Retisert

DRUG DESCRIPTION

RETISERT® (fluocinolone acetonide intravitreal implant) 0.59 mg is a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6 ?g/day, decreasing over the first month to a steady state between 0.3-0.4 ?g/day over approximately 30 months. The drug substance is the synthetic corticosteroid fluocinolone acetonide, represented by the following structural formula:

RETISERT (fluocinolone acetonide intravitreal implant) Structural Formula Illustration

C24H30F2O6     Mol. Wt. 452.50

Chemical Name: Pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy- 16,17-[(1-methyl-ethylidene)bis(oxy)],(6?,11? ,16?)-.

Fluocinolone acetonide is a white crystalline powder, insoluble in water, and soluble in methanol. It has a melting point of 265-266°C.

Each RETISERT consists of a tablet containing 0.59 mg of the active ingredient, Fluocinolone Acetonide, USP, and the following inactives: microcrystalline cellulose, polyvinyl alcohol, and magnesium stearate.

What are the possible side effects of fluocinolone ophthalmic implant (Retisert)?

For the first 1 to 4 weeks after receiving the implant, you may have a temporary decrease in vision. Call your doctor if your vision does not return to normal after 4 weeks. Fluocinolone ophthalmic implant will not correct vision problems (such as near-sightedness or far-sightedness) that you had before receiving the implant.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you...

Read All Potential Side Effects and See Pictures of Retisert »


Retisert Patient Information Including Side Effects

Brand Names: Retisert

Generic Name: fluocinolone ophthalmic implant (Pronunciation: floo oh SIN oh lone off THAL mik IM plant)

  • What is fluocinolone ophthalmic implant (Retisert)?
  • What are the possible side effects of fluocinolone ophthalmic implant (Retisert)?
  • What is the most important information I should know about fluocinolone ophthalmic implant (Retisert)?
  • What should I discuss with my healthcare provider before receiving a fluocinolone ophthalmic implant (Retisert)?
  • How is the fluocinolone ophthalmic implant put into place (Retisert)?
  • What happens if I miss a dose (Retisert)?
  • What happens if I overdose (Retisert)?
  • What should I avoid after receiving a fluocinolone ophthalmic implant (Retisert)?
  • What other drugs will affect fluocinolone ophthalmic implant (Retisert)?
  • Where can I get more information?

What is fluocinolone ophthalmic implant (Retisert)?

Fluocinolone is in a group of drugs called corticosteroids. It prevents the release of substances in the body that cause inflammation.

Fluocinolone ophthalmic (for the eye) implant is used to treat inflammation within the eye that may be caused by a variety of diseases or infections. The implant slowly releases fluocinolone into the eye over a period of approximately 30 months. Fluocinolone will not treat an eye infection.

Fluocinolone ophthalmic implant may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fluocinolone ophthalmic implant (Retisert)?

For the first 1 to 4 weeks after receiving the implant, you may have a temporary decrease in vision. Call your doctor if your vision does not return to normal after 4 weeks. Fluocinolone ophthalmic implant will not correct vision problems (such as near-sightedness or far-sightedness) that you had before receiving the implant.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • sudden vision loss, eye pain or redness;
  • bleeding, oozing, or crusting of your eyes;
  • cloudiness in the pupils or iris of your eyes;
  • seeing flashes of light, halos around lights, or "floaters" in your vision; or
  • tunnel vision, problems with peripheral (side) vision.

Less serious side effects may include:

  • swelling of the eyelids;
  • mild eye irritation;
  • dry or watery eyes;
  • itching, mild skin rash;
  • the feeling that something is in your eye;
  • headache, dizziness;
  • runny or stuffy nose, sore throat, fever, cough;
  • nausea, vomiting; or
  • back pain, joint or muscle pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fluocinolone ophthalmic implant (Retisert)?

The fluocinolone ophthalmic implant is surgically placed into the eye. If both eyes will be treated, the implants will most likely be placed at two separate times, to decrease your risk of infection in both eyes at the same time.

Before receiving the implant, tell your doctor if you are allergic to any drugs, or if you have glaucoma, herpes simplex or other eye infection, or if you have recently had cataract surgery.

Do not use any eye medications that your doctor has not prescribed.

Fluocinolone ophthalmic implant can cause dizziness or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

For the first 1 to 4 weeks after receiving the implant, you may have a temporary decrease in vision. Call your doctor if your vision does not return to normal after 4 weeks. Fluocinolone ophthalmic implant will not correct vision problems (such as near-sightedness or far-sightedness) that you had before receiving the implant.

The placement of the fluocinolone ophthalmic implant may increase your risk of developing cataracts and eventually needing cataract surgery. Talk with your doctor if you have concerns about this risk.

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