Tropicamide-SOLOFARM - instructions for use, doses, side effects, contraindications

Active substance:	0,5%	1,0%
Tropicamide	5.0 mg	10.0 mg
Excipients:
Benzalkonium chloride	0.1 mg
Sodium chloride	8.0 mg
Disodium edetate dihydrate (Trilon B)	0.1 mg
1M hydrochloric acid solution or 1 M sodium hydroxide solution	to pH 4.0-5.8
Water for injections	up to 1 ml

Description:

Transparent colorless or slightly colored liquid.

Pharmacotherapeutic group:M-holinoblokator

ATX: & nbsp

S.01.F.A Holinblockers

S.01.F.A.06 Tropicamide

Pharmacodynamics:

Tropicamide, blocking m-cholinergic receptors of the 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 two instillations of 1% solution on average arises after 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.

Pharmacokinetics:

After instillation of the drug into the conjunctival sac tropicamide to a small extent is subjected to systemic absorption (especially in children and the elderly).

Indications:

- For diagnostic purposes with ophthalmoscopy and determination of refraction;

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

- 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 anterior chamber or narrow angle of anterior chamber);

- hypersensitivity to the components of the drug;

- 1% solution is contraindicated in children under 6 years of age (0.5% solution should be used).

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 in local application on fertility have not been conducted.

Pregnancy

Data on the use of tropicamide by pregnant women are not available or insufficient. The drug 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 to stop / stop therapy with the drug should be made, taking into account the benefits of breastfeeding for the baby and the benefits of therapy for the woman.

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.

To reduce the risk of systemic side effects, it is recommended, after instillation, to squeeze the nasolacrimal canal by pressing the point at the inner corner of the eye for several minutes.

Side effects:

After instillation of the drug, 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 arranged in order of decreasing severity.

Local Reactions

Blurred vision, photophobia, pain in the eye, eye irritation, hyperemia.

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

Systemic reactions

Impaired nervous system: dizziness, headache.

Vascular disorders: fainting, hypotension.

Disorders from the gastrointestinal tract: nausea.

Disturbances from the skin and subcutaneous tissues: 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 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

Perhaps the development of mental 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 eye contact is excessive, it is recommended to wash eyes with warm water.

With topical application, there is general toxicity, especially in children. This is manifested in the form of redness and dryness of the skin (children may have a rash), blurred vision, tachycardia, rapid and irregular pulse, heat, bloating in newborns, seizures, hallucinations, loss of neuromuscular coordination.

Treatment is symptomatic and supportive. 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 with antimuscarinic properties - amantadine, some antihistamines, butyrophenones, phenothiazines, neuroleptics, tricyclic antidepressants.

If more than one local ophthalmic drug is used, the drugs should be used with at least a 5-minute interval. The latter should be used eye ointments.

Special instructions:

Tropicamide can cause an increase in intraocular pressure. Consider the possibility of having undiagnosed glaucoma in some categories of patients, such as the elderly. Before the start of treatment, it is necessary to measure the intraocular pressure and to estimate the depth of the anterior chamber angle.

In patients with hypersensitivity to anticholinergic drugs, tropicamide-induced psychotic reactions and behavioral disorders can develop. Particular care should be taken in individuals with sensitivity to alkaloids of belladonna (belladonna), which is associated with an increased risk of general toxic effects on the body.

The preparation 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 to establish them back no earlier than 15 minutes after instillation of 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 (vial dropper) to any surface to avoid contamination of the vial and its contents.

The bottle must be closed after each use.

Use only for instillations in the conjunctival sac. If swallowed accidentally, the drug may have a toxic effect.

Pediatric Use

Children under 6 years can only use 0.5% solution!

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, infantile cerebral palsy, or brain damage.

Parents should be warned about the toxicity of the drug when ingested by children and recommend washing their hands and the hands of the child after applying the drug.

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% and 1.0%.

Packaging:

For 5, 10 or 15 ml in a bottle with a dropper of low density polyethylene and a lid with a control of the first opening or in a vial of high-density polyethylene with a cap screwed and stopper-dropper or 10 ml in a bottle of polyethylene terephthalate with a dropper of plastic and a lid with the control of the first autopsy.

1 bottle of polyethylene terephthalate in a foil bag.

For 1 bottle or 1 packet of foil film together with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. After opening the bottle - 1 month.

Do not use after the expiration date!

Terms of leave from pharmacies:On prescription

Registration number:LP-004879

Date of registration:05.06.2018

Expiration Date:05.06.2023

The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia

Manufacturer: & nbsp

GROTEKS, LLC Russia

Information update date: & nbsp21.06.2018

Illustrated instructions

Instructions

Tropicamide-SOLOFARM (Tropicamidum-SOLOpharm)