Cyclosporine (Neoral)

Trade Name : Neoral

Novartis Pharmaceuticals Corporation

CAPSULE, LIQUID FILLED

Strength 25 mg/1

CYCLOSPORINE Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Cyclosporine (Neoral) which is also known as Neoral and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 25 mg/1 per ml. Read more

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About GNH

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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.

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.

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 n
Chemically, cyclosporine is designated as [-[,n -()]]-cyclic-(L-alanyl-D-alanyl--methyl-L-leucyl--methyl-L-leucyl--methyl-L-valyl-3-hydroxy-,4-dimethyl-L-2-amino-6-octenoyl-L-u03b1 -amino-butyryl--methylglycyl--methyl-L-leucyl-L-valyl--methyl-L-leucyl).

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. Cyclosporine has been demonstrated to suppress some humoral immunity and to a greater extent, cell-mediated immune reactions such as allograft rejection, delayed hypersensitivity, experimental allergic encephalomyelitis, Freundu2019s adjuvant arthritis, and graft versus host disease in many animal species for a variety of organs.
The effectiveness of cyclosporine results from specific and reversible inhibition of immunocompetent lymphocytes in the G- and G-phase of the cell cycle. T-lymphocytes are preferentially inhibited. The T-helper cell is the main target, although the T-suppressor cell may also be suppressed. Cyclosporine also inhibits lymphokine production and release including interleukin-2.
No effects on phagocytic function (changes in enzyme secretions, chemotactic migration of granulocytes, macrophage migration, carbon clearance ) have been detected in animals. Cyclosporine does not cause bone marrow suppression in animal models or man.

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(See also BOXED WARNING)

Hypertensionntttttttt
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. n
Vaccinationntttttttt
During treatment with cyclosporine, vaccination may be less effective; and the use of live attenuated vaccines should be avoided.
Special Monitoring of Rheumatoid Arthritis Patientsntttttttt
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. n
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 >140u00a0mmHg) 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 Patientsntttttttt
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 (2.5u00a0mg/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 patientu2019s 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 patientu2019s 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%u201350% 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) MODIFIEDu00a0should beu00a0diluted, preferably with orange or apple juice that is at room temperature. The combination of Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIEDu00a0withu00a0milk 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.

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. Serum lipids, magnesium, and potassium should also be monitored. Cyclosporine blood concentrations should be routinely monitored in transplant patients , and periodically monitored in rheumatoid arthritis patients.

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, concomitant use of NSAIDs with cyclosporine, particularly in the setting of dehydration, may potentiate renal dysfunction. Caution should be exercised when using other drugs which are known to impair renal function. ()
Drugs That May Potentiate Renal Dysfunctionntttttt
During the concomitant use of a drug that may exhibit additive or synergistic renal impairment with cyclosporine, close monitoring of renal function (in particular serum creatinine) should be performed. If a significant impairment of renal function occurs, the dosage of the coadministered drug should be reduced or an alternative treatment considered.
Cyclosporine is extensively metabolized by CYP 3A isoenzymes, in particular CYP3A4, and is a substrate of the multidrug efflux transporter P-glycoprotein. Various agents are known to either increase or decrease plasma or whole blood concentrations of cyclosporine usually by inhibition or induction of CYP3A4 or P-glycoprotein transporter or both. Compounds that decrease cyclosporine absorption such as orlistat should be avoided. Appropriate Neoral dosage adjustment to achieve the desired cyclosporine concentrations is essential when drugs that significantly alter cyclosporine concentrations are used concomitantly. n
1. Drugs That Cyclosporine Concentrationsntttttt
HIV Protease inhibitors
The HIV protease inhibitors (e.g., indinavir, nelfinavir, ritonavir, and saquinavir) are known to inhibit cytochrome P-450 3A and thus could potentially increase the concentrations of cyclosporine, however no formal studies of the interaction are available. Care should be exercised when these drugs are administered concomitantly.
Grapefruit juice
Grapefruit and grapefruit juice affect metabolism, increasing blood concentrations of cyclosporine, thus should be avoided.
2. Drugs/Dietary Supplements That Cyclosporine Concentrationsntttttt
Bosentan
Coadministration of bosentan (250 to 1000 mg every 12 hours based on tolerability) and cyclosporine (300 mg every 12 hours for 2 days then dosing to achieve a C of 200 to 250 ng/mL) for 7 days in healthy subjects resulted in decreases in the cyclosporine mean dose-normalized AUC, C, and trough concentration of approximately 50%, 30%, and 60%, respectively, compared to when cyclosporine was given alone . Coadministration of cyclosporine with bosentan should be avoided.
Boceprevir
Coadministration of boceprevir (800 mg three times daily for 7 days) and cyclosporine (100 mg single dose) in healthy subjects resulted in increases in the mean AUC and C of cyclosporine approximately 2.7-fold and 2-fold, respectively, compared to when cyclosporine was given alone.
Telaprevir
Coadministration of telaprevir (750 mg every 8 hours for 11 days) with cyclosporine (10 mg on day 8) in healthy subjects resulted in increases in the mean dose-normalized AUC and C of cyclosporine approximately 4.5-fold and 1.3-fold, respectively, compared to when cyclosporine (100 mg single dose) was given alone.
St. Johnu2019s Wort
There have been reports of a serious drug interaction between cyclosporine and the herbal dietary supplement St. Johnu2019s Wort. This interaction has been reported to produce a marked reduction in the blood concentrations of cyclosporine, resulting in subtherapeutic levels, rejection of transplanted organs, and graft loss.
Rifabutin
Rifabutin is known to increase the metabolism of other drugs metabolized by the cytochrome P-450 system. The interaction between rifabutin and cyclosporine has not been studied. Care should be exercised when these two drugs are administered concomitantly.
B. Effect of Cyclosporine on the Pharmacokinetics and/or Safety of Other Drugs or Agents
Cyclosporine is an inhibitor of CYP3A4 and of multiple drug efflux transporters (e.g., P-glycoprotein) and may increase plasma concentrations of comedications that are substrates of CYP3A4, P-glycoprotein or organic anion transporter proteins.
Cyclosporine may reduce the clearance of digoxin, colchicine, prednisolone, HMG-CoA reductase inhibitors (statins), and, aliskiren, bosentan, dabigatran, repaglinide, NSAIDs, sirolimus, etoposide, and other drugs.
See the full prescribing information of the other drug for further information and specific recommendations. The decision on coadministration of cyclosporine with other drugs or agents should be made by the healthcare provider following the careful assessment of benefits and risks.
Digoxin
Severe digitalis toxicity has been seen within days of starting cyclosporine in several patients taking digoxin. If digoxin is used concurrently with cyclosporine, serum digoxin concentrations should be monitored.
Colchicine
There are reports on the potential of cyclosporine to enhance the toxic effects of colchicine such as myopathy and neuropathy, especially in patients with renal dysfunction. Concomitant administration of cyclosporine and colchicine results in significant increases in colchicine plasma concentrations. If colchicine is used concurrently with cyclosporine, a reduction in the dosage of colchicine is recommended.
HMG-CoA reductase inhibitors (statins)
Literature and postmarketing cases of myotoxicity, including muscle pain and weakness, myositis, and rhabdomyolysis, have been reported with concomitant administration of cyclosporine with lovastatin, simvastatin, atorvastatin, pravastatin, and, rarely fluvastatin. When concurrently administered with cyclosporine, the dosage of these statins should be reduced according to label recommendations. Statin therapy needs to be temporarily withheld or discontinued in patients with signs and symptoms of myopathy or those with risk factors predisposing to severe renal injury, including renal failure, secondary to rhabdomyolysis.
Repaglinide
Cyclosporine may increase the plasma concentrations of repaglinide and thereby increase the risk of hypoglycemia. In 12 healthy male subjects who received two doses of 100 mg cyclosporine capsule orally 12 hours apart with a single dose of 0.25 mg repaglinide tablet (one-half of a 0.5mg tablet) orally 13 hours after the cyclosporine initial dose, the repaglinide mean C and AUC were increased 1.8 fold (range: 0.6 to u20133.7 fold) and 2.4 fold (range 1.2 to 5.3 fold), respectively. Close monitoring of blood glucose level is advisable for a patient taking cyclosporine and repaglinide concomitantly.
Ambrisentan
Coadministration of ambrisentan (5 mg daily) and cyclosporine (100 to 150 mg twice daily initially, then dosing to achieve C 150 to 200 ng/mL) for 8 days in healthy subjects resulted in mean increases in ambrisentan AUC and C of approximately 2-fold and 1.5u2013fold, respectively, compared to ambrisentan alone. When coadministering ambrisentan with cyclosporine, the ambrisentan dose should not be titrated to the recommended maximum daily dose
Anthracycline antibiotics
High doses of cyclosporine (e.g., at starting intravenous dose of 16 mg/kg/day) may increase the exposure to anthracycline antibiotics (e.g., doxorubicin, mitoxantrone, daunorubicin) in cancer patients.
Aliskiren
Cyclosporine alters the pharmacokinetics of aliskiren, a substrate of P-glycoprotein and CYP3A4. In 14 healthy subjects who received concomitantly single doses of cyclosporine (200 mg) and reduced dose aliskiren (75 mg), the mean C of aliskiren was increased by approximately 2.5-fold (90% CI: 1.96 to 3.17) and the mean AUC by approximately 4.3 fold (90% CI: 3.52 to 5.21), compared to when these subjects received aliskiren alone. The concomitant administration of aliskiren with cyclosporine prolonged the median aliskiren elimination half-life (26 hours versus 43 to 45 hours) and the T (0.5 hours versus 1.5 to 2.0 hours). The mean AUC and C of cyclosporine were comparable to reported literature values. Coadministration of cyclosporine and aliskiren in these subjects also resulted in an increase in the number and/or intensity of adverse events, mainly headache, hot flush, nausea, vomiting, and somnolence. The coadministration of cyclosporine with aliskiren is not recommended.
Bosentan
In healthy subjects, coadministration of bosentan and cyclosporine resulted in time-dependent mean increases in dose-normalized bosentan trough concentrations (i.e., approximately 21-fold on day 1 and 2-fold on day 8 (steady state)) compared to when bosentan was given alone as a single dose on day 1. Coadministration of cyclosporine with bosentan should be avoided.
Dabigatran
The effect of cyclosporine on dabigatran concentrations had not been formally studied. Concomitant administration of dabigatran and cyclosporine may result in increased plasma dabigatran concentrations due to the P-gp inhibitory activity of cyclosporine. Coadministration of cyclosporine with dabigatran should be avoided.
Potassium-Sparing Diuretics
Cyclosporine should not be used with potassium-sparing diuretics because hyperkalemia can occur. Caution is also required when cyclosporine is coadministered with potassiumsparing drugs (e.g., angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists), potassium-containing drugs as well as in patients on a potassium rich diet. Control of potassium levels in these situations is advisable.
Nonsteroidal Anti-inflammatory Drug (NSAID) Interactions
Clinical status and serum creatinine should be closely monitored when cyclosporine is used with NSAIDs in rheumatoid arthritis patients. n
Pharmacodynamic interactions have been reported to occur between cyclosporine and both naproxen and sulindac, in that concomitant use is associated with additive decreases in renal function, as determined by Tc-diethylenetriaminepentaacetic acid (DTPA) and (-aminohippuric acid) PAH clearances. Although concomitant administration of diclofenac does not affect blood concentrations of cyclosporine, it has been associated with approximate doubling of diclofenac blood concentrations and occasional reports of reversible decreases in renal function. Consequently, the dose of diclofenac should be in the lower end of the therapeutic range.
Methotrexate Interaction
Preliminary data indicate that when methotrexate and cyclosporine were coadministered to rheumatoid arthritis patients (N=20), methotrexate concentrations (AUCs) were increased approximately 30% and the concentrations (AUCs) of its metabolite, 7-hydroxy methotrexate, were decreased by approximately 80%. The clinical significance of this interaction is not known. Cyclosporine concentrations do not appear to have been altered (N=6).
Sirolimus
Elevations in serum creatinine were observed in studies using sirolimus in combination with full-dose cyclosporine. This effect is often reversible with cyclosporine dose reduction. Simultaneous coadministration of cyclosporine significantly increases blood levels of sirolimus. To minimize increases in sirolimus concentrations, it is recommended that sirolimus be given 4 hours after cyclosporine administration.
Nifedipine
Frequent gingival hyperplasia when nifedipine is given concurrently with cyclosporine has been reported. The concomitant use of nifedipine should be avoided in patients in whom gingival hyperplasia develops as a side effect of cyclosporine.
Methylprednisolone
Convulsions when high dose methylprednisolone is given concurrently with cyclosporine have been reported.
Other Immunosuppressive Drugs and Agents
Psoriasis patients receiving other immunosuppressive agents or radiation therapy (including PUVA and UVB) should not receive concurrent cyclosporine because of the possibility of excessive immunosuppression.
C. Effect of Cyclosporine on the Efficacy of Live Vaccines
During treatment with cyclosporine, vaccination may be less effective. The use of live vaccines should be avoided.
For additional information on Cyclosporine Drug Interactions please contact Novartis Medical Affairs Department at 1-888-NOW-NOVA [1-888-669-6682].

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, and the incidence of hepatocellular carcinomas in mid-dose males significantly exceeded the control value. In the 24-month rat study, pancreatic islet cell adenomas significantly exceeded the control rate in the low dose level. Doses used in the mouse and rat studies were 0.01 to 0.16 times the clinical maintenance dose (6 mg/kg). The hepatocellular carcinomas and pancreatic islet cell adenomas were not dose related. Published reports indicate that co-treatment of hairless mice with UV irradiation and cyclosporine or other immunosuppressive agents shorten the time to skin tumor formation compared to UV irradiation alone.
Cyclosporine was not mutagenic in appropriate test systems. Cyclosporine has not been found to be mutagenic/genotoxic in the Ames Test, the V79-HGPRT Test, the micronucleus test in mice and Chinese hamsters, the chromosome-aberration tests in Chinese hamster bone-marrow, the mouse dominant lethal assay, and the DNA-repair test in sperm from treated mice. A recent study analyzing sister chromatid exchange (SCE) induction by cyclosporine using human lymphocytes in vitrou00a0gave indication of a positive effect (i.e., induction of SCE), at high concentrations in this system. In two published research studies, rabbits exposed to cyclosporine in utero (10 mg/kg/day subcutaneously) demonstrated reduced numbers of nephrons, renal hypertrophy, systemic hypertension and progressive renal insufficiency up to 35 weeks of age. Pregnant rats which received 12 mg/kg/day of cyclosporine intravenously (twice the recommended human intravenous dose) had fetuses with an increased incidence of ventricular septal defect. These findings have not been demonstrated in other species and their relevance for humans is unknown.
No impairment in fertility was demonstrated in studies in male and female rats.
Widely distributed papillomatosis of the skin was observed after chronic treatment of dogs with cyclosporine at 9u00a0times the human initial psoriasis treatment dose of 2.5u00a0mg/kg, where doses are expressed on a body surface area basis. This papillomatosis showed a spontaneous regression upon discontinuation of cyclosporine.
An increased incidence of malignancy is a recognized complication of immunosuppression in recipients of organ transplants and patients with rheumatoid arthritis and psoriasis. The most common forms of neoplasms are non-Hodgkinu2019s lymphoma and carcinomas of the skin. The risk of malignancies in cyclosporine recipients is higher than in the normal, healthy population but similar to that in patients receiving other immunosuppressive therapies. Reduction or discontinuance of immunosuppression may cause the lesions to regress.
In psoriasis patients on cyclosporine, development of malignancies, especially those of the skin has been reported. u00a0Skin lesions not typical for psoriasis should be biopsied before starting cyclosporine treatment. Patients with malignant or premalignant changes of the skin should be treated with cyclosporine only after appropriate treatment of such lesions and if no other treatment option exists.

Pregnancy Category Cntttttt
Animal studies have shown reproductive toxicity in rats and rabbits. Cyclosporine gave no evidence of mutagenic or teratogenic effects in the standard test systems with oral application (rats up to 17 mg/kg and rabbits up to 30 mg/kg per day orally.)u00a0Only at dose levels toxic to dams, were adverse effects seen in reproduction studies in rats. Cyclosporine has been shown to be embryo- and fetotoxic in rats and rabbits following oral administration at maternally toxic doses. Fetal toxicity was noted in rats at 0.8 and rabbits at 5.4 times the transplant doses in humans of 6.0 mg/kg, where dose corrections are based on body surface area. Cyclosporine was embryo- and fetotoxic as indicated by increased pre- and postnatal mortality and reduced fetal weight together with related skeletal retardation.
There are no adequate and well-controlled studies in pregnant women therefore, Neoral should not be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the fetus.
In pregnant transplant recipients who are being treated with immunosuppressants the risk of premature birth is increased. The following data represent the reported outcomes of 116 pregnancies in women receiving cyclosporine during pregnancy, 90% of whom were transplant patients, and most of whom received cyclosporine throughout the entire gestational period. The only consistent patterns of abnormality were premature birth (gestational period of 28 to 36 weeks) and low birth weight for gestational age. Sixteen fetal losses occurred. Most of the pregnancies (85 of 100) were complicated by disorders; including, preeclampsia, eclampsia, premature labor, abruptio placentae, oligohydramnios, Rh incompatibility, and fetoplacental dysfunction. Pre-term delivery occurred in 47%. Seven malformations were reported in 5 viable infants and in 2u00a0cases of fetal loss. Twenty-eight percent of the infants were small for gestational age. Neonatal complications occurred in 27%. Therefore, the risks and benefits of using Neoral during pregnancy should be carefully weighed.
A limited number of observations in children exposed to cyclosporine in utero are available, up to an age of approximately 7 years. Renal function and blood pressure in these children were normal.
Because of the possible disruption of maternal-fetal interaction, the risk/benefit ratio of using Neoral in psoriasis patients during pregnancy should carefully be weighed with serious consideration for discontinuation of Neoral.
The alcohol content of the Neoral formulations should also be taken into account in pregnant women. ()

Cyclosporine is present in breast milk. Because of the potential for serious adverse drug reactions in nursing infants from Neoral, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Neoral contains ethanol. Ethanol will be present in human milk at levels similar to that found in maternal serum and if present in breast milk will be orally absorbed by a nursing infant .

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 and efficacy of Neoral treatment in children with juvenile rheumatoid arthritis or psoriasis below the age of 18 have not been established.

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 show serum creatinine rises u226550% above the baseline after 3 to 4 months of therapy.
Clinical studies of Neoral in transplant and psoriasis patients did not include a sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experiences have not identified differences in response between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

No data

There is a minimal experience with cyclosporine overdosage. Forced emesis and gastric lavageu00a0can be of value up to 2 hours after administration of Neoral.u00a0u00a0Transient 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.u00a0General 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.

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 ().

Neoralu00ae Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED
25 mg
Oval, blue-gray imprinted in red, u201cNeoralu201d over u201c25 mg.u201d
Packages of 30 unit-dose blisters (NDC 0078-0246-15).
100 mg
Oblong, blue-gray imprinted in red, u201cNEORALu201d over u201c100 mg.u201d
Packages of 30 unit-dose blisters (NDC 0078-0248-15).
Store and Dispense
In the original unit-dose container at controlled room temperature 68u00b0F to 77u00b0F (20u00b0C to 25u00b0C).
Neoralu00ae Oral Solution (cyclosporine oral solution, USP) MODIFIED
A clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).
Store and Dispensentttttt
In the original container at controlled room temperature 68u00b0F to 77u00b0F (20u00b0 to 25u00b0C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68u00b0F (20u00b0C) 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 77u00b0F (25u00b0C) to reverse these changes.
Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED
Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIED
Distributed by:
Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936
u00a9 Novartis
T2015-47March 2015

Package Label n- u2013n- u00a0n- 25 mg
Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0246-15
NEORALu00ae Soft Gelatin Capsules
(cyclosporine capsules, USP) MODIFIED
WARNING: Neoralu00ae (cyclosporine capsules, USP) MODIFIED is NOT BIOEQUIVALINET to
Sandimmuneu00ae (cyclosporine capsules, USP). Do NOT use interchangeably without a
physicianu2019s supervision.
Novartis Pharmaceuticals Corportation, East Hanover, New Jersey 07936
30 Soft Gelatin Capsules
25 mg

Package Label n- u2013n- u00a0n- 100 mg
Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0248-15
NEORALu00ae Soft Gelatin Capsules
(cyclosporine capsules, USP) MODIFIED
WARNING: Neoralu00ae (cyclosporine capsules, USP) MODIFIED is NOT BIOEQUIVALINET to
Sandimmuneu00ae (cyclosporine capsules, USP). Do NOT use interchangeably without a
physicianu2019s supervision.
Novartis Pharmaceuticals Corportation, East Hanover, New Jersey 07936
30 Soft Gelatin Capsules
100 mg

Package Label n- u2013n- u00a0n- 100 mg/mL
50 mL Size
Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0274-22
NEORALu00ae Soft Gelatin Capsules
(cyclosporine oral solution, USP) MODIFIED
WARNING: Neoralu00ae (cyclosporine Oral solution, USP) MODIFIED is NOT
BIOEQUIVALINET to Sandimmuneu00ae (cyclosporine oral solutions, USP).
Do NOT use interchangeably without a Physicianu2019s supervision.
Each mL contains:
cyclosporine, USP 100 mg
alcohol, USP dehydrated..11.9% v/v (9.5% wt/vol.)
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
100 mg/mL

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Cyclosporine (Neoral)

Trade Name : Neoral

CAPSULE, LIQUID FILLED

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Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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