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Nyolol
Timolol Maleate
Eye-drops
COMPOSITION
| 1 ml contains: |
0.25% |
0.50% |
| Active substance: |
|
|
| Timolol maleate |
3.4mg |
6.8mg |
| Quantity equivalent to timolol base |
2.5mg |
5.0mg |
| Excipient: |
Disodium hydrogenophosphate 11.0mg, Sodium dihydrogen phosphate
8.6mg, purified water to 1ml. |
| Preservative: |
Benzalkonium chloride 0.1mg |
Nyolol Eye Drops is an isotonic and quite iso-pH (~ pH 7) aqueous solution.
PHARMACOLOGICAL DATA
The action of NYOLOL is usually rapid occurring approx. 20 minutes following
ocular instillation. The maximum effect occurs in one to two hours and
significant lowering of intraocular pressure has been maintained for periods
as long as 24hours with NYOLOL 0.25% or 0.50%.
NYOLOL has the action of reducing elevated lntraocular pressure, whether or
not accompanied by glaucoma.
Pharmacological characteristics of Timolol maleate, the active ingredients
of NYOLOL eye drops, are:
– non-selective beta-blocking agent
– no intrinsic sympathomimetlc activity (I.S.A)
– non-significant local anaesthetic effect (membrane stabilizer)
Unlike miotics, NYOLOL has practically no effect on pupil size or
accommodation. No accommodative spasm nor change In visual acuity are
observed.
As with other antiglaucoma drugs, a diminished responsiveness to Timolol has
been reported in some patients after prolonged therapy.
PHARMACOKINETICS DATA
Systemic absorption: plasma levels following ocular instillation have not
been specified.
INDICATIONS
– Ocular hypertension
– Chronic open-angle glaucoma
– Aphakic glaucoma
– Narrow angle glaucoma, in combination with a miotic (see PRECAUTIONS).
DOSAGE AND ADMINISTRATION
The usual starting dose is one drop of 0.25% NYOLOL in the affected eye
twice a day.
If the clinical response is not adequate, the dosage may be changed to one
drop of 0.5% solution in the affected eye twice a day.
If necessary the physician may institute a concomitant therapy:
– either a sympathomimetic or parasympathomimetic antiglaucoma ophthalmic
solution
– or systemically administered carbonic anhydrase inhibitors in order to
obtain a better response
Since in some patients the pressure-lowering response to NYOLOL may require
a few weeks to stabilize, evaluation should include a determination of
Intraocular pressure after approximately 4 weeks of treatment with NYOLOL.
If the intraocular pressure is maintained at satisfactory levels, the dosage
schedule may be changed to one drop once a day.
Substitute to a prior treatment
– When NYOLOL should be administered in substitution to another
beta-blocking ophthalmic solution, discontinue this drug at the end of a
full day treatment. On the following day, one drop of NYOLOL 0.25% should be
administered In the affected eye twice a day. If a higher dosage of NYOLOL
is required substitute one drop of NYOLOL 0.5% in the affected eye twice a
day.
– When NYOLOL should be administered in substitution to a previously used
non beta-blocking antiglaucoma ophthalmio solution, continue the agent
already being used for one day and add one drop of NYOLOL 0.25% twice a day.
On the following day, discontinue the previously used antiglaucoma agent and
continue NYOLOL 0.25%. If a higher dosage of NYOLOL Is required, substitute
with one drop of NYOLOL 0.50%.
When NYOLOL should be substituted to several concomitantly administered
antiglaucoma agents, individualization is required.
The physician will decide to discontinue one or all the previously used
antiglaucoma agents.
When a patient is transferred from miotics to NYOLOL, a refractive
examination may be required when miotics have no longer effects.
The patient should follow strictly the directions for treatment and
lntraocular pressure should be controlled particularly at the beginning of
the treatment.
OVERDOSAGE
There have been reports of inadvertent overdosage with timolol resulting in
systemic effects similar to those seen with systemic p-adrenergic blocking
agents such as dizziness, headache, shortness of breath, bradycardia,
bronchospasm and cardiac arrest.
COINTRAINDICATIONS
Absolute:
– Bronchial asthma, bronchospasm, history of bronchial asthma or severe
chronic obstructive pulmonary disease – Uncontrolled congestive cardiac
insufficiency, cardiogenic shock
– High atrioventricular block (without apparatus)
– Raynaud phenomena
– High bradycardia (pulse rates < 45 to 50 pulses/min.)
– Hypersensitivity to any component
Relative:
- Combination with amiodarone
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