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BETOPTIC Eye drops, suspension (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

BETOPTIC 0.25% w/v Eye Drops, Suspension.

Qualitative and quantitative composition

Betaxolol 0.25% w/v (as hydrochloride). Excipients with known effect: 1ml of suspension contains 0.1mg benzalkonium chloride. For a full list of excipients see Section 6.1.

Pharmaceutical form

Eye Drops, Suspension.

Therapeutic indications

BETOPTIC SUSPENSION lowers the intraocular pressure and is indicated in patients with chronic open-angle glaucoma and ocular hypertension.

Posology and method of administration

Adults (including Elderly) The recommended dose is one drop in the affected eye(s) twice daily. In some patients, the intraocular pressure lowering responses to BETOPTIC SUSPENSION may require a few weeks ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in Section 6. Reactive airway disease including severe bronchial asthma or a history of severe bronchial asthma, severe chronic ...

Special warnings and precautions for use

For ocular use only. General Like other topically applied ophthalmic agents, betaxolol is absorbed systemically. Due to the beta-adrenergic component, betaxolol, the same types of cardiovascular, pulmonary ...

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 ...

Fertility, pregnancy and lactation

Fertility There are no data on the effects of Betaxolol Eye Drops on human fertility. Pregnancy Studies in animals with Betaxolol HCl was not shown to be teratogenic and there were no other adverse effects ...

Effects on ability to drive and use machines

Betoptic 0.25% eye drops suspension has no or negligible influence on the ability to drive and use machines. Temporary blurred vision or other visual disturbances may affect the ability to drive or use ...

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

In case of accidental ingestion, symptoms of overdose from beta blockade may include bradycardia, hypotension, cardiac failure and bronchospasm. If overdose with Betaxolol Eye Drops occurs, treatment should ...

Pharmacodynamic properties

Pharmacotherapeutic Group: Ophthalmologicals Antiglaucoma Preparations & Miotics ATC Code: S01ED02 Betaxolol, a cardioselective (beta1-adrenergic) receptor blocking agent, does not have significant membrane-stabilising ...

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

Reproduction studies have been conducted with orally administered betaxolol HCl in rats and rabbits. There was evidence of drug related postimplantation loss in rabbits and rats at dose levels above 12 ...

List of excipients

Benzalkonium chloride Poly (styrene divinylbenzene) sulphonic acid Carbomer Boric acid Mannitol Disodium edetate N-Lauroylsarcosine Hydrochloric acid and/or sodium hydroxide Purified water

Incompatibilities

Not applicable.

Shelf life

Shelf life: 24 months.

Special precautions for storage

Store the bottle in the outer carton in order to protect from light.

Nature and contents of container

BETOPTIC SUSPENSION is packaged as a 5 ml label fill in a 5 ml and a 10 ml label fill in a 10 ml natural low density polyethylene (LDPE), DROP-TAINER with a LDPE dispensing plug and a 15 mm white polypropylene ...

Special precautions for disposal and other handling

Shake before each use. Discard product 1 month after first opening.

Marketing authorization holder

Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Marketing authorization number(s)

PL 00101/0990

Date of first authorization / renewal of the authorization

Date of first authorisation: 27 August 1997 Date of renewal: 27 August 2002

Date of revision of the text

01 May 2017

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