Buy Olopatallerg eye drops 0.1% dropper bottle 5 ml

Olopatadine

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Available since: 2019-09-19

Dosage form

eye drops

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Package Size

0.1% dropper bottle 5 ml

$27.19

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Clinical Pharmacology

Antiallergic agent H1-histamine receptor blocker
Pharmacodynamics:

Olopatadine is a potent selective anti-allergic / antihistamine drug, the pharmacological effects of which are developed through several different mechanisms of action. It is a histamine antagonist (the main mediator of allergic reactions in humans) and prevents histamine-induced release of inflammatory cytokines in the epithelial cells of the conjunctiva. According to the results of in vitro studies, inhibition of the release of proinflammatory mediators by mast conjunctival cells is suggested.

In patients with passable nasolacrimal ducts, local use of Olopatadine in the form of instillations in the conjunctival sac allowed to reduce the severity of symptoms from the nose, often associated with seasonal allergic conjunctivitis.

Olopatadine has no clinically significant effect on the diameter of the pupil.

Pharmacokinetics:

Suction

Olopatadine undergoes systemic absorption, like other drugs intended for topical use. However, plasma Olopatadine concentrations after its topical application in ophthalmology are low and range from below the level of quantitative determination (<0.5 ng="" ml="" to="" 1="" 3="" the="" claimed="" plasma="" concentrations="" are="" 50="" 200="" times="" lower="" than="" those="" given="" by="" oral="" administration="" of="" therapeutic="" doses="" olopatadine="" p="">

Removal

According to pharmacokinetic studies of oral forms of Olopatadine, the half-life is from 8 to 12 hours, the drug is eliminated mainly by the kidneys. 60-70% of the administered dose is excreted in the urine unchanged, and low concentrations of 2 metabolites, mono-desmethyl and n-oxide, are also detected in the urine.

Due to the fact that Olopatadine is excreted by the kidneys mostly unchanged, impaired renal function leads to a change in the pharmacokinetics of Olopatadine, leading to a significant (2.3 times) increase in plasma concentration of Olopatadine in patients with severe renal insufficiency (creatinine clearance 13 ml / min) . Due to the fact that the concentration of Olopatadine in plasma after its topical administration in the form of instillations is 50–200 times lower than when oral doses of therapeutic doses are used, no changes in the dosage regimen in elderly patients or in patients with impaired renal function are required. Since the hepatic pathway of elimination is not essential for Olopatadine, dose adjustment is not required when used in patients with impaired liver function.

After oral administration of 10 mg of Olopatadine by hemodialysis patients, the concentration of Olopatadine in plasma was significantly lower on the day of hemodialysis compared with the days when hemodialysis was not performed. This suggests that elimination of Olopatadine using hemodialysis is possible.

According to the results of comparative studies of the pharmacokinetics of the oral dosage form of Olopatadine at a concentration of 10 mg in young (mean age 21 years) and elderly patients (average age 74 years), there were no significant differences in plasma concentrations of Olopatadine, plasma protein binding and drug elimination parameters in unchanged and in the form of metabolites.

Indications

Treatment of symptoms of seasonal allergic conjunctivitis.

Composition

1 ml - Olopatadine hydrochloride 1.1 mg, which corresponds to the content of Olopatadine 1 mg.
Excipients: disodium phosphate dodecahydrate - 12.5 mg, sodium chloride - 6.5 mg, benzalkonium chloride - 0.1 mg, sodium hydroxide solution 1M / hydrochloric acid solution 1M - to pH 7.1 ± 0.1, purified water - up to 1 ml.

Olopatadine is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Olopatallerg			eye drops
Vizallergol			eye drops
Opatanol	Alcon	USA	eye drops

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Dosage and Administration

Locally.

Instill 1 drop in the conjunctival sac of the affected eye 2 times a day (with an interval of 8 hours).

Duration of treatment up to four months.

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

To old people.

There is no need to adjust doses for elderly patients.

Children from 3 years.

Olopatallerg can be used in the same doses as in adults.

Kidney or liver failure

No studies have been conducted in patients with renal or hepatic insufficiency regarding Olopatadine in the form of eye drops. However, it is not expected that a dose adjustment will be necessary in patients with renal or hepatic insufficiency.

Do not touch the tip of the bottle to the eyelids, the skin of the peri-orbital area and other surfaces to avoid microbial contamination of the drug. Tightly close the lid after using the drug.

Adverse reactions

General information about the profile of adverse events

In clinical studies involving 1680 patients, the dosing regimen ranged from 1 to 4 drops per day, the duration of the course of therapy was up to 4 months, the use of Olopatadine was carried out both in monotherapy and together with loratadine at a dosage of 10 mg. The overall incidence of adverse events was about 4.5%, while cessation of participation in a clinical study due to the development of adverse reactions was observed only in 1.6% of cases. In clinical studies, no serious adverse events were noted either by the organ of vision or by the body as a whole. The most frequent adverse reaction associated with treatment was discomfort in the eye, this phenomenon was observed in 0.7% of patients.

Tabular data on adverse events

The following adverse events were observed during clinical studies and post-registration use of the drug and are classified according to the following gradation of the incidence of adverse events: very often (≥1 / 10), often (≥1 / 100 to

System organ class	Frequency of occurrence	Undesirable effects
Infectious disorders	Infrequently	Rhinitis
Immune system disorders	Frequency unknown	Hypersensitivity to the components of the drug, swelling of the face
Nervous system disorders	Often	Headache, dysgeusia
	Infrequently	Dizziness, hypesthesia
	Frequency unknown	Drowsiness
Violations by the organ of vision	Often	Eye pain, eye irritation, dry eye syndrome, unusual sensations in the eye.
	Infrequently	Corneal erosion, corneal epithelium defect, punctate keratitis, keratitis, accumulation of coloring pigment in the area of the cornea defect during diagnostic tests, eye discharge, photophobia, blurred vision, reduced visual acuity, blepharospasm, discomfort in the eye, eye itchiness, eye follicle, eye blemish, eye discomfort, eye itchiness, eye follicle, eyed acuity conjunctival side, foreign body sensation in the eye, lacrimation, eyelid erythema, eyelid edema, eyelid abnormalities, conjunctival injection.
	Frequency unknown	Corneal edema, conjunctival edema, conjunctivitis, mydriasis, impaired visual function, crust at the edges of the eyelids.
Disorders of the respiratory system, chest and mediastinum	Often	Dry nose
Disorders of the respiratory system, chest and mediastinum	Frequency unknown	Dyspnea, sinusitis
Disorders of the gastrointestinal tract	Frequency unknown	Nausea, vomiting
Violations by skin and subcutaneous fat	Infrequently	Contact dermatitis, feeling of burning skin, dry skin.
Violations by skin and subcutaneous fat	Frequency unknown	Dermatitis, erythema.
General violations	Often	Increased fatigue
General violations	Frequency unknown	Asthenia, malaise

In very rare cases, when phosphate-containing drops were used by patients with a concomitant significant corneal damage, corneal calcification developed.

Hypersensitivity to the components of the drug, pregnancy and breastfeeding period, age up to 3 years.

Carefully:

In patients with concomitant dry eye syndrome and corneal diseases.

Drug interactions

Studies of the interaction of Olopatadine with other drugs have not been conducted. In vitro studies have shown no inhibition of metabolic reactions mediated by isoenzymes 1A2, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4 of cytochrome P450.

Pregnancy and Lactation

Fertility

Studies on the effect of topical application of Olopatadine in ophthalmology on human fertility have not been conducted.

Pregnancy

Information about the local use of Olopatadine in ophthalmology for pregnant women is not available or is limited. In animal studies, data on the toxic effects of Olopatadine on reproductive function in systemic use were obtained. The use of Olopatadine during pregnancy and women of childbearing age who do not use contraceptive methods is not recommended.

Breastfeeding period

Marked excretion of Olopatadine in breast milk when using the drug in animals. Risk to newborns and infants cannot be excluded. The use of the drug Olopatallerg during breastfeeding is not recommended.

Special instructions

Olopatadinea hydrochloride is an anti-allergic / antihistamine drug for topical use in ophthalmology, and, despite topical use, can be absorbed into the systemic circulation. With the appearance of pronounced hypersensitivity reactions should discontinue use of the drug.

The drug contains benzalkoniya chloride, which can be adsorbed by soft contact lenses and cause eye irritation. It is necessary to remove contact lenses before instillation and install again no earlier than 15 minutes after instillation of the drug.

With frequent or long-term use of the drug, benzalkonium chloride can cause the occurrence of point keratitis or toxic ulcerative keratopathy in patients with dry eye or corneal pathology.

Impact on the ability to drive trans. Wed and fur .:

Olopatadine does not have a significant impact on the ability to drive vehicles, machinery. If there is a blurred vision immediately after instillation, it is necessary to wait for the restoration of visual perception clarity before driving vehicles and mechanisms.

Overdosage

There is no information about the development of toxic effects with the accidental introduction of an excess amount of the drug into the conjunctival cavity or with accidental ingestion. With the development of an overdose if accidentally swallowed, treatment should be supportive.