Phenylephrine-SOLOfarm - instructions for use, dose, side effects, contraindications

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 action, similar to the action of norepinephrine (norepinephrine), while it has virtually no chronotropic and ionotropic 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. The mydriasis is preserved after instillation of 2.5% solution for 2 hours. Mydriaz, caused by phenylephrine, is not accompanied by cycloplegia.

Pharmacokinetics:

Phenylephrine easily penetrates the eye tissues, the maximum concentration in the plasma is reached after 10-20 min after instillation into the eye. Phenylephrine is excreted by the kidneys in unchanged form (<20%) or in the form of inactive metabolites.

Indications:

Iridocyclitis (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 suspicion of occlusive glaucoma.

Differential diagnosis of superficial and deep injection of the eyeball.

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

Syndrome of accommodation.

Contraindications:

Hypersensitivity to the components of the drug.

Narrow-angle or angle-closure glaucoma.

Elderly age.

Severe cardiovascular or cerebrovascular disease.

Arterial hypertension in combination with coronary heart disease, aortic aneurysm, atrioventricular blockade of MP degree, arrhythmia.

Tachycardia.

Violation of tear production.

Prematurity; Children under 6 years of age (with accommodation spasm).

Hyperthyroidism.

Hepatic porphyria.

Congenital deficiency of glucose-6-phosphate dehydrogenase.

Rhinitis.

Carefully:

Diabetes mellitus (risk of increased blood pressure associated with a violation of autonomic regulation).

Simultaneous use with monoamine oxidase inhibitors (including within 21 days after discontinuation of their use).

Sickle-cell anemia, wearing contact lenses, after surgical interventions (reduction of healing due to hypoxia of the conjunctiva).

Pregnancy and lactation:

The effect of phenylephrine in pregnant women is not well understood, so the drug in this category of patients is only possible if the expected benefit for the mother exceeds the potential risk to the fetus or child. It is not known whether the drug is excreted in breast milk.

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

When appointing during lactation, breastfeeding should be stopped for the duration of treatment.

Dosing and Administration:

When iridotsiklitah the drug is used to prevent the development and rupture of the already formed rear synechia; 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 (eye) 2-3 times a day.

In the behavior of ophthalmoscopy, single instillations of the drug are used. how rule, to create mydriasis enough instillation 1 drop of the drug in conjunctive bag. The maximum mydriasis is reached after 15-30 minutes and persists for 1-3 hours.

If you need to maintain mydriasis for a long time, after 1 hour, you can re-instillate the drug.

For diagnostic procedures, a single instillation of the drug is used:

- as a provocative test in patients with a narrow angle profile of the anterior chamber of the eye and suspected of a closed-angle glaucoma. If the difference between the values of intraocular pressure before instillation of the drug 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 eyeball injection: if 5 minutes afterinstillation of the drug is marked by 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, since this indicates the expansion of the more deep-seated vessels.

To remove the spasm of accommodation in children from 6 years of age and adults, the drug is instillated 1 drop into each eye at night for 4 weeks.

Side effects:

From the side of the organ of vision

Conjunctivitis, periorbital edema.

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

Phenylephrine may cause a reactive miosis the next day after use. Repeated instillations of the drug at this time may lead to a less pronounced mydriasis than observed earlier. This effect is more common in elderly patients.

Due to a significant contraction of the muscle that dilates the pupil, after 30-45 minutes after instillation under the influence of phenylephrine in the moisture of the anterior chamber of the eye, pigment particles from the iris pigment sheet can be detected.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.

Systemic reactions

From the skin and its appendages: contact dermatitis.

From the cardiovascular system: palpitations, tachycardia, arrhythmia, increased blood pressure, ventricular arrhythmia, reflex bradycardia, coronary artery occlusion, pulmonary embolism.

Overdose:

Symptoms: restlessness, nervousness, dizziness, sweating, vomiting, palpitations, weak or shallow breathing.

Treatment: when a systemic effect of phenylephrine occurs, it is possible to quench unwanted effects by using α-blockers, for example, 5-10 mg of phentolamine intravenously. If necessary, you can repeat the injection.

Interaction:

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

The use of phenylephrine with monoamine oxidase inhibitors,as well as within 21 days after discontinuation of their use should be carried out with caution, since in this case there is the possibility of an uncontrolled rise in blood pressure. The vasopressor effect of α-adrenomimetics can also be potentiated when used simultaneously with tricyclic antidepressants, propranolol, reserpine, guanethidine, methyldopa, and m-holinoblokatorami.

Phenylephrine can potentiate the inhibition of cardiovascular activity with inhalation anesthesia.

Simultaneous use with other adrenomimetics and sympathomimetics can enhance the effect of phenylephrine on the cardiovascular system.

The use of phenylephrine can cause a weakening of concomitant antihypertensive therapy and lead to an increase in the level of arterial pressure, tachycardia.

Special instructions:

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.

Effect on the ability to drive transp. cf. and fur:

After applying the drug due to a change in accommodation and the width of the pupil, visual acuity can be reduced, therefore, it is not recommended to drive vehicles and engage in potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Eye drops 2.5%.

Packaging:

By 0,4 ml in a tube-dropper made of low-density polyethylene or polypropylene.

For 5 or 10 tubes of IV in a foil bag.

For 2 or 4 bags of foil film with 5 tubes or 1 or 2 bags of foil film with 10 tubes, along with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date!

Terms of leave from pharmacies:On prescription

Registration number:LP-004373

Date of registration:11.07.2017

Expiration Date:11.07.2022

The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia

Manufacturer: & nbsp

GROTEKS, LLC Russia

Information update date: & nbsp03.10.2017

Illustrated instructions

Instructions

Phenylephrine-SOLOfarm (Phenylephrine-SOLOpharm)