Tropicamide (Tropicamide)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTropicamideTropicamide
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    • Dosage form: & nbspeye drops
    Composition:

    1 ml of the solution contains:

    Active substance:

    tropicamide -5.0 mg, -10.0 mg

    Excipients:

    sodium chloride - 7.0 mg,

    disodium edetate 0.5 mg,

    benzalkonium chloride 50% solution - 0.2 mg,

    equivalent to 0.1 mg of benzalkonium chloride

    hydrochloric acid 1 M or - to pH 4.0-5.8,

    sodium hydroxide 1 M

    water for injection - up to 1 ml.

    Description:Transparent colorless liquid.
    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. Midriaz develops through 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 a 2-fold instillation of 1% solution on average arises after 25 minutes and persists for 30 minutes. Complete restoration of accommodation occurs in 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 in the conduct of 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 anterior chamber or narrow angle of anterior chamber).

    Hypersensitivity to one of the components of the drug.

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

    If you have any of the listed diseases, before taking the drug, be sure to consult a doctor.

    Carefully:

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

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

    If you have any of these diseases, consult a doctor before taking the drug.

    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 the drug by pregnant women are not available or insufficient. The use of the drug in pregnancy is not recommended. Application in breastfeeding

    At the present time, it is not known whether tropicamide or its metabolites in human breast milk; However, the risk for an infant can not be ruled out. The decision to terminate breast-feeding or the termination / suspension of drug therapy should be made taking into account the benefit of breast-feeding for the child and the benefit 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.

    To reduce the risk of systemic side effects after instillation recommended nasolacrimal duct clamped by clamping point at the inner corner of the eye within a few minutes.

    Side effects:

    WHO classification of unwanted adverse reactions according to the frequency of development

    Very Frequent - 1/10 appointments (≥ 10%)

    Frequent - 1/100 appointments (≥ 1%, but <10%)

    Infrequent - 1/1000 appointments (≥ 0.1%, but <1%)

    Rare - 1/10000 appointments (≥ 0.01%, but <0.1%)

    Very rare - less than 1 / 10,000 appointments (<0.01%)

    The frequency is unknown (can not be estimated from the available data). Within each system-organ class, unwanted reactions are arranged in order of decreasing severity.

    Side effects with unknown frequency:

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

    Systemic reactions:

    Disorders from the central and peripheral nervous system: dizziness, headache.

    From the cardiovascular system: fainting, hypotension.

    From the digestive system: nausea.

    From the skin: rash.

    General and local reactions: prolongation of mydriatic action (mydriasis).

    Local reactions can be characterized by photophobia and blurring of 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.

    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, dry skin, 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.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

    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 heartbeat, heat, bloating in newborns, hallucinations, seizures, loss of neuromuscular coordination.

    Treatment is symptomatic and supportive. Young children should moisturize the surface of the skin. If you accidentally ingest vomiting and rinsing the stomach, in severe cases, physostigmine can be prescribed.

    Interaction:

    The anticholinergic effect of the drug may be enhanced by the joint use of other drugs with anticholinergic effects, for example, some antihistamines, tricyclic antidepressants, amantadine, neuroleptics, phenothiazine derivatives, butyrophenone.

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

    Special instructions:

    Use only for instillations in the conjunctival sac.

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

    The bottle-dropper must be closed after each use.

    To reduce the risk of systemic side effects, it is recommended to lightly press the finger in the area of ​​the projection of the lacrimal sac the the inner corner of the eye within 1-2 minutes after instillation of the drug.

    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.

    Before using the drug for diagnostic purposes, the patient or an accompanying person should be warned about temporary visual disturbance and photophobia.

    In patients with hypersensitivity to anticholinergic drugs, tropicamide-induced psychomotor reactions and behavioral disorders can develop.

    Special care must be taken in children and persons with increased sensitivity to alkaloids of belladonna (belladonna), which is associated with an increased risk of general toxic effects 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. Patients should be instructed to remove contact lenses before using the drug and to install them no earlier than 15 minutes after instillation.

    Pediatric Use

    Tropicamide can cause disturbances in the central nervous system, which can be menacing in 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 when ingested by children and recommend washing their hands and the hands of the child after applying the drug.

    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:

    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%.

    Packaging:

    10 ml in the dropper-dropper polymer. 1 bottle-dropper with instructions for the use of the drug in a pack of cardboard.

    The text of the instruction for the use of the dropper bottle is applied to the pack.

    Storage conditions:

    In the dark place at a temperature of no higher than 15 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years. Shelf life after opening - 30 days.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004139
    Date of registration:13.02.2017
    Expiration Date:13.02.2022
    The owner of the registration certificate:MOSCOW ENDOCRINE FACTORY, FSUE MOSCOW ENDOCRINE FACTORY, FSUE Russia
    Manufacturer: & nbsp
    Information update date: & nbsp22.03.2017
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