Iopidine 0.5% Ophthalmic solution (2011)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Alcon Laboratories (U.K) Limited |
|---|---|
| Διεύθυνση | Pentagon Park, Boundary Way, Hemel Hempstead, Hertfordshire, HP2 7UD |
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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: 1 ml of solution contains 0.1 mg benzalkonium chloride For a 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 children, in patients with a history of severe or unstable and uncontrolled cardiovascular disease including severe uncontrolled arterial hypertension. IOPIDINE is contraindicated ...
Special warnings and precautions for use
Warnings For ocular use only. Not for injection or oral ingestion. While the topical administration of IOPIDINE had minimal effect on heart rate or blood pressure in clinical studies evaluating glaucoma ...
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 ...
Fertility, pregnancy and lactation
Fertility Studies have not been performed to evaluate the effect of topical ocular administration of IOPIDINE on fertility. Pregnancy There are no or limited studies of IOPIDINE in pregnant women. IOPIDINE ...
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: SO1E A03. 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
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
Alcon Laboratories (UK) Limited Pentagon Park Boundary Way Hemel Hempstead Hertfordshire HP2 7UD United Kingdom
Marketing authorization number(s)
PL 00649/0132
Date of first authorization / renewal of the authorization
29 December 1994/Renewed 20 October 2010
Date of revision of the text
October 2011