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Drugs reference index «Restasis»

Restasis

Generic Name: cyclosporine (Ophthalmic route)

sye-kloe-SPOR-een

Oral routeCapsuleCapsule, Liquid FilledSolution

Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Sandimmune(R) (cyclosporine). Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

Sandimmune(R) (cyclosporine) should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.

Sandimmune(R) soft gelatin capsules (cyclosporine capsules, USP) and Sandimmune(R) oral solution (cyclosporine oral solution, USP) have decreased bioavailability in comparison to Neoral(R) soft gelatin capsules (cyclosporine capsules, USP) MODIFIED and Neoral(R) oral solution (cyclosporine oral solution, USP) MODIFIED.

Sandimmune(R) and Neoral(R) are not bioequivalent and cannot be used interchangeably without physician supervision.

The absorption of cyclosporine during chronic administration of Sandimmune(R) Soft Gelatin Capsules and Oral Solution was found to be erratic. It is recommended that patients taking the soft gelatin capsules or oral solution over a period of time be monitored at repeated intervals for cyclosporine blood levels and subsequent dose adjustments be made in order to avoid toxicity due to high levels and possible organ rejection due to low absorption of cyclosporine. This is of special importance in liver transplants. Numerous assays are being developed to measure blood levels of cyclosporine. Comparison of levels in published literature to patient levels using current assays must be done with detailed knowledge of the assay methods employed .

Cyclosporine should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. SANDIMMUNE(R) and NEORAL(R) are not bioequivalent and cannot be used interchangeably without physician supervision. Monitor cyclosporine blood levels to avoid toxicity due to high levels and possible organ rejection due to low levels as a result of the erratic absorption of cyclosporine during chronic administration of SANDIMMUNE(R) .

Intravenous routeSolution

Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Sandimmune(R) (cyclosporine). Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

Sandimmune(R) (cyclosporine) should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.

Sandimmune(R) soft gelatin capsules (cyclosporine capsules, USP) and Sandimmune(R) oral solution (cyclosporine oral solution, USP) have decreased bioavailability in comparison to Neoral(R) soft gelatin capsules (cyclosporine capsules, USP) MODIFIED and Neoral(R) oral solution (cyclosporine oral solution, USP) MODIFIED.

Sandimmune(R) and Neoral(R) are not bioequivalent and cannot be used interchangeably without physician supervision.

The absorption of cyclosporine during chronic administration of Sandimmune(R) Soft Gelatin Capsules and Oral Solution was found to be erratic. It is recommended that patients taking the soft gelatin capsules or oral solution over a period of time be monitored at repeated intervals for cyclosporine blood levels and subsequent dose adjustments be made in order to avoid toxicity due to high levels and possible organ rejection due to low absorption of cyclosporine. This is of special importance in liver transplants. Numerous assays are being developed to measure blood levels of cyclosporine. Comparison of levels in published literature to patient levels using current assays must be done with detailed knowledge of the assay methods employed .

Cyclosporine should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. SANDIMMUNE(R) and NEORAL(R) are not bioequivalent and cannot be used interchangeably without physician supervision. Monitor cyclosporine blood levels to avoid toxicity due to high levels and possible organ rejection due to low levels as a result of the erratic absorption of cyclosporine during chronic administration of SANDIMMUNE(R) .

Oral routeCapsule, Liquid FilledSolution

Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe Neoral(R). At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe Neoral(R). Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite of the follow-up of the patient.

Neoral(R), a systemic immunosuppressant, may increase the susceptibility to infection and the development of neoplasia. In kidney, liver, and heart transplant patients Neoral(R) may be administered with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma and other neoplasms may result from the increase in the degree of immunosuppression in transplant patients.

Neoral(R) soft gelatin capsules (cyclosporine capsules, USP) modified and Neoral(R) oral solution (cyclosporine oral solution, USP) modified have increased bioavailability in comparison to Sandimmune(R) soft gelatin capsules (cyclosporine capsules, USP) and Sandimmune(R) oral solution (cyclosporine oral solution, USP). Neoral(R) and Sandimmune(R) are not bioequivalent and cannot be used interchangeably without physician supervision. For a given trough concentration, cyclosporine exposure will be greater with Neoral(R) than with Sandimmune(R). If a patient who is receiving exceptionally high doses of Sandimmune(R) is converted to Neoral(R), particular caution should be exercised. Cyclosporine blood concentrations should be monitored in transplant and rheumatoid arthritis patients taking Neoral(R) to avoid toxicity due to high concentrations. Dose adjustments should be made in transplant patients to minimize possible organ rejection due to low concentrations. Comparison of blood concentrations in the published literature with blood concentrations obtained using current assays must be done with detailed knowledge of the assay methods employed.

For psoriasis patients: Psoriasis patients previously treated with PUVA and to a lesser extent, methotrexate or other immunosuppressive agents, UVB, coal tar, or radiation therapy, are at an increased risk of developing skin malignancies when taking Neoral(R).

Cyclosporine, the active ingredient in Neoral(R), in recommended dosages, can cause systemic hypertension and nephrotoxicity. The risk increases with increasing dose and duration of cyclosporine therapy. Renal dysfunction, including structural kidney damage, is a potential consequence of cyclosporine, and therefore, renal function must be monitored during therapy .

Cyclosporine, a systemic immunosuppressant, may increase the susceptibility to infection and development of neoplasia. Hypertension and nephrotoxicity can occur at recommended dosages, and the risk increases with increasing dose and duration of cyclosporine therapy. Monitor blood levels and renal function to avoid toxicity. Neoral(R) and Sandimmune(R) are not bioequivalent and cannot be used interchangeably without physician supervision. Psoriasis patients previously treated with PUVA and to a lesser extent, methotrexate or other immunosuppressive agents, UVB, coal tar, or radiation therapy, are at an increased risk of developing skin malignancies when taking cyclosporine .

Commonly used brand name(s):

In the U.S.

  • Restasis

Available Dosage Forms:

  • Emulsion

Therapeutic Class: Anti-Inflammatory

Uses For Restasis

Cyclosporine belongs to a class of medicines known as immunosuppressants. It is used to increase tear production in people who have a certain eye condition.

This medicine is available only with your doctor's prescription.

Before Using Restasis

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Cyclosporine eye drops have only been studied in children age 16 and older. Discuss with your child's doctor the good that this medicine may do as well as the risks of using it.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Current eye infections or
  • Hypersensitivity to cyclosporine or any ingredients in cyclosporine—This medicine should not be used if you have these conditions.
  • History of herpes infection of your cornea—Caution should be used with this medicine if you have this condition.
  • If you are a contact lens user—Patients with decreased tear production should not wear contacts.

Proper Use of Restasis

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

You should not use cyclosporine eye drops if you have contact lenses in your eyes. Remove your contact lenses before putting the medicine in your eyes. You can reinsert your contacts 15 minutes after you put the medicine in your eyes.

You may use cyclosporine eye drops if you use artificial tears. However, after putting in your artificial tears, you must wait 15 minutes before putting the cyclosporine eye drops into your eyes.

Do not shake the vial. Instead, rotate the vial gently back and forth before use.

Use this medicine only once, then throw away any unused drug.

To use:

  • First, wash your hands. Tilt the head back and pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink.
  • If you think you did not get the drop of medicine into your eye properly, use another drop.
  • Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
  • To keep the medicine as germ free as possible, do not touch the applicator tip to any surface (including the eye).
  • For ophthalmic emulsion (eye drops) dosage form:
    • For dry eyes:
      • Adults—Instill one drop into the eye every 12 hours.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Restasis

It is very important that your doctor check you at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

If your symptoms do not improve or if they become worse, check with your doctor.

This medicine may cause blurred vision or other vision problems. If any of these occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well.

Restasis Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common
  • Burning or other discomfort of the eye
Less common
  • Blurred vision
  • clear or yellow fluid from eye
  • difficulty reading
  • eye pain
  • feeling of having something in the eye
  • halos around lights
  • itching skin
  • redness of the white part of your eyes or inside of your eyelids
  • sticky or matted eyelashes
  • stinging
  • watery eye

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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  • Restasis Prescribing Information (FDA)
  • Restasis Detailed Consumer Information (PDR)
  • Restasis Drops MedFacts Consumer Leaflet (Wolters Kluwer)
  • Restasis Consumer Overview

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