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Gengraf (cyclosporine) Product Info

What is/are Cyclosporine?

CYCLOSPORINE is used to decrease the immune system's response to a transplanted organ. The medicine (Neoral only) is also used for rheumatoid arthritis and psoriasis. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care providers before I take this medicine?

They need to know if you have any of these conditions:

• cancer
• high blood pressure
• immune system problems
• infection
• kidney disease
• liver disease
• previous coal tar, PUVA, ultraviolet, or radiation therapy
• an unusual or allergic reaction to cyclosporine, alcohol, corn oil (Neoral only), castor oil (Neoral only), other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Use the dosing syringe provided to measure your dose. For the Sandimmune brand, mix your dose in milk, chocolate milk, or orange juice (at room temperature). If you are taking any other brand of cyclosporine, mix the measured dose in a glass of orange or apple juice that is at room temperature. Do not use grapefruit juice or milk. Mix in a glass container (not plastic) and stir well just before taking. Rinse the glass with more liquid and swallow to make sure you get all the dose. Try to mix with the same diluent for each dose. This will help you keep a constant amount of cyclosporine in your body. After use, dry the outside of the dosing syringe with a clean towel. Do not rinse with water or any other cleaning agent. The dosing syringe must be dry before use. Take your medicine at regular intervals. Take it at the same time each day and at the same time in relation to meals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this drug may be prescribed for children as young as 1 year for selected conditions (Neoral) and for children as young as 6 months for selected conditions (Sandimmune), precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

Note: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Call your doctor or health care professional if you miss more than one dose or if you miss doses on a regular basis.

What may interact with this medicine?

Do not take this medicine with any of the following:

• bosentan
• cidofovir
• cisapride
• mibefradil
• ranolazine
• red yeast rice, monascus purpureus
• St. John's wort
• tacrolimus

This medicine may also interact with the following:

• acyclovir
• allopurinol
• amiloride
• amiodarone
• antibiotics like ciprofloxacin, gentamicin, tobramycin, vancomycin, trimethoprim; sulfamethoxazole, nafcillin, rifampin, rifabutin, azithromycin, clarithromycin, erythromycin, and quinupristin; dalfopristin
• bromocriptine
• carbamazepine
• cimetidine
• colchicine
• danazol
• digoxin
• female hormones, including contraceptive or birth control pills
• imatinib
• medicines for fungal infections like amphotericin B, fluconazole, itraconazole, terbinafine, and ketoconazole
• medicines for blood pressure like diltiazem, nicardipine, verapamil, enalapril, ramipril, and losartan
• medicines for cholesterol like lovastatin, simvastatin, atorvastatin, and fenofibrate
• medicines for HIV infection like indinavir, nelfinavir, ritonavir, and saquinavir
• medicines that suppress the immune system
• melphalan
• methotrexate
• metoclopramide
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• octreotide
• orlistat
• oxcarbazepine
• phenobarbital
• phenytoin
• ranitidine
• sirolimus
• spironolactone
• steroid medicines like prednisone or cortisone
• sulfinpyrazone
• ticlopidine
• triamterene
• vaccines
• voriconazole

This list may not describe all possible interactions. Give your health care providers a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What side effects may I notice from this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• changes in vision
• high blood pressure
• increased urge to urinate or frequent urination
• numbness or tingling in the hands and feet
• seizures
• severe stomach pain
• vomiting
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• bleeding or tender gums, overgrowth of gum tissue
• diarrhea
• excessive hair growth on the face or body
• nausea
• tremors

This list may not describe all possible side effects.

What should I watch for while using this medicine?

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Visit your doctor or health care professional for regular checks on your progress. You will have regular blood checks. Do not change the brand of medicine unless directed by your doctor or health care professional.

If you get a cold or other infection while taking this medicine, call your doctor or health care professional. Do not treat yourself. The medicine may decrease your body's ability to fight infections.

The medicine can cause unusual growth of gum tissue and can make your gums bleed. Practice good oral hygiene, and be careful when brushing and flossing your teeth. See your dentist regularly.

Where should I keep this medicine?

Keep out of the reach of children.

Store Neoral at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Store Sandimmune below 30 degrees C (86 degrees F). Do not keep in the refrigerator. Do not freeze. Keep the medicine in the original packaging. Throw away any unused medicine after two months of opening the bottle or after the expiration date.

At a temperature below 20 degrees C (68 degrees F) some brands of cyclosporine oral solution (e.g., Neoral and its generic forms) may form a gel or sediment. If this happens, let the medicine warm to room temperature (about 77 degrees F) before use. ,

What is/are Cyclosporine?

CYCLOSPORINE is used to decrease the immune system's response to a transplanted organ. The medicine (Neoral only) is also used for rheumatoid arthritis and psoriasis. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care providers before I take this medicine?

They need to know if you have any of these conditions:

• cancer
• high blood pressure
• immune system problems
• infection
• kidney disease
• liver disease
• previous coal tar, PUVA, ultraviolet, or radiation therapy
• an unusual or allergic reaction to cyclosporine, alcohol, corn oil (Neoral only), castor oil (Neoral only), other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Use the dosing syringe provided to measure your dose. For the Sandimmune brand, mix your dose in milk, chocolate milk, or orange juice (at room temperature). If you are taking any other brand of cyclosporine, mix the measured dose in a glass of orange or apple juice that is at room temperature. Do not use grapefruit juice or milk. Mix in a glass container (not plastic) and stir well just before taking. Rinse the glass with more liquid and swallow to make sure you get all the dose. Try to mix with the same diluent for each dose. This will help you keep a constant amount of cyclosporine in your body. After use, dry the outside of the dosing syringe with a clean towel. Do not rinse with water or any other cleaning agent. The dosing syringe must be dry before use. Take your medicine at regular intervals. Take it at the same time each day and at the same time in relation to meals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this drug may be prescribed for children as young as 1 year for selected conditions (Neoral) and for children as young as 6 months for selected conditions (Sandimmune), precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

Note: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Call your doctor or health care professional if you miss more than one dose or if you miss doses on a regular basis.

What may interact with this medicine?

Do not take this medicine with any of the following:

• bosentan
• cidofovir
• cisapride
• mibefradil
• ranolazine
• red yeast rice, monascus purpureus
• St. John's wort
• tacrolimus

This medicine may also interact with the following:

• acyclovir
• allopurinol
• amiloride
• amiodarone
• antibiotics like ciprofloxacin, gentamicin, tobramycin, vancomycin, trimethoprim; sulfamethoxazole, nafcillin, rifampin, rifabutin, azithromycin, clarithromycin, erythromycin, and quinupristin; dalfopristin
• bromocriptine
• carbamazepine
• cimetidine
• colchicine
• danazol
• digoxin
• female hormones, including contraceptive or birth control pills
• imatinib
• medicines for fungal infections like amphotericin B, fluconazole, itraconazole, terbinafine, and ketoconazole
• medicines for blood pressure like diltiazem, nicardipine, verapamil, enalapril, ramipril, and losartan
• medicines for cholesterol like lovastatin, simvastatin, atorvastatin, and fenofibrate
• medicines for HIV infection like indinavir, nelfinavir, ritonavir, and saquinavir
• medicines that suppress the immune system
• melphalan
• methotrexate
• metoclopramide
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• octreotide
• orlistat
• oxcarbazepine
• phenobarbital
• phenytoin
• ranitidine
• sirolimus
• spironolactone
• steroid medicines like prednisone or cortisone
• sulfinpyrazone
• ticlopidine
• triamterene
• vaccines
• voriconazole

This list may not describe all possible interactions. Give your health care providers a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What side effects may I notice from this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• changes in vision
• high blood pressure
• increased urge to urinate or frequent urination
• numbness or tingling in the hands and feet
• seizures
• severe stomach pain
• vomiting
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• bleeding or tender gums, overgrowth of gum tissue
• diarrhea
• excessive hair growth on the face or body
• nausea
• tremors

This list may not describe all possible side effects.

What should I watch for while using this medicine?

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Visit your doctor or health care professional for regular checks on your progress. You will have regular blood checks. Do not change the brand of medicine unless directed by your doctor or health care professional.

If you get a cold or other infection while taking this medicine, call your doctor or health care professional. Do not treat yourself. The medicine may decrease your body's ability to fight infections.

The medicine can cause unusual growth of gum tissue and can make your gums bleed. Practice good oral hygiene, and be careful when brushing and flossing your teeth. See your dentist regularly.

Where should I keep this medicine?

Keep out of the reach of children.

Store Neoral at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Store Sandimmune below 30 degrees C (86 degrees F). Do not keep in the refrigerator. Do not freeze. Keep the medicine in the original packaging. Throw away any unused medicine after two months of opening the bottle or after the expiration date.

At a temperature below 20 degrees C (68 degrees F) some brands of cyclosporine oral solution (e.g., Neoral and its generic forms) may form a gel or sediment. If this happens, let the medicine warm to room temperature (about 77 degrees F) before use.

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