Betoptic Eye Drops Solution (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Alcon Laboratories (U.K) Limited |
|---|---|
| Διεύθυνση | Pentagon Park, Boundary Way, Hemel Hempstead, Hertfordshire, HP2 7UD |
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Name of the medicinal product
Betoptic 0.5% w/v eye drops, solution.
Qualitative and quantitative composition
Betaxolol 0.5% w/v (as hydrochloride).
Pharmaceutical form
Eye Drops, Solution.
Therapeutic indications
Betoptic is indicated for the reduction of elevated intraocular pressure in patients with ocular hypertension and chronic open angle glaucoma.
Posology and method of administration
Adults (including the elderly): The usual dose is one drop to be instilled into the affected eye(s) twice daily. Children: Betoptic is not recommended for use in children. When using nasolacrimal occlusion ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Reactive airway disease including severe bronchial asthma or a history of severe bronchial asthma, severe chronic obstructive pulmonary ...
Special warnings and precautions for use
Like other topically applied ophthalmic agents, betaxolol is absorbed systemically. Due to the beta-adrenergic component, betaxolol, the same types of cardiovascular, pulmonary and other adverse reactions ...
Interaction with other medicinal products and other forms of interaction
No specific drug interaction studies have been performed with betaxolol. There is a potential for additive effects resulting in hypotension and/or marked bradycardia when ophthalmic beta-blockers solution ...
Pregnancy and lactation
Pregnancy There are no adequate data for the use of betaxolol in pregnant women. Betaxolol should not be used during pregnancy unless clearly necessary. To reduce the systemic absorption, see section 4.2. ...
Effects on ability to drive and use machines
No effects on ability to drive and use machines have been reported.
Undesirable effects
Like other topically applied ophthalmic drugs, betaxolol is absorbed into the systemic circulation. This may cause similar undesirable effects as seen with systemic beta-blocking agents. Incidence of systemic ...
Overdose
A topical overdose of Betoptic may be flushed from the eye(s) with warm tap water.
Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmologicals: Antiglaucoma Preparations & Miotics. ATC Code: S01ED02 Betaxolol is a cardioselective Beta1 receptor blocker which, when applied topically to the eye, lowers ...
Pharmacokinetic properties
Betaxolol is highly lipophilic which results in good permeation of the cornea, allowing high intraocular levels of the drug. Betaxolol is characterised by its good oral absorption, low first pass loss ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Disodium edetate Sodium chloride Benzalkonium chloride Sodium hydroxide Hydrochloric acid Purified water
Incompatibilities
None known.
Shelf life
Unopened 36 months, after opening 28 days.
Special precautions for storage
Do not store above 25°C. Keep in the outer carton in order to protect from light.
Nature and contents of container
5 ml & 10 ml LDPE bottles (10 ml present in 15 ml container) with natural LDPE plug and blue polystyrene or polypropylene cap.
Special precautions for disposal and other handling
Do not touch the top of the bottle to any surface as this may contaminate the contents.
Marketing authorization holder
Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way HemelHempstead Herts. HP2 7UD
Marketing authorization number(s)
PL 0649/0097
Date of first authorization / renewal of the authorization
19th August 1986 / 14th November 2001
Date of revision of the text
26th March 2012