IOPIDINE 5mg/ml Eye Drops, Solution

13.00

Iopidine 5mg/ml Eye Drops, solution contain apraclonidine (as hydrochloride) as the  active substance.

Category:

Description

1. Name of the medicinal product

IOPIDINE 5mg/ml Eye Drops, Solution

2. Qualitative and quantitative composition

1 ml of solution contains Apraclonidine 5 mg (as hydrochloride).

Excipients with known effect

1 ml of solution contains 0.1 mg benzalkonium chloride.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Eye drops, solution.

A colourless to pale yellow solution.

4. Clinical particulars
4.1 Therapeutic indications

IOPIDINE 5mg/ml is indicated for short-term adjunctive therapy of chronic glaucoma in patients on maximally tolerated medical therapy who require additional intraocular pressure (IOP) reduction to delay laser treatment or glaucoma surgery.

The IOP lowering efficacy of IOPIDINE diminishes over time in most patients. Although some patients have received successful treatment with IOPIDINE for longer periods, the benefit for most patients is less than one month.

The addition of IOPIDINE to patients already using two aqueous suppressing drugs (i.e. beta-blockers plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. This is because IOPIDINE is an aqueous suppressing drug and the addition of a third aqueous suppressant may not significantly reduce IOP.