Midax 10 ml of 1% eye drops

The instruction for medical use


of MIDAKS medicine




Trade names
of Midaks

the International unlicensed


name Tropikamid Lekarstvennaya a form
Eye drops of 0.5% and 1.0% on 10 ml

Structure
of 1 ml of drug contains 0.5% of 1.0%
active agent - tropikamid 5 mg 10 mg
excipients: a benzalkoniya chloride, sodium chloride, edetat sodium a dihydrate, acid chlorohydrogen (for adjustment rn), the water purified.

The description
Colourless transparent liquid

Pharmacotherapeutic group
Drugs for treatment of diseases of an eye. Midriatiki
Kod of automatic telephone exchange of S01FA06

the Pharmacological

Pharmacokinetics Expansion properties and paralysis of a pupil comes after 5 minutes from the moment of administration of drug in a conjunctival sac.
The maximum mydriasis comes after 5-20 minutes from the moment of administration of drug and keeps within 1 hour in case of use of 5 mg/ml of solution of a tropikamid and 2 hours – 10 mg/ml of solution of a tropikamid. Full stopping of symptoms of expansion of pupils comes after 3-5 hours.
The maximum paralysis of accommodation after twofold introduction of 10 mg/ml of a tropikamid comes in 25 minutes from the moment of its introduction to a conjunctival sac and about 30 minutes last. Full stopping of paralysis comes approximately after 3 hours. At administration of drug in a conjunctival sac, it begins to be soaked up, and in small degree is exposed to system absorption, especially at children and at people of advanced age.
The pharmacodynamics
of Midaks - anticholinergic, blocks M-holinoretseptory a sphincter of an iris and a tsiliarny muscle, causing a short-term mydriasis and paralysis of accommodation.
Increases intraocular pressure a little.

The indication to use
With the diagnostic purposes:
- in need of a mydriasis at a research of an eyeground and assessment of a condition of a crystalline lens
- in need of accommodation paralysis at a refraction research
- at hypersensitivity to other drugs expanding a pupil (atropine, Scopolaminum)
Before carrying out surgeries:
- crystalline lens surgery
- laser therapy of a retina
- surgery of a retina and vitreous.
With the therapeutic purposes:
- as a component of complex therapy of inflammatory diseases of eyes and in the postoperative period for prevention of development of synechias

the Route of administration and doses
dig in Drug in a conjunctival sac.
For mydriasis 1.0% or 2 drops of 0.5% of solution of the drug Midaks dig in 1 drop (with a 5-min. interval). In 10 min. it is possible to carry out an oftalmoskopiya. At insufficiency of effect (very high intensity of light, use) it is possible to apply to a rupture of back synechias together with Phenylephrinum.
For achievement of paralysis of accommodation (at a refraction research) dig in 1 drop of 1.0% of Midaksa solution of 6 times with an interval of 6-12 min. It is preferable to carry out a research within 25-50 min. from the moment of the last burying drug.
During burying drug it is necessary to press slightly plaintive canals to limit excessive absorption of a tropikamid and to prevent systemic anticholinergic action of drug.
The dosing mode in the therapeutic purposes is set individually (depending on a condition of the patient).

Side effects
- increase in intraocular pressure
- disturbance of visual acuity
- a photophobia
- symptoms of a circulatory unefficiency and breath (especially at children and
teenagers), tachycardia (at adults)
- dryness in a mouth
- allergic reactions
Seldom
- a lowering of arterial pressure
- psychotic symptoms, a behavior disorder (especially at children and teenagers)
- headaches (at adults)
- confusion of consciousness, a hallucination, spasm
- a hyperthermia
- constipations,

the Contraindication dysuria
- hypersensitivity to drug components.
- glaucoma (especially closed-angle and mixed primary)
- intraocular hypertensia
- the first trimester of pregnancy
- children's age up to 8 years

Medicinal interactions
Simultaneous use of anticholinergics and blockers of histamine H1 receptors, fenotiazin, tricyclic antidepressants, procaineamide, quinidine, MAO inhibitors, benzodiazepines and antipsychotic means mutually strengthens action of each other.
The accommodation paralysis caused by Midaks amplifies at its simultaneous use with sympathomimetic means and is weakened at simultaneous use with parasympathomimetic means.
At simultaneous use of Midaks and nitrates, nitrites, the alkalinizing medicines, Disopyramidum, GKS and a haloperidol increase in intraocular pressure at the accompanying closed-angle glaucoma is possible.
Tropikamid reduces action of the tablets with nitrates applied to language because of dryness in an oral cavity.

Special instructions
Before Midaks's use for mydriasis at a research of an eyeground it is necessary to perform examination of the patient for detection of possible closed-angle glaucoma (to specify the anamnesis, to carry out the assessment of depth of an anterior chamber, a gonioskopiya) since bad attacks of glaucoma after drug use are possible.
Before Midaks's use in the diagnostic purposes it is necessary to warn the patient or the accompanying person about a temporary visual disturbance and a photophobia.
It is not necessary to touch a dropper tip since it can cause pollution of contents of a bottle.
The benzalkoniya chloride (preservative) which can be laid for surfaces of soft contact lenses is a part of drug. In this regard during treatment it is not recommended to use soft contact lenses.
It is possible to establish them again not earlier than in 30 min. from the moment of burying drug.
Use in pediatrics
Before Midaks's use in the diagnostic purposes for children it is necessary to warn the accompanying person about a temporary visual disturbance and a photophobia.
Use of drug for babies and children of younger age can cause disorders from central nervous system.
Pregnancy and the period of a lactation
Midaks's Use at pregnancy (II, the III trimester) is possible only when the expected advantage for mother exceeds potential risk for a fruit.
It is not recommended to apply in the I trimester of pregnancy.
It is necessary to use with care drug in the period of a lactation.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
At Midaks's use should not run vehicles and to work with mechanisms.

Overdose
Now about drug Midaks overdose cases (at instillation in a conjunctival sac) it was not reported.



A form of release and packing
On 10 ml in a plastic bottle with a stopper a dropper and the screwing-up protective cap supplied with a safety ring.
On 1 bottle together with the instruction for medical use in the state and Russian languages put in a box of cardboard.


To Store storage conditions in the place protected from light at a temperature not above 25 °C.
To store out of children's reach!


3 years
After opening of a bottle drug to use a period of storage within 4 weeks.
Not to apply after an expiration date.


Prescription status
According to the prescription

the Producer
the Owner of a trademark and the certificate of registration of a yavlyaetsyakompaniye UORLD of OFTALMIKS MEDICINE, Great Britain ('WORLD MEDICINE', Great Britain). Made RompharmKompaniS.RL., Otopen, St. Eroilor1A, Romania ('Rompharm Company S.R.L.', Otopeni, Eroilorstreet 1 A, Romania).
The owner of the registration certificate the UORLD of OFTALMIKS MEDICINE company, Great Britain
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
of RK, Almaty, Turksibsky district, Suyunbaya Ave., 222
Ph. / fax: 8 (7272) 529090
www.worldmedicine.kz