Midimax® (Midrimax®)

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

Each 1 ml of the preparation contains:

active substance: phenylephrine hydrochloride 50.0 mg, tropicamide 8.0 mg;

Excipients: sodium metabisulphite 2 mg, benzalkonium chloride 0.1 mg, disodium edetate 1.0 mg, hypromellose 5.0 mg, sodium hydroxide q.s., hydrochloric acid q.s., water for injection up to 1 ml.

Description:Transparent solution from colorless to light brownish-yellow color.
Pharmacotherapeutic group:ophthalmic diseases diagnostic tool (m-cholinoblocker + alpha-adrenomimetic)
ATX: & nbsp
  • Tropicamide in combination with other drugs
    • Pharmacodynamics:

    Phenylephrine non-selective α-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 α-adrenoceptors, has a very weak effect on β1-adrenoceptors. 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 adds to the effect of tropicamide, because the mechanisms of their action are different. Introduction together with tropicamide phenylephrine reduces or reduces the ability of tropicamide to increase intraocular pressure.

    Tropicamide - m-holinoblokator, blocks 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.
    Pharmacokinetics:

    Phenylephrine easily penetrates the tissues of the eye, 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.

    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 at 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.
    Indications:

    It is used as a mydriatic agent:

    1) with diagnostic ophthalmologic procedures;

    2) before surgical and laser operations.

    Contraindications:

    - Hypersensitivity to any of the components;

    - narrow-angle and angle-closure glaucoma;

    - age up to 18 years;

    - diseases of the cardiovascular system (including coronary atherosclerosis, angina, arrhythmia, hypertensive crisis);

    - thyrotoxicosis;

    - Type 1 diabetes mellitus;

    - simultaneous reception (as well as 3 weeks after their cancellation) of monoamine oxidase (MAO) inhibitors;

    - Pregnancy;

    - the period of breastfeeding.
    Carefully:Diabetes mellitus type 2, elderly age (risk of ventricular arrhythmia and myocardial infarction in patients with cardiovascular disease).
    Dosing and Administration:To dilate the pupil with diagnostic ophthalmic and surgical interventions in the conjunctival bag, instill 1-2 drops in 15-30 minutes before the procedure or operation.
    Side effects:

    Local:

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

    System:

    Pale skin, dry mouth, redness and dryness of the skin, contact dermatitis, headache, bradycardia, tachycardia and arrhythmia, increased blood pressure, ventricular occlusion of the coronary arteries, pulmonary embolism, CNS disorders and muscle rigidity, frequent urination , 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:

    Symptoms (in case of accidental ingestion): 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 - α-adrenoblockers (5-10 mg of phentolamine intravenously, if necessary, repeat the injection).

    Interaction:

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

    - Because of the risk of hypertensive crisis is not recommended joint use of phenylephrine and guanethidine, as well as any other adrenoblocker or monoamine reuptake inhibitor.

    - Simultaneous use with monoamine oxidase inhibitors and for three weeks after discontinuation of 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.

    - Pre-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 30-45 min after instillation, particles of the pigment from the iris pigment layer can be detected in the moisture of the anterior chamber of the eye. 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.

    Preservatives contained in the preparation can be absorbed by soft contact lenses. The drug can be irritating to the eye when wearing contact lenses, so any contact lenses should be removed before instillation and put on not earlier than 15 minutes after it.

    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, therefore, the use of the drug is not recommended for driving vehicles, and for other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.
    Form release / dosage:Eye drops.
    Packaging:

    5 ml in a plastic dropper bottle with a screw cap or in a plastic bottle sealed with a stopper capper, closed with a plastic screw cap with the control of the first autopsy.

    Each bottle-dropper or plastic bottle together with the instruction for use is placed in a cardboard box.

    Storage conditions:

    Store at a temperature of no higher than 25 ° C, in a place protected from light.

    Do not freeze. Keep out of the reach of children.

    Shelf life:

    2 years.

    1 month 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-000966
    Date of registration:18.10.2011 / 04.12.2013
    Date of cancellation:2016-10-18
    The owner of the registration certificate:Sentiss Pharma Pvt. Ltd.Sentiss Pharma Pvt. Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspSENTISS RUSS LLCSENTISS RUSS LLCRussia
    Information update date: & nbsp16.03.2016
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