Phenylephrine-SZ eye drops 2.5%, 5ml

Composition

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1 ml of the drug contains:

Active ingredient:

phenylephrine hydrochloride-25 mg;

excipients:

sodium edetate dihydrate – 1.0 mg,

citric acid 1.0 mg,

sodium citrate dihydrate – 5.0 mg,

benzalkonium chloride 0.1 mg,

sodium metabisulfite – 3.0 mg,

sodium hydroxide solution,1 M for reduction of pH,

purified water – up to 1.0 ml.

Pharmacological action

Pharmacodynamics

Phenylephrine – alpha-agonists, has expressed neselektivno-adrenomimetic action. When used in therapeutic doses, it 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.

Weakly affects beta-adrenergic receptors, including the heart (does not have a positive chrono – and inotropic effect). 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 30-90 seconds after instillation, lasting 2-6 hours.

After instillation of phenylephrine, the pupil dilator contracts, which leads to mydriasis, and the smooth muscles of the conjunctival arterioles contract. Mydriasis occurs within 10-60 minutes after a single instillation, persists for 2 hours and is not accompanied by cycloplegia.

Pharmacokinetics

Phenylephrine easily penetrates the eye tissue, the maximum concentration in plasma is reached 10-20 minutes after instillation into the eye. Pre-instillation of local anesthetics may increase systemic phenylephrine absorption and prolong mydriasis.

Phenylephrine is excreted unchanged by the kidneys (

Indications

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

For diagnostic dilation of the pupil 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.

Red eye syndrome (to reduce hyperemia and irritability of the eye mucosa).

Spasm of accommodation.

Use during pregnancy and lactation

The effect of phenylephrine in pregnant women has not been sufficiently studied, so the use of the drug during pregnancy is possible if the potential benefit to the mother exceeds the possible risk to the fetus.

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

It is not known whether the drug is excreted in breast milk. When prescribing the drug, it is recommended to stop breastfeeding for the duration of treatment.

Contraindications

Hypersensitivity to the components of the drug.

Narrow-angle or closed-angle glaucoma.

Advanced age.

Severe cardiovascular or cerebrovascular diseases.

Arterial hypertension in combination with coronary heart disease, aortic aneurysm, atrioventricular block of I-III degree, arrhythmia.

Tachycardia.

Violation of tear production.

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

Hyperthyroidism.

Hepatic porphyria.

Congenital deficiency of glucose-6-phosphate dehydrogenase.

Rhinitis.

With caution

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

Concomitant use with monoamine oxidase inhibitors (including for 21 days after discontinuation of their use).

Sickle cell anemia, contact lens wear, after surgery (reduced healing due to conjunctival hypoxia).

Side effects

From the side of the visual organ

Conjunctivitis, periorbital edema.

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

Phenylephrine can cause reactive miosis the day after use. Repeated instillations of the drug for a short period of time can lead to less pronounced mydriasis than previously observed. This effect is more often seen in older patients.

Due to a significant contraction of the pupil dilating muscle, after 30-45 minutes after instillation 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. Suspension in the chamber moisture must be differentiated with the manifestations of anterior uveitis or with the ingress of shaped blood elements into the moisture of the anterior chamber.

Systemic reactions

From the skin and its appendages: contact dermatitis.

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

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 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 a possibility of an uncontrolled rise in blood pressure.

The vasopressor effect of alpha-adrenomimetics can also be potentiated when used concomitantly with tricyclic antidepressants, propranolol, reserpine, guanethidine, methyldopa, and m-holinoblockers.

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 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 a possibility of an uncontrolled rise in blood pressure.

The vasopressor effect of alpha-adrenomimetics can also be potentiated when used concomitantly with tricyclic antidepressants, propranolol, reserpine, guanethidine, methyldopa, and m-holinoblockers.

How to take, course of use and dosage

For topical application.

In 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 patient’s eye (s) 2-3 times a day.

During ophthalmoscopy, a single instillation of the drug is used. As a rule, instillation of 1 drop of the drug into the conjunctival sac is sufficient to create mydriasis. Maximum mydriasis is reached in 15-30 minutes and persists for 1-3 hours.

If it is necessary to maintain mydriasis for a long time, repeated instillation of the drug is possible after 1 hour.

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

– as a provocative test in patients with a narrow profile of the angle of the anterior chamber of the eye and suspected angle-closure glaucoma. If the difference between the values of intraocular pressure prior to instillation of the drug 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: if after 5 minutes after instillation of the drug observed 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, as it expands deeper vessels.

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

Overdose

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

Treatment: if a systemic effect of phenylephrine occurs, adverse events can be stopped by injecting alpha-blockers, for example,5-10 mg of phentolamine intravenously. If necessary, you can repeat the injection.

Description

Clear solution from colorless to light yellow.

Special instructions

Exceeding the recommended dose of 2.5% solution in patients with injuries, diseases of the eye or its appendages, in the postoperative period, or with reduced tear production (anesthesia) may lead to increased absorption of phenylephrine and the development of systemic side effects.

The preservative benzalkonium chloride, which is part of the drug, can cause ulcerative toxic keratopathy with prolonged use, especially in patients with concomitant corneal diseases and dry eye syndrome. Caution should be exercised when using the drug in this group of patients, as well as ensure monitoring of the condition of the cornea with frequent use of the drug in such patients. Benzalkonium chloride can discolor soft contact lenses and irritate the eye mucosa. Before instilling the drug, remove the contact lenses and insert them again no earlier than 15 minutes after instillation.

Influence on the ability to drive vehicles and mechanisms

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

Form of production

Eye drops 2.5%.5 ml or 10 ml in FKP type dropper bottles made of low-pressure polyethylene 10% + high-pressure polyethylene 90% with PC type dropper stoppers made of high-pressure polyethylene + sliding additive and screw-on caps made of low-pressure polyethylene KN. 1 dropper bottle together with the instructions for use is placed in a cardboard pack.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 ° C. Do not freeze it. Keep out of reach of children.

Shelf

life is 2 years. Use within 28 days after opening the bottle. Do not use after the expiration date indicated on the package.

Active ingredient

Phenylephrine

Conditions of release from pharmacies

By prescription

Dosage form

eye drops