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Dexamethasone (ophthalmic): Drug information

Dexamethasone (ophthalmic): Drug information
(For additional information see "Dexamethasone (ophthalmic): Patient drug information" and see "Dexamethasone (ophthalmic): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Dextenza;
  • Dexycu;
  • Maxidex;
  • Ozurdex
Brand Names: Canada
  • Maxidex;
  • Odan-Dexamethasone;
  • Ozurdex;
  • PMS-Dexamethasone Sod Phos
Pharmacologic Category
  • Anti-inflammatory Agent, Ophthalmic;
  • Corticosteroid, Ophthalmic;
  • Corticosteroid, Otic
Dosing: Adult

Ocular inflammation:

Ophthalmic, topical:

0.1% ointment [Canadian product]: Apply thin coating of ointment into conjunctival sac 3 to 4 times/day; when clinically indicated, may reduce application frequency gradually to once daily.

0.1% solution: Instill 1 to 2 drops into conjunctival sac every hour during the day and every other hour during the night; gradually reduce dose to 1 drop every 4 hours, then to 3 to 4 times/day.

0.1% suspension: Instill 1 to 2 drops into conjunctival sac up to 4 to 6 times/day; may use hourly in severe disease; taper prior to discontinuation.

Ocular itching associated with allergic conjunctivitis (0.4 mg insert): Intracanalicular: Place single 0.4 mg insert into the lower lacrimal canaliculus.

Ocular postoperative inflammation (9% suspension): Intraocular: Inject 0.005 mL (517 mcg) into the posterior chamber at the end of ocular surgery.

Ocular postoperative inflammation and pain (0.4 mg insert): Intracanalicular: Place single 0.4 mg insert into the lower lacrimal canaliculus.

Otic inflammation: Otic: 0.1% ophthalmic solution, topical: Initial: Instill 3 to 4 drops into the aural canal 2 to 3 times a day; reduce dose gradually once a favorable response is obtained. Alternately, may pack the aural canal with a gauze wick saturated with the solution; remove from the ear after 12 to 24 hours. Repeat as necessary.

Diabetic macular edema (pseudophakic or phakic patients scheduled for cataract surgery) or macular edema (following BRVO or CRVO): Ocular implant: Intravitreal injection: 0.7 mg implant injected in affected eye

Noninfective uveitis: Ocular implant: Intravitreal injection: 0.7 mg implant injected in affected eye

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

(For additional information see "Dexamethasone (ophthalmic): Pediatric drug information")

Ocular inflammation: Infants, Children, and Adolescents:

Solution 0.1%: Ophthalmic: Limited data available: Instill 1 to 2 drops into conjunctival sac every hour during the day and every other hour during the night; gradually reduce dose to every 3 to 4 hours, then to 3 to 4 times/day (Cassidy 2001)

Suspension 0.1%: Ophthalmic: Instill 1 to 2 drops into conjunctival sac up to 4 to 6 times per day in mild disease; may use hourly in severe disease; taper prior to discontinuation as inflammation subsides. Twice daily dosing has been shown to control inflammation in children ≤10 years receiving dexamethasone after strabismus surgery while resulting in less of an increase in IOP compared to administration 4 times daily (Lam 2005; Ng 2000).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing. Solution/suspension: Use cautiously in the elderly in the smallest possible dose.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Implant, Intravitreal [preservative free]:

Ozurdex: 0.7 mg (1 ea)

Insert, Ophthalmic [preservative free]:

Dextenza: 0.4 mg (1 ea, 10 ea)

Solution, Ophthalmic, as phosphate:

Generic: 0.1% (5 mL)

Suspension, Intraocular [preservative free]:

Dexycu: 9% (0.5 mL)

Suspension, Ophthalmic:

Maxidex: 0.1% (5 mL)

Generic Equivalent Available: US

May be product dependent

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Implant, Intravitreal:

Ozurdex: 0.7 mg (1 ea)

Ointment, Ophthalmic:

Maxidex: 0.1% (3.5 g) [contains methylparaben, propylparaben]

Solution, Combination:

Generic: 0.1% (5 mL)

Solution, Ophthalmic, as phosphate:

Generic: 0.1% (5 mL)

Suspension, Ophthalmic:

Maxidex: 0.1% (5 mL) [contains benzalkonium chloride, edetate (edta) disodium, polysorbate 80]

Administration: Adult

Ophthalmic, topical:

Ophthalmic 0.1% ointment [Canadian product]: Gently pull down under eye to form pocket between eyeball and lower eyelid, then apply ointment into pocket; patient should look down prior to closing eye. Do not touch tip of dropper to eye(s) or any other surface.

Ophthalmic 0.1% solution or suspension: Remove soft contact lenses prior to using solutions containing benzalkonium chloride. Do not touch tip of container to eye. Shake suspension well prior to use.

Ophthalmic 0.1% solution may also be administered otically. Prior to use, clean the aural canal thoroughly and sponge dry.

Intracanalicular 0.4 mg insert: Prior to insertion, may dilate punctum with ophthalmic dilator, if necessary. Insert in the lower lacrimal punctum into the canaliculus. Do not insert if canaliculus is perforated. Insert must be hydrated after fully inserted (if hydration occurs prior to full insertion, discard product and use new insert); 1 to 2 drops of balanced salt solution may be instilled into the punctum to aid in insert hydration. Refer to manufacturer's prescribing information for additional administration instructions.

Intraocular 9% suspension: Preparation and administration of the dose must occur in a sterile surgical setting. Administer the dose into the posterior chamber inferiorly behind the iris at the end of ocular surgery. Refer to manufacturer's prescribing information for details related to preparation and administration technique.

Intravitreal ophthalmic implant: Administer under controlled aseptic conditions (eg, sterile gloves, sterile drape, sterile eyelid speculum). Administer adequate anesthesia and a broad-spectrum bactericidal to the periocular skin, eyelid, and ocular surfaces prior to injection. Refer to manufacturer's prescribing information for administration technique. If administration is required in the second eye, a new applicator should be used and the sterile field, syringe, gloves, drapes, and eyelid speculum should be changed.

Administration: Pediatric

Ophthalmic: Avoid contact of container tip with skin or eye; remove soft contact lenses prior to using solutions containing benzalkonium chloride. Shake suspension well prior to use.

Solution and suspension (0.1%): Apply finger pressure to lacrimal sac during and for 1 to 2 minutes after instillation to decrease risk of absorption and systemic effects.

Use: Labeled Indications

Intracanalicular (0.4 mg insert [Dextenza]): Treatment of ocular inflammation and pain following ophthalmic surgery; treatment of ocular itching associated with allergic conjunctivitis.

Intraocular (9% suspension [Dexycu]): Treatment of postoperative inflammation.

Intravitreal implant (Ozurdex): Treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO); treatment of noninfective uveitis affecting the posterior segment of the eye; treatment of diabetic macular edema.

Ophthalmic, topical (0.1% solution, suspension, or ointment [Canadian product]): Management of steroid-responsive inflammatory conditions such as allergic conjunctivitis, iritis, or cyclitis; symptomatic treatment of corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. The 0.1% ophthalmic solution is also indicated for otic use to treat steroid-responsive inflammatory conditions of the external auditory meatus.

Medication Safety Issues
Sound-alike/look-alike issues:

DexAMETHasone may be confused with desoximetasone, dexmedeTOMIDine, dextroamphetamine

Maxidex may be confused with Maxzide

Administration issues:

Dexamethasone 0.1% ophthalmic suspension (Maxidex), intended for topical ophthalmic administration, may be confused with dexamethasone 9% intraocular suspension (Dexycu), intended for intraocular administration at the end of ocular surgery.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.

Intraocular implant/injection:

>10%:

Cardiovascular: Hypertension (implant: 13%)

Ophthalmic: Cataract (implant: 5% to 68%; incidence increases in patients requiring a second injection), conjunctival hemorrhage (implant: 22% to 23%), corneal edema (injection: 5% to 15%; implant: ≤1%), increased intraocular pressure (3% to 28%), iritis (injection: 5% to 15%)

1% to 10%:

Cardiovascular: Aneurysm (implant: 3%; retinal)

Nervous system: Headache (implant: 1% to 4%)

Ophthalmic: Anterior chamber inflammation (implant: 2% to 10%; including iridocyclitis), blepharitis (injection: 1% to 5%), blepharoptosis (implant: ≤2%), blurred vision (injection: 1% to 5%), conjunctival edema (implant: 5%), conjunctival hyperemia (implant: ≤7%), conjunctivitis (implant: ≤6%), corneal erosion (≤5%), cystoid macular edema (1% to 5%), decreased visual acuity (1% to 9%), eye discharge (implant: 1%), eye pain (≤8%), foreign body sensation of eye (≤5%), increased lacrimation (implant: 1%), keratitis (implant: ≤2%), ocular hypertension (implant: 5%), ophthalmic inflammation (injection: 1% to 5%), photophobia (injection: 1% to 5%), retinal hole without detachment (implant: 2%), secondary cataract (injection: 1% to 5%), vitreous detachment (1% to 5%), vitreous opacity (1% to 5%), xerophthalmia (≤5%)

Respiratory: Bronchitis (implant: 5%)

Frequency not defined: Ophthalmic: Glaucoma (injection)

Ophthalmic solution/suspension:

1% to 10%: Ophthalmic: Eye discomfort (10%), eye irritation (1%)

<1%: Ophthalmic: Abnormal sensation in the eyes, blurred vision, conjunctivitis, crusting of eyelid, dry eye syndrome, eye pruritus, foreign body sensation of eye, increased lacrimation, keratitis, ocular hyperemia, photophobia

Frequency not defined:

Infection: Secondary ocular infection

Ophthalmic: Burning sensation of eyes, cataract, decreased visual acuity, eye perforation, glaucoma (with optic nerve damage), inadvertent filtering bleb, stinging of eyes, visual field defect

Postmarketing (all routes):

Hypersensitivity: Hypersensitivity reaction

Nervous system: Dizziness, headache

Ophthalmic: Blepharoptosis, corneal erosion, endophthalmitis, eye pain, hypotony of eye (associated with vitreous leakage from injection), injury to eye region (complication of device insertion resulting in ocular tissue injury including sclera, subconjunctival lens, and retina), mydriasis, retinal detachment

Contraindications

Intracanalicular (0.4 mg insert): Active corneal, conjunctival, or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella; mycobacterial infections; ophthalmic fungal disease and dacryocystitis

Intraocular (9% suspension): There are no contraindications listed in the manufacturer's labeling.

Intravitreal ocular implant: Hypersensitivity to dexamethasone or any component of the formulation or product; glaucoma with cup to disc ratios of >0.8; active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases; use in patients with a posterior lens capsule that is torn or ruptured

Ophthalmic, topical (0.1% suspension, solution, or ointment [Canadian product]): Hypersensitivity to dexamethasone or any component of the formulation or product; viral disease of the cornea and conjunctiva (including epithelial herpes simplex keratitis, vaccinia, varicella); mycobacterial or fungal infection of the eye; acute, purulent untreated bacterial infections of the eye; the solution should also not be used for otic indications if perforation of a drum membrane is present

Warnings/Precautions

Concerns related to adverse effects:

• Immunosuppression: Prolonged use may increase the hazard of secondary ocular infections. May mask infection or enhance existing infection. The possibility of persistent corneal fungal infection should be considered after prolonged use. Corticosteroids should not be used to treat ocular herpes simplex; use caution in patients with a history of ocular herpes simplex; reactivation of viral infection may occur.

• Ocular effects: Avoid prolonged use, which may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Hypotony of the eyes have also been reported with the implant, some of which were serious. Monitor intraocular pressure if topical ophthalmic products are used for 10 days or longer.

Disease-related concerns:

• Ocular disease: Perforations may occur in diseases which cause thinning of the cornea or sclera.

Special populations:

• Contact lens wearers: Some topical ophthalmic products may contain benzalkonium chloride which may be absorbed by contact lenses; contact lens should not be worn during treatment of ophthalmic infections.

Dosage form specific issues:

• Intracanalicular insert: Appropriate use: Use only after proper eye examination with the aid of magnification (eg, slit lamp biomicroscopy) and fluorescein staining, when appropriate. Patients should be re-evaluated if symptoms fail to improve after 2 days.

• Intravitreal implant: Endophthalmitis, ocular inflammation, intraocular pressure elevations and retinal detachments may occur with intravitreal injection. Intraocular pressure elevations peak ~8 weeks following injection; prolonged monitoring of intraocular pressure may be required. A risk of implant migration into the anterior chamber may be present if the posterior capsule of the lens is absent or torn. Temporary blurring may occur following intravitreal injections; patients should not drive until this resolves. Administer adequate anesthesia and a broad-spectrum microbicide prior to procedure.

• Sulfite sensitivity: Some products may contain sulfites, which may cause allergic reactions in susceptible individuals.

Warnings: Additional Pediatric Considerations

Increased IOP may occur especially with prolonged use; in children, increased IOP has been shown to be dose dependent and produce a greater IOP in children <6 years than older children (Lam 2005).

Metabolism/Transport Effects

Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

CYP3A4 Inhibitors (Strong): May increase the serum concentration of DexAMETHasone (Ophthalmic). Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Risk C: Monitor therapy

Pregnancy Considerations

Information related to the use of the intravitreal implant during pregnancy is limited (Concillado 2016; Hodzic-Hadzibegovic 2017). Following use of the intraocular suspension, systemic exposure is below the limit of quantification after 15 days.

If ophthalmic drops (eg, dexamethasone 0.1% solution) are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease potential exposure to the fetus (Samples 1988).

Breastfeeding Considerations

It is not known if detectable concentrations of dexamethasone are found in breast milk following intravitreal, intraocular, or topical ophthalmic administration.

Single doses of oral dexamethasone are considered compatible with breastfeeding. In addition, some ophthalmic agents are considered compatible, although information is not specific to dexamethasone (WHO 2002). The decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

Intracanalicular 0.4 mg insert: Intraocular pressure

Intraocular 9% suspension: Intraocular pressure

Ophthalmic 0.1% solution/suspension, topical: Intraocular pressure (with use >10 days)

Ophthalmic implant (intravitreal injection): Following injection, monitor for increased intraocular pressure and endophthalmitis; check for perfusion of optic nerve head immediately after injection, tonometry within 30 minutes, biomicroscopy between 2 to 7 days after injection.

Mechanism of Action

Decreases inflammation by suppression of neutrophil migration, decreased production of inflammatory mediators, and reversal of increased capillary permeability; suppresses normal immune response.

Pharmacokinetics

Onset of action: Ocular implant: BRVO/CRVO: Improvement observed in 20% to 30% of patients within first 2 months following intravitreal injection

Duration of effect: Ocular implant: BRVO/CRVO: ~1 to 3 months (following onset of improvement)

Absorption:

Ocular implant: Systemic levels negligible in majority of patients (≤50 pg/mL) ≤90 days following implant, highest systemic concentration observed: 102 pg/mL

Intracanalicular insert: Systemic levels negligible in majority of patients (≤50 pg/mL) ≤29 days following insertion, highest systemic concentration observed: 810 pg/mL

Intraocular suspension: Dexamethasone plasma concentrations ranged from 0.07 to 2.79 ng/mL on post-surgery Day 1 following a single intraocular injection at the end of cataract surgery. By post-surgery Day 15 or Day 30, very few patients had quantifiable plasma concentrations.

Pricing: US

Implant (Ozurdex Intravitreal)

0.7 mg (per each): $1,599.60

INST (Dextenza Ophthalmic)

0.4 mg (per each): $666.00

Solution (Dexamethasone Sodium Phosphate Ophthalmic)

0.1% (per mL): $12.94

Suspension (Dexycu Intraocular)

9% (per 0.5 mL): $714.00

Suspension (Maxidex Ophthalmic)

0.1% (per mL): $18.10

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Acilot (LK);
  • Apidex (BD);
  • Betam-Ophtal (ID);
  • Decadron (CO, EC);
  • Dexa-Sine SE (NO);
  • Dexacip (LK);
  • Dexacip Eye Drops (ZW);
  • Dexafree (CH, ES, FR, GB, IE, PL, PT);
  • Dexagel (TH);
  • Dexason (BD);
  • Dexomet (LK);
  • Dian Shu (CN);
  • Dropodex (IE, MT);
  • Isopto-Dex (DE);
  • Isopto-Maxidex (AR, CO, NO, PY);
  • Maradex (VE);
  • Maxidex (AE, AU, BB, BE, BF, BH, BJ, BR, CH, CI, CL, CY, CZ, DK, EC, EE, EG, ES, ET, FR, GB, GH, GM, GN, GR, HN, HR, HU, IE, IL, IQ, IR, IS, JO, KE, KR, KW, LB, LK, LR, LT, LU, LY, MA, ML, MR, MT, MU, MW, MY, NE, NG, NZ, OM, PE, PH, PK, QA, RO, RU, SA, SC, SD, SE, SG, SI, SL, SN, SY, TN, TR, TW, TZ, UA, UG, VN, YE, ZA, ZM, ZW);
  • Monodex (AT);
  • Nexadron Oftal (AR);
  • Oculodex (AT);
  • Oftan (UA);
  • Oftan Dexa (EE, FI);
  • Opnol (SE);
  • Orbidex (LK);
  • Ozurdex (AE, AT, AU, BE, CH, CO, CZ, DE, DK, EE, EG, FR, GB, HK, HR, IE, IL, IS, JO, KR, KW, LB, LK, LT, LU, LV, MT, MY, NL, NO, NZ, PL, PT, RO, SE, SG, SI, SK, TH, UA, VN);
  • Posurdex (NZ);
  • Santeson (PH);
  • Spersadex (CH, DE, HK, LU, NO, ZA);
  • Sterodex (IL);
  • Steron (BD);
  • Thilodexine (GR);
  • Visumetazone (IT)


For country abbreviations used in Lexicomp (show table)

REFERENCES

  1. American Academy of Pediatrics Committee on Drugs, "'Inactive' Ingredients in Pharmaceutical Products: Update (Subject Review)," Pediatrics, 1997, 99(2):268-78. [PubMed 9024461]
  2. Cassidy L, Rahi J, Nischal K, et al, "Outcome of Lens Aspiration and Intraocular Lens Implantation in Children Aged 5 Years and Under," Br J Ophthalmol, 2001, 85(5):540-2. [PubMed 11316711]
  3. Concillado M, Lund-Andersen H, Mathiesen ER, Larsen M. Dexamethasone intravitreal implant for diabetic macular edema during pregnancy. Am J Ophthalmol. 2016;165:7-15. doi: 10.1016/j.ajo.2016.02.004. [PubMed 26896557]
  4. Dexamethasone Sodium Phosphate Ophthalmic Solution 1% [prescribing information]. Tampa, FL: Bausch & Lomb; received September 2012.
  5. Dexamethasone solution/drops [prescribing information]. Bridgewater, NJ: Bausch & Lomb; January 2017.
  6. Dextenza (dexamethasone) [prescribing information]. Bedford, MA: Ocular Therapeutix Inc; October 2021.
  7. Dexycu (dexamethasone) [prescribing information]. Watertown, MA: EyePoint Pharmaceuticals US Inc; June 2020.
  8. Hodzic-Hadzibegovic D, Ba-Ali S, Valerius M, Lund-Andersen H. Quantification of fluid resorption from diabetic macular oedema with foveal serous detachment after dexamethasone intravitreal implant (Ozurdex®) in a pregnant diabetic. Acta Ophthalmol. 2017;95(3):324-325. doi: 10.1111/aos.13282. [PubMed 27778454]
  9. Lam DS, Fan DS, Ng JS, et al, "Ocular Hypertensive and Anti-Inflammatory Responses to Different Dosages of Topical Dexamethasone in Children: A Randomized Trial," Clin Experiment Ophthalmol, 2005, 33(3):252-8. [PubMed 15932528]
  10. Lowder C, Belfort R Jr, Lightman S, et al, "Ozurdex HURON Study Group. Dexamethasone Intravitreal Implant for Noninfectious Intermediate or Posterior Uveitis," Arch Ophthalmol, 2011, 129(5):545-53. [PubMed 21220619]
  11. Maxidex (dexamethasone) [prescribing information]. Fort Worth, Texas: Alcon Laboratories Inc; May 2018.
  12. Maxidex (dexamethasone) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals; December 2021.
  13. Maxidex (dexamethasone) [product monograph]. Mississauga, Ontario, Canada: Alcon Canada Inc; July 2018.
  14. Ng JS, Fan DS, Young AL, et al, "Ocular Hypertensive Response to Topical Dexamethasone in Children: A Dose-Dependent Phenomenon," Ophthalmology, 2000, 107(11):2097-100. [PubMed 11054340]
  15. Ozurdex (dexamethasone) [prescribing information]. Irvine, CA: Allergan Inc; May 2018.
  16. Ozurdex (dexamethasone) [prescribing information]. Madison, NJ: Allergan USA Inc; October 2020.
  17. Ozurdex (dexamethasone) [product monograph]. Markham, Ontario, Canada: Allergan Inc; August 2019.
  18. Samples JR, Meyer SM. Use of ophthalmic medications in pregnant and nursing women. Am J Ophthalmol. 1988;106(5):616-623. [PubMed 2903673]
  19. World Health Organization (WHO). Breastfeeding and maternal medication, recommendations for drugs in the eleventh WHO model list of essential drugs. 2002. Available at http://www.who.int/maternal_child_adolescent/documents/55732/en/.
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