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Nyolol

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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