TIMOLAIN (Timolol Maleate Ophthalmic Solution USP (Timolol 0.5%))

Land: Malaysia

Sprog: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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Produktets egenskaber Produktets egenskaber (SPC)
03-12-2019

Aktiv bestanddel:

TIMOLOL MALEATE

Tilgængelig fra:

AIN MEDICARE SDN. BHD.

INN (International Name):

TIMOLOL MALEATE

Enheder i pakken:

5ml ml

Fremstillet af:

AIN MEDICARE SDN. BHD.

Produktets egenskaber

                                USER INFORMATION
TIMOLAIN
TIMOLOL MALEATE OPHTHALMIC SOLUTION USP
(TIMOLOL 0.5%)
PRODUCT DESCRIPTION:
Timolol Maleate Ophthalmic Solution is a sterile, aqueous solution of
Timolol Maleate. The solution is a clear and colourless to light
yellow solution. Each mL solution
contains Timolol 5mg corresponding to 6.8mg of Timolol Maleate and
Benzalkonium Chloride 0.01% w/v as preservative.
PHARMACODYNAMICS:
Timolol Maleate is a non-selective beta-adrenergic receptor blocking
agent that does not have significant intrinsic sympathomimetic,
direct myocardial depressant, or local
anaesthetic activity. Timolol Maleate combines reversibly with the
beta-adrenergic receptor, and this inhibits the usual biologic
response that would occur with stimulation
of that receptor. This specific competitive antagonism blocks
stimulation of the beta-adrenergic stimulating (agonist) activity,
whether these originate from an endogenous
or exogenous source. Reversal of this blockade can be accomplished by
increasing the concentration of the agonist which will restore the
usual biological response. Unlike
miotics, TIMOLAIN reduces IOP with little or no effect on
accommodation or pupil size. In patients with cataracts, the inability
to see around lenticular opacities when the
pupil is constricted is avoided. When changing patients from miotics
to TIMOLAIN; a refraction might be necessary when the effects of the
miotic have passed. _Paediatric _
_Population:_ There is only very limited data available on the use of
Timolol in the paediatric population.
PHARMACOKINETICS:
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 as long as 24 hours with a
single dose. _Paediatric Population:_ As already confirmed by adult
data, 80% of each eye drop passes
through the nasolacrimal system where it may be rapidly absorbed into
the systemic circulation via the nasal mucosa, conjunctiva,
nasolacrimal du
                                
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