Vizoptin 0.05% Eye Drops 15 ml.

The instruction for medical use


of VIZOPTIN medicine

the Trade name
Vizoptin

Mezhdunarodnoye the unlicensed

name Tetrizolin Lekarstvennaya a form
Eye drops, solution of 0.05% - 15.0 ml

Structure
of 1 ml of solution contains
active agent - a tetrizolin a hydrochloride of 0.5 mg,
excipients: boric acid, sodium tetraborate decahydrate, dinatrium edetat a dihydrate, a benzalkoniya chloride, water purified.

The description
Solution transparent colourless, without visible particles.

Pharmacotherapeutic group
Decongestants and antiallergic drugs. Sympathomimetics.
The code of automatic telephone exchange S01GA02

the Pharmacological

Pharmacokinetics Later properties of burying vasoconstrictive effect develops in a few minutes and proceeds 4-8 h. At topical administration system absorption low.

Vizoptin's pharmacodynamics - sympathomimetic drug which stimulates alpha adrenoceptors of sympathetic nervous system, but has no or has weak effect on beta adrenoceptors. Being sympathomimetic amine, tetrizolin possesses vasoconstrictive action and reduces hypostasis of fabrics. At topical administration reduces a chemosis, burning sensations, morbidity of a mucous membrane of eyes, dacryagogue. At use of a tetrizolin diameter of a pupil, accommodation and intraocular pressure practically do not change.

Indications
- moderate irritation of eyes: the itching, hypostasis and hyperaemia of a conjunctiva, burning, dacryagogue, an injetsirovannost of scleras caused by chemical and physical factors (smoke, dust, cosmetics, contact lenses, swimming in the chlorinated water, effect of bright light or radiation of the monitor of the computer)
- allergic conjunctivitis

the Route of administration and doses
to Adults and children is more senior than 3 years in each eye in the lower conjunctival sac – on 1-2 drops 2-3 times a day.
Without consultation of the oculist it is not necessary to use drug more than 4 days.
Side effects
Locally
- increase in intraocular pressure, burning sensation and a reactive hyperemia of an eye, a sight zatumanennost, irritation of a conjunctiva, is rare – mydriasis
System effects
- arterial hypertension
- disturbance of action of the heart
-
the Contraindication hyperglycemia
- hypersensitivity to drug components
- closed-angle glaucoma
- a syndrome of a dry eye
- epithelial – endothelial dystrophies of a cornea
- children's age to 3-x years

Medicinal interactions
it is not necessary to use Drug along with MAO inhibitors (fenelzin, Nialamidum, iproniazid, etc.) and within 10 days after the termination of their reception.

The special
instructions Drug should be used with care at patients with a serious cardiovascular illness (including an ischemic heart disease (coronary heart disease, arrhythmia, heart aneurysm, arterial hypertension), a hyperthyroidism, diabetes, a pheochromocytoma, during treatment by the medicines raising the ABP.
Tetrizolin in the form of eye drops it is reasonable to apply only at slight irritation of eyes. If the irritation and hyperaemia of a conjunctiva are connected with an infectious disease, existence of a foreign body or a corrosive burn of a cornea, consultation of the oculist is necessary.
If during 48 h after use of eye drops the symptoms of a disease remain, become more expressed or side effect is shown, it is necessary to stop use of drug and to consult with the oculist.
At appearance of a megalgia in eyes, a headache, a disorder of vision, sudden emergence of floating spots before eyes, reddenings of eyes, pains at influence of light or doubling in eyes, it is necessary to see a doctor immediately.
When carrying contact lenses they are removed before burying drug and again established in 15 minutes after burying. It is necessary to avoid direct contact of eye drops with soft contact lenses because of possible disturbance of their transparency.
Not to touch a bottle tip any surfaces. After use to screw up a bottle dropper cover.
Pregnancy and a lactation
Use at pregnancy and feeding by a breast perhaps only after careful comparison of possible advantage for mother and risk for a fruit or the child.
Influence on ability to drive the car and to work with mechanisms
during treatment it is necessary to be careful during the driving of motor transport and occupation other potentially dangerous types of activity demanding the increased concentration of attention, speed of psychomotor reactions and good sight (after use of eye drops the mydriasis and emergence of a zatumanennost of sight is possible).

Overdose
Development of system symptoms of overdose is possible at accidental or deliberate administration of drug inside or excessive instillation drug in an eye.
Symptoms: mydriasis, nausea, cyanosis, fever, spasms, tachycardia/bradycardia, arterial hypertension, dizziness, a shocklike syndrome with hypotension and bradycardia.
The overdose at children can be shown by the oppression of central nervous system which is followed by drowsiness, the excessive sweating expressed by hypotension up to shock.
Treatment: to wash out eyes a large amount of warm water. Prescribing of activated carbon, gastric lavage, symptomatic therapy (oxygen inhalation, use febrifugal, anticonvulsants). Specific antidote is unknown.

The form of release and
Plastic packaging a bottle dropper containing 15 ml of sterile solution
together with the instruction for use in a cardboard box.
Storage conditions
At a temperature from +15 to + 250C, in original packing.
After opening of a bottle of a drop it is necessary to use within 4 weeks.
To store out of children's reach!
A period of storage
of 5 years
do not use drug after the expiry date specified on packing.
Prescription status
Without prescription


of Proizvoditel Rompharm Company of S.R. L.,
Romania Eroilor St. 1A, Otopen.
ph. +40 21 208 9743, +40 21 208 97 42, fax: +40 21 266 49 38