Rimexolone

In more serious cases, and if the posterior part of the globe is affected, subconjunctival injection or treatment is recommended. But rimexolone is not for injection. Prolonged use may result in ocular hypertension/glaucoma, damage to the optic nerve, defects in visual acuity and visual fields, and posterior subcapsular cataract formation. Prolonged use may also result in secondary ocular infections due to suppression of host response.

There are no adequate data from the use of rimexolone in pregnant women.

Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown.

Rimexolone should not be used during pregnancy unless clearly necessary.

Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.

It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human breast milk. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman; a decision should be made whether to discontinue nursing or discontinue therapy, taking into consideration the importance of the drug to the mother.

Temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision or visual disturbances occur, the patient must wait until the vision clears before driving or using machinery.

In clinical studies with rimexolone, the most frequently reported adverse events and local symptoms were: blurred vision (2.6%) and ocular discharge (2.2%).

The following undesirable effects were reported during clinical trials with rimexolone:

Infections and Infestations

Uncommon (≥0.1% <1%): rhinitis, pharyngitis.

Nervous System Disorders

Uncommon (≥0.1% <1%): headache (including browache), dysgeusia (taste perversion).

Eye Disorders

Common (≥1% <10%): vision blurred, eye discharge, ocular discomfort, eye pain, foreign body sensation in eye.

Uncommon (≥0.1% <1%): ocular hyperaemia, eye pruritus, abnormal sensation in eye (sticky sensation), anterior chamber fibrin, dry eye, conjunctival oedema, keratitis, lacrimation increased, photophobia, eye oedema, eye irritation, corneal ulcer, eyelid margin crusting, corneal oedema, corneal infiltrates, corneal erosion.

Vascular Disorders

Uncommon (≥0.1% <1%): hypotension.

Investigations

Common (≥1% <10%): intraocular pressure increased.

Uncommon (≥0.1% <1%): corneal staining.

In post-marketing experience, the most frequently reported events are eye irritation, lid margin crusting, ocular hyperaemia and intraocular pressure increase. These events are similar to those identified during clinical trials.

Use of topical corticosteroids may cause increased intraocular pressure.