Cyclosporine eent

Name: Cyclosporine eent

Cautions for Cyclosporine

Contraindications

  • Known hypersensitivity to cyclosporine or any ingredient in the formulation.1

  • Active ocular infections.1

Warnings/Precautions

Warnings

Safety and efficacy not established in patients with history of herpes keratitis.1

Specific Populations

Pregnancy

Category C.1

Lactation

Distributed into milk after systemic administration; it is not known whether distributed into milk after topical application to the eye.1 Caution advised if used in nursing women.1

Pediatric Use

Safety and efficacy not established in children <16 years of age.1

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.1

Common Adverse Effects

Ocular burning, conjunctival hyperemia, discharge, epiphora, ocular pain, foreign body sensation, pruritus, stinging, visual disturbance (e.g., blurring).1

Interactions for Cyclosporine

No formal drug interaction studies to date.9

Advice to Patients

  • Importance of learning and adhering to proper administration techniques to avoid contamination of the product.1

  • Importance of administering ophthalmic emulsion immediately after opening single-use vial and discarding any unused portion immediately after administration.1

  • Importance of not wearing contact lenses in presence of decreased tear production.1 If contact lenses are worn, importance of removing lenses prior to administration and delaying reinsertion of lenses for 15 minutes after instillation.1

  • Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

  • If using artificial tears and ophthalmic cyclosporine, importance of allowing at least 15 minutes to elapse between administration.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

In Summary

Commonly reported side effects of cyclosporine ophthalmic include: burning sensation of eyes. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to cyclosporine ophthalmic: ophthalmic emulsion

Along with its needed effects, cyclosporine ophthalmic 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 of cyclosporine ophthalmic 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 the eye
  • difficulty with 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

Usual Adult Dose for Keratoconjunctivitis Sicca

1 drop 2 times a day in each eye approximately 12 hours apart

Comments:
-This drug can be used concomitantly with artificial tears, allowing a 15 minute interval between products.

Use: To increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca

Renal Dose Adjustments

Data not available

Cyclosporine ophthalmic Pregnancy Warnings

Use is not recommended unless clearly needed. US FDA pregnancy category: C Comments: -This drug is not recommended in women of childbearing potential not using effective contraception.

Animal studies have shown reproductive toxicity following systemic administration at exposure considered sufficiently in excess of the maximum human exposure. There are no adequate and well-controlled studies in pregnant women. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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