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Clobetasol (ophthalmic): Drug information

Clobetasol (ophthalmic): Drug information
2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Clobetasol (ophthalmic): Patient drug information"

For abbreviations, symbols, and age group definitions show table
Pharmacologic Category
  • Corticosteroid, Ophthalmic
Dosing: Adult
Postoperative inflammation and pain

Postoperative inflammation and pain: Ophthalmic: Place 1 drop into the affected eye(s) 2 times daily. Start the day following surgery and continue for 2 weeks.

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.

Adverse Reactions

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

1% to 10%: Ophthalmic: Anterior chamber inflammation (2%), corneal edema (2%), cystoid macular edema (2%), increased intraocular pressure (1%), ophthalmic inflammation (2%), photophobia (1%), vitreous detachment (1%)

Contraindications

Active viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella; mycobacterial infection of the eye; fungal diseases of ocular structures.

Warnings/Precautions

Concerns related to adverse effects:

• Cataracts: Prolonged use of corticosteroids may result in posterior subcapsular cataract formation. Use following cataract surgery may delay healing or increase the incidence of bleb formation.

• Corneal thinning: Various ophthalmic disorders, as well as prolonged use of corticosteroids, may result in corneal and scleral thinning. Continued use in a patient with thinning may result in perforation.

• Glaucoma: Prolonged use of corticosteroids may result in elevated intraocular pressure (IOP) and/or glaucoma, damage to the optic nerve, and defects in visual acuity and fields of vision. Use with caution in patients with glaucoma; monitor IOP in any patient receiving treatment for ≥10 days.

• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), or prolong or exacerbate viral infections. Corticosteroids should not be used to treat ocular herpes simplex; use caution in patients with a history of ocular herpes simplex. Fungal infection should be suspected in any patient with persistent corneal ulceration who has received corticosteroids.

• Systemic absorption: Studies have demonstrated topical ophthalmic corticosteroids are absorbed systemically and may cause endogenous corticosteroid production reduction. Caution is advised with prolonged use of topical ophthalmic corticosteroids in terms of systemic immunosuppression and additional systemic hazard of corticosteroid exposure (Ref).

Product Availability

Clobetasol (ophthalmic): FDA approved March 2024; availability anticipated summer 2024.

Administration: Adult

Ophthalmic: For topical ophthalmic use only; to avoid eye injury or contamination, do not touch dropper tip to eyelids or other surfaces when placing drops in eyes. Wash hands before use. When using >1 eye drop other than clobetasol, wait at least 5 minutes between administrations. Do not instill drops while wearing contact lenses; reinsert lenses 15 minutes after administration.

Use: Labeled Indications

Postoperative inflammation and pain: Treatment of postoperative inflammation and pain following ocular surgery.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Nirmatrelvir and Ritonavir: May increase the serum concentration of Corticosteroids (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

Adverse events were observed in animal reproduction studies following SUBQ dosing.

Systemic absorption following ophthalmic administration is limited. If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease potential exposure to the fetus (Ref).

Breastfeeding Considerations

It is not known if clobetasol is present in breast milk following ophthalmic administration.

Systemic absorption following ophthalmic administration is limited. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

Monitor intraocular pressure in any patient receiving treatment for ≥10 days.

Mechanism of Action

Decreases inflammation; also has antipruritic and vasoconstrictive properties.

Pharmacokinetics (Adult Data Unless Noted)

Time to peak: 0.5 to 1 hours.

  1. Burch PG, Migeon CJ. Systemic absorption of topical steroids. Arch Ophthalmol. 1968;79(2):174-176. doi:10.1001/archopht.1968.03850040176013 [PubMed 5635343]
  2. Clobetasol (ophthalmic) [prescribing information]. Taipei, Taiwan: Formosa Pharmaceuticals Inc; March 2024.
  3. Samples JR, Meyer SM. Use of ophthalmic medications in pregnant and nursing women. Am J Ophthalmol. 1988;106(5):616-623. doi:10.1016/0002-9394(88)90597-1 [PubMed 2903673]
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