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

Excipients: sodium chloride - 7.0 mg, disodium salt ethylenediaminetetraacetic acid 0.5 mg, benzalkonium chloride 50% 0.2 mg, hydrochloric acid 10% to pH ~ 5, water for injection up to 1 ml.

1 ml of a solution of 1%

Active substance: Tropicamide - 10.0 mg.

Excipients: sodium chloride - 7.0 mg, disodium salt ethylenediaminetetraacetic acid 0.5 mg, benzalkonium chloride 50% 0.2 mg, hydrochloric acid 10% to pH ~ 5, water for injection up to 1 ml.

Description:colorless transparent liquid

Pharmacotherapeutic group:m-holinoblokator

ATX: & nbsp

S.01.F.A Holinblockers

S.01.F.A.06 Tropicamide

Pharmacodynamics:Anticholinergic, blocks the receptors of the iris and ciliary muscle sphincter, causing short-term mydriasis (when applied at a dosage of 0.5%) and paralysis of accommodation (when applied at a dosage of 1%). Slightly increases intraocular pressure. The mechanism of action of tropicamide is based on a competitive blockade of m-cholinergic receptors.

The mydriasis develops 5 minutes after instillation and reaches a maximum by the 15-20 minute. The dilatation of the pupil is maintained for 1 hour (when using 0.5% solution) and 2 hours (when using 1% solution). Complete cessation of signs of pupil enlargement occurs 3-5 hours later.

The maximum paralysis of accommodation after 2-fold instillations of 1% solution occurs on average in 25 minutes and lasts for 30 minutes. Complete suppression of paralysis of accommodation occurs in 3 hours.

Pharmacokinetics:

Tropicamide in small amounts can enter the systemic circulation, especially in children and the elderly.

Indications:

As a mydriatic and cycloplegic agent for topical application:

- for diagnostic purposes with ophthalmoscopy (examination of the fundus) and determination of refraction;

- for short-term mydriatic effect before and after surgical and laser operations.

Contraindications:

- hypersensitivity to tropicamide or other components of the drug;

- glaucoma or predisposition to glaucoma (for example, a narrow angle of the anterior chamber).

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

Carefully:

Increased intraocular pressure; increased sensitivity to alkaloids of belladonna; childhood. Use with caution in inflammation of the eyes, since hyperemia significantly increases systemic absorption through conjunctivitis.

Pregnancy and lactation:

Fertility

Information on the effect of tropicamide on fertility of men and women is absent.

Pregnancy

Data on the use of the drug during pregnancy are absent.

Use in pregnant women is only possible according to the prescription of the attending physician if the expected benefit for the mother exceeds the potential risk to the fetus.

Application in breastfeeding

The risk is not excluded for a child who is breastfeeding, because It is not known whether the drug penetrates into breast milk. If you need to use the drug during this period, breastfeeding should be discontinued.

Dosing and Administration:

Locally, in the conjunctival sac.

Ophthalmoscopy (examination of the fundus)

Adults and children: 1 - 2 drops of 0.5% solution is instilled in the conjunctival sac 15-20 minutes before the test.

Determination of refraction

Adults: 1 drop of 1% solution is instilled in the conjunctival sac 2 times with an interval of 5 minutes. Examination should be carried out within 25 - 50 minutes from the time of the last administration of the drug.

Short-term mydriatic effect before and after surgical and laser operations

Adults and children over 6 years of age: 1 drop of 1% or 2 drops of 0.5% solution (with an interval of 5 minutes).

Children under 6 years: 2 drops of 0.5% solution (with an interval of 5 minutes).

In the event that the patient's examination did not take place within 15-30 min after the application of the drug, you can drip an additional 1 drop of the drug to prolong the mydriatic action. The maximum dilatation of the pupil occurs approximately 15 minutes after the administration of the drug. The duration of the drug remains up to 3 hours.

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 tropicamide into the conjunctival sac, the following undesirable reactions (with unknown frequency) were observed:

Impaired nervous system: dizziness, headache.

Disorders from the side of the organ of vision: blurred vision, photophobia, eye pain, eye irritation, eye hyperemia.

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 mydriatic action.

In predisposed patients, the agents that cause cycloplegia are able to increase intraocular pressure and mediate the development of closed-angle glaucoma. With the use of anticholinergic drugs, the development of psychotic reactions, behavioral disorders and cardiopulmonary collapse was reported, especially in children.

Other undesirable reactions of anticholinergic drugs include hyperemia, dry mucous membranes, dry skin, bradycardia, turning into tachycardia, accompanied by flutter and rhythm disturbance, decreased secretion of sweat glands,decrease in nasal, bronchial and tear secretion, suppression of peristalsis of the gastrointestinal tract, leading to constipation, vomiting, urge to urinate, unsteady walking.

Local side effects: increased intraocular pressure, burning, photophobia due to dilated pupils. Long-term use can lead to local irritation, hyperemia, swelling and conjunctivitis.

Have children may appear: a rash; violations of the central nervous system, which can be of menacing nature; respiratory insufficiency and circulatory insufficiency; in babies - bloating.

Overdose:

With the development of an overdose when applied as instillations, an excessive amount of the drug can be removed by rinsing with warm water.

In case of an overdose when administered in the form of instillations or inadvertent ingestion, typical symptoms are dry skin (rashes are possible in children), tachycardia, fever, bloating (in infants), blurred vision, rapid irregular pulse, hallucinations, convulsions, loss of neuromuscular coordination . Treatment is symptomatic.Young children should moisturize the surface of the skin. If accidentally ingested, induce vomiting and rinse the stomach.

Interaction:

Adrenomimetics increase the effect of tropicamide, m-holinomimetiki - weaken. The anticholinergic effect of the drug may be enhanced by the simultaneous use of other drugs that have anticholinergic effects, for example, amantadine, blockers Hi-gistamine receptors, neuroleptics, phenothiazine derivatives, tricyclic antidepressants.

With the simultaneous use of several ophthalmic drugs, the interval between their administration should be at least 5 minutes, ophthalmic ointments should be used last.

Special instructions:

Before the application of tropicamide for the dilatation of the pupil for the purpose of examination of the fundus, it is necessary to exclude the diagnosis of glaucoma, including the closed-angle and narrow-angle (anamnesis, depth of anterior chamber, gonioscopy). Especially this applies to elderly people and patients with a tendency to increase intraocular pressure, as the use of the drug can cause an acute attack of closed-angle glaucoma after a single instillation.

In patients with increased sensitivity to anticholinergic drugs, tropicamide-induced psychotic reactions and frustration may develop behavior.

Particular care should be taken in children and people with increased sensitivity to alkaloids of belladonna, which is associated with an increased risk of the occurrence of a general toxic effect on the body (see section "Side effect"),

Benzalkonium chloride, which is part of the drug, can cause eye irritation and change the color of soft contact lenses. Before applying the drug, it is necessary to remove soft contact lenses. Patients should be instructed to remove contact lenses before using the drug and install them no earlier than 15 minutes after instillation.

Use in children

Tropicamide can cause disturbances in the central nervous system, which can be of menacing nature in children.

When an overdose of the drug in children can cause symptoms of systemic toxicity. With extreme caution, the drug should be used in infants, premature or underdeveloped children, as well as in children with Down's syndrome, spastic paralysis and brain damage.

If swallowed accidentally, the drug may have a toxic effect, which must be taken into account when used in children. It is necessary to monitor the cleanliness of the hands of both the child and adults when using the drug.

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

When using the drug may appear dizziness, blurred vision and photophobia. It is necessary to refrain from managing motor transport and other mechanisms to restore the clearness of vision, which occurs within approximately 6 hours after application of the drug.

Form release / dosage:

Eye drops 0.5% and 1%.

Packaging:

The bottle-dropper made of polyethylene, sealed with a lid of polyethylene or polypropylene with the control of the first opening and containing 5 ml of the preparation. A label is attached to the vial.

One or two vials are packed in a cardboard box with instructions for use.

Storage conditions:

In the dark place at a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. After opening the bottle - no more than 4 weeks.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015023 / 01-2003

Date of registration:01.07.2008

The owner of the registration certificate:Warsaw Pharmaceutical Plant Polfa, JSCWarsaw Pharmaceutical Plant Polfa, JSC Poland

Manufacturer: & nbsp

Warsaw Pharmaceutical Factory Polfa A.O. Poland

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp20.10.2015

Illustrated instructions

Instructions

Tropicamide (Tropicamide)