Irifrin BK, eye drops 2.5%, 0.4ml, 15pcs

Composition

Active ingredient:  

phenylephrine hydrochloride 25 mg;

Auxiliary substances:

disodium edetate 1.0 mg,

sodium metabisulfite 2.0 mg,

citric acid 1.16 mg,

sodium citrate dihydrate e. e.,

hyprmellose 3.0 mg,

water for injection q. s.

Pharmacological action

Irifrin BC has an alpha-adrenomimetic effect.

Pharmacodynamics

of Phenylephrine-adrenomimetic. It has a pronounced alpha-adrenergic activity and when used in normal doses does not have a significant stimulating effect on the central nervous system.

When applied topically in ophthalmology, it causes dilation 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-adrenergic receptors, has a very weak effect on beta-adrenergic receptors of the heart, it has almost no positive chronotropic and inotropic effect on the heart. The drug has a vasoconstrictor effect similar to that of norepinephrine (norepinephrine). The vasopressor effect of phenylephrine is weaker than that of norepinephrine, but is longer lasting. Causes vasoconstriction in 30-90 seconds after instillation, duration — 2-6 hours.

After instillation, phenylephrine reduces the dilator of the pupil, thereby causing dilation of the pupil and smooth muscles of the conjunctival arterioles. Mydriasis occurs within 10-60 minutes after a single instillation; it continues after instillation of a 2.5% solution for 2 hours; 10% solution-3-6 hours. Mydriasis caused by phenylephrine is not accompanied by cycloplegia.

Pharmacokinetics

Phenylephrine easily penetrates the eye tissue, Cmax in plasma occurs 10-20 minutes after topical application. Pre-instillation of local anesthetics may increase systemic absorption and prolong mydriasis. Phenylephrine is excreted unchanged in the urine (

Indications

• iridocyclitis (to prevent the back of adhesions and decrease exudation in the iris);
• mydriasis during ophthalmoscopy and other diagnostic procedures necessary to control the state of the posterior segment of the eye;
• conduct a provocative test in patients with a narrow profile of the anterior chamber angle and suspected angle closure glaucoma;
• differential diagnosis of superficial and deep injections of the eyeball;
• in ophthalmic surgery in the preoperative preparation for pupil dilation (10% solution);
• the laser interventions in the fundus and in vitreoretinal surgery;
• treatment glycomimetics crises;
• treatment of the syndrome of red eyes

Use during pregnancy and lactation

Pregnancy

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

The effect of Irifrin CD in pregnant women has not been sufficiently studied, so the drug should be used in this category of patients only if the expected benefit to the mother exceeds the risk of possible side effects for the fetus.

Lactation

If the drug is prescribed during lactation, breast-feeding should be discontinued.

Contraindications

• hypersensitivity to the drug;
• narrow-angle or angle-closure glaucoma;
• older age with severe disorders of the cardiovascular or cerebrovascular system;
• additional mydriasis during surgery in patients with impaired integrity of the eyeball and in violation of lesoprodukt;
• hyperthyroidism;
• hepatic porphyria,
• congenital deficiency of glucose-6-phosphate dehydrogenase;
• children under 12 years of age and patients with aneurysms of the arteries (10% solution);
• premature children (2.5% solution).

With caution:  patients with type 2 diabetes mellitus (increased risk of increased blood pressure associated with impaired autonomic regulation); elderly patients (increased risk of reactive miosis); concomitant use with MAO inhibitors and for 21 days after discontinuation of their use; due to the fact that it causes conjunctival hypoxia: patients with sickle cell anemia, wearing contact lenses, after surgery (reduced healing).

Side effects

Local users

Conjunctivitis, periorbital edema. In some cases, patients report a burning sensation (at the beginning of application), blurred vision, irritation, discomfort, lacrimation, increased intraocular pressure.

Phenylephrine can cause reactive miosis on the next day after application; at this time, repeated instillations of drugs can give less pronounced mydriasis than the day before; the effect is more often manifested in elderly patients.

Due to a significant reduction of the pupil dilator under the influence of phenylephrine, pigment particles from the iris pigment sheet can be detected in the moisture of the anterior chamber of the eye 30-45 minutes after instillation. Suspension in the chamber moisture must be differentiated with the manifestations of anterior uveitis or the ingress of shaped blood elements into the moisture of the anterior chamber.

System requirements:  contact dermatitis.

From the CCC side:  rapid heartbeat, tachycardia, cardiac arrhythmia, increased blood pressure Blood pressure, ventricular arrhythmia, reflex bradycardia, coronary artery occlusion, pulmonary embolism.

In rare cases, local use of 10% phenylephrine may result in myocardial infarction, vascular collapse, and intracranial hemorrhage.

Interaction

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

The use of Irifrin BC for 21 days after discontinuation of monoamine oxidase inhibitors and tricyclic antidepressants in patients should be carried out with caution, since in this case there is a possibility of an uncontrolled rise in blood pressure.

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

Irifrin CD may potentiate the inhibition of cardiovascular activity during inhalation anesthesia as a result of increased myocardial sensitivity to sympathomimetics and the occurrence of ventricular fibrillation.

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

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

Pre-instillation of local anesthetics may increase systemic absorption and prolong Mydriasis

How to take, course of use and dosage

Conjunctival. During ophthalmoscopy, single instillations of a 2.5% solution of Irifrin ® BK are used. As a rule, the introduction of 1 drop of 2.5% solution of Irifrin® BK into the conjunctival sac is sufficient to create mydriasis.

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

During diagnostic procedures:

– as a provocative test in patients with a narrow profile of the anterior chamber angle and suspected angle-closure glaucoma,1 drop of the drug is instilled once. If the difference between the values of intraocular pressure prior to instillation of Erythrina® BC and after pupil dilation is 3 to 5 mm Hg. article, the provocation test is considered positive;

– for the differential diagnosis of the type of injection of the eyeball instilled 1 drop of the drug once; if 5 minutes after instillation of marked narrowing of the vessels of the eyeball, the injection is classified as superficial, while maintaining the redness of the eyes, one should carefully examine the patient for the presence of iridocyclitis or scleritis, because it indicates the extension of the underlying vessels.

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

In schoolchildren with mild myopia,1 drop of Irifrin® BK is instilled in the evening before bedtime to prevent spasm of accommodation during periods of high visual load, 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 case of hypermetropia with a tendency to a spasm of accommodation with high visual load, Irifrin® BK is instilled in the evening in combination with a 1% cyclopentolate solution. With normal visual load, Irifrin® BK is instilled 3 times a week in the evening before going to bed.

In the treatment of false and true myopia-1 drop of Irifrin ® BK is instilled in the evening before going to bed 2-3 times a week for a month.

Overdose

Symptoms of overdose include restlessness, nervousness, dizziness, sweating, vomiting, rapid heartbeat, and weak or shallow breathing.

Treatment: if a systemic effect of phenylephrine occurs, adverse events can be stopped by using alpha-blocking agents, for example, from 5 to 10 mg of phentolamine intravenously.

If necessary, the injection can be repeated.

Form of production

Eye drops

Storage conditions

In a dark place, at a temperature not exceeding 25 °C. Do not freeze it.

Shelf life

2 years

Active ingredient

Phenylephrine

Conditions of release from pharmacies

By prescription

Dosage form

eye drops