Tropicam - instructions for use, doses, side effects, contraindications

Excipients: disodium edetate dihydrate 0.25 mg; sodium chloride 6.0 mg; benzalkonium chloride 50% solution 0.2 mg (in terms of benzalkonium chloride 0.1 mg); hydrochloric acid q.s. to a pH of 5.3-5.6; sodium hydroxide q.s. to a pH of 5.3-5.6; water for injection up to 1 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. The mydriatic and cycloplegic action of the preparation is significantly shorter compared 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 installations are necessary (see dosage). The maximum paralysis of accommodation after 2 multiple installations 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 closed-angle 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 Tropicam in local application to fertility have not been conducted.

Pregnancy

There are no data on the use of the drug during pregnancy or they are inadequate. The use of the drug Tropicam during pregnancy is not recommended.

Breastfeeding period

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

The decision to stop breastfeeding or to stop / stop Tropicam therapy should be made, taking into account the benefits of breastfeeding for the baby and the benefits of therapy for the mother.

Pediatric Use

Children under 6 years can only use 0.5% solution!

Dosing and Administration:

Locally, in the conjunctival sac.

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

Side effects:

After instillation Tropicam observed the following undesirable reactions (the frequency of undesirable reactions do not allow to evaluate the available data). Within each system-organ class, unwanted reactions are arranged in order of severity.

Local reactions: blurring of vision, photophobia, pain in the eye, eye irritation, hyperemia.

Local reactions can be characterized by photophobia, 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:

Disturbances from the 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 tear 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. 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. Symptoms of overdose are redness and dryness of the skin (children may have a rash), blurred vision, tachycardia,rapid and irregular pulse, heat, convulsions, hallucinations, loss of neuromuscular coordination.

Treatment is symptomatic. 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.

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.

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

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 belladonna alkaloids (belladonna), which is associated with an increased risk of a general toxic effect on the body.

The Tropicam drug contains benzalkonium chloride, which can cause eye irritation and discoloration of soft contact lenses. Avoid contacts of the drug with soft contact lenses. Patients should to instruct about that, it is necessary to remove contact lenses before application of a preparation and to establish them back not earlier than 15 minutes after instillation of the drug.

Pediatric Use

Tropicamide can cause disorders from the central nervous system, which can be of menacing nature to children.

Excessive administration of the drug to children can cause symptoms of systemic toxicity. It should be used with extreme caution in children with Down's syndrome, spastic paralysis or brain damage.

Parents should be warned about the toxicity of the drug Tropicam when ingested by children and recommend washing their hands and the hands of the child 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 drug is not intended for injection.

Effect on the ability to drive transp. cf. and fur:

Tropicamide can cause drowsiness, blurred vision, and sensitivity to light.

After using the drug, 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, 1 %.

Packaging:

5 ml per bottle of low density polyethylene, sealed with a screw cap of low density polyethylene.

1 bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 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:LP-004624

Date of registration:12.01.2018

Expiration Date:12.01.2023

The owner of the registration certificate:Rowecq LimitedRowecq Limited United Kingdom

Manufacturer: & nbsp

SCAN BIOTECH, Ltd. India

Representation: & nbspROUTEC LIMITEDROUTEC LIMITEDUnited Kingdom

Information update date: & nbsp20.02.2018

Illustrated instructions

Instructions

Tropicam (Tropicam)