Cyclopentolate-SOLOfarm (Cyclopentolate-SOLOpharm)

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

    Composition of the preparation per ml

    Active substance:

    Cyclopentolate hydrochloride 10.0 mg

    Excipients:

    Benzalkonium chloride 0.1 mg

    Disodium edetate dihydrate (Trilon B) 1.0 mg

    Sodium chloride 7.0 mg

    Water for injection up to 1.0 ml.

    Description:

    Transparent colorless liquid.

    Pharmacotherapeutic group:M-holinoblokator
    ATX: & nbsp

    S.01.F.A   Holinblockers

    S.01.F.A.04   Cyclopentolate

    Pharmacodynamics:

    Cyclopentolate, blocking m-holinoretseptory, prevents the action of the mediator of cholinergic synapses - acetylcholine.

    As a result of blocking of m-holinoretseptorov located in the sphincter of the pupil and in the ciliary muscle, the pupil dilates due to the predominance of the muscle tone that dilates the pupil and the relaxation of the muscle that narrows the pupil. Simultaneously, due to relaxation of the ciliary muscle, paralysis of accommodation (cycloplegia) occurs. Dilation of the pupil occurs within 25-75 minutes after a single instillation. Mydriasis persists for 6-12 hours, in particularly sensitive patients the lung mydriasis can last much longer. Residual phenomena of cycloplegia persist for 12-24 hours. The drug has a weak antispasmodic effect, reduces the secretion of salivary, gastric, bronchial, sweat glands and pancreas; increases intraocular pressure; reduces the tone of the vagus nerve, which leads to an increase in heart rate with a slight increase in blood pressure.

    Penetrates through the blood-brain barrier; in moderate therapeutic doses has a moderate stimulating effect on the central nervous system, stimulates respiration.

    Pharmacokinetics:

    Well absorbed through the conjunctiva. Concentration in the central nervous system (CNS) is achieved after 0.5-1 hour. Binding to plasma proteins is moderate. The half-life (T1 / 2) is 2 hours.

    Indications:

    For diagnostic purposes: with ophthalmoscopy; when determining refraction.

    In preoperative preparation: to dilate the pupil when extracting cataracts.

    In inflammatory diseases of the anterior part of the eye - episcleritis, sclerites, keratitis, iridocyclitis, uevita - as part of complex therapy.

    Contraindications:

    Hypersensitivity to the components of the drug, zakratougolnaya glaucoma, suspicion of glaucoma, post-traumatic paresis of the sphincter pupil, children under 3 years of age, pregnancy, lactation.

    Carefully:

    Elderly age, intestinal obstruction, prostatic hyperplasia.

    Pregnancy and lactation:

    Application during pregnancy and during lactation is contraindicated (see section "Contraindications").

    Dosing and Administration:

    Locally.

    Adults and children:

    For diagnostic purposes: 1-2 drops of the drug in each conjunctival bag, if necessary, repeat the dose after 5-10 minutes.

    To achieve cycloplegia in the study of refraction: 2-3 times a day for 1-2 drops with an interval of 15-20 minutes.

    For inflammatory diseases: 1 drop 3 times a day for 5-10 days, in severe cases, 1 drop every 3-4 hours is acceptable.

    Side effects:

    Local reactions: burning, hyperemia, conjunctival edema and eyeball, photophobia, increased intraocular pressure, decreased visual acuity, blepharoconjunctivitis, acne keratitis.

    In rare cases - manifestations of systemic action (usually in children): weakness, nausea, dry mouth, dizziness, headache, drowsiness, tachycardia, intestinal atony, atony of the bladder, acute urinary retention.

    Overdose:

    Symptoms: disorders of mental reactions and behavior disorder (incoherent speech, hallucinations, seizures, disorientation in time and space, change in emotional state), ataxia, excessive fatigue, impaired recognition of objects from close range, coma (up to fatal outcome).

    Treatment: intravenous introduction of a specific antidote - physostigmine, children in a dose of 0.5 mg, if necessary (in the absence of effect after 5 minutes) dose is repeated (maximum dose should not exceed 2 mg); Adult antidote administered in a dose of 2 mg, in the absence of effect after 20 minutes, the administration is repeated at a dose of 1 -2 mg.

    Interaction:

    Weaken the effect of m-cholinomimetics and cholinesterase inhibitors.

    The effect of cyclopentolate is enhanced by adrenomimetics.

    Special instructions:

    When using the drug requires monitoring of intraocular pressure.

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

    The drug is less effective in people with dark pigmented irises.At the given patients at use of a preparation the residual accommodation can reach 2-4 diopters.

    In children with a semi-stable or persistent spasm of accommodation, it is better to use atropine sulfate for cycloplegia.

    Patients with increased sensitivity to atropine do not give a cross-allergy to the drug Cyclopentolate-SOLOfarm, which allows it to be used in this category of patients.

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

    When using the drug, it is not recommended to drive vehicles and engage in potentially hazardous activities requiring a rapid psychomotor reaction.

    Form release / dosage:

    Eye drops 1%.

    Packaging:

    5 ml per bottle with a dropper of low-density polyethylene and a lid with a control of the first opening or a flask-dropper made of high-density polyethylene, complete with a cap screwed and stopper-dropper.

    1 bottle 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:

    2 years.

    After opening the bottle - 1 month.

    Do not use after the expiration date!

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004322
    Date of registration:05.06.2017
    Expiration Date:05.06.2022
    The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp13.11.2017
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