dexamethasone ophthalmic (Rx)

Brand and Other Names:Maxidex
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ophthalmic suspension

  • 0.1% (Maxidex)

ophthalmic solution

  • 0.1% (various generics)

Inflammatory Ocular Conditions

Mild disease: Instill 1-2 gtt in conjunctival sac(s) q4-6hr; taper frequency as symptoms subside

Severe disease: Instill 1-2 gtt(s) in conjunctival sac(s); may use hourly, and then tapered to discontinue as the inflammation subsides

Indications

  • Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe (eg, allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation)
  • Corneal injury from chemical, radiation, thermal burns, or foreign body penetration

Dosage Forms & Strengths

ophthalmic suspension

  • 0.1% (Maxidex)

ophthalmic solution

  • 0.1% (various generics)

Inflammatory Ocular Conditions

Mild disease: Instill 1-2 gtt in conjunctival sac(s) q4-6hr; taper frequency as symptoms subside

Severe disease: Instill 1-2 gtt(s) in conjunctival sac(s); may use hourly, and then tapered to discontinue as the inflammation subsides

Indications

  • Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe (eg, allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation)
  • Corneal injury from chemical, radiation, thermal burns, or foreign body penetration
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Adverse Effects

Frequency Not Defined

Cataract (4% )

Ocular hypertension

Open-angle glaucoma, optic nerve damage, and defects in visual acuity and field of vision (after prolonged use)

<1%

Transient ocular stinging, burning, local irritation, ocular discharge, ocular discomfort or pain, foreign body sensation, hyperemia, abnormal vision/blurring, pruritus, lid margin crusting, sticky sensation, increased fibrin, dry eye, conjunctival edema, corneal staining, keratitis, tearing, edema, irritation, corneal ulcer, browache, eyelid erythema, corneal edema, infiltrate, corneal erosion, mydriasis, ptosis, epithelial punctate keratitis, and possible corneal or scleral malacia, [posterior subcapsular cataracts] (prolonged use)

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Warnings

Contraindications

Hypersensitivity

Glaucoma, epithelial defect

Viral diseases including epithelial herpes simplex keratitis, acute infectious stages of vaccinia, varicella, and other diseases of cornea & conjunctiva

Mycobacterial infection of eye, fungal diseases

Cautions

Avoid prolonged treatment, if possible, because of the ocular side effects of glaucoma, secondary infection (herpes simplex), cataract formations, etc

May mask infection or enhance existing infection

Reduce to lowest dose, use suspension last, wait 5min between gtts if using multiple drugs

Contact lenses should not be worn during treatment of ophthalmic infections

Perforations may occur in diseases that cause thinning of the cornea or sclera

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Pregnancy & Lactation

Pregnancy

There are no adequate or well-controlled studies in pregnant women; should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus

However, prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation

Animal studies

  • Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose In mice, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate
  • In rabbits, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, and palate

Lactation

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects

Unknown whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Inhibits the inflammatory response to mechanical, chemical, or immunologic agents

Corticosteroids inhibit edema, fibrin deposition, capillary dilatation, and migration of leukocytes and phagocytes in the acute inflammatory response

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Administration

Ophthalmic Administration

Suspension: Shake well before using

Instill 1-2 gtt in conjunctival sac(s)

Storage

Store upright at 8-25°C (46-77°F)

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.