Active substancePhenylephrinePhenylephrine
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  • Dosage form: & nbspeye drops
    Composition:

    1 ml of a 2.5% solution of the preparation contains:

    active substance: phenylephrine hydrochloride 25 mg;

    Excipients: benzalkonium chloride 0.1 mg, disodium edetate 1.0 mg, hypromellose 3.0 mg, sodium metabisulfite 2.0 mg, citric acid 1.16 mg, sodium citrate dihydrate 7.5 mg, water for injection q.s.

    1 ml of a 10.0% solution of the preparation contains:

    active substance: phenylephrine hydrochloride 100 mg;

    Excipients: benzalkonium chloride 0.1 mg, disodium edetate 1.0 mg, sodium hydroxide 0.24 mg, sodium hydrogen phosphate dihydrate 0.24 mg, sodium dihydrophosphate anhydrous 1.1 mg, sodium metabisulphite 3.0 mg, citric acid 2.0 mg, sodium citrate dihydrate 2.0 mg,water for injections q.s.

    Description:

    Transparent solution from colorless to light yellow color.

    Pharmacotherapeutic group:Alpha-adrenomimetic
    ATX: & nbsp

    S.01.F.B.01   Ibopamine

    Pharmacodynamics:

    Phenylephrine is a sympathomimetic. Has a pronounced alpha-adrenergic activity and when used in normal doses does not have a significant stimulating effect on the central nervous system.

    With topical application in ophthalmology causes the dilatation of the pupil, improves the outflow of intraocular fluid and narrows the vessels of the conjunctiva.

    Phenylephrine has a pronounced stimulating effect on postsynaptic alpha-adrenoceptors, has a very weak effect on the beta-adrenoreceptors of the heart. The drug has a vasoconstrictive effect, similar to the action of norepinephrine (noradrenaline), while it has virtually no chronotropic and inotropic effects on the heart. The vasopressor effect of phenylephrine is weaker than that of norepinephrine, but is more prolonged. Causes vasoconstriction after 30-90 seconds after instillation, duration 2-6 hours.

    After instillation phenylephrine reduces the dilator pupil and smooth muscle arterioles of the conjunctiva, thereby causing a dilated pupil. Midriaz occurs within 10-60 minutes after a single instillation. Continues after instillation of 2.5% solution and stored for 2 hours, 10% solution - 3-7 hours. Mydriaz, caused by phenylephrine, is not accompanied by cycloplegia.

    Pharmacokinetics:

    Phenylephrine easily penetrates the tissues of the eye, the peak concentration in the plasma occurs 10 to 20 minutes after topical application. Pre-instillation of local anesthetics can increase systemic absorption and prolong mydriasis. Phenylephrine is excreted in the urine in unchanged form (<20%) or in the form of inactive metabolites.

    Indications:

    The drug is used for:

    - iridotsiklite (for the prevention of the appearance of posterior synechia and reduction of exudation from the iris);

    - for diagnostic dilatation of the pupil in ophthalmoscopy and other diagnostic procedures necessary for monitoring the state of the posterior segment of the eye;

    - conducting a provocative test in patients with a narrow anterior chamber angle profile and suspected closure angle glaucoma;

    - differential diagnosis of superficial and deep injection of the eyeball;

    - 10% solution in ophthalmic surgery in preoperative preparation for pupil dilatation;

    - carrying out laser interventions on the fundus and vitreoretinal surgery for the dilatation of the pupil;

    - treatment of glaucoma-cyclical crises. In the treatment of the "red eye" syndrome, a 2.5% solution of Irifrin® can help reduce hyperemia and irritation of the eye membranes;

    - spasm of accommodation.

    Contraindications:

    - Hypersensitivity to the drug;

    - theangle or angle-closure glaucoma;

    - PThe drug is contraindicated in elderly patients with serious impairment of the cardiovascular or cerebrovascular system;

    - PContraindicated use of the drug for additional expansion of the pupil during surgery in patients with impaired integrity of the eyeball, as well as in violation of tear production;

    - 10% solution of the drug is contraindicated in children under 12 years of age;

    - patients with an aneurysm of the arteries;

    - 2.5% solution of the drug is contraindicated in premature babies;

    - ghyperthyroidism;

    - Phepatic porphyria;

    - atborn deficiency of glucose-6-phosphate dehydrogenase.

    Carefully:

    Patients with diabetes mellitus - an increased risk of increased blood pressure associated with a violation of autonomic regulation.

    In elderly patients - increased risk of reactive miosis.

    Simultaneous application with MAO inhibitors (including within 21 days after discontinuation of their intake).

    Exceeding the recommended dose of 2.5% solution in patients with trauma, eye disease or its appendages, in the postoperative period, or with reduced tear production (anesthesia) can lead to an increase in the absorption of phenylephrine and the development of systemic side effects.

    Because of what causes conjunctival hypoxia - in patients with sickle cell anemia, with contact lenses, after surgical interventions (decreased healing).

    Pregnancy and lactation:

    Since the action of Irifrin® in pregnant women and nursing mothers is not well understood, it is necessary to apply the drug in these categories of patients only if the expected effect exceeds the risk of possible side effects in the fetus.

    Dosing and Administration:

    When conducting ophthalmoscopy, single-dose instillation 2.5% solution Irifrin®. Typically, for the creation of mydriasis, it is sufficient to administer 1 drop of 2.5% irifrin® to the conjunctival sac.

    The maximum mydriasis is reached after 15-30 minutes and lasts for 1-3 hours.

    If it is necessary to maintain mydriasis for a long time, after 1 hour, repeated instillation of Irifrin® is possible.

    In adults and children over 12 years with insufficient expansion of the pupil, as well as in patients with a rigid iris (marked pigmentation), 10% irifrin can be used in the same dose for diagnostic dilatation of the pupil.

    To remove the spasm of accommodation, a 2.5% solution of Irifrin® in children from 6 years of age and adults is prescribed 1 drop in each eye at night for 4 weeks.

    In the case of a persistent accommodation spasm, 10% of the solution of Irifrina® can be used in children from the age of 12 and adults in 1 drop in each eye daily for the night for 2 weeks.

    For the diagnostic procedures, a single instillation of a 2.5% solution of Irifrin® is applied:

    - as a provocative test in patients with a narrow angle profile of the anterior chamber and suspected of a closed-angle glaucoma. If the difference between the values ​​of intraocular pressure before instillation of Irifrin® and after dilating the pupil is from 3 to 5 mm Hg, the provocative test is considered positive;

    - for differential diagnosis of the type of injection of the eyeball: if, after 5 minutes after instillation, the narrowing of the vessels of the eyeball is noted, the injection is classified as superficial, while maintaining the redness of the eye, it is necessary to carefully examine the patient for the presence of iridocyclitis or scleritis, since this indicates the expansion of the more deep-seated vessels .

    Iridocyclitis 2.5% or 10.0% Irifrina® solution is used to prevent the development of the posterior synechia that has already formed; to reduce exudation in the anterior chamber of the eye. To this end, 1 drop of the drug is buried in the conjunctival sac of the diseased eye (eyes) 2-3 times a day.

    In glaucoma-cyclical crises, the vasoconstrictor effect of phenylephrine helps to reduce intraocular pressure, which is most pronounced with a 10% solution of the drug.

    For relief of glaucoma-cyclical crises, 10% of Irifrin® is digested 2-3 times a day.

    When preparing patients for surgical interventions 30-60 minutes prior to surgery, a single instillation of 10% Irifrin® solution is made to achieve mydriasis.After opening the shells of the eyeball, repeated instillation of the drug is not allowed. 10% solution is not used for irrigation, impregnation of tampons during surgery and for subconjunctival administration.

    Side effects:

    Local

    Conjunctivitis, periorbital edema.

    In some cases, patients note a burning sensation at the beginning of the application, blurred vision, irritation, a feeling of discomfort, lacrimation, increased intraocular pressure.

    Phenylephrine may cause a reactive miosis the next day after application. 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.

    Due to a significant reduction in the pupil dilator under the influence of phenylephrine, particles of the pigment from the iris pigmentary leaf can be detected 30-45 minutes after instillation 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.

    System

    Contact dermatitis

    From the cardiovascular system:

    Heart palpitations, tachycardia, cardiac arrhythmia, increased blood pressure, ventricular arrhythmia, reflex bradycardia, coronary artery occlusion, pulmonary embolism.

    In rare cases, after topical use of a 10% solution of phenylephrine, serious cardiovascular disorders may occur, including myocardial infarction, vascular collapse, and intracranial hemorrhage.

    Overdose:

    If a systemic effect of phenylephrine occurs, it is possible to quench unwanted effects by using alpha-adrenergic blocking agents, for example 5 to 10 mg of phentolamine intravenously. If necessary, you can repeat the injection.

    Interaction:

    The mydriatic effect of phenylephrine is enhanced when used in combination with topical application of atropine. Because of the increased vasopressor effect, tachycardia can develop.

    Use of 2.5% or 10% Irifrina® with monoamine oxidase inhibitors, and also within 21 days after discontinuation of these drugs should be carried out with caution, since in this case there is the possibility of uncontrolled rise in blood pressure.

    The vasopressor effect of adrenergic agents can also be potentiated when combined with tricyclic antidepressants, propranolol, reserpine, guanethidine, methyldopa and m-holinoblokatorami.

    Use of a 10% solution of Irifrina® in combination with systemic application of beta-blockers can lead to acute hypertension.

    Irifrin® can potentiate oppression of cardiovascular activity with inhalation anesthesia.

    Application in conjunction with sympathomimetics can increase the cardiovascular effects of phenylephrine.

    Form release / dosage:

    Eye drops, 2.5% and 10.0%.

    Packaging:

    - 5 ml per bottle of dark glass, closed with a rubber stopper, crimped with an aluminum cap with a safety plastic cap. One glass a bottle with a sterile dropper packed in a plastic bag is placed in a cardboard box together with instructions for use.

    - 5 ml each in a plastic dropper bottle with a screw cap. Each vial-dropper along 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 dark place. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    After opening the bottle, the expiration date is 1 month.

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

    Terms of leave from pharmacies:On prescription
    Registration number:П N013268 / 01
    Date of registration:04.05.2008 / 04.12.2013
    Expiration Date:Unlimited
    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: & nbsp28.11.2017
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