Phenicamid (Phenycamid)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTropicamide + PhenylephrineTropicamide + Phenylephrine
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  • Appamage Plus
    drops d / eye 
    Apparel Ocular Device (P) Ltd. (Pharma Division)     India
  • Phenicamid
    drops d / eye 
    GROTEKS, LLC     Russia
    • Dosage form: & nbspeye drops
    Composition:

    Composition of the preparation per 1 ml:

    Active substances:

    Tropicamide 8.0 mg

    Phenylephrine hydrochloride 50.0 mg

    Excipients:

    Benzalkonium chloride 0.1 mg

    Sodium hydrophosphate dihydrate 0.28 mg

    Sodium dihydrogen phosphate dihydrate 0.005 mg

    Sodium chloride 4.5 mg

    Disodium edetate dihydrate (Trilon B) 0.5 mg

    1 M hydrochloric acid solution to pH 3.0 - 5.8

    or 1 M sodium hydroxide solution

    Water for injection up to 1 ml.

    Description:Transparent from colorless to yellow or brownish-yellow liquid.
    Pharmacotherapeutic group:Ophthalmic diseases diagnostic tool (m-cholinoblocker + alpha-adrenomimetic)
    ATX: & nbsp

    S.01.F.A.56   Tropicamide in combination with other drugs

    Pharmacodynamics:

    Tropicamide. M-holinoblokator, blocks the m-holinoretseptory sphincter pupil and ciliary muscle, causing short-term mydriasis and paralysis of accommodation. Slightly increases the intraocular pressure. Midriaz against the background of tropicamide application develops in 5-10 minutes and reaches a maximum by 20-45 minutes. The maximum dilatation of the pupil is maintained for 1 hour and normalizes after 6 hours.

    Phenylephrine. Non-selective alpha-adrenomimetic.When instillation in the eye causes a dilated pupil, improves the flow of intraocular fluid and narrows the vessels of the conjunctiva. Phenylephrine has a pronounced stimulating effect on postsynaptic alpha-adrenoreceptors, has a very weak effect on beta 1-adrenergic receptors. Has vasoconstrictive action, similar to the action of norepinephrine (norepinephrine), while it has virtually no chronotropic and inotropic effect on the heart. The vasopressor effect of phenylephrine is weaker than that of norepinephrine, but is more prolonged. After instillation phenylephrine reduces the dilator pupil and smooth muscle arterioles of the conjunctiva, thereby causing a dilated pupil. The mydriasis occurs within 10-60 min after a single instillation and lasts for 4-6 hours. The mydrias caused by phenylephrine is not accompanied by cycloplegia.

    Phenylephrine complements the action of tropicamide, since the mechanisms of their action are different. Introduction together with tropicamide phenylephrine reduces or reduces the ability of tropicamide to increase intraocular pressure.

    Pharmacokinetics:

    Tropicamide. Easily penetrates into the tissues of the eye and is quickly absorbed into the bloodstream.Using a modified radio-receptor assay, the lower limit for the determination of tropicamide in plasma was less than 240 ng / ml, the detection range was 240 ng / ml-10 ng / ml. The mean maximum plasma concentration in the fifth minute after the administration was 2.8 ± 1.7 ng / ml. At the 60th minute, the concentration of tropicamide in the plasma was 0.46 ± 0.51 ng / ml, and at the 120th - below 240 ng / ml.

    Phenylephrine. Easily penetrates into the eye tissue, the maximum concentration in the plasma occurs 10-20 minutes after topical application. Phenylephrine is excreted by the kidneys in unchanged form (<20%) or in the form of inactive metabolites.

    Indications:

    It is used as a mydriatic agent:

    - with diagnostic ophthalmologic procedures;

    - before surgical and laser operations.

    Contraindications:

    Hypersensitivity to any of the components, children under 18 years of age, narrow-angle and angle-closure glaucoma, mixed glaucoma, diseases of the cardiovascular system (including coronary sclerosis, angina pectoris, arrhythmia, hypertensive crisis), renal porphyria, thyrotoxicosis, Type I diabetes mellitus, pregnancy , the period of breastfeeding, simultaneous administration (as well as within 3 weeks after their withdrawal) of inhibitor oxidase (MAO).

    Carefully:

    Diabetes II type, elderly age (risk of developing ventricular arrhythmias and myocardial infarction in patients with cardiovascular diseases), patients with cerebrovascular diseases, postoperative conditions (reduction of conjunctival healing).

    Pregnancy and lactation:

    The use of the drug during pregnancy and during breastfeeding is contraindicated.

    Dosing and Administration:

    To dilate the pupil with diagnostic ophthalmologic and surgical interventions in the conjunctival cavity, drop in 1-2 drops for 15-30 minutes before the procedure or operation.

    Side effects:

    Local Reactions

    Allergic reactions, increased intraocular pressure, transient pain, burning in the eye and photophobia, transient decrease in vision, release of the pigment into aqueous humor with temporary increase in intraocular pressure, blockage of the anterior chamber angle (with narrowing of the angle), pain in the region of the superciliary arches, lacrimation, hyperemia conjunctiva, keratitis; rarely - reactive miosis the day after (repeated instillations of the drug at this time may give less pronounced mydriasis than the day before, this effect is more common in elderly patients).

    Systemic reactions

    Pale skin, dry mouth, reddening and dry skin, contact dermatitis, headache, fainting, lowering of blood pressure, palpitations, tachycardia and arrhythmia, bradycardia, ventricular occlusion of the coronary arteries, pulmonary embolism, CNS disorders and muscle rigidity , frequent urge to urinate, difficulty urinating, decrease in the tone of the gastrointestinal tract and peristalsis leading to constipation. Sometimes - vomiting and dizziness. In elderly patients with diseases of the cardiovascular system, ventricular arrhythmias, myocardial infarction are possible.

    Overdose:

    Data on overdose of tropicamide and phenylephrine in local application are absent.

    Symptoms (with a random intake of the drug inside): dry skin and mucous membranes, hyperthermia, tachycardia, mydriasis, agitation, convulsions, coma, respiratory depression.

    Treatment: gastric lavage, reception of activated charcoal; as an antidote - physostigmine (0.03 mg / kg intravenously slowly), benzodiazepines; to eliminate hyperthermia - cold compresses. To stop the systemic action of phenylephrine - alpha-adrenoblockers (5-10 mg of phentolamine intravenously, if necessary, repeat the injection).

    Interaction:

    Adrenomimetics strengthen, m-holinomimetiki weaken the effect of tropicamide. Tricyclic antidepressants, phenothiazines, amantadine, quinidine, antihistamines increase the likelihood of systemic side effects of tropicamide.

    Atropine enhances mydriatic effect of phenylephrine. Simultaneous application with MAO inhibitors, and also within 21 days after discontinuation of their intake increases the risk of systemic adrenergic effects.

    The vasopressor effect of alpha-adrenomimetics can also be enhanced when combined with tricyclic antidepressants, propranolol, guanethidine, methyldopa and m-holinoblokatorami. Beta-blockers increase the risk of a sharp increase in blood pressure. Phenylephrine increases the risk of cardiovascular depression while inhaling general anesthesia.

    With the appointment of beta-adrenoblockers, it is possible to intensify the vasoconstrictive effect of phenylephrine by suppressing them by vasodilation.

    Because of the risk of hypertensive crisis, it is not recommended to share phenylephrine and guanethidine, as well as any other adrenoblocker or monoamine reuptake inhibitor.

    Simultaneous use with monoamine oxidase inhibitors and within three weeks after stopping their intake increases the risk of systemic adrenergic effects.

    The vasopressor effect of adrenomimetics can also be enhanced when combined with tricyclic antidepressants, methyldopa and m-holinoblokatorami. Preliminary instillation of local anesthetics can increase systemic absorption of active substances and prolong mydriasis.

    Special instructions:

    Due to a significant reduction in the dilator of the pupil, after 30-45 minutes after instillation in the moisture of the anterior chamber of the eye, pigment particles from the iris pigment layer can be detected. The suspension in the chamber moisture must be differentiated with the manifestations of anterior uveitis or with the ingress of the formed elements of blood into the moisture of the anterior chamber.

    Benzalkonium chloride, which is often used in ophthalmic preparations as a preservative, can cause point keratopathy and / or toxic ulcer keratopathy. Because the drug contains benzalkonium chloride, careful monitoring is necessary in case of frequent or prolonged use in patients with the syndrome"dry" eyes or in cases of damage to the cornea. Benzalkonium chloride can change the color of soft contact lenses. It is necessary to remove soft contact lenses before using the drug and wear them again 15 minutes after instillation. Cycloplegics can increase intraocular pressure and provoke the development of closed-angle glaucoma in predisposed individuals, which must be taken into account and conduct a thorough evaluation before starting treatment; tropicamide can induce the onset of psychosis.

    When using drops, avoid contacting the tip of the vial with any surface. To reduce the risk of developing a systemic side effect, it is recommended to lightly press a finger on the area of ​​the projection of lacrimal sacs at the inner corner of the eye within 1-2 minutes after instillation.

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

    After using the drug due to a change in accommodation and the width of the pupil, visual acuity can be reduced, so the use of the drug is not recommended when driving vehicles and when engaging in other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Eye drops.

    Packaging:

    To 5 or 10 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 a high-pressure polyethylene with a cap screwed and a stopper-dropper or 10 ml in a bottle of polyethylene terephthalate with a dropper 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:

    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-004830
    Date of registration:26.04.2018
    Expiration Date:26.04.2023
    The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp28.05.2018
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