Oloridin, eye drops 0.1% 5 ml

Pharmacotherapeutic group: Antiallergic agent – H1-histamine receptor blocker.

ATC code: S01GX09

Pharmacological properties

Pharmacodynamics

Indications

Active ingredient

How to take, the dosage

Topically.

Push 1 drop of the solution into the conjunctival sac of the affected eye twice a day (8 hours apart).

The treatment duration is up to four months.

If necessary, the drug can be used in combination with other drugs. In this case, the interval between their application should be at least 5 minutes.

Elderly people

There is no need to adjust doses for elderly patients.

Children 3 years and older

The drug can be used in the same doses as in adults.

Renal or hepatic impairment

There have been no studies in patients with renal or hepatic impairment regarding the administration of olopatadine in the form of eye drops. However, no dose adjustments are expected to be necessary in patients with renal or hepatic impairment.

Interaction

Studies of interaction of olopatadine with other medicinal products have not been conducted.

In in vitro studies it was demonstrated no inhibition of metabolic reactions mediated by cytochrome Р450 isoenzymes 1A2, 2С8, 2С9, 2С19, 2D6, 2Е1 and 3А4. According to the results obtained, the probability of entering into metabolic reactions of olopatadine when co-administered with other drugs is estimated to be low.

Special Instructions

Olopatadine hydrochloride is an anti-allergic/antihistamine drug for topical use in ophthalmology, and despite local use, it may be absorbed into the systemic bloodstream. In case of pronounced hypersensitivity reactions the drug should be discontinued. The drug contains benzalkonium chloride, which may cause eye irritation and discoloration of soft contact lenses. Contact of the drug with soft contact lenses should be avoided. Patients should be instructed to remove their contact lenses before using the product and put them back on not earlier than 15 min after injecting.

Benzalkonium chloride may cause keratitis pitting or toxic ulcerative keratopathy if patients have dry eye or corneal pathology with frequent or prolonged use.

Synopsis

Contraindications

Hypersensitivity to the components of the drug, pregnancy and breastfeeding, age less than 3 years.

With caution

In patients with concomitant dry eye syndrome and corneal diseases.

Side effects

General information on the profile of adverse events

In clinical trials involving 1680 patients the dosing regimen was 1 to 4 drops per day, the duration of therapy was up to 4 months, and olopatadine was used both in monotherapy and together with loratadine in a dose of 10 mg. The overall incidence of adverse events was about 4.5%, while only 1.6% of cases were reported of clinical trial termination due to adverse reactions. No adverse events have been reported in the clinical trials, either in the visual organ or in the body as a whole. The most frequent adverse reaction associated with the treatment was discomfort in the eye, this phenomenon was noted in 0.7% of patients.

Table data on adverse events

System-organ class

Frequency of occurrence

Undesirable phenomena

Immune system disorders

Frequency unknown

Hypersensitivity to drug components, facial swelling

Frequency unknown

Eye pain, eye irritation, dry eye syndrome, unusual sensation in the eye

Corneal erosion, corneal epithelial defect, pitting keratitis, keratitis, accumulation of dye pigment in area of corneal defect in diagnostic tests, ocular discharge, photophobia, blurred vision, decreased visual acuity, blepharospasm, discomfort in the eye, itching in the eye, conjunctival folliculosis, conjunctival disorders, feeling of a foreign body in the eye, lacrimation, erythema of the eyelids, eyelid edema, eyelid disorders, conjunctival injection/p>

Corneal edema, conjunctival edema, conjunctivitis, mydriasis, visual impairment, crusts on the edges of the eyelids

Respiratory, thoracic and mediastinal disorders

Frequent unknown

Dry mouth Dyspnea, sinusitis

Gastrointestinal tract disorders

Frequency unknown

Nausea, vomiting

Skin and subcutaneous fatty system disorders

Infrequent

Frequency unknown

Contact dermatitis, burning sensation of the skin, dry skin

/p>

Dermatitis, erythema

General disorders

Frequent Unknown

Increased fatigue Asthenia, feelings of malaise

Overdose

Pregnancy use

Fertility

There have been no studies on the effect of topical use of Olopatadine in ophthalmology on human fertility.

Pregnancy

There are no or limited data on topical use of olopatadine in ophthalmology in pregnant women. Animal studies have reported toxic effects of olopatadine on reproductive function when used systemically. The use of olopatadine during pregnancy and women of childbearing age who do not use contraception is not recommended.

Breastfeeding

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