Emadine Other names: Emedastine Emedastine difumarate

Ocular corneal infiltrates were reported in conjunction with the use of EMADINE. In case of corneal infiltrates, the product should be discontinued and appropriate management should be implemented.

There are no adequate data from the use of emedastine in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Nevertheless, considering the absence of effects of emedastine on adrenergic, dopaminergic and serotonin receptors, emedastine can be used during pregnancy if the dosage recommendation is respected.

Emedastine has been identified in the milk of rats following oral administration. It is not known whether topical administration to humans could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised if emedastine is administered during breast-feeding.

Fertility

Studies in animals have shown no evidence of impaired fertility. No human fertility data are available.

Emedastine has no or negligible influence on the ability to drive and use machines, however as with any ocular medication, if transient blurred vision or other visual disturbance occurs at instillation, the patient should wait until the vision clears before driving or using machinery.

Summary of safety profile

In 13 clinical studies involving 696 patients, emedastine was administered one to four times daily in both eyes for up to 42 days. In clinical trials, approximately 7% of patients experienced an adverse drug reaction associated with the use of emedastine; however, less than 1% of these patients discontinued therapy due to these adverse drug reactions. No serious ophthalmic or systemic adverse drug reactions were reported in the clinical trials. The most common adverse drug reactions were eye pain and eye pruritus occurring in 1% to 2.0% of patients.

List of adverse reactions

The following adverse reactions listed below were observed in clinical studies or with post marketing experience. They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in decreasing order of seriousness.

Psychiatric disorders

Uncommon: abnormal dreams

Nervous system disorders

Uncommon: headache, sinus headache, dysgeusia

Eye disorders

Common: eye pain, eye pruritus, conjunctival hyperaemia

Uncommon: corneal infiltrates, corneal staining, blurred vision, eye irritation, dry eye, foreign body sensation in eyes, lacrimation increased, asthenopia, ocular hyperaemia

Cardiac disorders

Not known: tachycardia

Skin and subcutaneous tissue disorders

Uncommon: rash