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Sandoz Cyclosporine

Sandoz Cyclosporine

(cyclosporine)

Cyclosporine belongs to the groups of medications known as immunosuppressant agents. It is used to prevent the rejection of organ transplants and bone marrow transplants by suppressing the body's natural defence, the immune system.

Available form

Dosage

Capsule

10MG, 25MG, 50MG, 100MG

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Sandoz Cyclosporine information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

The recommended dose of cyclosporine varies according to weight and circumstances.

For solid organ transplants, the recommended dose is 10 mg to 15 mg per kilogram of body weight daily (in 2 divided doses) starting at least 12 hours before surgery. The dose usually stays the same for 1 or 2 weeks after the operation and then is reduced gradually by the doctor so that a particular level of the medication in the bloodstream is reached.

For bone marrow transplants, the oral form of the medication is usually given as a daily dose of 12.5 mg to 15 mg per kilogram of body weight in 2 divided doses. This dose is usually continued for 3 to 6 months and then decreased gradually until it is stopped, about one year after the transplant.

For treatment of psoriasis, the recommended oral starting dose is 2.5 mg per kilogram of body weight per day in 2 divided doses. If no improvement is seen in one month, the doctor may increase the daily dose gradually. The daily dose of cyclosporine should not go above 5 mg per kilogram of body weight per day. If there is still no improvement after 6 weeks of treatment, the treatment should be stopped. If the psoriasis improves, the doctor may gradually decrease the dose. Psoriasis often returns once the medication is stopped, so the goal of treatment is usually to find the smallest dose that will be effective.

For treatment of rheumatoid arthritis, the recommended dose is 2.5 mg per kilogram of body weight per day in 2 divided doses for the first 6 weeks of treatment. If the desired improvement is not seen, the doctor may increase the dose gradually to a maximum of 5 mg per kilogram of body weight per day, as long as the medication is still well tolerated.

For nephrotic syndrome, the recommended starting dose is 3.5 mg per kilogram of body weight per day for adults and 4.2 mg per kilogram of body weight per day for children. People with reduced kidney function should not receive more than 2.5 mg per kg body weight per day as the starting dose. The total daily dose is usually increased to a maximum of 5 mg per kilogram in adults, or 6 mg per kilogram in children. Treatment should be stopped if no improvement is seen within 3 months of starting treatment.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

Swallow the capsules whole with some fluid. The oral solution should be diluted with a small amount of orange or apple juice, stirred, then swallowed immediately. Use a small amount of the juice to rinse the cup, stir, and swallow the contents again, to ensure the entire dose is taken.

It is important that Sandoz Cyclosporine be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store cyclosporine capsules and solution at room temperature and protect from direct light. Keep the capsules in their original package until you are ready to take your dose. When the box of capsules is opened for the first time, there may be a distinct odour from the capsules. This is normal and does not mean the medication needs to be replaced.

Once the solution has been opened, it must be used within 2 months. It should not be stored below 20°C for a long period of time because a jelly-like formation may occur. If minor flakes or slight sediments are seen, the effectiveness and safety of the product and dosing will remain accurate.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Sandoz Cyclosporine. If you are concerned about side effects, discuss the risks and benefits of Sandoz Cyclosporine with your doctor.

The following side effects have been reported by at least 1% of people taking Sandoz Cyclosporine. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

Acne or oily skin
changes to menstrual bleeding
Constipation
decreased appetite
Diarrhea
fatigue
headache, including migraine
hot flushes
increase in hair growth
leg cramps
nausea
night sweats
trembling hands (tremor)
vomiting
weakness

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

agitation
anxiety
bleeding, tender, or enlarged gums
confusion
decreased coordination
difficulty sleeping
disorientation
hearing loss
increased blood pressure
muscle or joint pain
nervousness
numbness or tingling in hands, feet, or lips
rash
severe nausea, vomiting
signs of Anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
signs of infection (symptoms may include Fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine)
signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
symptoms of too much potassium in the body (e.g., muscle fatigue, weakness, difficulty moving, abnormal heart rhythms, nausea)
tremor
vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

facial swelling
seizures
signs of a Anaphylaxis (severe allergic reaction) (e.g., swelling of the mouth, tongue, or eyes)
symptoms of progressive multifocal leukoencephalopathy (e.g., seizures, paralysis, vision loss, trouble thinking clearly, difficulty walking)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Sandoz Cyclosporine.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Sandoz Cyclosporine.

Cancer: Cyclosporine reduces the number of cells that fight infection in the body (white blood cells). This may increase your risk of developing infections and cancer, especially those of the skin and lymphoid tissue.

People with psoriasis may be at increased risk of developing skin cancer as a result of previous psoriasis treatments. While you are taking cyclosporine, it is important to limit your exposure to the sun and use appropriate sun protection such as sunscreen and protective clothing. Your doctor will monitor you for skin cancer while you are taking Sandoz Cyclosporine. Talk to your doctor if you have any concerns.

Dental health: It is particularly important to maintain good dental hygiene while taking Sandoz Cyclosporine, and to see a dentist regularly for teeth cleaning.

High blood pressure: Sandoz Cyclosporine may cause high blood pressure. Your doctor should monitor your blood pressure regularly while you are taking Sandoz Cyclosporine.

High Cholesterol: Sandoz Cyclosporine may increase cholesterol. Your doctor should monitor the amount of cholesterol in your blood regularly while you are taking cyclosporine.

Infection: Cyclosporine works by reducing the number of white blood cells in the body, making it easier to develop an infection. If possible, avoid contact with people who have contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Kidney function: Cyclosporine can have harmful effects on the kidney when it is taken for long periods of time. If you experience signs of decreased kidney function, such as reduced urine production; fluid build-up; or swelling in the ankles, feet and hands; fatigue; or abdominal pain, contact your doctor as soon as possible.

If you have reduced kidney function or Kidney Disease, discuss with your doctor how Sandoz Cyclosporine may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Cyclosporine, and whether any special monitoring is needed.

Liver function: People taking cyclosporine may have changes in liver function that produce abnormal liver test results. Liver disease or reduced liver function may cause Sandoz Cyclosporine to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Sandoz Cyclosporine may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Cyclosporine, and whether any special monitoring is needed.

Your doctor will likely recommend regular liver tests while you are taking Sandoz Cyclosporine. If you have severe changes in liver function, your doctor may recommend that you take a lower dose of Sandoz Cyclosporine or stop taking it altogether.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Potassium levels: Cyclosporine increases the risk of high levels of potassium in your body, especially for people who have decreased kidney function. Your doctor will monitor the amount of potassium in your blood with blood tests. If you experience unexplained nausea, fatigue, muscle weakness or tingling sensations, contact your doctor, as these may be signs of too much potassium.

Progressive Multifocal leukoencephalopathy (PML): There have been reports of PML after using cyclosporine. PML is a rare disorder that causes nerve damage in the brain. If you experience memory loss, vision changes, trouble thinking, seizures, sleeplessness, disorientation, personality changes or difficulty walking, contact your doctor immediately.

Vaccines: People taking cyclosporine may not respond as well to vaccines or may be at risk of becoming ill from a live vaccine. Talk to your doctor if you need any vaccinations while taking Sandoz Cyclosporine.

Pregnancy: Sandoz Cyclosporine should be used during pregnancy only if the benefits outweigh the risks. If you become pregnant while taking Sandoz Cyclosporine, contact your doctor immediately. Do not stop taking Sandoz Cyclosporine without guidance from your doctor.

Breast-feeding: Sandoz Cyclosporine passes into breast milk. If you are a breast-feeding mother and are taking cyclosporine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Many studies have shown that children require higher doses per kilogram of body weight than adults. It is not recommended for children for the treatment of psoriasis or rheumatoid arthritis.

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