Vizallergol - instructions for use, doses, side effects, contraindications

Active substanceOlopatadineOlopatadine

Similar drugsTo uncover

Vizallergol®

drops d / eye

Sentiss Pharma Pvt. Ltd. India

Olopatallerg

drops d / eye

K.O.Ромфарм Компани С.Р.Л. Romania

Opatanol®

drops d / eye

ALKON PHARMACEUTICS, LLC Russia

Dosage form: & nbsptoapley eye

Composition:

In 1 ml contains:

active substance: olopatadine hydrochloride 2.22 mg (equivalent to 2.0 mg of olopatadine);

Excipients: benzalkonium chloride 0.1 mg Povidone K-29/32 18.0 mg Sodium hydrogenphosphate, anhydrous 5.0 mg Sodium chloride 5,5 mg Disodium edetate 0.1 mg, hydrochloric acid and / or sodium hydroxide to pH 7 , 0, water for injection up to 1 ml.

Description:Transparent solution from colorless to light yellow color.

Pharmacotherapeutic group:Antiallergic agent - H1-histamine receptor blocker

ATX: & nbsp

S.01.G.X.09 Olopatadine

Pharmacodynamics:

Olopatadine is a potent selective antiallergic / antihistamine drug whose pharmacological effects are developed through several different mechanisms of action. It is an antagonist of histamine (main mediator of allergic reactions in humans) and prevents histamine-induced release of inflammatory cytokines in the cells of the conjunctival epithelium. Based on research results in vitro it is supposed that inhibition of the release of anti-inflammatory mediators by mast cells of the conjunctiva.

In patients with passable nasolacial ducts, local application of olopatadine in the form of instillations into the conjunctival sac allowed to reduce the severity of the symptoms from the nose, often associated with seasonal allergic conjunctivitis.

Olopatadine does not have a clinically significant effect on the diameter of the pupil.

Pharmacokinetics:

Suction

Olopatadin undergoes systemic absorption, as well as other drugs intended for topical application. However, plasma concentrations of olopatadine after its topical application in ophthalmology are low and range from below the quantitative level (<0.5 ng / ml) to 1.3 ng / ml. The claimed concentrations in plasma are 50-200 times lower than those for oral administration of therapeutic doses of olopatadine.

Excretion

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

Due to olopatadine is excreted mainly by the kidneys in an unchanged form, disrupting the kidneys leads to a change in the pharmacokinetics of olopatadine, leading to a significant (2.3-fold increase) in the plasma concentration of olopatadine in patients with severe renal insufficiency (creatinine clearance 13 ml / min).

The concentration of olopatadine in the plasma after its topical application in the form of instillations is 50-200 times lower than for oral administration of therapeutic doses, therefore, changes in the dosing regimen in patients with impaired renal function not required.

Since the hepatic elimination pathway is not the main one for olopatadine, dose adjustment is not required when applying patients with impaired hepatic function.

After oral administration of 10 mg of olopatadine by patients on hemodialysis, the concentration of olopatadine in plasma was significantly lower on the day of hemodialysis compared to days when hemodialysis was not performed. This indicates that the removal of olopatadine with hemodialysis is possible.

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

Indications:Kupirovanie eye itching with allergic conjunctivitis.

Contraindications:

Hypersensitivity to the components of the drug.

Children under 3 years.

Pregnancy and the period of breastfeeding.

Pregnancy and lactation:

Fertility

Studies of the effects of topical application of olopatadine in ophthalmology on human fertility have not been conducted.

Pregnancy

Information on the local use of olopatadine in ophthalmology by pregnant women is absent or limited. In animal studies, data have been obtained on the toxic effect of olopatadine on reproductive function in systemic use. It is not recommended to use olopatadine during pregnancy and women of childbearing age who do not use contraceptive methods.

Breastfeeding period

Excretion of olopatadine in breast milk with application of the preparation in animals was noted. Risk for newborns and infants can not be ruled out.It is not recommended to use the drug Vizallergol^® in the period of breastfeeding.

Dosing and Administration:

The drug Vizallergol® is instilled 1 drop once a day into the affected eye (eyes). The duration of the course of therapy, if necessary, can be up to 4 months.

Application in the elderly

Do not change the dosage regimen in elderly patients.

Use in the pediatric population

Application of Vizallergol® is possible in children older than 3 years in the same doses as in adults. The effectiveness and safety of the use of olopatadine in children younger than 3 years is not confirmed.

Use in patients with renal and hepatic impairment

The use of olopatadine in the form of eye drops has not been studied in patients with renal or hepatic insufficiency. No dosage adjustment is required for the declared category of patients.

Do not touch the tip of the vial to the eyelids, the skin of the peri-ocular area and other surfaces to avoid microbial contamination of the drug. Close the lid tightly after using the product.

If necessary, can be used in combination with other medicines for the localapplication in ophthalmology, in this case the interval between their use should be at least 5 minutes.

Side effects:

General information about the profile of undesirable phenomena

In clinical trials with 1,680 patients, the dosing regimen was 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 in conjunction with loratadine in a dosage of 10 mg. The overall frequency of occurrence of adverse events was about 4.5%, while the termination of participation in the clinical study due to the development of adverse reactions was noted only in 1.6% of cases. In the course of clinical studies, there were no serious adverse events, either from the organ of vision or from the body as a whole. The most common adverse reaction associated with treatment was pain in the eye, this phenomenon was noted in 0.7% of patients.

Table data on undesirable phenomena

The following undesirable phenomena were noted during clinical trials and post-marketing use of the drug and classified according to the following incidence of undesirable events: very often (> 1/10), often (> 1/100 to <1/10), infrequently (> 1 / 1,000 to <1/100), rarely (from> 1 / 10,000 to <1/1000),very rarely (<1 / 10,000), the frequency is unknown (frequency of occurrence can not be determined based on available data). Within each group, adverse events are listed in order of severity

System-Organ Class	Frequency of occurrence	Adverse events
Infectious violations	Infrequently	Rhinitis
Immune system disorders	Frequency unknown	Hypersensitivity, swelling of the face
Disturbances from the nervous system	Often	Headache, dysgeusia
	Infrequently	Dizziness, hypoesthesia
	Frequency unknown	Drowsiness
Disturbances on the part of the organ of sight	Often	Pain in the eye, eye irritation, dry eye syndrome, unusual sensations in the eye.
	Infrequently	Corneal erosion, corneal epithelial defect, spot keratitis, keratitis, accumulation of coloring pigment in the area of corneal defect during diagnostic tests, discharge from the eyes, photophobia, blurred vision, decreased visual acuity, blepharospasm, discomfort in the eye, itching in eye, conjunctival conjunctival follicles, conjunctival disorders, foreign body sensation in the eye, lacrimation, erythema eyelids, eyelid edema, eyelid disorders, conjunctival injection.
	Frequency unknown	Edema of the cornea, edema of the conjunctiva, conjunctivitis, mydriasis, impaired visual function, crusts on the edges of the eyelids.
Disturbances from the respiratory system, organs of the chest and mediastinum	Often	Dryness in the nose
	Frequency unknown	Dispno, sinusitis
Infringements from gastrointestinal tract	Frequency unknown	Nausea, vomiting
Disturbances from the skin and subcutaneous fatty tissue	Infrequently	Contact dermatitis, burning sensation of the skin, dry skin.
Disturbances from the skin and subcutaneous fatty tissue	Frequency unknown	Dermatitis, erythema.
Common violations	Often	Increased fatigue
Common violations	Frequency unknown	Asthenia, a feeling of indisposition

In very rare cases, with the use of phosphate-containing drops in patients with concomitant significant damage to the cornea, calcification of the cornea developed.

Overdose:

There is no information on the development of toxic phenomena with the occasional introduction of excessive amounts of the drug into the conjunctival cavity or accidental ingestion.

When developing an overdose with accidental ingestion, treatment is symptomatic.

Interaction:

Studies of the interaction of olopatadine with other drugs have not been conducted.

In studies in vitro demonstrated the absence of inhibition of metabolic reactions mediated by isoenzymes 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4 of cytochrome P-450.

According to the results obtained, the likelihood of the introduction of olopatadine into metabolic reactions when combined with other drugs is assessed as low.

Special instructions:

Olopatadine hydrochloride is an anti-allergic / antihistamine drug for topical application in ophthalmology, and, despite local application, it can be absorbed into the systemic bloodstream. If severe hypersensitivity reactions develop, discontinue use.

Vizallergol® should not be used to stop conjunctival injection caused by the use of contact lenses.

The preparation contains benzalkonium 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 not earlier than 15 minutes after instillation of the drug.

According to a number of studies, benzalkonium chloride can provoke the development of point keratopathy and / or toxic ulcer keratopathy.

Careful monitoring of the patient's eyes is necessary with frequent or prolonged use of Vizallergol® with concomitant dry eye syndrome and with corneal involvement.

Effect on the ability to drive transp. cf. and fur:

Visallergol^® does not have a significant impact on the ability to manage vehicles, mechanisms. In the event that blurred vision is observed immediately after instillation, it is necessary to refrain from controlling vehicles and mechanisms until the clarity of visual perception is restored.

Form release / dosage:

Eye drops, 0,2%.

Packaging:

For 2.5 ml in a polyethylene bottle with a stopper and a screw cap with the control of the first opening.

For 1 bottle with instructions for use in a cardboard bundle.

Storage conditions:

Store at a temperature of 2 to 25 ° C.

Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Drops should be used within 28 days after opening the vial.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-003950

Date of registration:09.11.2016

Expiration Date:09.11.2021

The owner of the registration certificate:Sentiss Pharma Pvt. Ltd.Sentiss Pharma Pvt. Ltd. India

Manufacturer: & nbsp

SENTISS PHARMA Pvt. Ltd India

Representation: & nbspSENTISS RUSS LLCSENTISS RUSS LLCRussia

Information update date: & nbsp11.01.2017

Illustrated instructions

Instructions

Vizallergol® (Vizallergol®)