Instructions for use: Visallergol eye drops 2 mg/ml, 2.5 ml bottle
Composition
active ingredient: olopatadine;
1 ml of solution contains 2.22 mg of olopatadine hydrochloride equivalent to 2.0 mg of olopatadine;
excipients: benzalkonium chloride, povidone K-29/32, sodium chloride, disodium edetate, anhydrous sodium hydrogen phosphate, hydrochloric acid, sodium hydroxide, water for injections.
Dosage form
Eye drops.
Main physicochemical properties: transparent solution from colorless to light yellow.
Pharmacotherapeutic group
Means for use in ophthalmology. Anti-edematous and anti-allergic agents.
ATX code S01G X09.
Pharmacological properties
Pharmacodynamics.
Olopatadine is a potent, selective antiallergic/antihistamine with several distinct mechanisms of action. It antagonizes the release of histamine (the main mediator of allergic reactions in humans) and prevents histamine-induced cytokine production by human conjunctival epithelial cells. In vitro studies have shown that the drug acts on human conjunctival mast cells, inhibiting the release of inflammatory mediators. Topical ophthalmic use of Visallergol in patients with preserved nasolacrimal patency has been shown to reduce the nasal signs and symptoms that often accompany seasonal allergic conjunctivitis. The drug does not cause clinically significant changes in pupil diameter.
Preclinical data revealed no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Animal studies have shown developmental delays in lactating animals of dams receiving systemic doses of olopatadine at doses exceeding the maximum recommended human ophthalmic dose. Olopatadine has been detected in the milk of animals following oral administration.
Pharmacokinetics.
Olopatadine is absorbed systemically, as are other topical drugs. However, with topical application of olopatadine, systemic absorption is minimal and plasma concentrations range from sub-quantitative (<0.5 ng/mL) to 1.3 ng/mL. These concentrations are 50-200 times lower than those achieved with oral administration at well-tolerated doses.
Since olopatadine is excreted in the urine mainly as unchanged active substance, the pharmacokinetics of olopatadine are altered in renal impairment, with peak plasma concentrations in patients with severe renal impairment (mean creatinine clearance 13 ml/min) being 2-3 times higher than in healthy adult volunteers.
Indication
Treatment of seasonal allergic conjunctivitis.
Contraindication
Hypersensitivity to olopatadine or to any of the excipients of the drug.
Interaction with other medicinal products and other types of interactions
No studies have been conducted on the interaction of Visallergol with other drugs.
In vitro studies have shown that olopatadine does not inhibit the metabolic reactions of cytochrome P450 isoenzymes 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4. These results indicate that olopatadine does not lead to metabolic interactions with other active substances when used concomitantly.
Application features
Visallergol is an antiallergic/antihistamine that is applied topically but is absorbed systemically. If any signs of serious reactions or hypersensitivity occur, the drug should be discontinued.
Visallergol contains benzalkonium chloride, which may cause eye irritation.
Benzalkonium chloride has also been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Patients with dry eye syndrome or corneal lesions who use the drug frequently or for a long time should be carefully monitored.
Contact lenses
Benzalkonium chloride is known to discolour contact lenses. Contact with soft contact lenses should be avoided. Patients should be advised to remove contact lenses before using the product and to wait at least 15 minutes after instillation before reinserting contact lenses.
If more than one ophthalmic agent is applied topically, the interval between their applications should be at least 5 minutes. Eye ointments should be applied last.
Use during pregnancy or breastfeeding
Pregnancy
There are no or limited amount of ophthalmic data from the use of olopatadine in pregnant women. Animal studies have shown reproductive toxicity after systemic administration (see section 5.1). Olopatadine is not recommended for use in pregnant women and women of childbearing potential not using contraception.
Animal studies have shown that olopatadine is excreted in breast milk after oral administration (for details see section 5.1). A risk to the newborn/infant cannot be excluded. Visallergol should not be used during breast-feeding.
Reproductive function
No studies have been conducted on the effect of olopatadine on human reproductive function following topical ophthalmic administration.
Ability to influence reaction speed when driving vehicles or other mechanisms
Visallergol has no or negligible influence on the ability to drive and use machines. As with any eye drops, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs during instillation, the patient should wait until the vision clears before driving or using machines.
Method of administration and doses
For ophthalmic use only.
1 drop of Visallergol should be instilled into the conjunctival sac of the affected eye(s) once a day. If necessary, treatment may last up to 4 months.
Use in elderly patients
There is no need for dosage adjustment for this category of patients.
Use in children and adolescents
The drug Visallergol can be used in children from 3 years of age in the same dosage as in adults. The safety and efficacy of Visallergol in children under 3 years of age have not been studied. Data for this age group are not available.
Use in liver and kidney dysfunction
Olopatadine in the form of Visallergol eye drops has not been studied in patients with impaired hepatic or renal function. However, no dosage adjustment is necessary in cases of impaired hepatic or renal function (for detailed information, see section "Pharmacokinetics").
After the first opening of the bottle, the protective ring intended to control the first opening should be removed.
To prevent contamination of the dropper tip and contents of the bottle, care should be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip. Close the dropper bottle tightly after each use.
Children.
The drug Visallergol can be used in children aged 3 years and older in the same dosage as adults.
Overdose
There are no data on overdose in humans after accidental or intentional ingestion. Olopatadine has shown low acute toxicity in animals. Accidental ingestion of the entire vial of Visallergol will result in a maximum systemic exposure of 5 mg olopatadine. This exposure may occur at a final dose of 0.5 mg/ml in a child weighing 10 kg with 100% absorption.
In animals, QT prolongation was observed only at doses significantly in excess of the maximum human dose, indicating that QT prolongation is unlikely to occur in clinical practice. In a study of 102 healthy male, female, and elderly subjects administered 5 mg orally twice daily for 2.5 days, there was a slight increase in QT interval compared to placebo. In this study, peak plasma concentrations of olopatadine (35 to 127 ng/mg) were at least 70-fold greater than those observed with topical olopatadine for its effects on cardiac repolarization.
In case of overdose, appropriate examination and symptomatic treatment of the patient should be carried out.
Side effects
The following adverse reactions are classified according to the following criteria: very common (≥1/10), common (>1/100, <1/10), uncommon (>1/1000, ≤1/100), rare (>1/10000, ≤1/1000), rare (≤1/10000) or frequency unknown (frequency cannot be estimated from the available data). Within each grouping, adverse reactions are presented in order of decreasing seriousness.
| Organ system classes | Frequency | Adverse reactions |
| Infections and infestations | Infrequent | Rhinitis, pharyngitis, influenza-like illness, infections |
| On the part of the immune system | Frequency unknown | Hypersensitivity, facial swelling |
| From the nervous system | Frequent | Headache, dysgeusia |
| Infrequent | Dizziness, hypoesthesia | |
| Frequency unknown | Drowsiness | |
| From the organs of vision | Frequent | Eye pain, eye irritation, dry eye, abnormal eye sensitivity, burning or stinging |
| Infrequent | Corneal erosion, corneal epithelial damage, corneal epithelial disorder, punctate keratitis, keratitis, corneal discoloration, eye discharge, photophobia, blurred vision, visual acuity reduced, blepharospasm, eye discomfort, eye pruritus, conjunctival follicles, conjunctival disorder, foreign body sensation in eye, lacrimation increased, eyelid erythema, eyelid edema, eyelid disorder, eye hyperemia | |
| Frequency unknown | Corneal edema, eye edema, eye swelling, conjunctivitis, mydriasis, visual impairment, eyelid margin scaling | |
Respiratory, thoracic and mediastinal disorders | Frequent | Dry nose, increased cough | | Frequency unknown | Dyspnea, sinusitis | |
| Gastrointestinal tract | Frequency unknown | Nausea, vomiting |
| Skin and subcutaneous tissue disorders | Infrequent | Contact dermatitis, burning sensation on the skin, dry skin |
| Frequency unknown | Dermatitis, erythema | |
| General disorders and administration site conditions | Frequent | Fatigue |
| Frequency unknown | Asthenia, malaise, back pain | |
In patients with significant corneal damage, cases of corneal calcification have been reported very rarely with the use of eye drops containing phosphates.
Reporting suspected adverse reactions to a registered medicinal product is very important. This allows for continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report suspected adverse reactions via the channels established by applicable legislation.
Expiration date
2 years.
Do not use more than 28 days after first opening the bottle.
Storage conditions
Store at a temperature of 2°C to 25°C in the original packaging.
Keep out of reach of children.
Packaging
2.5 ml in a plastic bottle with a dropper, No. 1 in a pack.
Vacation category
According to the recipe.
Producer
SENTISS PHARMA PVT. LTD., India/SENTISS PHARMA PVT. LTD., India.
Address
212/D-1, Ashirwad Commercial Complex, Green Park, New Delhi, 110016, India/
212/D-1, Ashirwad Commercial Complex, Green Park, New Delhi, 110016, India.
Applicant
SENTISS PHARMA PVT. LTD., India/SENTISS PHARMA PVT. LTD., India.
