Midratsil - instructions for use, dose, side effects, contraindications

Excipients: benzalkonium chloride, solution,is equivalent to benzalkonium chloride 0.1 mg; sodium chloride 8.0 mg; disodium edetate 0.1 mg; acid hydrochloric concentrated and / or sodium hydroxide to adjust the pH; water purified to 1.0 ml.

1% solution contains:

Active substance: Tropicamide 10.0 mg

Excipients: benzalkonium chloride, solution, is equivalent to benzalkonium chloride 0.1 mg; sodium chloride 7.0 mg; disodium edetate 0.1 mg; acid to adjust pH; purified water. Hydrochloric concentrated and / or sodium hydroxide to adjust the pH; water purified to 1.0 ml.

Description:A clear, colorless solution.

Pharmacotherapeutic group:M-holinoblokator

ATX: & nbsp

S.01.F.A Holinblockers

S.01.F.A.06 Tropicamide

Pharmacodynamics:

Tropicamide, blocking the M-holinoretseptora sphincter of the iris and ciliary muscle, causes the development of mydriasis and paralysis of accommodation. Midriatic and the cycloplegic effect of the drug is significantly shorter in comparison with atropine. Tropicamide has less influence on the state of the ophthalmotonus, however, it is possible to increase the intraocular pressure with the drug.

The mydriasis develops 5-10 minutes after instillation and reaches a maximum by 15-20 minutes. The dilatation of the pupil persists for 1-2 hours.

To develop paralysis of accommodation, multiple instillations are necessary (see dosage). The maximum paralysis of accommodation after 2-fold instillations of 1% solution occurs on average in 25 minutes and persists for 30 minutes. The cessation of paralysis of accommodation occurs on average after 3 hours.

Coping all the effects of tropicamide is achieved on average after 6 hours.

Indications:

- For diagnostic purposes with ophthalmoscopy and determination of refraction;

- dilated pupil before surgical (extraction of cataract, operations on the retina and vitreous body) and laser operations (laser coagulation of the retina);

- as a component of the complex therapy of inflammatory eye diseases and in the postoperative period for the prevention of the development of synechia.

Contraindications:

- Glaucoma, especially occlusive and mixed primary glaucoma or predisposition to glaucoma (small front camera or narrow angle front chamber);

- hypersensitivity to components of the drug;

- 1% solution is contraindicated in children age to 6 years (should use a 0.5% solution).

Carefully:

With increased intraocular pressure, a shallow anterior chamber of the eye.

With inflammation of the eyes, since hyperemia significantly increases the level of systemic absorption through conjunctivitis.

Pregnancy and lactation:

Fertility

Studies on the effect of the drug Midratsil with local application for fertility have not been conducted.

Pregnancy

Data on the use of tropicamide by pregnant women are not available or insufficient. Midratsil is not recommended for pregnancy.

Breastfeeding period

At the present time, there is no data on whether tropicamide or its metabolites in human breast milk; However, the risk for an infant can not be ruled out.

The decision to stop breastfeeding or stop / stop medication with Midratsil should be taken, taking into account the benefits of breastfeeding for the baby and the benefits of therapy for the woman.

Pediatric Use

Children under 6 years can only use 0.5% solution!

Dosing and Administration:

Locally.

To diagnose the dilatation of the pupil, drop 1-2 drops of 0.5% solution 15-20 minutes before the examination.

To determine the refraction of 1-2 drops 1% solution is instilled 2 times a day at intervals of 5 minutes. To prolong the effect, one more instillation can be added.

Side effects:

After instillation of the preparation Midratsil, the following undesirable reactions were observed (the frequency of undesired reactions does not allow to evaluate the available data). Within each system-organ class Unwanted reactions are located in order to reduce the severity.

Local Reactions

blurring of vision, photophobia, pain in eye, eye irritation, hyperemia.

Local reactions can be characterized by photophobia and blurring of vision due to expansion pupil and loss of accommodation; increased intraocular pressure; allergic reactions; short-term painful burning after instillation; hyperemia and edema of the conjunctiva.

Systemic reactions

Disturbances from the nervous system

Dizziness, headache.

Vascular disorders

Fainting, hypotension.

Disorders from the gastro-intestinal tract

Nausea.

Disturbances from the skin and subcutaneous fabrics

Rash.

General disorders and disorders at the site of administration

Prolongation of the drug (mydriasis).

Cycloplegics can increase intraocular pressure and provoke the development of a closed-angle glaucoma in predisposed patients.

Other toxic manifestations of anticholinergic drugs are reddening of the skin, dry mucous membranes, tachycardia, decreased secretion of sweat glands and dry mouth, decreased motility of the gastrointestinal tract and constipation, delayed urination and decreased secretion of nasal, bronchial and lacrimal glands.Severe reactions occur with hypotension with rapidly progressive respiratory failure.

Pediatric Use

Possible development of psychotic reactions and behavioral disorders, especially in children. Children may develop a rash; in newborns - bloating. Cases of cardiopulmonary collapse in children with this class of drugs are also described.

Overdose:

If the eye gets excess amount of the drug is recommended Rinse your eyes with warm water. When topical application takes place general toxicity, especially in children. it manifested in the form of redness and dryness skin (children may have a rash), blurred vision, tachycardia, rapid and irregular pulse, heat, bloating in newborns, seizures, hallucinations, loss of neuromuscular coordination.

Treatment symptomatic and supporting. Young children should moisturize the surface of the skin. In case of accidental ingestion, induce vomiting and rinse the stomach, physostigmine may be prescribed in severe cases.

Interaction:

The effect of M-holinoblokatorov can be strengthened by the joint use of drugs withantimuscarinic properties - amantadine, some antihistamines, butyrophenones, phenothiazines, antipsychotics, tricyclic antidepressants.

Special instructions:

Tropicamide can cause increased intraocular pressure. Consider the possibility of having undiagnosed glaucoma in some categories of patients, such as the elderly. Before starting treatment is necessary to measure intraocular pressure and assess the depth of the anterior chamber.

In patients with increased sensitivity to anticholinergic drugs, tropicamide-induced psychotic reactions and behavioral disorders. Special caution must be observed in individuals with sensitivity to alkaloids belladonna (belladonna), which is associated with an increased risk of a common toxic effect on the body. Midratsil contains benzalkonium chloride, which can cause eye irritation and discoloration of soft contact lenses. Avoid contact with soft contact lenses. Patients should be instructed that,that it is necessary to remove contact lenses before using the drug and install them back no earlier than 15 minutes after instillation of the drug.

Pediatric Use

Tropicamide can cause disorders of the central nervous system, which can be menacing for children, including infants.

Excessive administration of the drug to children can cause symptoms of systemic toxicity. Special care should be taken to prescribe the drug to newborns, young children, premature infants, children with Down's syndrome, spastic paralysis or brain damage.

Parents should be warned about the toxicity of the drug Midratsil at ingestion by children and recommend washing their hands and hands after applying the drug.

To reduce the risk of developing systemic adverse reactions, it is recommended after the instillation of the drug to squeeze the tear ducts at the inner corner of the eye (for 1 -2 minutes).

Do not touch the tip of the dropper bottle to any surface to avoid contamination of the dropper and its contents.

The bottle must be closed after each use.

Effect on the ability to drive transp. cf. and fur:Tropicamide can cause drowsiness, blurred vision, and sensitivity to light. After application, it is not recommended to drive vehicles and engage in activities requiring increased attention and reaction, until the vision is completely restored, which occurs within approximately 6 hours after application of the drug.

Form release / dosage:

Eye drops 0.5%; 1%.

Packaging:

15 ml per bottle-dropper "Droptainer ™" from low density polyethylene.

For 1 bottle with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of 8 to 30 ° C.

Keep out of the reach of children.

Refers to the IV list of PKU "Other medicines subject to subject-quantitative accounting".

Shelf life:

3 years.

Use within 4 weeks after opening the vial.

Do not use after the expiry date printed on the package!

Terms of leave from pharmacies:On prescription

Registration number:П N014551 / 01

Date of registration:08.08.2008 / 28.09.2017

Expiration Date:Unlimited

The owner of the registration certificate:Novartis Pharma AGNovartis Pharma AG Switzerland

Manufacturer: & nbsp

ALCON-COUVREUR, n.v. s.a. Belgium

Representation: & nbspNOVARTIS PHARMA LLCNOVARTIS PHARMA LLC

Information update date: & nbsp24.04.2018

Illustrated instructions

Instructions

Midratsil (Mydriacyl)