Tropikamid-Pharmak

General characteristics. Structure:

Active ingredient: tropicamide;

1 ml Tropikamida-Pharmak, drops eye 1%, contains a tropikamid of 10 mg in terms of 100% dry matter;

1 ml Tropikamida-Pharmak, drops eye 0,5%, contains a tropikamid of 5,0 mg in terms of 100% dry matter;

excipients: dinatrium эдетат, a benzalkoniya chloride, sodium chloride, 1 M Acidum hydrochloricum solution, water for injections.

Pharmacological properties:

Pharmacodynamics. Blocks m-holinoretseptory of a sphincter of an iris and a tsiliarny muscle. Expands a pupil, causes accommodation paralysis. Action bystry and short. After single instillation of 1% of solution the mydriasis begins in 5 min., reaches a maximum in 20-45 min. and remains within 2 hours. The maximum paralysis of accommodation after twofold instillation comes in 25 min. from the moment of an instillation and about 30 min. proceed. Full vosstanovleyony accommodations and the sizes of a pupil occurs in 6 hours.

Pharmacokinetics. In insignificant degree is exposed to system absorption (especially at children and elderly people).

Pharmaceutical characteristics

Main physical and chemical properties: transparent colourless liquid.

Indications to use:

For achievement of a mydriasis (a research of an eyeground, condition of a crystalline lens or vitreous). And achievements of a tsikloplegiya when determining a refraction when carrying out diagnosis in ophthalmology.

Route of administration and doses:

Before the procedure wash up hands with soap. Be convinced of integrity of a bottle and dropper. Opening of a bottle is made by a puncture of an upper part of a mouth turn of a cap against the stop. Before holding a procedure it is necessary to avoid a contact of a mucous membrane of eyes and other parts of a body with a bottle dropper. It is not necessary to touch a dropper tip as it can cause pollution of contents. Before Tropikamid's use it is necessary to remove soft contact lenses. It is possible to dress them again not earlier than in 30 min. from the moment of a drug instillation.

Incline the head back, displace a lower eyelid of an eye an index finger so that the pocket was formed. You hold with other hand a bottle a dropper so close down to an eye as far as it is possible, without touching a mucous membrane. Looking up, it is necessary to squeeze softly bottle walls so that one drop got to the pocket formed by a lower eyelid. Then release a lower eyelid. Close an eye, and within 2-3 minutes slightly incline the head down as though you look at a floor. Try not to blink or close eyes. Press down accurately a finger in a projection of the lacrimal channel for decrease in a reabsorption. Remove excess liquid with fabric from a face. Do not wipe and do not rinse a bottle dropper. Close a cover on a bottle. Wash up hands to remove the drug remains.

For a research of a condition of a crystalline lens and definition of a refraction: 1-2 drops of 1% of solution twice with an interval of 5 min., in need of prolongation of mydriatic effect in 20-30 min. in addition dig in one more drop of drug.

Fundoskopiya: to dig 1-2 drops of 0,5% of solution in 15-20 minutes prior to a research.

Features of use:

Before use Tropikamida-Pharmak 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 necessary to remember that at treatment of children and patients with hypersensitivity to alkaloid of a belladonna toxic action after drug use increases. It is necessary to inform parents on potentially toxic effect of drug in case of its intake, and also on need to wash hands after each instillation of drug.

At elderly people it is necessary to conduct examination for detection of possible closed-angle glaucoma (to specify the anamnesis, to carry out assessment of depth of an anterior chamber, a gonioskopiya) since bad attacks of glaucoma after drug use are possible, and it is also necessary to remember higher risk of development of side reactions in this category of patients. If the eyeground research is necessary, and inspection for detection of glaucoma is impossible, it is necessary to administer at once after the conducted research the drug narrowing a pupil (Pilocarpinum a hydrochloride, карбахол and others).

It is necessary to use with care drug at inflammatory diseases of eyes as in these conditions absorbability of medicine and its hit in a system blood stream increases. At the same time at administration of drug it is necessary to press easily within a minute on the lacrimal tubules for the prevention of excessive absorption of drug and the prevention of undesirable system reactions. At inflammatory diseases of eyes to apply with care since the hyperemia increases absorption of drug through a conjunctiva.

Ability to influence speed of response at control of motor transport or work with other mechanisms

At drug use the patient should not be engaged in potentially dangerous types of activity requiring special attention (driving of motor transport and work with other mechanisms.).

Side effects:

At use of drug local ophthalmologic reactions are possible: increase in intraocular pressure, the visual acuity disturbance which are taking place the pricking pains, a photophobia, opacification of a cornea. Right after an instillation of drug the burning and dacryagogue proceeding during about 15-20 sec. are possible. Prolonged use of drug can cause reactions of local irritation: hyperemia, hypostasis and conjunctivitis.

At use of drug emergence of the general anticholinergic reactions is possible: from digestive tract: dryness in a mouth, disturbance of a gastrointestinal vermicular movement which can lead to locks.

Changes from skin and hypodermic cellulose: xeroderma, feeling of inflows. Cardial disturbances: bradycardia with the previous tachycardia and arrhythmia.

Disturbance from an urinary system: dysuric phenomena, ischuria.

Vomiting, dizziness, shaky gait, skin rashes can be observed at children, abdominal distention at newborns. Children can also have psychotic symptoms, behavior disorders, heart and respiratory failure.

Others: allergic reactions (including acute anaphylaxis).

Interaction with other medicines:

Simultaneous use of anticholinergics and blockers of histamine H1 receptors, fenotiazin, tricyclic antidepressants, procaineamide, quinidine, MAO inhibitors, benzodiazepiyon and antipsychotic means mutually strengthens action of each other.

At simultaneous use of Tropikamid and nitrates, nitrites, medicines with alkali reaction, Disopyramidum, glucocorticosteroids and a haloperidol increase in intraocular pressure (is possible especially at the accompanying glaucoma).

Contraindications:

Glaucoma is primary, especially closed-angle and glaucoma with a narrow corner of an anterior chamber. Hypersensitivity to a tropikamid or to any component of drug. Not to apply to the patients using soft contact lenses as the chloride benzalkoniya is a part of drug.

Overdose:

The overdose, as a rule, arises at system intoxication after local purpose of drug, especially at children.

Symptoms: dryness in a mouth, rush of blood to the person (hyperemia), swallowing difficulty, a headache, dizziness, nausea, vomiting, an asthma, disturbance of clearness of visual perception, a photophobia. Are in certain cases possible: concern, spasms, hallucinations, loss of nervnomyshechny coordination, tachycardia, arrhythmia, hypotension, a hyperthermia, the dysuric phenomena, dryness of integuments, rashes, abdominal distention at newborns.

Treatment: physostigmine salicylate (0,03 mg/kg of body weight intravenously slowly), drugs of group of benzodiazepines, β-adrenoblockers.......... For elimination of a hyperthermia cold compresses and moistening of a body surface, especially at children are recommended. Symptomatic treatment.

Use during pregnancy or feeding by a breast

There is no reliable information about influence of drug on course of pregnancy and negative action on a fruit. Expediency of purpose of drug during pregnancy is defined by the doctor, considering a ratio advantage for mother/risk for the fruit/child.

At topical administration the system reabsorption and secretion with breast milk are not known. Therefore with care pregnant women and the feeding women should appoint drug.

Children

Appoint Tropikamid-Pharmak only in the form of 0,5% of solution. At drug use Tropikamid – Pharmak the potential risk of emergence of side effects from the central nervous system at children is higher, than at adult patients.

Storage conditions:

Period of validity. 3 years. A period of validity after opening of a bottle – 28 days. To store in the place protected from light at a temperature from 15 °C to 25 °C. To store in the place, unavailable to children!

Issue conditions:

According to the recipe

Packaging:

On 5 ml or 10 ml in the bottle enclosed in a pack.