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Novartis India Ltd

Sandimmun 50mg Injection 1ml

Auto Immune Disease
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    Introduction About SANDIMMUN 50MG INJECTION

    SANDIMMUN 50MG INJECTION contains Cyclosporine which belongs to the group of medicines called Immunosuppressants. It is used to manage graft rejection in patients undergoing transplantation of any organ, bone marrow or stem cells. It can also be used to manage an ongoing graft rejection of the newly transplanted organ.

    Before receiving SANDIMMUN 50MG INJECTION inform your doctor if you have any liver problems or any signs of infections (such as fever or sore throat). You must also inform your doctor if you have hepatitis C infection, fits, low blood magnesium levels, gout, alcohol dependence or if you are about to receive any vaccinations as a precaution.

    SANDIMMUN 50MG INJECTION is not recommended for use in patients with severe uncontrollable infections, any types of cancer or severe high blood pressure. Do not take SANDIMMUN 50MG INJECTION without consulting your doctor if you are pregnant or breastfeeding

    While undergoing therapy with SANDIMMUN 50MG INJECTION your doctor will periodically monitor your blood pressure, blood cholesterol levels, liver and kidney functions to avoid the risk of side effects. Avoid consuming grapefruit or drinking grapefruit juice while receiving SANDIMMUN 50MG INJECTION as it may increase the risk of side effects.

    Your doctor may also prescribe you blood tests and urine tests at regular intervals to access the improvement in your health conditions. During management with SANDIMMUN 50MG INJECTION, avoid exposing your skin towards direct sunlight. Wear protective loose-fitting clothes and apply sunscreen while going outdoors.

    The most common side effects of receiving SANDIMMUN 50MG INJECTION are increase in blood sugar levels, increase in blood cholesterol levels, increased blood potassium levels, high blood pressure, headache, loss of appetite, acne, hot flushes, tiredness, excessive facial hair and low blood magnesium levels in blood. Consult your doctor if any of these side effects worsen.

    Uses Of SANDIMMUN 50MG INJECTION

    • Prevents graft rejection following organ transplantation

    How SANDIMMUN 50MG INJECTION Works

    SANDIMMUN 50MG INJECTION is an immunosuppressive agent. It works by blocking the release of certain chemicals in the body (such as T-cells, interleukins and cytokines) that triggers the immune response. This action suppresses your body’s immune functions and enables your body to accept the transplanted organ. As a result, it manages the risk of graft rejection and increases the survival of the newly transplanted organ.

    How to use SANDIMMUN 50MG INJECTION

    SANDIMMUN 50MG INJECTION will be given to you only by a doctor or a nurse into the vein (intravenously).

    Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition. Do not stop receiving SANDIMMUN 50MG INJECTION without consulting your doctor.

    Side Effects Of SANDIMMUN 50MG INJECTION

    Common

    • high blood pressure
    • headache, shakiness
    • nausea, vomiting, loss of appetite, stomach pain, diarrhoea
    • acne, hot flushes, fever, tiredness
    • excessive facial hair
    • high blood cholesterol levels
    • high blood sugar levels
    • tingling sensation in the body
    • muscle spasm, swollen gums
    • high blood levels of uric acid or potassium
    • low levels of magnesium in blood

    Uncommon

    • lack of sleep
    • oedema, weight gain

    Rare

    • inflammation of the pancreas, severe upper stomach pain
    • menstrual irregularities, breast enlargement in men

    Contact your doctor immediately if you experience any of the following side effects while or after receiving SANDIMMUN 50MG INJECTION:

    • signs of infections (such as fever or sore throat)
    • signs of brain infection called progressive multifocal leukoencephalopathy (such as vision changes, loss of coordination, being clumsy, memory loss, problems in speaking or understanding, muscle weakness)
    • brain problems (causing seizures, confusion, disorientation, lack of response, behavioural changes, agitation, sleeplessness, vision changes, paralysis, stiff neck, loss of coordination with or without unusual speech or eye movements)
    • swelling at the back of the eye with blurred vision
    • signs of liver problems (such as yellow skin and eyes, nausea, loss of appetite and dark urine)
    • low urine output, kidney problems
    • low level of red blood cells or platelets (causing pale skin, tiredness, breathlessness, having dark urine, bruising or bleeding with no obvious reasons, confusion, disorientation, being less alert and having kidney problems)

    How To Manage Side Effects

    Nausea or vomiting:

    Stick to simple meals and avoid oil rich or spicy foods. Consult your doctor if nausea worsens.

    Headache:  

    Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.

    Warning & Precautions

    Pregnancy

    SANDIMMUN 50MG INJECTION is not recommended for use in pregnant women unless considered necessary by the physician. Therefore, consult your doctor before receiving it.

    Breastfeeding

    SANDIMMUN 50MG INJECTION may pass through the breast milk. Therefore, it is not recommended for use in breastfeeding woman. However, consult your doctor before receiving it.

    Driving and Using Machines

    Do not drive or operate any heavy tools or machines if your ability is affected by SANDIMMUN 50MG INJECTION.

    Alcohol

    Avoid consumption of alcohol while receiving SANDIMMUN 50MG INJECTION as it might worsen your condition.

    Kidney

    SANDIMMUN 50MG INJECTION is not recommended for use in patients with other kidney problems (except for nephrotic syndrome). Therefore, consult your doctor before receiving it.

    Liver

    SANDIMMUN 50MG INJECTION should be used with caution in patients with liver problems (including Hepatitis C infection). Therefore, consult your doctor before receiving it.

    Allergy

    Talk to your doctor before receiving SANDIMMUN 50MG INJECTION if you are allergic to cyclosporine.

    Others

    SANDIMMUN 50MG INJECTION is not recommended for use if you:

    • have severe infections in the body which is unable to control
    • have any type of cancer
    • have uncontrollably high blood pressure

    Before receiving SANDIMMUN 50MG INJECTION inform your doctor if you:

    • have any signs of infection, such as fever or sore throat
    • have low levels of magnesium in the body
    • have high blood potassium levels
    • have gout (joint pain caused due to fluid accumulation)
    • are about to receive any vaccination
    • have or ever had alcohol-related problems
    • have epilepsy

    Use in paediatrics:

    The safety and effectiveness of SANDIMMUN 50MG INJECTION have not been established in children and adolescents (aged below 18 years). Therefore, consult your doctor before receiving it.

    Use in geriatrics:

    SANDIMMUN 50MG INJECTION should be used with caution in elderly patients. Therefore, consult your doctor before receiving it. Proper dose adjustments and careful monitoring are required in such patients.

    Interactions

    A. Drug - Drug interactions:

    Before receiving SANDIMMUN 50MG INJECTION, inform your doctor if you are taking any of the following medicines such as:

    • St. John’s Wort (an herbal medicine used to manage depression)
    • dabigatran etexilate (a medicine used to manage blood clots after surgery)
    • bosentan or aliskiren (medicines used to manage high blood pressure)
    • vaccines
    • medicines that can increase blood potassium levels in the body (such as potassium supplements or potassium-sparing diuretics (Ex. amiloride, triamterene or spironolactone))
    • methotrexate (a medicine used to manage cancer and severe rheumatoid arthritis)
    • medicines used to manage bacterial infections (Ex. erythromycin, azithromycin, gentamycin, tobramycin, ciprofloxacin)
    • medicines used to manage fungal infections (Ex. voriconazole, itraconazole, terbinafine, amphotericin B)
    • medicines used for heart problems or high blood pressure (Ex. diltiazem, nicardipine, verapamil, digoxin, amiodarone)
    • metoclopramide (a medicine used to stop nausea and vomiting)
    • danazol (a medicine used to manage overgrowth in the uterus)
    • oral contraceptives (birth control pills) Ex. ethinylestradiol
    • medicines used to manage gout (Ex. colchicine, allopurinol)
    • medicines used to manage gallstones (Ex. ursodiol)
    • medicines used to manage leukaemia and other cancers (Ex. imatinib, melphalan, etoposide, doxorubicin)
    • barbiturates (used to reduce anxiety and to induce sleep) Ex. phenobarbital
    • medicines used to manage epilepsy (Ex. carbamazepine, phenytoin, cannabidiol)
    • octreotide (a medicine used to manage hormonal disorder, (acromegaly) and tumours)
    • orlistat (a medicine that helps in weight loss)
    • ticlopidine (a medicine used to manage blood clots due to platelet aggregation)
    • other medicines used to supress immune system (Ex. everolimus, sirolimus, tacrolimus)
    • medicine used to reduce pain and inflammation Ex. diclofenac
    • medicines used to lower cholesterol levels (Ex. fenofibrate, atorvastatin, Fluvastatin)
    • medicines used to manage tuberculosis (Ex. isoniazid, rifampicin)
    • medicines used to manage HIV infections (Ex. acyclovir, ritonavir, nelfinavir, saquinavir, efavirenz, etravirine, nevirapine)
    • medicines used to manage hepatitis C infection (Ex. telaprevir, boceprevir, the combination ombitasvir/paritaprevir/ritonavir with or without dasabuvir, elbasvir/grazoprevir and glecaprevir/pibrentasvir)
    • medicines used to manage gastric problems (Ex. omeprazole, cimetidine, magnesium hydroxide, aluminum hydroxide)
    • trimethoprim or cotrimoxazole (used to manage bacterial infections)
    • corticosteroids (used to manage allergic or autoimmune diseases) Ex. prednisolone, methylprednisolone
    • medicines used to manage diabetes (Ex. repaglinide)

    B. Drug – food interactions

    Avoid consuming grapes or grapefruit juice while receiving SANDIMMUN 50MG INJECTION as it may increase the risk of side effects.

    Overdosage:

    SANDIMMUN 50MG INJECTION will be administered to you only by a doctor or a nurse in a hospital, and so it is unlikely to receive an overdose. However, consult your doctor if you experience any unusual side effects.

    Synopsis

    Drug :   Cyclosporine
    Pharmacological Category :   Calcineurin inhibitors
    Therapeutic Indication :   Graft rejection, Autoimmune diseases
    Dosage Forms :   Tablet, Capsule, Injection, Infusion, Oral Solution, Oral Suspension, Eye Drops, Ophthalmic Emulsion

    More Information

    • Keep SANDIMMUN 50MG INJECTION out of reach of children
    • Store SANDIMMUN 50MG INJECTION at room temperature

    FAQs About SANDIMMUN 50MG INJECTION

    What is the use of SANDIMMUN 50MG INJECTION?

    SANDIMMUN 50MG INJECTION is used to manage graft rejection in patients undergoing transplantation of any organ, bone marrow or stem cells. It can also be used to manage various auto-immune disease conditions such as psoriasis, atopic dermatitis (or eczema), rheumatoid arthritis, nephrotic syndrome or eye inflammation (such as endogenous uveitis, including Behçet's uveitis).

    How SANDIMMUN 50MG INJECTION works?

    SANDIMMUN 50MG INJECTION is an immunosuppressive agent. It works by blocking the release of certain chemicals in the body (such as T-cells, interleukins and cytokines) that triggers the immune response. This action suppresses your body’s immune functions and enables your body to accept the newly transplanted organ. It also stops the abnormal immune response in the body and manages your body from attacking its own cells.

    How SANDIMMUN 50MG INJECTION is administered?

    SANDIMMUN 50MG INJECTION will be given to you only by a doctor or a nurse into the vein (intravenously).

    Is SANDIMMUN 50MG INJECTION an antibiotic?

    No. SANDIMMUN 50MG INJECTION is an immunosuppressive agent. It suppresses your body’s immune functions and enables your body to accept the transplanted organ. It also stops the abnormal immune response in the body and manages your body from attacking its own cells.

    What precautions must be followed while receiving SANDIMMUN 50MG INJECTION?

    Before receiving SANDIMMUN 50MG INJECTION inform your doctor if you have any liver problems or any signs of infections (such as fever or sore throat). You must also inform your doctor if you have hepatitis C infection, fits, low blood magnesium levels, gout, alcohol dependence, severe uncontrollable infections, any types of cancer, severe high blood pressure or if you are about to receive any vaccinations as a precaution. Inform your doctor before receiving SANDIMMUN 50MG INJECTION if you are pregnant or breastfeeding.

    How long should I receive SANDIMMUN 50MG INJECTION?

    You need to receive therapy with SANDIMMUN 50MG INJECTION for the stipulated duration prescribed by your doctor. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.

    Is SANDIMMUN 50MG INJECTION safe?

    The most common side effects of receiving SANDIMMUN 50MG INJECTION are increase in blood sugar levels, increase in blood cholesterol levels, increased blood potassium levels, high blood pressure, headache, loss of appetite, acne, hot flushes, tiredness, excessive facial hair and low blood magnesium levels in blood. Consult your doctor if any of these side effects worsen.

    Can I stop receiving SANDIMMUN 50MG INJECTION without consulting your doctor?

    No. You should not stop receiving SANDIMMUN 50MG INJECTION without consulting your doctor because your body’s immune system may once again attempt to reject the newly transplanted organ. Therefore, take SANDIMMUN 50MG INJECTION for the stipulated duration recommended by your doctor to achieve maximum results.

    What happens if I received more SANDIMMUN 50MG INJECTION?

    SANDIMMUN 50MG INJECTION will be administered to you only by a doctor or a nurse in a hospital, and so it is unlikely to receive an overdose. However, consult your doctor if you experience any unusual side effects.

    Can I use SANDIMMUN 50MG INJECTION if I suffer from kidney diseases?

    SANDIMMUN 50MG INJECTION is not recommended for use in patients with other kidney problems (except for nephrotic syndrome). Therefore, consult your doctor before receiving it.

    Will receiving a higher dose of SANDIMMUN 50MG INJECTION be more effective?

    No, receiving a higher dose of SANDIMMUN 50MG INJECTION will not be effective rather it can lead to toxicity. Always take the dose prescribed by your doctor. If the prescribed dose is not effective for you, consult your doctor for advice. Your doctor might increase the dose or suggest an alternative therapy.

    Can I take medication for high blood pressure along with SANDIMMUN 50MG INJECTION?

    It is not advisable to take medicines to control blood pressure while receiving SANDIMMUN 50MG INJECTION without consulting your doctor as they have known interactions with SANDIMMUN 50MG INJECTION.

    Can SANDIMMUN 50MG INJECTION be used in pregnant women?

    SANDIMMUN 50MG INJECTION is not recommended for use in pregnant women unless considered necessary by the physician. Therefore, consult your doctor before receiving it.

    How much SANDIMMUN 50MG INJECTION should I take?

    SANDIMMUN 50MG INJECTION should be used only under medical supervision. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body condition and severity of the disease condition.

    Is SANDIMMUN 50MG INJECTION a steroid?

    No. SANDIMMUN 50MG INJECTION is an immunosuppressive agent. It suppresses your body’s immune functions and enables your body to accept the transplanted organ. It also stops the abnormal immune response in the body and manages your body from attacking its own cells.

    References

    1. KD. Tripathi. Immunosuppressant Drugs. Essentials of Medical pharmacology. 7th Edition. 2013. Page – 878.

    2. Carolina Tapia, Trevor A. Nessel, Patrick M. Zito. Cyclosporine. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. August 2022. [Accessed on 21st November 2022] https://www.ncbi.nlm.nih.gov/books/NBK482450/

    3. James F. Burke, Jr., John D. Pirsch, Eleanor L. Ramos, Daniel R. Salomon, Donald M. Stablein, David H. Van Buren, and John C. West. Long-Term Efficacy and Safety of Cyclosporine in Renal-Transplant Recipients. The New England Journal of Medicine. August 1994. [Accessed on 21st November 2022] https://www.nejm.org/doi/full/10.1056/NEJM199408113310604

    4. Novartis Pharmaceuticals UK Limited. Electronic Medicines Compendium (EMC) [Revised in May 2022] [ Accessed on 21st November 2022] https://www.medicines.org.uk/emc/files/pil.1036.pdf

    5. Novartis Pharmaceuticals Canada Inc [Revised in August 2022] [ Accessed on 21st November 2022] https://www.ask.novartispharma.ca/download.htm?res=neoral_scrip_e.pdf&resTitleId=691

    Author Details

    Written By Srilekha. R - B.Pharm
    Reviewed For Accuracy By Dr. M N Himaja - MBBS
    Last updated on 22 Nov 2022 | 11:56 PM(IST)
    Lab updated