Phenylephrine optic, eye drops 2.5% 5 ml

Phenylephrine is an a-adrenomimetic with a marked non-selective a-adrenomimetic effect. When used in therapeutic doses it has no significant stimulating effect on the central nervous system.

When used topically in ophthalmology it causes dilation of the pupil, improves the outflow of intraocular fluid and narrows the conjunctival vessels.

It weakly affects β-adrenoreceptors including those in the heart (does not have positive chrono- and inotropic effects). The drug has a vasoconstrictor effect similar to that of norepinephrine (noradrenaline). The vasopressor effect of phenylephrine is weaker than that of norepinephrine, but it is more durable. Causes vasoconstriction 30-90 seconds after instillation, duration 2-6 h.

Phenylephrine causes contraction of the pupil dilation muscle after instillation, thereby causing pupil dilation. Midriasis occurs within 10-60 minutes after a single instillation. Midriasis persists for 2 hours. Midriasis caused by phenylephrine is not accompanied by cycloplegia.

Indications

Iridocyclitis (to prevent 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.

The provocation test in patients with a narrow anterior chamber angle profile and suspected closed angle glaucoma.

The differential diagnosis of superficial and deep eyeball injection.

The “red eye” syndrome (to reduce hyperemia and irritation of the eye membranes).

Accommodation spasm.

Active ingredient

Composition

Active substances:

Auxiliary substances:

benzalkonium chloride, in terms of anhydrous substance – 0.1 mg,

dinatrium edetate – 1.0 mg,

sodium hydroxide – 0.24 mg,

sodium disulfite – 3.0 mg,

citric acid monohydrate – 1.0 mg,

Interaction

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

The use of phenylephrine with monoamine oxidase inhibitors, and for 21 days after stopping their use, should be used with caution, because in this case there is a possibility of uncontrolled rise in blood pressure.

The vasopressor effect of α-adrenomimetics may also be potentiated with tricyclic antidepressants, propranolol, reserpine, guanethidine, methyldopa and m-cholinoblockers.

Phenylephrine may potentiate cardiovascular depression during inhalation anesthesia.

Concomitant use with other adrenomimetics and sympathomimetics may increase the cardiovascular effects of phenylephrine.

Phenylephrine use may cause impairment of concomitant hypotensive therapy and lead to increased blood pressure, tachycardia.

Directions for use

Topically.

In iridocyclitis the drug is used to prevent development and rupture of already formed posterior synechias; 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 affected eye (eye) 2-3 times a day.

In 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 achieved in 15-30 minutes and lasts for 1-3 hours.

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

A single instillation of the drug is used for diagnostic procedures:

– as a provocative test in patients with a narrow anterior chamber angle profile and suspected closed-angle glaucoma. If the difference between the intraocular pressure values before injecting and after pupil dilation is between 3 and 5 mmHg,

For differential diagnosis of the type of ocular injection: if a narrowing of the globe vessels is noted 5 minutes after instillation, the injection is classified as superficial, and if redness remains, the patient must be closely monitored for iridocyclitis or scleritis, as this would indicate dilation of the deeper vessels.

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

Special Instructions

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

The use of phenylephrine with monoamine oxidase inhibitors, and for 21 days after stopping their use, should be used with caution, because in this case there is a possibility of uncontrolled rise in blood pressure.

The vasopressor effect of α-adrenomimetics may also be potentiated with tricyclic antidepressants, propranolol, reserpine, guanethidine, methyldopa and m-cholinoblockers.

Phenylephrine may potentiate cardiovascular depression during inhalation anesthesia.

Concomitant use with other adrenomimetics and sympathomimetics may increase the cardiovascular effects of phenylephrine.

Phenylephrine use may cause impairment of concomitant hypotensive therapy and lead to increased blood pressure, tachycardia.

Contraindications

Hypersensitivity to the components of the drug.

Narrow-angle or closed-angle glaucoma.

Elderly age.

Severe cardiovascular or cerebrovascular disease.

Hypertension combined with CHD, aortic aneurysm, grade I-III atrioventricular block, arrhythmia.

Tachycardia.

Tear production disorder.

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

Hyperthyroidism.

Hepatic porphyria.

Congenital deficiency of glucose-6-phosphate dehydrogenase.

Rinitis.

With caution

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

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

Sickle cell anemia, contact lens wear, after surgical interventions (decreased healing due to conjunctival hypoxia).

Side effects

Eye disorders

Conjunctivitis, periorbital edema.

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

Phenylephrine may cause reactive miosis the day after use.

Repeated instillations of the drug over a short period of time may result in less severe mydriasis than previously observed. This effect is more common in older patients.

Phenylephrine-induced significant contraction of the pupil dilation muscle may cause iris pigment particles to be seen in the moisture of the anterior chamber 30-45 minutes after instillation.

The suspension in the chamber humor must be differentiated from manifestations of anterior uveitis or from blood cell infiltration into the anterior chamber humor.

Systemic reactions

Skin and skin appendages: contact dermatitis.

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

Overdose

Eye disorders

Conjunctivitis, periorbital edema.

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

Phenylephrine may cause reactive miosis the day after use.

Repeated instillations of the drug over a short period of time may result in less severe mydriasis than previously observed. This effect is more common in older patients.

Phenylephrine-induced significant contraction of the pupil dilation muscle may cause pigment particles from the iris pigment sheet to be seen in the anterior chamber humor 30-45 minutes after instillation. Suspension in the chamber humor must be differentiated from manifestations of anterior uveitis, or from blood cells in the anterior chamber humor.

Systemic reactions

Skin and its appendages: contact dermatitis.

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

Pregnancy use

There is insufficient experience with the use of phenylephrine during pregnancy.

Hence, the use of the drug by prescription during pregnancy is possible if the potential benefit to the mother outweighs the possible risk to the fetus. It is not known whether the drug is excreted with the breast milk.

Breastfeeding should be discontinued when the drug is prescribed.

Similarities