"(Reuters) - Valeant Pharmaceuticals International Inc's experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said"...
Gengraf Capsules Consumer
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
CYCLOSPORINE MICROEMULSION CAPSULE - ORAL
COMMON BRAND NAME(S): Gengraf, Neoral
WARNING: Cyclosporine is a drug that reduces the body's ability to fight illness/disease (an immunosuppressant), leaving patients vulnerable to infection or other problems (including cancers such as lymphoma). Using other drugs that treat organ transplant rejection along with this drug may increase these tendencies.
Cyclosporine can also cause high blood pressure and kidney problems. The risk of both problems increases with higher doses and longer treatment with this drug. Psoriasis patients who have had certain previous treatments (e.g., coal tar, methotrexate, PUVA, UVB, or other radiation therapy) are at increased risk to develop skin cancer. Therefore, cyclosporine must be given only under close medical supervision.
Because different brands deliver different amounts of medication, do not switch brands of cyclosporine without your doctor's permission and directions.
Laboratory tests (e.g., kidney function tests, blood tests) may be performed to monitor your progress.
USES: This medication is used to prevent organ rejection in people who have received a liver, kidney, or heart transplant. It is usually taken along with other medications to allow your new organ to function normally. Cyclosporine is also used to treat severe rheumatoid arthritis and a certain skin condition (severe psoriasis). Cyclosporine belongs to a class of drugs known as immunosuppressants. It works by slowing down your body's defense system (immune system) to prevent your body from rejecting a transplanted organ, further damaging your joints (in rheumatoid arthritis patients), or further damaging your skin (in psoriasis patients). For the treatment of psoriasis or arthritis, it is generally used to treat people who cannot take other medications or have not found relief from other treatments.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug may also be used to prevent rejection in other types of organ transplants (e.g., cornea, pancreas) or bone marrow transplant. It may also be used to treat other conditions that may be helped by affecting the immune system (e.g., Crohn's disease).
HOW TO USE: Take this medication by mouth, usually twice daily at the same times each day, or take as directed by your doctor. You may take this medication with or without food, but you should choose one or the other and take every dose that way. If you take this medication with food, eat the same amount and type of food each time you take it. Swallow this medication whole. Do not crush or chew the capsules. Dosage is based on your medical condition, cyclosporine blood level, kidney function, and response to therapy. Follow the dosing schedule for this medication carefully.
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 times 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.
Additional Gengraf Capsules Information
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