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IOPIDINE Eye drops, solution (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

IOPIDINE 5mg/ml Eye Drops, Solution.

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. ...

Pharmaceutical form

Eye drops, solution. A colourless to pale yellow solution.

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 ...

Posology and method of administration

Posology One drop of IOPIDINE should be instilled into the affected eye(s) three times per day (t.i.d.). Since IOPIDINE will be used with other ocular glaucoma therapies, an approximate five minute interval ...

Contraindications

IOPIDINE is contraindicated in patients with a history of severe or unstable and uncontrolled cardiovascular disease including severe uncontrolled arterial hypertension. IOPIDINE is contraindicated in ...

Special warnings and precautions for use

While the topical administration of IOPIDINE had minimal effect on heart rate or blood pressure in clinical studies evaluating glaucoma patients including those with cardiovascular disease, the possibility ...

Interaction with other medicinal products and other forms of interaction

IOPIDINE is contraindicated in patients receiving monoamine oxidase inhibitors, systemic sympathomimetics or tricyclic antidepressants (see section 4.3). The risk of clinically relevant interactions appears ...

Pregnancy and lactation

Pregnancy There are no or limited studies of IOPIDINE in pregnant women. IOPIDINE is not recommended during pregnancy. Animal studies have been conducted which have demonstrated an absence of teratogenic ...

Effects on ability to drive and use machines

IOPIDINE has a moderate influence on the ability to drive and use machines. Since clonidine-like drugs may cause dizziness or somnolence, patients so affected are advised not to drive or operate machinery. ...

Undesirable effects

Summary of the safety profile In clinical trials using IOPIDINE the most common adverse reactions were ocular hyperaemia, eye pruritus, and conjunctivitis, occurring in approximately 12% to 23% of patients. ...

Overdose

IOPIDINE may be flushed from the eyes with lukewarm water or sterile saline solution. Accidental or intentional ingestion of oral clonidine has been reported to cause hypotension, transient hypertension, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals; Antiglaucoma Preparation and Miotics ATC code: SO1EA03 Apraclonidine is a relatively selective alpha-2-adrenergic agonist which does not possess significant ...

Pharmacokinetic properties

Following topical ocular administration to New Zealand White rabbits, apraclonidine reached peak concentrations after two hours in the aqueous humour, iris, ciliary body and lens. The cornea exhibited ...

Preclinical safety data

Administration of apraclonidine intravenously and via the topical ocular route to both cats and monkeys resulted in a reduced anterior segment blood flow, whereas flow to the posterior segment, i.e., retina, ...

List of excipients

Benzalkonium chloride Sodium acetate (trihydrate) Sodium chloride Hydrochloric acid and/or Sodium hydroxide (for pH adjustment) Purified water

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years. 4 weeks after first opening.

Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze. Keep the container in the outer carton.

Nature and contents of container

5 ml and/or 10 ml white LDPE DROP-TAINER dispensers with a natural LDPE dispensing plug and white polypropylene closure. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom

Marketing authorization number(s)

PL 00101/0996

Date of first authorization / renewal of the authorization

29 December 1994 / 02 December 2009

Date of revision of the text

04 January 2020

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