Olopatallerg eye drops 0.1%, 5 ml
Expiration Date: 05/2027
Russian Pharmacy name:
Олопаталлерг капли глазные 0,1%, 5 мл
treating symptoms of seasonal allergic conjunctivitis.
Locally. Instill 1 drop into the conjunctival sac of the affected eye 2 times / day (with an interval of 8 hours).
The duration of treatment is up to 4 months.
If necessary, Olopatallerg can be used in combination with other drugs. In this case, the interval between their application should be at least 5 minutes.
There is no need to adjust the dose in elderly patients .
In children aged 3 years and older , Olopatallerg can be used in the same doses as in adults.
No studies have been conducted in patients with renal or hepatic impairment regarding the use of olopatadine in the form of eye drops. However, dose adjustment is not expected to be necessary in patients with renal or hepatic impairment.
Do not touch the tip of the bottle to the eyelids, the skin of the periorbital region and other surfaces in order to avoid microbial contamination of the drug. Close the lid tightly after using the drug.
for 1 ml
Active substance:
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 - up to pH 7.1 ± 0.1, purified water - up to 1 ml
hypersensitivity to drug components;
pregnancy;
breastfeeding period;
age up to 3 years.
With caution: in patients with concomitant dry eye syndrome and corneal diseases.
Trade name: Olopatallerg
Description:
Eye drops in the form of a clear, colorless solution.
Ingredients: 1 ml
Active substance:
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 - up to pH 7.1 ± 0.1, purified water - up to 1 ml
Clinical and pharmacological group: Antiallergic drug for local use in ophthalmology
Pharmaco-therapeutic group: Antiallergic agent - H1-histamine receptor blocker
pharmachologic effect
Olopatadine is a potent selective antiallergic / antihistamine drug whose pharmacological effects are mediated through several different mechanisms of action. It is an antagonist of histamine (the main mediator of allergic reactions in humans) and prevents histamine-induced release of inflammatory cytokines in the epithelial cells of the conjunctiva.
In vitro studies suggest inhibition of the release of proinflammatory mediators by mast cells of the conjunctiva.
In patients with patent nasolacrimal ducts, topical application of olopatadine in the form of instillations into the conjunctival sac made it possible to reduce the severity of nasal symptoms that are often associated with seasonal allergic conjunctivitis.
Olopatadine has no clinically significant effect on pupil diameter.
Pharmacokinetics
Suction
Olopatadine undergoes systemic absorption, like other topical preparations. However, plasma concentrations of olopatadine after topical application in ophthalmology are low and range from below the level of quantitation (<0.5 ng / ml) to 1.3 ng / ml. The stated plasma concentrations are 50-200 times lower than those for oral administration of therapeutic doses of olopatadin.
Withdrawal
According to pharmacokinetic studies of oral forms of olopatadin T1 / 2 is from 8 to 12 hours, the excretion of the drug is carried out 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.
Pharmacokinetics in special clinical situations
Due to the fact that olopatadine is excreted by the kidneys mainly unchanged, impaired renal function leads to a change in the pharmacokinetics of olopatadine, leading to a significant (2.3 times) increase in the plasma concentration of olopatadine in patients with severe renal failure (CC 13 ml / min). Due to the fact that the concentration of olopatadine in plasma after its local application in the form of instillations is 50-200 times lower than with oral administration of therapeutic doses, no change in the dosage regimen is required in elderly patients or in patients with impaired renal function. Since the hepatic elimination pathway is not the main one for olopatadin, dose adjustment is not required when used in patients with impaired liver function.
After oral administration of 10 mg of olopatadine in hemodialysis patients, the plasma concentration of olopatadine was significantly lower on the day of hemodialysis compared to the days when hemodialysis was not performed. This indicates that the elimination of olopatadine by 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 (average 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 excretion parameters. unchanged and in the form of metabolites.
Indications
treating symptoms of seasonal allergic conjunctivitis.
Dosage regimen
Locally. Instill 1 drop into the conjunctival sac of the affected eye 2 times / day (with an interval of 8 hours).
The duration of treatment is up to 4 months.
If necessary, Olopatallerg can be used in combination with other drugs. In this case, the interval between their application should be at least 5 minutes.
There is no need to adjust the dose in elderly patients .
In children aged 3 years and older , Olopatallerg can be used in the same doses as in adults.
No studies have been conducted in patients with renal or hepatic impairment regarding the use of olopatadine in the form of eye drops. However, dose adjustment is not expected to be necessary in patients with renal or hepatic impairment.
Do not touch the tip of the bottle to the eyelids, the skin of the periorbital region and other surfaces in order to avoid microbial contamination of the drug. Close the lid tightly after using the drug.
Side effect
In clinical studies involving 1680 patients, the dosage regimen ranged from 1 to 4 drops / 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 at a dose of 10 mg. The overall incidence of adverse events was about 4.5%, while termination of participation in a clinical trial due to the development of adverse reactions was noted in only 1.6% of cases. In the course of clinical studies, no serious adverse events were noted either on the part of the organ of vision or on the part of the body as a whole. The most common treatment-related adverse reaction was eye discomfort, which was reported in 0.7% of patients.
The following adverse events were observed during clinical trials and post-marketing use of the drug and are classified according to the following gradation of the frequency of occurrence of adverse events: very often (? 1/10), often (from? 1/100 to <1/10), infrequently (from? 1 / 1000 to <1/100), rarely (from? 1/10 000 to <1/1000), very rare (<1/10 000), the frequency is unknown (the frequency of occurrence cannot be determined from the available data). Within each group, adverse events are listed in order of decreasing severity.
From the immune system: frequency unknown - hypersensitivity to the components of the drug, swelling of the face.
From the nervous system: often - headache, dysgeusia; infrequently - dizziness, hypesthesia; frequency unknown - drowsiness.
From the side of the organ of vision: often - eye pain, eye irritation, dry eye syndrome, unusual sensations in the eye; infrequently - corneal erosion, corneal epithelial defect, punctate keratitis, keratitis, accumulation of coloring pigment in the corneal defect during diagnostic tests, eye discharge, photophobia, blurred vision, decreased visual acuity, blepharospasm, eye discomfort, itching in the eye, follicle conjunctiva, disorders of the conjunctiva, feeling of a foreign body in the eye, lacrimation, erythema of the eyelids, edema of the eyelids, disorders of the eyelids, conjunctival injection; the frequency is unknown - corneal edema, conjunctival edema, conjunctivitis, mydriasis, visual impairment, crusts at the edges of the eyelids.
From the respiratory system: often - dry nose; infrequently - rhinitis; frequency unknown - dyspnea, sinusitis.
From the digestive system: the frequency is unknown - nausea, vomiting.
On the part of the skin and subcutaneous fat: infrequently - contact dermatitis, burning sensation of the skin, dry skin; frequency unknown - dermatitis, erythema.
Others: often - increased fatigue; frequency is unknown - asthenia, feeling of malaise.
In very rare cases, when using phosphate-containing drops in patients with concomitant significant damage to the cornea, corneal calcification has developed.
Contraindications for use
hypersensitivity to drug components;
pregnancy;
breastfeeding period;
age up to 3 years.
With caution: in patients with concomitant dry eye syndrome and corneal diseases.
Application during pregnancy and lactation
Pregnancy
Information on the local use of olopatadine in ophthalmology by pregnant women is absent or limited. In animal studies, data were obtained on the toxic effect of olopatadine on reproductive function with systemic use. It is not recommended to use olopatadine during pregnancy and women of childbearing age who do not use contraceptive methods.
Breastfeeding period
The excretion of olopatadine into breast milk was noted when using the drug in animals. The risk to newborns and babies cannot be excluded. It is not recommended to use the drug Olopatallerg during breastfeeding.
Fertility
Studies of the effect of topical use of olopatadine in ophthalmology on human fertility have not been conducted.
Application for violations of liver function
There have been no studies in patients with hepatic impairment regarding the administration of olopatadine in the form of eye drops.
Application for impaired renal function
There have been no studies in patients with renal insufficiency regarding the use of olopatadine in the form of eye drops.
Application in children
Use is contraindicated under the age of 3 years.
Use in elderly patients
There is no need to adjust the dose in elderly patients.
special instructions
Olopatadine hydrochloride, despite topical application, can be absorbed into the systemic circulation. If severe hypersensitivity reactions occur, the drug should be discontinued.
The drug contains benzalkonium chloride, which can be absorbed 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 prolonged use of the drug, benzalkonium chloride can cause the occurrence of punctate keratitis or toxic ulcerative keratopathy in patients with dry eye syndrome or corneal pathology.
Influence on the ability to drive vehicles and use mechanisms
Olopatadine does not significantly affect the ability to drive vehicles and mechanisms. In the event that blurred vision is noted immediately after instillation, it is necessary to wait until the clarity of visual perception is restored before driving vehicles and mechanisms.
Overdose
There is no information on the development of toxic phenomena in case of accidental introduction of an excessive amount of the drug into the conjunctival cavity or in case of accidental ingestion.
Treatment: with the development of an overdose in case of accidental swallowing, supportive therapy is carried out.
Drug interactions
Studies of the interaction of olopatadine with other drugs have not been conducted. In vitro studies demonstrated the absence of inhibition of metabolic reactions mediated by isoenzymes 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4 of cytochrome P450. According to the results obtained, the likelihood of the entry of olopatadine into metabolic reactions when combined with other drugs is assessed as low.
Storage conditions
The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25 ? C.
Shelf life
Shelf life is 3 years.
Do not use after the expiration date.
After opening the bottle, the drops should be used within 4 weeks.
Terms of sale
The drug is available with a prescription.