Sandimmum Neoral Capsule

Sandimmum Neoral Capsule is used for: Ulcerative colitis, Rheumatoid arthritis, Psoriasis, Missed abortion, Nephrotic syndrome, Urticaria, Bone marrow transplantation, Organ transplantation, Atopic dermatitis

Oral Immunosuppression in organ transplantation Adult: Initially, 10-15 mg/kg/day, starting 4-12 hr before procedure and continued for 1-2 wk; Usual maintenance: 2-6 mg/kg/day. Lower doses may be used when combined with other immunosuppressants. Severe Atopic dermatitis, Psoriasis Adult: Initially, 2.5 mg/kg/day, in 2 divided doses. Reduce to the lowest effective dose once remission is achieved. Stop treatment if there is no sufficient improvement to max dose within 6 weeks. Max: 5 mg/kg/day. Rheumatoid arthritis Adult: 2.5 mg/kg/day, in 2 divided doses. Treatment should continue for 6-8 weeks. If the response is insufficient, may increase the dose gradually. Max: 4 mg/kg/day. Nephrotic syndrome Adult: 5 mg/kg daily, given in 2 divided doses. Intravenous Prophylaxis of graft rejection in bone marrow transplantation Adult: Initially, 3-5 mg/kg/day starting on the day before transplantation and continue for up to 2 wk or until oral therapy can be initiated at a maintenance of 12.5 mg/kg/day. Continue maintenance dose for at least 3-6 months. Immunosuppression in organ transplantation Adult: Initially: 5-6 mg/kg/day as a single dose, infuse dose over 2-6 hr. Switch to an oral dosage form as soon as possible.

Oral Nephrotic syndrome Child: 6 mg/kg daily, given in 2 divided doses.

May be taken with or without food. Take consistently w/ regard to time of day & relation to meals. Avoid grapefruit juice. Neoral and Sandimmune are NOT bioequivalent, exercise caution if switching between brands/generics IV Preparation Dilute 1 mL (50 mg) of concentrated inj soln in 20-100 mL of D5W or NS Stability of injection of parenteral admixture at room temp (25°C) is 6 hr in PVC; 24 hr in Excel, PAB containers, or glass Polyoxyethylated castor oil surfactant in cyclosporine injection may leach phthalate from PVC containers such as bags and tubing Actual amount of DEHP plasticizer leached from PVC containers and administration sets may vary in clinical situations, depending on surfactant concentration, bag size, & contact time IV Administration Following dilution, infuse over 2-6 hr Continuously monitor for at least the first 30 min of the infusion, and then frequently thereafter Anaphylaxis possible with IV use; reserve only for patients unable to take oral form Maintain airway; other supportive measures & agents for treating anaphylaxis should be present

Hypersensitivity; malignant neoplasms; uncontrolled hypertension; psoriasis; lactation.

Should be prescribed only by physicians who have experience with immunosuppression in solid organ transplant recipients and can provide necessary follow-up and appropriate monitoring Sandimmune and Neoral are not bioequivalent and should not be interchanged without physician approval; Neoral (capsules and oral solution) has increased bioavailability compared with Sandimmune (capsules and oral solution) For a given trough concentration, cyclosporine exposure will be greater with Neoral than with Sandimmune Sandimmune has decreased bioavailability compared with Neoral and erratic absorption; requires careful monitoring of blood levels and subsequent dosage adjustments Coadministration with other immunosuppressants in kidney, liver, and heart transplant recipients, but risk of infection and neoplasia may be increased Increased risk for development of lymphomas and other malignancies, particularly those of the skin; avoid excess UV light exposure Increased risk appears related to the intensity and duration of immunosuppression rather than to the use of specific agents; oversuppression of the immune system may result in infection or malignancy; caution with regimens containing multiple immunosuppressants Patients with psoriasis who have been treated with PUVA, methotrexate or immunosuppressants, UVB, coal tar, or radiation are at increased risk for skin malignancies, hypertension, and renal dysfunction Risk of hepatotoxicity and nephrotoxicity Myelosuppression may be severe and prolonged; monitor complete blood and platelet counts Potential increase risk for optic disk edema and infusion-related anaphylactic reactions Some malignancies caused by cyclosporine immunosuppression may be fatal (eg, lymphoma) Serious and fatal cerebral, gastrointestinal and pulmonary hemorrhage; monitor platelets and coagulation parameters and treat accordingly Increased risk for serious infection with fatal outcome because of immunosuppression, including activation of latent viruses, eg, BK virus-induced nephropathy Patients with psoriasis who received coal tar, PUVA, methotrexate, or other immunosuppressants have higher risk of skin cancer with Neoral Discontinue therapy if exfoliative or bullous rash suspected or if Stevens-Johnson syndrome or toxic epidermal necrolysis suspected Significant hyperkalemia and hyperuricemia may occur Neurotoxicity may occur, particularly with high dose methylprednisolone; caution with other drugs that may cause neurotoxicity Mild or moderate hypertension and rarely severe hypertension may occur; incidence decreases over time; Gingival hyperplasia may occur; avoid concomitant nifedipine administration in patients who develop gingival hyperplasia Seizures may occur when used in combination with high-dose corticosteroids Cyclosporine may impact the ability to drive and use machines Monitoring Parameters Monitor BP, serum electrolytes, renal and hepatic function. Monitor for and discontinue promptly if systemic inflammatory response or capillary leak syndrome suspected Monitor for signs and symptoms of infection; severe and fatal sepsis as a result of bone marrow suppression; discontinue therapy promptly if infection occur Monitor for and discontinue if venous occlusive disease of the liver suspected Monitor liver enzymes and discontinue therapy at first signs of severe hepatotoxicity; fatal hepatotoxicity may occur Monitor renal function and interrupt or discontinue if creatinine levels increase or acute renal failure occur Monitor for signs and symptoms of enterocolitis and treat promptly Monitor for signs and symptoms of tumor lysis syndrome occur; treat promptly

Pregnancy Available data from published literature, including the Transplant Pregnancy Registry International, observational cohort studies, case-controlled studies, meta-analysis, case series, and case reports, over decades of use with cyclosporine in pregnancy have not identified a drug-associated risk of major birth defects, or miscarriage; adverse maternal or fetal outcomes including hypertension, preeclampsia, preterm birth, and low birth weight are increased in patients treated with cyclosporine; however, patients receiving cyclosporine during pregnancy have underlying medical conditions and may be treated with concomitant medications that limit the interpretability of these findings Animal data Embryo-fetal developmental (EFD) studies in rats and rabbits with cyclosporine have shown embryo-fetal toxicity at dose levels below the maximum recommended human dose (MRHD) based on body surface area (BSA) The alcohol content in some formulations should be taken into account when given to pregnant women Lactation Cyclosporine and its metabolites are present in human milk following oral and intravenous administration; adverse effects on breastfed infants have not been reported; there are no data on effects of the drug on milk production The alcohol content in some formulations should be taken into account when given to lactating women Lactating women are encouraged to avoid additional alcohol intake during treatment; the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this medication and any potential adverse effects on the breastfed infant from this medication or from the underlying maternal condition

Increased ciclosporin level by diltiazem, doxycycline, erythromycin, ketoconazole, methylprednisolone (high doses), nicardipine, verapamil, oral contraceptives. Drugs which reduce ciclosporin level are carbamazepine, isoniazid, phenobarbitone, phenytoin and rifampicin. Increased risk of convulsion when used concurrently with high-dose methylprednisolone. Potentially Fatal: Additive nephrotoxicity when used with aminoglycosides, amphotericin B, ciprofloxacin, colchicine, melphalan, co-trimoxazole and NSAIDs. Contraindicated (14) amphotericin B deoxycholate atorvastatin bosentan cidofovir dronedarone elagolix elbasvir/grazoprevir flibanserin lonafarnib mifepristone pimozide pitavastatin simvastatin upadacitinib

Side effects of Cyclosporine : >10% Tremor (12-55%),Nephrotoxicity (32%),Hypertension (26%),Infection (3-25%),Headache (2-25%),Nausea (23%),Hirsutism (21%),Hypertrichosis (5-19%),Female reproductive disorder (5-19%),Gum hyperplasia (2-16%),Triglycerides increased (15%),Abdominal discomfort (1-15%),URI (1-14%),Diarrhea (3-13%),Dyspepsia (2-12%),Leg cramps (2-12%),Parathesia (1-11%) 1-10% Acne,Convulsions,Pruitus,Hyperkalemia, hypomagnesemia,Pancreatitis,,Hepatotoxicity,Flu-like syndrome Frequency Not Defined Leukopenia,Thrombocytopenia,Anaphylaxis,Glomerular capillary thrombosis,Hypomagnesemia,Migraine,Hyponatremia

Ciclosporin is a strong immunosuppressant that acts mainly on the helper T-cells. It inhibits the activation of calcineurin and production of interleukin-2, thus reducing cell-mediated immune response.

Sandimmum Neoral 25mg Capsule manufactured by Novartis (Bangladesh) Ltd.. Its generic name is Cyclosporine. Sandimmum Neoral is availble in Bangladesh. Farmaco BD drug index information on Sandimmum Neoral Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.