Irifrin® eye drops

Benzalkonium chloride, di-sodium EDTA, hypermellose, sodium hydroxide, sodium meta-bisulfite, sodium hydrophosphate di-hydrate, sodium di- hydrophosphate anhydrous, citric acid, sodium citrate di-hydrate, water for injections.

Composition:

Each ml contains :

Active component: Phenylephrine hydrochloride – 25 mg

Excipients:

Benzalkonium chloride, di-sodium EDTA, hypermellose, sodium hydroxide, sodium meta-bisulfite, sodium hydrophosphate di-hydrate, sodium di- hydrophosphate anhydrous, citric acid, sodium citrate di-hydrate, water for injections.

Pharmacotherapeutic Group:

a-adrenomimetic: Mydriatic and cycloplegic

Indications:

The drug is used in:

  • Iridocyclitis (for prevention of posterior synechia and reduce exudation from the iris).
  • Diagnostic pupil dilation with ophthalmoscopy and other diagnostic procedures required for control of posterior segment eye.
  • Carrying out a provocative test in patients with a narrow profile and the anterior chamber angle-closure glaucoma suspected.
  • Differential diagnosis of superficial and deep injections of the eyeball.
  • Expanding the pupil during the laser interventions in the fundus and vitreoretinal surgery.
  • Treatment of glaucoma-cyclic crises.
  • In the treatment of syndrome of “red eye” 2,5% Irifrin ® solution can help reduce irritation, hyperemia of eye tissues.
  • Spasm of accommodation.

Dosage and administration:

In conducting ophthalmoscopy one instillation of 2.5% solution of Irifrin® is used. Typically, to create mydriasis introduction of 1 drop of 2.5% of Irifrin ® into conjunctival sac is sufficient.

Maximal mydriasis is achieved in15-30 minutes, and remains at sufficient level for 1-3 hours. In the case of the need to maintain mydriasis for longer time, repeated instillation of Irifrin ® in1 hour after first instillation is possible.

To remove the spasm of accommodation in children 6 years and adults 2.5% solution of Irifrin ® 1 drop in each eye at night every day for 4 weeks is recommended .

For diagnostic procedures single instillation of 2.5% solution of Irifrin® is used:

  • as a provocative test in patients with a narrow profile anterior chamber angle and suspicion for closure glaucoma. If difference between the values of intraocular pressure before instillation of Irifrin ® and after dilatation of pupils ranges from 3 to 5 mm Hg., then a provocative test considered positive;
  • for differential diagnosis of eye apple injection type: If after 5 minutes instillation marked narrowing vessels of the eyeball, the injection classified as superficial. While maintaining the eyes reddening patients should be carefully examined for the presence of iridocyсlitis or sclerites, as it demonstrates dilatation of more deep-lying vessels.

In iridocyclitis 2.5% Irifrin® solution is used to prevent the development and rupture of already formed posterior synechia; to reduce the exudation in the anterior chamber of the eye. For this purpose, 1 drop of drug instilled in conjunctival sac of the patient eye (eyes) 2-3 times a day.

Contraindications:

  • Enhanced sensitivity to the drug.
  • Narrow-angle or closed-angle glaucoma.
  • The drug is contraindicated in elderly patients with serious impairment of cardiovascular or cerebrovascular system.
  • The drug is contraindicated for additional pupil dilatation during surgical operations in patients with solution of eyeball continuity, as well as during disturbed tear production.
  • 2.5% drug solution is contraindicated in low-weight newborns.
  • Hyperthyroidism.
  • Hepatic porphyria.
  • Congenital deficiency of glucose-6-phosphate dehydrogenase.

Warning and precautions:

In patients with diabetes mellitus due to increased risk of elevated blood pressure associated with disturbed vegetative regulation. In elderly patients there is a risk of reactive miosis.

Concomitant administration with the MAO inhibitors (inclusive of 21 days after cessation of their administration) Elevation of recommended dose of 2.5% solution in patients with injuries, diseases of eye or eye appendages, patients in post-operation period or patients with reduced tear production (anesthesia), can bring about increased phenylephrine absorption and development of systemic adverse effects.

In patients with crescent cell anemia, contact lenses’ wearers and after surgical interventions (reduced healing), due to the drug-causing hypoxia of conjunctiva.

Adverse effects:

Local effects:

Conjunctivitis, peri-orbital swelling

In some cases patients note burning sensation in the beginning of administration, blurred vision, irritation, feeling of discomfort, lacrimation or intraocular pressure increase.

Phenylephrine can cause reactive miosis on the next day after administration. Repeated drug administrations at this time can produce less marked mydriasis than the day before. This effect is more often manifested in elderly patients.

Due to significant constriction of pupil dilator by phenylephrine, in 30-45 minutes after its instillation the pigment particles derived from the iris pigment leaf can be found in the humor of anterior eye chamber. The particulates in the chamber humor should be differentiated from the manifestations of anterior uveitis or ingress of formed elements in the humor of anterior eye chamber.

Systemic effects:

Contact dermatitis

On the part of cardiovascular system:

Palpitation, tachycardia, cardiac arrhythmia, increased blood pressure, ventricular arrhythmia, reflex bradycardia, occlusion of coronary arteries, embolism of pulmonary artery.

Drug Interaction:

The mydriatic effect of phenylephrine is enhanced upon its combination with topical administration of atropine. Due to its augmentation of vasoconstricting effect, the tachycardia can develop.

Administration of 2.5% of Irifrin® solution with monoaminooxidase inhibitors, as well as during 21 days after cessation of taking these drugs by patients, should be carried out with caution, as in this case there is a possibility of uncontrolled rise of blood pressure.

The vasoconstricting effect of adrenergic agents can be also potentiated by concomitant administration of tricyclic anti-depressants, such as propranolol, reserpine, guanethidine, methyl-dopa and m-choline blockers. Irifrin® can potentiate inhibition of cardiovascular activity during general inhalation anesthesia. Combined Irifrin® administration with sympathomimetics can augment cardiovascular effects by phenylephrine.

Over-dosage:

In case of manifestation of phenylephrine systemic effect, the adverse events can be arrested by using alpha-adrenoblocking drugs, for instance, 5 – 10 mg of phentolamine intravenously. The injection can be repeated, if necessary.

Other related information:

Pregnancy and breastfeeding

Since the effect of Irifrin® in pregnant women and breastfeeding mothers is not well known through enough studies, the drug should be administered in these categories of patients only if the expected effect exceeds the risk of development of possible adverse effects in fetus.

Packaging:

Ophthalmic drops 2.5%

  • By 5 ml in a dark glass bottle sealed with rubber stopper and bunch fold by aluminum cap with protective plastic cap. One glass bottle with sterile dropper packed in polyethylene bag is placed in a carton box along with instruction for application.
  • By 5 ml in a plastic dropper bottle with screw-on cap. Every dropper bottle along with instruction for application is placed in a carton pack.

Storage Conditions:

Store at temperature not above 25°С in a light-protected place. Do not freeze. Store in places out of reach by children

Shelf-life:

  • 2 years
  • After opening the bottle the drug should be used within one month
  • Do not use beyond the expiry date indicated on the package.