Timoptol Unit Dose 0.5%w/v Eye Drops Solution.

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Timolol Maleate

제공처:

Santen OY

ATC 코드:

S01ED51

INN (국제 이름):

Timolol Maleate

복용량:

0.5%w/v

약제 형태:

Eye drops, solution

관리 경로:

via the ocular route

패키지 단위:

0.20 ml Unit Dose in packs of 30

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 징후:

It is a beta-adrenoreceptor blocking agent used topically in the reduction of elevated intraocular pressure in various conditions including the following: patients with ocular hypertension; patients with chronic open-angle glaucoma including aphakic patients; some patients with secondary glaucoma

승인 상태:

Authorised

승인 날짜:

2015-07-31

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Timoptol Unit Dose 0.5 % w/v Eye Drops Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Timoptol Unit Dose 0.5% w/v Eye Drops Solution contains timolol maleate equivalent to 5.0mg/ml of timolol without
preservative.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless to light yellow, sterile eye-drops.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Timoptol Eye Drops Solution is a beta-adrenoreceptor blocking agent used topically in the reduction of elevated intra-
ocular pressure in various conditions including the following: patients with ocular hypertension; patients with chronic
open-angle glaucoma including aphakic patients; some patients with secondary glaucoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Recommended therapy is one drop 0.25% solution in the affected eye twice a day.
When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may
result in a decrease in systemic side effects and an increase in local activity
If clinical response is not adequate, dosage may be changed to one drop 0.5% solution in each affected eye twice a
day. If needed, ‘Timoptol’ may be used with other agent(s) for lowering intra-ocular pressure. The use of two topical
beta
-adrenergic blocking agents is not recommended (see 4.4 ‘Special warnings and precautions for use’).
Intra-ocular pressure should be reassessed approximately four weeks after starting treatment because response to
‘Timoptol’ may take a few weeks to stabilise.
Provided that the intra-ocular pressure is maintained at satisfactory levels, many patients can then be placed on once-a-
day therapy.
_Transfer from other agents_
When ano