Irifrin BK® Eye Drop 0.4ml

Registration number : ЛСР-006929/10

Trade name:

Irifrin ® BK

International nonproprietary name:

phenylephrine

Dosage form:

eye drops (without preservative)

Ingredients:

Each mL of 2.5% solution of the drug contains:
Active ingredient: Phenylephrine hydrochloride – 25 mg

Excipients:

Disodium edetate, sodium metabisulfite, citric acid, sodium citrate dihydrate, hypromellose, water for injection.

Description:

Clear solution from colorless to light yellow.

Pharmacotherapeutic Group:

Adrenoagonists

Pharmacological Properties:

Pharmacodynamics

Phenylephrine – sympathomimetic activity. It has expressed the alpha-adrenergic activity. In local application in ophthalmology is dilated pupils, increases the outflow of intraocular fluid and narrows blood vessels of the conjunctiva.

Phenylephrine has a pronounced stimulating effect on the postsynaptic alpha-adrenergic receptors, has very little effect on beta-adrenergic receptors of the heart. The drug has vasoconstrictor action, such action of norepinephrine (noradrenaline), while it had no chronotropism and inotropic effects on the heart. Pressor effect of phenylephrine is weaker than that of noradrenaline, but is more prolonged. Causes vasoconstriction after 30-90 seconds after instillation, duration 2-6 hours. After the instillation of phenylephrine reduces the dilator muscle and smooth muscle of arterioles of the conjunctiva, thus causing the expansion of the pupil. Mydriasis occurs within 10-60 minutes after a single instillation. Continues after the instillation of 2.5% solution and stored for 2 hours. Mydriasis caused by phenylephrine, not accompanied by a cycloplegia.

Pharmacokinetics:

Phenylephrine easily penetrate the eye tissues, the peak plasma concentrations occurs 10-20 minutes after local application. Phenylephrine is allocated kidneys unchanged (<20%) or in the form of inactive metabolites.

Indications:

  • Iridocyclitis (for prevention of posterior synechia and reduce exudation from the iris).
  • Dilated pupils with ophthalmoscopy and other diagnostic procedures required for control of posterior segment eye during the laser interference in the fundus and vitreoretinal surgery.
  • Carrying out a provocative test in patients with a narrow profile and the anterior chamber angle-closure glaucoma suspected.
  • Differential diagnosis of superficial and deep injections of the eyeball.
  • Syndrome of “red eye” (to reduce hyperemia and eye irritation).
  • Prevention of asthenopia and spasm of accommodation in patients with high visual load.
  • Treatment of false myopia (spasm of accommodation) and prevention of progression of myopia true in patients with high visual load.

Contraindications:

  • Hypersensitivity to the drug’s components.
  • Narrow-angle or angle-closure glaucoma.
  • Arterial hypertension combined with ischemic heart disease, aortic aneurysm, AV block I – III degree fibrillation.
  • Tachycardia.
  • Diabetes mellitus type I in history.
  • Permanent receiving MAO inhibitors, tricyclic antidepressants, antihypertensive drugs.
  • Additional expansion of the pupil during surgery in patients with a violation of the integrity of the eyeball, as well as in violation of lacrimation.
  • Reduce body weight in newborns
  • Hyperthyroidism.
  • Hepatic porphyria.
  • Congenital deficiency of glucose-6-phosphate dehydrogenase.
  • Period of breastfeeding.

Precautions:

Patients with diabetes mellitus type II – an increased risk of elevated blood pressure. In elderly patients – increased risk of reactive miosis.

Exceeding the recommended dose of 2.5% solution in patients with injuries, eye diseases, or its appendages, in the postoperative period, or with reduced lacrimation may increase the absorption of phenylephrine and the development of systemic side effects.

Because drug causes hypoxia of the conjunctiva – in patients with sickle cell anemia, while wearing contact lenses, after surgical interventions (reduction of healing). With cerebral arteriosclerosis, long-existing asthma.

Pregnancy and lactation:

In animals in late pregnancy phenylephrine caused fetal growth retardation and has stimulated early onset of labor.

Effect of Irifrin® in pregnant women wasn’t adequately studied, so use of the drug in such patients should only if the expected benefits to the mother outweigh the risks of possible side effects to the fetus. In the case of a drug during lactation, breast-feeding should be discontinued.

Dosing and Administration:

For ophthalmoscopy a one-time instillation of 2.5% solution Irifrin® is used. Typically, to create mydriasis it is sufficient to introduce a drop of 2,5% solution Irifrin® in the conjunctival sac. Maximal mydriasis is achieved after 15-30 minutes and maintained at a sufficient level within 1-3 hours. In the case of the need to maintain mydriasis during a long time, after 1 hour it is possible to re-instill Irifrin®.

To carry out diagnostic procedures:

As a provocative test in patients with a narrow profile and the anterior chamber angle-closure glaucoma suspected instill 1 drop of the drug once. If the difference between the values of intraocular pressure before instillation of Irifrin® and after pupil dilation from 3 to 5 mm Hg., the provocative test is considered positive

For the differential diagnosis of type injection eyeball instilled 1 drop of the drug only once: if 5 minutes after instillation marked narrowing of the vessels of the eyeball, the injection is classified as superficial, while maintaining the redness of the eyes should be carefully examined patients for the presence of iridocyclitis or sclerites, as it indicates the dilatation of a deep-lying vessels.

In patients with iridocyclitis – to prevent the development and rupture of the already formed posterior synechia and reduce exudation into the anterior chamber of the eye, 1 drop of the drug instilled in the conjunctival sac of the patient’s eyes 2-3 times a day 5-10 days depending on the severity of the disease.

In students with a low degree of myopia for the prevention of spasm of accommodation in a period of high visual load, 1 drop Irifrin ® instilled the evening before bedtime, with progressive myopia moderately 3 times a week at night before bed, with emmetropia – during the day depending on the load.

In patients with hyperopia with a tendency to spasm of accommodation with a high visual load instill Irifrin ® in the evening in combination with a cyclopentolate 1% solution. In a typical visual loading bury Irifrin ® 3 times a week in the evening before bedtime. In the treatment of false and true myopia instill 1 drop of Irifrin ® the evening before going to bed 2-3 times a week during the month.

Side effect:

Local

Conjunctivitis, keratitis, periorbital swelling, pain in the eye, burning during instillation, lacrimation, blurred vision, irritation, discomfort, increased intraocular pressure, blocking the anterior chamber angle (narrowing of the angle), allergic reactions, reactive hyperemia. Phenylephrine can cause reactive miosis on the day after application. Repeated instillation of the drug at this time may give a less pronounced mydriasis than the day before. This effect is often seen in elderly patients.

Due to a significant reduction in dilator muscle under the influence of phenylephrine 30-45 minutes after instillation of moisture in the anterior chamber of the eye can be detected particles of pigment from the pigment layer of the iris. The suspension in the chamber humidity should be differentiated from the manifestations of anterior uveitis or with spillage of blood cells in the anterior chamber of the moisture.

Contact Dermatitis:

From the cardiovascular system:

Heart palpitations, tachycardia, arrhythmia, high blood pressure, ventricular arrhythmias, reflex bradycardia, occlusion of coronary arteries, pulmonary embolism.

Overdose:

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

If you have any systemic effects of phenylephrine to arrest the adverse effects can be achieved by the use of alpha-adrenoceptor blocking agent, for example, from 5 to 10 mg fentolamine intravenously. If necessary, the injection can be repeated.

Interaction with other drugs:

Mydriatic effect of phenylephrine enhanced when used in combination with local application of atropine. Because of the increasing pressor action may develop tachycardia.

Application of Irifrin® within 21 days after patients stopped taking MAO inhibitors and tricyclic antidepressants should be done with caution, since in this case there is the possibility of an uncontrolled rise in blood pressure.

Vasopressor action of adrenergic agents may also potentiate in joint application with the tricyclic antidepressants, beta blockers, reserpine, guanetidin, methyldopa and m-holinoblocers.

Irifrin ® may potentiate the inhibition of cardiovascular activity during inhalation anesthesia by increasing the sensitivity of the myocardium to sympathomimetics and occurrence of ventricular fibrillation.

Use in conjunction with other sympathomimetics may increase cardiovascular effects of phenylephrine.

The use of phenylephrine may cause weakening of concomitant antihypertensive therapy and lead to an increase in blood pressure, tachycardia.

Pre-instillation of local anesthetics may increase the systemic absorption and prolong mydriasis.

Product:

Eye drops 2,5% (without preservative). 0.4 ml in tube-dropper. 5 tube-dropper in a pouch of laminated paper. 3 pouches of laminated paper in a carton unit with instructions for use.

Expiration date:

  • 2 years
  • Do not use after the expiry date stated on the packaging.

Storage conditions:

  • In the dark place at temperatures below 25 ° C. Do not freeze
  • Keep out of reach of children.

Release condition:

By Prescription.