Cyclosporine Oral Solution

Take this medication by mouth, usually once daily at the same time each day, or take as directed by your doctor. You may take it with or without food, but it is important to choose one way and take every dose that way. Dosage is based on your medical condition, cyclosporine blood level, kidney function, and response to therapy. Follow the dosing schedule for this medication carefully.To improve the taste of this liquid medication, mix it with milk, chocolate milk, or orange juice. Using the dosing syringe, measure your dose into a cup of milk or orange juice, stir well, and drink as soon as possible. It is best to use a glass cup whenever possible, but a hard plastic cup may also be used. Do not use plastic foam cups. To make sure that all the medication is taken, add more juice to the cup, stir, and drink, then repeat. Dry the outside of the dropper. Do not rinse it in water.Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit products can increase the amount of this medication in your bloodstream. Consult your doctor or pharmacist for more details.Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.This medication works best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.If you are taking this drug to treat arthritis, it may take 4-8 weeks to notice improvement, and up to 4 months for the full benefit.If you are taking this drug to treat psoriasis, it may take 2-4 weeks to notice improvement, and up to 4 months for the full benefit. Your dose will slowly be increased during your therapy with this drug. Inform your doctor if your condition does not improve after 6 weeks of taking the highest recommended dose. If you are taking this medication to treat psoriasis, do not take it continuously for longer than one year unless directed to do so by your doctor.

See also the Warning section.Headache, nausea, vomiting, diarrhea, stomach upset, acne, cramps, increased hair growth on the face/body, shaking fingers/hands (tremor), swollen/red/painful gums, dizziness, flushing, and high blood pressure may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Your risk of infection may be higher while you are taking this medication. Tell your doctor immediately if any of these symptoms of infection occur: fever, sore throat, flu-like symptoms, painful urination.Tell your doctor right away if you have any serious side effects, including: muscle spasms/weakness, fast/irregular heartbeat, change in the amount/color of urine, unusual weight gain/loss, tingling of the hands/feet, hearing problems, easy bruising/bleeding, unusual tiredness, dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing of the skin/eyes, vomit that looks like coffee grounds, change in the appearance or size of skin moles/lesions, changes in skin color, loss of consciousness, mental/mood changes (such as confusion, difficulty concentrating), vision changes, swollen glands, unusual lumps, night sweats, problems with speech, clumsiness, loss of coordination, weakness on one side of the body.Get medical help right away if you have any very serious side effects, including: chest pain, seizures.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Use cyclosporine oral solution as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Always take with food or always take on an empty stomach.
• If you are taking sirolimus, take it 4 hours after taking this medicine.
• To gain the most benefit, do not miss doses.
• Keep taking cyclosporine oral solution as you have been told by your doctor or other health care provider, even if you feel well.
• Take this medicine at the same time of day.
• Measure liquid doses carefully. Use the measuring device that comes with cyclosporine oral solution.
• Do not rinse the syringe that comes with this medicine before or after you take your dose. If you need to wash it, be sure it is completely dry before you use it again.
• Mix solution in glass with 1 cup of milk, chocolate milk, or orange juice at room temperature and drink it right away. Rinse glass with more juice or milk and drink.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about cyclosporine oral solution, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about cyclosporine oral solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using cyclosporine oral solution.

Review Date: October 4, 2017

All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

What Are You Taking This Medication For?

Rheumatoid arthritis Form: Oral solution Strengths: 100 mg/mL Adult Dosage (ages 18 years and older)

• Dosage is based on weight.
• The initial dose is 2.5 mg/kg per day
• The maximum dose is 4 mg/kg per day.
• If you don’t get good results after 16 weeks of treatment, stop taking cyclosporine.

Child Dosage (ages 0-17 years)

Dosage hasn’t been established for people younger than 17 years.

Special Considerations

Kidney Disorders: Cyclosporine may cause kidney disease. If you already have kidney problems, your doctor may reduce your dose of cyclosporine.

Liver Disorders: Cyclosporine may cause liver disease. If you already have liver problems, your doctor may reduce your dose of cyclosporine.

Psoriasis Form: Oral solution Strengths: 100 mg/mL Adult Dosage (ages 18 years and older)

• Dosage is based on weight.
• The initial dose is 2.5 mg/kg per day
• The maximum dose is 4 mg/kg per day.
• If you don’t get good results after 6 weeks of treatment, stop taking cyclosporine.

Child Dosage (ages 0-17 years)

Dosage hasn’t been established for people younger than 17 years.

Special Considerations

Kidney Disorders: Cyclosporine may cause kidney disease. If you already have kidney problems, your doctor may reduce your dose of cyclosporine.

Liver Disorders: Cyclosporine may cause liver disease. If you already have liver problems, your doctor may reduce your dose of cyclosporine.

Prevent rejection of an organ transplant Form: Oral solution Strengths: 100 mg/mL Adult Dosage (ages 18 years and older)

The dosage of cyclosporine may vary, depending on your weight, the organ that has been transplanted, and other medications you’re taking.

Generic and all Brands but Sandimmune:

Dosage may vary. The typical daily dose is 7–9 mg per kilogram (kg) of bodyweight taken in two even doses spaced evenly throughout the day.

Sandimmune:

• Take your first dose 4–12 hours before your transplant. This dose is typically 15 mg/kg. Your doctor may give you a dose that’s 10–14 mg/kg per day.
• Continue taking the same dose after your transplant surgery for 1–2 weeks. After that, reduce it by 5 percent per week to a maintenance dose of 5–10 mg/kg per day.

Child Dosage (ages 1-17 years)

Generic and all Brands but Sandimmune:

Dosage may vary. The typical daily dose is 4–12 mg per kilogram (kg) of bodyweight taken in two even doses spaced evenly throughout the day.

Sandimmune:

• Take your first dose 4–12 hours before your transplant. This dose is typically 15 mg/kg. Your doctor may give you a dose that’s 10–14 mg/kg per day.
• Continue taking the same dose after your transplant surgery for 1–2 weeks. After that, reduce it by 5 percent per week to a maintenance dose of 5–10 mg/kg per day.

Child Dosage (ages 0-11 months)

Dosage hasn’t been established for children younger than 1 year.

Special Considerations

Kidney Disorders: Cyclosporine may cause kidney disease. If you already have kidney problems, your doctor may reduce your dose of cyclosporine.

Liver Disorders: Cyclosporine may cause liver disease. If you already have liver problems, your doctor may reduce your dose of cyclosporine.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you. Important Considerations for Taking Cyclosporine

Take cyclosporine at the same time every day

Store at room temperature: 68–77°F (20–25Cº)

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Prescription is refillable

Travel

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Clinical Monitoring

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Are There Any Alternatives?