Eye Care / Glaucoma

Oftan timolol 0.5% eye drops 5 ml.

Brands: Santen (Finland)

$8.00

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Oftan timolol 0.5% eye drops 5 ml. quantity

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1bfc533e165a

Brands:: Santen (Finland)

Description

The instruction for medical use of TIMOLOLUM OFTAN® medicine
the Trade name
of Oftan® Timolol
the International unlicensed

name Timololum Dosage Form
of the Drop eye, 5 mg/ml, 5 ml
Structure
of 1 ml of solution contains
active agent – Timololum a maleate 6.84 (it is equivalent to Timololum – 5.0 mg),
excipients: a benzalkoniya chloride, sodium dihydrophosphate a dihydrate, dinatrium phosphate dodecahydrate, sodium hydroxide, water for injections.
Description
Transparent, colourless solution

Pharmacotherapeutic group
Ophthalmologic drugs. Protivoglaukomny drugs and miotik. Beta blockers. Timolol.
The ATX S 01E D 01 code
the Pharmacological

Pharmacokinetics At properties topical administration of Timololum a maleate quickly gets through a cornea. After instillation of eye drops the maximum concentration of Timololum in watery moisture of an eye is reached in 1-2 hours.
80% of Timololum applied in the form of eye drops get to a system blood stream by absorption through vessels of a conjunctiva, mucous a nose and the lacrimal channel. Timololum, mainly, in a liver by enzyme P450 2D6 cytochrome (CYP2D6) is metabolized. Removal of metabolites of Timololum is carried out mainly by kidneys.
At newborns and small children the concentration of Timololum significantly exceeds its maximum concentration (Cmax) in blood plasma of adults.
The pharmacodynamics
Oftan Timolol is a non-selective blocker of beta adrenoceptors. Has no internal sympathomimetic and membrane stabilizing activity.
At topical administration in the form of eye drops reduces both the normal, and increased intraocular pressure due to reduction of formation of intraocular liquid. Does not influence the size of a pupil and accommodation. Effect of drug is shown in 20 minutes after instillation in a conjunctival cavity. The maximum decrease in intraocular pressure occurs in 1-2 hours and remains within 24 hours.

Indications
– the increased intraocular pressure (oftalmogipertenziya)
– an open angle glaucoma
– secondary glaucoma
– glaucoma, after cataract surgeries
– as an additional tool for decrease in intraocular
pressure in closed-angle glaucoma (in a combination from miotika)
– inborn glaucoma (at inefficiency of other means)
the Route of administration and doses
Treatment is recommended to begin with 1 drop of Oftanâ of Timolol 5.0 mg/ml in the affected eye 1-2 times a day.
If intraocular pressure at regular use is normalized, it is necessary to lower a dose to the 1st drop once a day in the morning.
Treatment of Oftanâ by Timolol is carried out, as a rule, for an appreciable length of time. Having rummaged in treatment or change of a dosage of drug are carried out only according to the instruction of the attending physician.

Side effects
Often (≥1/100 & lt, 1/10):
– a headache
Seldom (& gt, 11000 – & lt, 1100):
– decrease in sensitivity of a cornea
– a superficial dot keratitis
– bradycardia, cardiac arrest, collapse, atrioventricular block
– dispnoe, pulmonary insufficiency, rattles, cough
– weakness, paresthesia
– nausea, vomiting, subjective disorder of taste
– a depression, fatigue
Very seldom (³1/10000 & lt, 1/1000):
– dizziness, confusion of consciousness, faints, disturbance of cerebral circulation
– a syndrome of a dry eye, blefarokonjyunktivit
– a disorder of vision, a diplopia, a ptosis
– stagnant heart failure, arrhythmia, hypotonia
– decrease in peripheral and cerebral perfusion of blood
– hallucinations, concern, nightmares, an asthenia
– a bronchospasm (especially at patients with asthma and heart failure)
– congestion of a nose
– reaction of hypersensitivity: rash, urticaria
– baldness
– disturbance of sexual functions, decrease in a libido
–
the Contraindication hypoglycemia
– bronchial asthma or other heavy chronic obstructive
respiratory diseases, bronchial hyperreactivity
– sinus bradycardia, a sick sinus syndrome, the sinuatrial block
– atrioventricular block of the II-III degree, cardiogenic shock
– dekompensirovanny heart failure
– dystrophic processes in a cornea
– allergic reactions to drug components
– a Raynaud’s disease
– the lactation period
Medicinal interactions
the Drugs breaking deposition of catecholamines (reserpine) contribute to the development of arterial hypotension (including orthostatic), bradycardia and dizziness.
Simultaneous use of beta blockers and slow blockers of a calcium channel leads to strengthening of their pharmacological effect and increases risk of development of disturbances of warm conductivity and arterial hypotension.
Timololum is not recommended to administer the following drugs along with Oftan®: Amiodaronum, the halogenated flying anesthetics, antiarrhytmic drugs (propafenon and agents of the class Ia), Baclofenum, a clonidine and lidocaine.
CYP2D6 inhibitors, such as quinidine and Cimetidinum, can increase concentration of Timololum in blood plasma.

Special instructions
Eye drops of Oftan® Timololum should not be applied along with other eye drops containing beta blockers.
Eye drops of Oftan® Timololum contain in quality of preservative a benzalkoniya chloride and they are not recommended to be used when carrying contact lenses. Before use of drug it is necessary to remove contact lenses and again to establish them not earlier than in 15 minutes after instillation.
Short-term misting of sight can be observed after instillation of Oftan® of Timololum.
Timololum, can hide hypoglycemia symptoms at patients with diabetes or symptoms of hyperfunction of a thyroid gland.
Some patients receiving beta blockers tested long heavy hypotension during anesthesia. Therefore, in case of the forthcoming planned surgery, gradual cancellation of beta blockers is recommended.
With care of Oftan® Timololum needs to be applied at patients with pulmonary insufficiency, heavy cerebrovascular insufficiency, heart failure in compensation stage, arterial hypotension, diabetes, a hypoglycemia, a thyrotoxicosis, a myasthenia, Reynaud’s syndrome, a pheochromocytoma, atrophic rhinitis and also at co-administration of other beta blockers and psychoactive medicines which strengthen epinephrine discharge,
the Use in pediatrics
Because of limited amount of data drug is recommended to be used only in primary inborn glaucoma and primary juvenile glaucoma, during the transition period the decision on surgical approach is made so far. Офтан® Timololum needs to be applied with the maximum care at newborns, babies and children of younger age because of possibility of an apnoea and Cheyn-Stokes’s breath. Drug is recommended to be used at newborns, babies and children of younger age only under observation of the ophthalmologist.
It is important to notify parents on possible side effects that if necessary they could stop immediately treatment by this drug.
Pregnancy and the period of a lactation
Eye drops of Oftan® Timololum should not be used during pregnancy. Timololum is excreted in breast milk. Because of a possibility of serious side reactions on Timololum at babies, the decision on the termination either feedings by maternal milk, or drug uses, taking into account its importance for the nursing mother has to be made.
The feature influence on ability to run motor transport and potentially dangerous mechanisms
needs to be careful at control of motor transport and potentially dangerous mechanisms because of a possibility of emergence of short-term misting of sight.

Overdose
Symptoms: development of the system effects characteristic of beta blockers: dizziness, headache, arrhythmia, bradycardia, bronchospasm, nausea, vomiting.
Treatment: to immediately wash eyes with water or normal saline solution, symptomatic therapy.
A form of release and packing
On 5 ml in the bottles from polyethylene corked by the pipette dropper from polyethylene with the screw-on plastic cap.
On 1 bottle together with the instruction for medical use in the state and Russian languages place in a cardboard box.

At a temperature from 15 °C to 25 °C
to Store storage conditions out of children’s reach!
A period of storage
3 years
the Period of storage after opening of a bottle – 1 month.
Not to use drug after the expiry date specified on packing.
Prescription status
According to the prescription

JSC Sangteng Ao Producer, Niittyukhaankatu, 20, 33720 Tampere, Finland

the Owner of the registration certificate
Sangteng AO, Niittyukhaankatu 20, 33720 Tampere, Finland

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products Representative office of JSC Santen in
Kazakhstan Almaty, Zheltoksan St. 115, office
338 Phone number –
250-39-17 Fax – 250-39-17Электронная mail:

To Develop atlana_kz@rambler.ru

Additional information