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: disodium edetate 1.0 mg, sodium metabisulfite 2.0 mg, citric acid 1.16 mg, sodium citrate dihydrate q.s., hypromellose 3.0 mg, water for injection up to 1 ml.

    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.

    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 2.5% solution and stored for 2 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. Phenylephrine is excreted by the kidneys in unchanged form (<20%) or in the form of inactive metabolites.

    Indications:

    1. Iridocyclitis (for the prevention of the appearance of posterior synechia and reduction of exudation from the iris).

    2. Expansion of the pupil in ophthalmoscopy and other diagnostic procedures necessary to monitor the state of the posterior segment of the eye, with laser interventions on the fundus and vitreoretinal surgery.

    3. Conducting a provocative test in patients with a narrow anterior chamber angle profile and suspicion of occlusive glaucoma.

    4. Differential diagnosis of superficial and deep injection of the eyeball.

    5. The syndrome of "red eye" (to reduce hyperemia and irritation of the mucous membrane of the eye).

    6. Prevention of asthenopia and spasm of accommodation in patients with high visual load.

    7. Treatment of false myopia (spasm of accommodation) and prevention of progression of true myopia in patients with high visual load.

    Contraindications:

    1. Hypersensitivity to the components of the drug.

    2. Narrow-angle or angle-closure glaucoma.

    3. Arterial hypertension in combination with IHD, aortic aneurysm, atrioventricular blockade of I-III degree, arrhythmia.

    4. Tachycardia.

    5. Diabetes mellitus type I in the anamnesis.

    6. Permanent intake of monoamine oxidase inhibitors, tricyclic antidepressants, antihypertensive drugs.

    7. Additional expansion of the pupil during surgical operations in patients with impaired integrity of the eyeball, as well as in violation of tear production.

    8. Reduced body weight in newborns

    9. Hyperthyroidism.

    10. Hepatic porphyria.

    11. Congenital deficiency of glucose-6-phosphate dehydrogenase.

    12. The period of breastfeeding.

    Carefully:

    In patients with type II diabetes - an increased risk of increasing blood pressure.

    In elderly patients - increased risk of reactive miosis.

    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 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).

    At a cerebral atherosclerosis, long-term existing bronchial asthma.
    Pregnancy and lactation:

    In animals in late pregnancy phenylephrine caused a delay in fetal growth and stimulated the early onset of labor.

    The action of Irifrin® in pregnant women has not been sufficiently studied, therefore, the use of the drug in this category of patients should only be if the expected benefit for the mother exceeds the risk of developing possible side effects for the fetus.

    In the case of the appointment of the drug in lactation, breast-feeding should be discontinued.

    Dosing and Administration:

    When conducting ophthalmoscopy, single instillations of 2.5% solution of Irifrin®. As a rule, for the creation of mydriasis, it is sufficient to administer 1 drop of a 2.5% solution of Irifrin® to the conjunctival sac.

    The maximum mydriasis is reached after 15-30 minutes and remains at a sufficient level for 1-3 hours. If it is necessary to maintain mydriasis for a long time, after 1 hour, repeated instillation of Irifrin® is possible.

    For diagnostic procedures:

    - as a provocative test in patients with a narrow angle of the anterior chamber and suspected of a closed-angle glaucoma, one drop of the drug is instilled once.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, 1 drop of the drug is injected once: if 5 minutes after instillation there is a narrowing of the vessels of the eyeball, 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, expansion of deeper lying vessels.

    With iridocyclites, to prevent the development and rupture of the already formed posterior synechia and to reduce exudation into the anterior chamber of the eye, 1 drop of the drug is instilled in the conjunctival sac of the diseased eye 2-3 times a day, 5-10 days, depending on the severity of the disease.

    For schoolchildren with low degree of myopia to prevent spasm of accommodation during a high visual load, 1 drop of Irifrin® is instilled in the evening before bed, with progressive myopia of moderate degree 3 times a week in the evening before bedtime, with emmetropia - in the daytime, depending on the load.

    In hypermetropia with a tendency to spasmodic accommodation with a high visual load, the evening Irifrin® is administered in combination with 1% cyclopentolate solution. Irritin® 3 times a week in the evening before bedtime is instilled in normal visual exertion. In the treatment of false and true myopia, 1 drop of Irifrin® is buried in the evening before bedtime 2-3 times a week for a month.

    Side effects:

    Local

    Conjunctivitis, keratitis, periorbital edema, pain in the eye, burning with instillation, lacrimation, blurring of vision, irritation, discomfort, increased intraocular pressure, blockage of the anterior chamber angle (with narrowing of the angle), allergic reactions, reactive hyperemia.

    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:

    Rapid heart rate, tachycardia, arrhythmia, increased blood pressure, ventricular arrhythmia, reflex bradycardia, coronary artery occlusion, pulmonary embolism.

    Overdose:

    Symptoms of overdose are anxiety, nervousness, dizziness, sweating, vomiting, heart palpitations, weak or shallow breathing.

    When 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, the injection can be repeated.

    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.

    Irifrin® for 21 days after discontinuation of monoamine oxidase inhibitors and tricyclic antidepressantsbe carried out with caution, since in this case there is the possibility of an uncontrolled rise in blood pressure.

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

    Irifrin® can potentiate the inhibition of cardiovascular activity during inhalation anesthesia as a result of an increase in the sensitivity of the myocardium to sympathomimetics and the occurrence of ventricular fibrillation.

    The use together with other sympathomimetics can increase the cardiovascular effects of phenylephrine.

    The use of phenylephrine can cause a weakening of concomitant antihypertensive therapy and lead to an increase in the level of arterial pressure, tachycardia. Pre-instillation of local anesthetics can increase systemic absorption and prolong mydriasis.

    Form release / dosage:Eye drops, 2.5% (without preservative).
    Packaging:

    To 0.4 ml in disposable tubes-droppers.

    On 5 tubes-droppers in a package of laminated paper.

    For 3 packages of laminated paper in a pack of cardboard along with instructions for use.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-006929/10
    Date of registration:21.07.2010 / 05.12.2013
    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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