Retisert Implant (Fluocinolone Acetonide)

Adult dosage

This medication is implanted into the posterior segment of the inflamed eye through a section of the pars plana. The implant contains 0.59 mg of fluocinolone acetonide and initially releases the medication at a rate of 0.6 μg/day. From the first month, the release rate is designed to decrease gradually to 0.3-0.4 μg/day over approximately 30 months. In case of recurrence of uveitis, this medication may be replaced.

This medication should not be used in patients with viral keratitis or conjunctivitis, particularly herpes simplex keratitis, smallpox, or varicella (chickenpox). Additionally, patients with mycobacterial infections or fungal diseases in the eye should not use this medication. It should not be administered in cases of known or suspected allergic reactions to this medication or other corticosteroids. Surgical implantation of this medication into the eye carries various risks of complications including cataracts, retinal detachment, vision loss, intraocular inflammation, changes in intraocular pressure, retinal detachment, and vitreous hemorrhage. Vision may temporarily decrease for about 1 to 4 weeks post-surgery, which is a normal occurrence during the surgical process. Continued use of corticosteroids may lead to glaucoma, optic nerve damage, decreased vision and visual field, and posterior cataract formation; therefore, intraocular pressure should be monitored regularly. Within approximately 34 weeks post-implantation, many patients may require medication to lower intraocular pressure, and some patients may need filtration surgery within an average of 2 years. The use of corticosteroids can exacerbate eye viral infections, so particular caution is warranted for patients with a history of herpes simplex. Corticosteroids can also suppress immune responses, increasing the risk of eye infections, so use should be avoided during acute symptoms of eye infections. The administration of this medication post-cataract surgery may delay recovery and increase blister formation. While using this medication, various adverse reactions may occur, including glaucoma, cataracts, increased intraocular pressure, eye pain, surgery-related complications, infections, thus, regular ophthalmic check-ups are necessary. During surgery, the sterile condition of this medication must be strictly maintained, and care should be taken not to damage the implant. This medication is not re-sterilized. It is advisable to avoid simultaneous surgery on both eyes as it may increase the risk of infection. While this medication treats eye inflammation, it is not used for potential treatment of other diseases, so additional medications may be used as directed by a physician. If movement of the implant occurs within the eye, corneal damage or visual disturbances may arise, therefore if any abnormal symptoms occur, immediate assessment is necessary. During pregnancy, the use should be limited to situations where the potential benefits outweigh the risks to the fetus, and in nursing mothers, caution should be exercised due to possible transmission of the medication through breast milk. It is advisable not to use this medication in children under 12 years of age, as safety and efficacy have not been established. This medication should be stored out of reach of children, in a tightly sealed container protected from direct sunlight, and in a cool place to prevent freezing.

Serious side effects

Glaucoma, optic nerve damage, formation of posterior subcapsular cataract, delayed wound healing, perforation of the eye in areas with thin sclera, secondary eye infections (bacterial, fungal, and viral), corneal ulcer, need for cataract surgery, increased intraocular pressure, surgical complications, retained lens pieces in the eye, implant dislocation, wound rupture, choroidal detachment, endophthalmitis, low intraocular pressure.

Mild side effects

• Headache
• vision loss
• conjunctival hemorrhage
• conjunctival hyperemia
• blurred vision
• abnormal sensations in the eye
• eye irritation
• low intraocular pressure
• itching
• vitreous floaters

This medication should be stored in a tightly sealed container that prevents light exposure, ideally at a cool room temperature between 15 to 25 degrees Celsius.

Appearance

This medication is contained in a silicone elastomer cup with a sealing tab, inside a polycarbonate plastic case (case base and case cup) sealed with aluminum foil in a Tyvek? package.

Package unit

1 unit