Ozurdex Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage Patient Counseling Information MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Dexamethasone

Indications/Uses

Adults w/ macular edema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Non-infectious uveitis affecting posterior segment of the eye. Diabetic macular edema.

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Dosage/Direction for Use

Ophth intravitreal inj Macular edema following BRVO or CRVO, non-infectious uveitis affecting posterior segment of the eye, diabetic macular edema 0.7 mg/eye. Re-occurrence of macular edema due to BRVO, CRVO or vascular leakage in macula Re-inj 0.7 mg.

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Overdosage

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Contraindications

Hypersensitivity. Patients w/ active or suspected ocular or periocular infection including most viral corneal & conjunctival diseases including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections & fungal diseases; advanced glaucoma; aphakic eyes w/ ruptured posterior lens cap; eyes w/ anterior chamber intraocular lens (ACIOL), iris or transscleral fixated IOLs & ruptured posterior lens cap.

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Special Precautions

Not to be used in active ocular herpes simplex. Endophthalmitis, intraocular inflammation, increased IOP & retinal detachment; posterior subcapsular cataracts & glaucoma. Risk of implant migration into anterior chamber for patients who had tear in posterior lens cap (eg, due to cataract surgery) or iris opening to vitreous cavity (eg, due to iridectomy) leading to corneal edema. May enhance establishment of secondary ocular infections due to bacteria, fungi, or viruses. History of ocular herpes simplex. Monitor patients following inj for infection or increased IOP. Regularly monitor patients w/ persistent severe corneal edema. May experience temporary visual blurring & should not drive & use machines. Not to be used during pregnancy & lactation. Ped patients.

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Use In Pregnancy & Lactation

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Adverse Reactions

Increased IOP, conjunctival hemorrhage & hyperemia, eye pain, ocular HTN, cataract, vitreous detachment; headache. Increased lacrimation, subcapsular cataract, visual disturbance, retinal vein occlusion, vitreous opacities. Vitreous hemorrhage. Myodesopsia, blepharitis, scleral hyperaemia, visual impairment, abnormal sensation in the eye, eyelids pruritus; migraine. Reduced visual acuity, conjunctivitis, vitreous floaters, conjunctival edema, dry eye, retinal aneurysm, foreign body sensation, corneal erosion, keratitis, anterior chamber inflammation, retinal tear, eyelid ptosis; HTN, bronchitis. Endophthalmitis, hypotony of eye (associated w/ vitreous leakage due to inj), retinal detachment; device insertion complication resulting in ocular tissue injury (implant misplacement), device dislocation w/ or w/o corneal edema.

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Storage

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Description

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Action

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MIMS Class

Eye Corticosteroids

ATC Classification

S01BA01 - dexamethasone ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye.

Thai FDA Category

Patient Counseling Information

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Presentation/Packing

Form

Ozurdex intravitreal implant 0.7 mg

Packing/Price

((foil)) 1's

Ozurdex

dexamethasone

Manufacturer:

AbbVie

Distributor:

DKSH