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TIMOPTOL Eye drops, solution (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Timoptol 0.25% w/v eye drops, solution. Timoptol 0.5% w/v eye drops, solution.

Qualitative and quantitative composition

Each millilitre of 0.25% w/v solution contains an amount of timolol maleate equivalent to 2.5 mg timolol. Each millilitre of 0.5% w/v solution contains an amount of timolol maleate equivalent to 5 mg timolol. ...

Pharmaceutical form

Eye drops, solution. Clear, colourless to light yellow, sterile eye drops, solution.

Therapeutic indications

Timoptol is a beta-adrenoreceptor blocking agent used topically in the reduction of elevated intra-ocular pressure in various conditions including following: patients with ocular hypertension; patients ...

Posology and method of administration

Posology Recommended therapy is one drop 0.25% solution in the affected eye twice a day. If clinical response is not adequate, dosage may be changed to one drop 0.5% solution in each affected eye twice ...

Contraindications

Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease; sinus bradycardia, sick sinus syndrome sino-atrial block, second- and ...

Special warnings and precautions for use

Like other topically applied ophthalmic agents, timolol is absorbed systemically. Due to beta-adrenergic component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions seen ...

Interaction with other medicinal products and other forms of interaction

No specific drug interaction studies have been performed with timolol maleate. There is a potential for additive effects resulting in hypotension and/or marked bradycardia when ophthalmic beta-blockers ...

Pregnancy and lactation

Pregnancy There are no adequate data for the use of timolol maleate in pregnant women. Timoptol should not be used during pregnancy unless clearly necessary. To reduce the systemic absorption, see section ...

Effects on ability to drive and use machines

Possible side effects such as dizziness, visual disturbances, refractive changes, diplopia, ptosis, frequent episodes of mild and transient blurred vision and fatigue may affect some patients' ability ...

Undesirable effects

Like other topically applied ophthalmic drugs, timolol is absorbed into the systemic circulation. This may cause similar undesirable effects as seen with systemic beta-blocking agents. Incidence of systemic ...

Overdose

There have been reports of inadvertent overdosage with Timoptol resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as dizziness, headache, shortness ...

Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals, antiglaucoma preparations and miotics, betablocking agents ATC code: S01ED01 Mechanism of action Timolol maleate is a non-selective beta-adrenergic receptor ...

Pharmacokinetic properties

The onset of reduction in intra-ocular pressure can be detected within one-half hour after a single dose. The maximum effect occurs in one or two hours; significant lowering of IOP can be maintained for ...

Preclinical safety data

No adverse ocular effects were observed in rabbits and dogs administered Timoptol topically in studies lasting one and two years, respectively. The oral LD<sub>50</sub> of the drug is 1,190 and 900 mg/kg ...

List of excipients

Disodium phosphate dodecahydrate Sodium dihydrogen phosphate dihydrate Sodium hydroxide Benzalkonium chloride Water for injections

Incompatibilities

None known.

Shelf life

36 months. Discard solution 28 days after opening the bottle.

Special precautions for storage

Do not store above 25°C. Store the bottle in the outer carton in order to protect from light.

Nature and contents of container

Timoptol Eye Drops Solution bottle contains 5 ml of solution. Two alternative bottles may be marketed. White translucent low-density polyethylene (LDPE) bottle with a transparent linear LDPE dropper tip ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Santen Oy, Niittyhaankatu 20, 33720, Tampere, Finland

Marketing authorization number(s)

0.25% w/v eye drops, solution: PL 16058/0020 0.5% w/v eye drops, solution: PL 16058/0019

Date of first authorization / renewal of the authorization

Date of first authorisation: 5 January 1979 Date of the latest renewal: 5 March 2010

Date of revision of the text

16/11/2018

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