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

auxiliary substances: benzalkonium chloride 50% solution 0.2 mg (in terms of benzalkonium chloride 0.1 mg), disodium edetate dihydrate 0.1 mg, water for injection up to 1 ml.

Description:

Transparent from a colorless to pale yellow solution.

Pharmacotherapeutic group:Antiallergic agent - stabilizer of membranes of mast cells

ATX: & nbsp

S.01.G.X.01 Cromoglycic acid

R.03.B.C.01 Cromoglycic acid

Pharmacodynamics:

Antiallergic, prevents the degranulation of mast cells and the release of them mediators of allergic reactions - histamine and leukotrienes (especially SRS-A). The mechanism of action is probably based on the stabilization of the membranes of mast cells and the blocking of calcium channels, which inhibits the release of mediators. Cromoglycic acid blocks both early and late allergic reactions.

The drug does not have antihistamine and vasoconstrictive effects.

Pharmacokinetics:

Absorption through the mucous membrane of the eye is negligible. Systemic bioavailability is less than 0.03%. Relationship with plasma proteins - 65%. The half-life (T1 / 2) is 5-10 minutes. It is not metabolized, excreted by the kidneys and through the intestines in unchanged form (approximately in equal amounts within 24 hours after application).

Indications:

Seasonal and year-round allergic conjunctivitis.

Contraindications:

- Hypersensitivity to the components of the drug.

- Children's age (up to 4 years).

Carefully:

Pregnancy and lactation:

The safety of the drug during pregnancy and during breastfeeding is not established, so during this period the drug should be used with caution and only if the intended benefit to the mother exceeds the potential risk to the fetus or infant.

The drug Optivella is excreted into breast milk. During the treatment with the drug, the question of stopping breastfeeding should be resolved.

Dosing and Administration:

The drug is most effective for preventive use. A noticeable clinical effect occurs in a few days or weeks of use.

Treatment begins with instillatsii drug 1 drop 2 times a day in both eyes, if necessary, the dosing regimen can be changed to instillatsii 1 drop 4 times a day in both eyes.

When seasonal allergic conjunctivitis treatment should be started immediately after the appearance of the first symptoms or applied prophylactically before the beginning of the season of the appearance of pollen. Treatment continues throughout the flowering season or longer,if symptoms persist.

Instructions for use

Before using the product, you should thoroughly wash your hands. Remove the lid and drip the drug into the conjunctival sac. If the drop does not hit the conjunctival sac, repeat the instillation. After burying, close your eyes, do not blink and do not open them for about 2 minutes for better contact of the eye mucosa with the drug. Close the vial.

If you miss the introduction of the drug, it should be dripped as soon as possible. Then return to regular use of the drug.

The need to change the dose or duration of treatment is determined by the doctor individually.

Side effects:

The undesirable effects listed below are given according to the following gradations of their frequency: very often> 10%

Frequently ≥1%, <10%

Infrequently ≥ 0.1%, <1%

Rarely ≥0,01 %, <0,1 %

very rarely <0.01%, including individual messages

Chsata is not known from the available data to set the frequency appearance is not possible

Undesirable drug reactions are presented in descending order of severity.

From the side of the organ of vision: ≥ 1/100 - short-term burning sensation, local eye irritation and rapidly passing violation of visual clarity, conjunctival edema, foreign body sensation, dry eyes, lacrimation, meibomite (barley), superficial lesion of the corneal epithelium.

Other: <1/10 000 - allergic reactions, changes in taste.

Frequency unknown: In very rare cases, anaphylactic reactions (bronchospasm) have been observed in some patients receiving drugs containing cromoglycic acid.

Overdose:Currently, cases of overdose of the drug Optivell is not described.

Interaction:

Not installed. In the case of the use of other drugs in the dosage form of the drop, the eye interval between instillations should be at least 5 minutes.

Special instructions:

The composition of the drug includes a preservative benzalkonium chloride, which can be adsorbed by soft contact lenses and change their color. Before using the drug, contact lenses should be removed and installed no earlier than 15 minutes after instillation. Benzalkonium chloride can provoke the development of superficial punctate keratopathy and / or toxic ulcerative keratopathy.

When the original package is opened, the sterility of the dropper bottle is impaired. To prevent contamination of the drug solution during instillation, patients should not touch the tip of the dropper bottle to any surface. To avoid infection, the tip of the dropper should not touch the eyes.

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

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

After the instillation of the drug for the first few minutes, visual impairment is possible, and therefore it is necessary to wait for the resolution of the symptoms before proceeding to drive by car and engage in other potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Eye drops, 2.0%.

Packaging:

By 5 ml or 10 ml of the drug into the bottles-droppers of low-density polyethylene (LDP), sealed with a screw cap of high-density polyethylene (PEP) with a point for piercing the dropper.

One bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

The drug should not be used after the expiration date.

After opening the bottle, eye drops should be used within 4 weeks.

Terms of leave from pharmacies:On prescription

Registration number:LP-003384

Date of registration:28.12.2015

Expiration Date:28.12.2020

Date of cancellation:2018-05-10

The owner of the registration certificate:Micro Labs LimitedMicro Labs Limited India

Manufacturer: & nbsp

MICRO LABS, Limited India

Representation: & nbspMICRO LABS LIMITED MICRO LABS LIMITED India

Information update date: & nbsp15.05.2018

Illustrated instructions

Instructions

Optivell (Optiwell)