Phenylephrine optic eye drops 2.5%, 5ml

Composition

Active ingredient:  

• phenylephrine hydrochloride – 25.0 mg.

Auxiliary substances:  

• benzalkonium chloride, in terms of anhydrous substance-0.1 mg,

• disodium edetate-1.0 mg,

• sodium hydroxide-0.24 mg,

• sodium disulfite-3.0 mg,

• citric acid monohydrate-1.0 mg,

• sodium citrate dihydrate-5.0 mg,

• purified water-up to 1 ml.

Pharmacological action

Phenylephrine is an a-adrenomimetic, has a pronounced non-selective a-adrenomimetic effect. 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 vasoconstrictive 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, phenylephrine causes contraction of the pupil dilating muscle, thereby causing pupil dilation. Mydriasis occurs within 10-60 minutes after a single instillation. Mydriasis persists for 2 hours. Mydriasis caused by phenylephrine is not accompanied by cycloplegia.

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 irritation of the membranes of the eye).

Spasm of accommodation.

Use during pregnancy and lactation

There is no sufficient experience with the use of phenylephrine during pregnancy.

Therefore, the use of the drug as prescribed by the attending physician during pregnancy is possible if the potential benefit to the mother exceeds the possible risk to the fetus. 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.

Recommendations for use

Locally.

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, re-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 indicates the extension to the more deep-lying 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.

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 IHD, 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, increased 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.

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

Concomitant use with other adrenomimetics and sympathomimetics may increase the effect of phenylephrine on the cardiovascular system.

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

Overdose

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, increased 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.

Special instructions

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.

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

Concomitant use with other adrenomimetics and sympathomimetics may increase the effect of phenylephrine on the cardiovascular system.

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

Storage conditions

Store in a dark place at a temperature not exceeding 25 C.

Keep out of the reach of children.

Shelf

life is 2 years. Do not use the product after the expiration date indicated on the package. Keep the opened dropper bottle for no more than 30 days.

Active ingredient

Phenylephrine

Conditions of release from pharmacies

By prescription

Dosage form

eye drops