. FARYDAK capsules should not be opened, crushed, or chewed. Direct contact of the powder in FARYDAK capsules with the skin or mucous membranes should be avoided. If such contact occurs wash thoroughly. Personnel should avoid exposure to crushed and/or broken capsules.FARYDAK is a cytotoxic drug. Follow special handling and disposal procedures .Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED25 mg Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”Packages of 30 unit-dose blisters (NDC 0078-0246-15).100 mg Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”Packages of 30 unit-dose blisters (NDC 0078-0248-15).Store and DispenseIn the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIEDA clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).Store and Dispense In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDDistributed by:Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936© NovartisT2015-47March 2015


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Clinical Information

Chemical Structure

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Clinical Pharmacology

The immunosuppressive activity of cyclosporine is primarily due to parent drug. Following oral administration, absorption of cyclosporine is incomplete. The extent of absorption of cyclosporine is dependent on the individual patient, the patient population, and the formulation. Elimination of cyclosporine is primarily biliary with only 6% of the dose (parent drug and metabolites) excreted in urine. The disposition of cyclosporine from blood is generally biphasic, with a terminal half-life of approximately 8.4 hours (range 5 to 18 hours). Following intravenous administration, the blood clearance of cyclosporine (assay: HPLC) is approximately 5 to 7 mL/min/kg in adult recipients of renal or liver allografts. Blood cyclosporine clearance appears to be slightly slower in cardiac transplant patients.

The Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED and Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIED are bioequivalent. Neoral Oral Solution diluted with orange juice or apple juice is bioequivalent to Neoral Oral Solution diluted with water. The effect of milk on the bioavailability of cyclosporine when administered as Neoral Oral Solution has not been evaluated.

The relationship between administered dose and exposure (area under the concentration versus time curve, AUC) is linear within the therapeutic dose range. The intersubject variability (total, %CV) of cyclosporine exposure (AUC) when Neoral or Sandimmune is administered ranges from approximately 20% to 50% in renal transplant patients. This intersubject variability contributes to the need for individualization of the dosing regimen for optimal therapy . Intrasubject variability of AUC in renal transplant recipients (%CV) was 9% to 21% for Neoral and 19% to 26% for Sandimmune. In the same studies, intrasubject variability of trough concentrations (%CV) was 17% to 30% for Neoral and 16% to 38% for Sandimmune.

Non-Clinical Toxicology
(See also BOXED WARNING)

Ranitidine has been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and inhibition of cytochrome P450 enzymes.

Hypertension

Cyclosporine is the active ingredient of Neoral. Hypertension is a common side effect of cyclosporine therapy which may persist.Mild or moderate hypertension is encountered more frequently than severe hypertension and the incidence decreases over time. In recipients of kidney, liver, and heart allografts treated with cyclosporine, antihypertensive therapy may be required. However, since cyclosporine may cause hyperkalemia, potassium-sparing diuretics should not be used. While calcium antagonists can be effective agents in treating cyclosporine-associated hypertension, they can interfere with cyclosporine metabolism.

Vaccination

During treatment with cyclosporine, vaccination may be less effective; and the use of live attenuated vaccines should be avoided.

Special Monitoring of Rheumatoid Arthritis Patients

Before initiating treatment, a careful physical examination, including blood pressure measurements (on at least two occasions) and two creatinine levels to estimate baseline should be performed. Blood pressure and serum creatinine should be evaluated every 2 weeks during the initial 3 months and then monthly if the patient is stable. It is advisable to monitor serum creatinine and blood pressure always after an increase of the dose of nonsteroidal anti-inflammatory drugs (NSAIDs) and after initiation of new NSAID therapy during Neoral treatment. If coadministered with methotrexate, CBC and liver function tests are recommended to be monitored monthly.

In patients who are receiving cyclosporine, the dose of Neoral should be decreased by 25% to 50% if hypertension occurs. If hypertension persists, the dose of Neoral should be further reduced or blood pressure should be controlled with antihypertensive agents. In most cases, blood pressure has returned to baseline when cyclosporine was discontinued.

In placebo-controlled trials of rheumatoid arthritis patients, systolic hypertension (defined as an occurrence of two systolic blood pressure readings >140 mmHg) and diastolic hypertension (defined as two diastolic blood pressure readings >90 mmHg) occurred in 33% and 19% of patients treated with cyclosporine, respectively. The corresponding placebo rates were 22% and 8%.

Special Monitoring for Psoriasis Patients

Before initiating treatment, a careful dermatological and physical examination, including blood pressure measurements (on at least two occasions) should be performed. Since Neoral is an immunosuppressive agent, patients should be evaluated for the presence of occult infection on their first physical examination and for the presence of tumors initially, and throughout treatment with Neoral. Skin lesions not typical for psoriasis should be biopsied before starting Neoral. Patients with malignant or premalignant changes of the skin should be treated with Neoral only after appropriate treatment of such lesions and if no other treatment option exists.

Baseline laboratories should include serum creatinine (on two occasions), BUN, CBC, serum magnesium, potassium, uric acid, and lipids.

The risk of cyclosporine nephropathy is reduced when the starting dose is low (2.5 mg/kg/day), the maximum dose does not exceed 4.0 mg/kg/day, serum creatinine is monitored regularly while cyclosporine is administered, and the dose of Neoral is decreased when the rise in creatinine is greater than or equal to 25% above the patient’s pretreatment level. The increase in creatinine is generally reversible upon timely decrease of the dose of Neoral or its discontinuation.

Serum creatinine and BUN should be evaluated every 2 weeks during the initial 3 months of therapy and then monthly if the patient is stable. If the serum creatinine is greater than or equal to 25% above the patient’s pretreatment level, serum creatinine should be repeated within two weeks. If the change in serum creatinine remains greater than or equal to 25% above baseline, Neoral should be reduced by 25% to 50%. If at the serum creatinine increases by greater than or equal to 50% above pretreatment level, Neoral should be reduced by 25% to 50%. Neoral should be discontinued if reversibility (within 25% of baseline) of serum creatinine is not achievable after two dosage modifications. It is advisable to monitor serum creatinine after an increase of the dose of nonsteroidal anti-inflammatory drug and after initiation of new nonsteroidal anti-inflammatory therapy during Neoral treatment.

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. Patients without a history of previous hypertension before initiation of treatment with Neoral, should have the drug reduced by 25%-50% if found to have sustained hypertension. If the patient continues to be hypertensive despite multiple reductions of Neoral, then Neoral should be discontinued. For patients with treated hypertension, before the initiation of Neoral therapy, their medication should be adjusted to control hypertension while on Neoral. Neoral should be discontinued if a change in hypertension management is not effective or tolerable.

CBC, uric acid, potassium, lipids, and magnesium should also be monitored every 2 weeks for the first 3 months of therapy, and then monthly if the patient is stable or more frequently when dosage adjustments are made. Neoral dosage should be reduced by 25%–50% for any abnormality of clinical concern.

In controlled trials of cyclosporine in psoriasis patients, cyclosporine blood concentrations did not correlate well with either improvement or with side effects such as renal dysfunction.

Information for Patients: Patients should be advised that any change of cyclosporine formulation should be made cautiously and only under physician supervision because it may result in the need for a change in dosage.

Patients should be informed of the necessity of repeated laboratory tests while they are receiving cyclosporine. Patients should be advised of the potential risks during pregnancy and informed of the increased risk of neoplasia. Patients should also be informed of the risk of hypertension and renal dysfunction.

Patients should be advised that during treatment with cyclosporine, vaccination may be less effective and the use of live attenuated vaccines should be avoided.

Patients should be given careful dosage instructions. Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIED should be diluted, preferably with orange or apple juice that is at room temperature. The combination of Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIED with milk can be unpalatable.

Patients should be advised to take Neoral on a consistent schedule with regard to time of day and relation to meals. Grapefruit and grapefruit juice affect metabolism, increasing blood concentration of cyclosporine, thus should be avoided.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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