Stelfrin supra eye drops 2.5%, 10ml # 1

-Iridocyclitis (to prevent the occurrence of posterior synechiae and reduce exudation from the iris).

-For diagnostic pupil dilation during ophthalmoscopy and other diagnostic procedures necessary to monitor the condition of the posterior segment of the eye.

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

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

-Syndrome 'red eye' (to reduce hyperemia and irritation of the mucous membrane of the eye).

- Spasm of accommodation.

With iridocyclitis, the drug is used to prevent the development and rupture of already formed posterior synechiae; to reduce exudation into the anterior chamber of the eye. For this purpose, 1 drop of the drug is instilled into the conjunctival sac of the diseased eye (s) 2-3 times a day.

When conducting ophthalmoscopy, single instillations of the drug are used. As a rule, instillation of 1 drop of the drug into the conjunctival sac is sufficient to create mydriasis. The maximum mydriasis is achieved in 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 the drug is possible.

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

- as a provocative test in patients with a narrow anterior chamber angle profile and suspected angle-closure glaucoma. If the difference between the values ??of intraocular pressure before instillation of the drug and after dilatation of the pupil is from 3 to 5 mm Hg. Art., then the provocative test is considered positive;

- for differential diagnosis of the type of injection of the eyeball: if, 5 minutes after instillation of the drug, there is a narrowing of the vessels of the eyeball, then the injection is classified as superficial, while the redness of the eye persists, it is necessary to carefully examine the patient for the presence of iridocyclitis or scleritis, as this indicates the expansion of deeper vessels.

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

How to work with a dropper tube:

1. Separate one dropper tube.

2. Open the dropper tube (making sure that the solution is in the lower part of the dropper tube, rotate and separate the valve with rotating movements).

3. Drop the required amount of the drug into the eyes. The dose contained in the dropper tube is sufficient for one instillation in both eyes. Throw away the dropper tube after a single use, even if any contents remain.

How to work with a bottle complete with a drop dispenser:

1. Remove the safety ring before using the bottle for the first time.

2. Carefully remove the cap from the bottle. Without touching the dispenser, turn the bottle upside down with the dispenser, fixing it between the thumb and forefinger. Before starting use, it is recommended to pump the dispenser until the first drop of the drug appears by several presses with the index finger on top of the bottle.

3. Tilt your head back, position the bottle dispenser over the eye and pull the lower eyelid down with the index finger of one hand. Press lightly on the bottle and drop the required amount of solution into the conjunctival sac of the eye. Avoid contact of the tip of an open bottle with the surface of the eye and hands.

4. After use, put the cap on the bottle. After opening the bottle, the drug can be used throughout the shelf life.

After this period, the drug should be destroyed. In case of visible damage to the vial, the drug should not be used.

1 ml of the drug contains:

Active substance:

Phenylephrine hydrochloride 25.0 mg

Excipients:

Polyethylene glycol 300 (macrogol 300) 19.0 mg

Sodium hyaluronate 2.7 mg

Water for injection up to 1.0 ml

Hypromellose 3.0 mg

Disodium edetate dihydrate (Trilon B) 1.0 mg

Water for injection up to 1 ml

-Hypersensitivity to the components of the drug.

- Narrow-angle or angle-closure glaucoma.

-Elderly age.

- Severe cardiovascular or cerebrovascular diseases.

-Arterial hypertension in combination with ischemic heart disease, aortic aneurysm, atrioventricular block I-III 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 impaired autonomic regulation).

- Simultaneous use with monoamine oxidase inhibitors (including within 21 days after stopping their use). -Serve cell anemia, wearing contact lenses, after surgery (decreased healing due to conjunctival hypoxia).

Pharmacodynamics

Phenylephrine is a sympathomimetic. Has a pronounced alpha-adrenergic activity. When applied topically in ophthalmology, it causes 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-adrenergic receptors, has a very weak effect on the beta-adrenergic receptors of the heart. The drug has a vasoconstrictor effect similar to that of norepinephrine (norepinephrine), while it has practically 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 30-90 s after instillation, duration - 2-6 hours. After instillation, phenylephrine reduces the pupil dilator and smooth muscles of the conjunctival arterioles,thereby causing pupil dilation. Mydriasis occurs within 10 to 60 minutes after a single instillation. Mydriasis persists after instillation of a 2.5% solution for 2 hours. Mydriasis caused by phenylephrine is not accompanied by cycloplegia.

Pharmacokinetics

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

Side effects

On the part of the organ of vision

Conjunctivitis, periorbital edema. In some cases, patients note a burning sensation at the beginning of use, blurred vision, irritation, a feeling of discomfort in the eye, increased lacrimation, and an increase in intraocular pressure. Phenylephrine can cause reactive miosis the day after application. Repeated instillations of the drug at this time can lead to less pronounced mydriasis than previously observed. This effect is more common in older patients. Due to a significant contraction of the muscle that dilates the pupil, 30-45 minutes after instillation under the influence of phenylephrine, particles of pigment from the pigment layer of the iris can be found in the moisture of the anterior chamber of the eye.The suspension in the chamber moisture must be differentiated with manifestations of anterior uveitis or with the ingress of blood cells into the moisture of the anterior chamber.

Systemic reactions

On the part of the skin and its appendages: contact dermatitis. From the side of the cardiovascular system: palpitations, tachycardia, arrhythmia, increased blood pressure, ventricular arrhythmia, reflex bradycardia, coronary artery occlusion, pulmonary embolism.

Special conditions

Exceeding the recommended dose of a 2.5% solution in patients with injuries, diseases of the eye 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. The drug does not contain a preservative in its composition, which avoids the undesirable effect of the preservative on the outer tissues of the eye, conjunctiva and cornea, and also eliminates the risk of developing allergic reactions to the preservative.

Influence on the ability to drive vehicles and mechanisms

After using the drug, due to changes in accommodation and pupil width, a decrease in visual acuity is possible, therefore, until it is restored, it is not recommended to drive vehicles and engage in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Drug interactions

The mydriatic effect of phenylephrine is enhanced when used in combination with topical atropine. Due to increased vasopressor action, tachycardia may develop. The use of phenylephrine with monoamine oxidase inhibitors, as well as within 21 days after the termination of their use, 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 ?-adrenomimetics can also be potentiated when used simultaneously with tricyclic antidepressants, propranolol, reserpine, guanethidine, methyldopa and m-anticholinergics. Phenylephrine can potentiate the inhibition of cardiovascular activity during inhalation anesthesia.Concomitant use with other adrenergic agonists and sympathomimetics may 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 blood pressure, tachycardia.