Dipolkrom - instructions for use, dose, side effects, contraindications

Excipients: sorbitol 16.00 mg, sodium hydrogen phosphate dodecahydrate 4.78 mg, sodium d and hydrophosphate monohydrate 2.61 mg, disodium edetate dihydrate 0.10 mg, sodium chloride 3.00 mg, benzalkonium chloride solution 50 % - 0.20 mg, (which corresponds to 0.10 mg of 100% benzalkonium chloride), polysorbate 80 - 1.00 mg, water purified to 1 ml.

Description:Transparent liquid of greenish color.

Pharmacotherapeutic group:Antiallergic - a 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.

The acidity of the drops (pH value) is the same as the lacrimal fluid.

Pharmacokinetics:

Absorption through the mucous membrane of the eye is negligible. Systemic bioavailability is less than 0.03%. Connection with plasma proteins - 65 %. The half-life period (T1/2) is 5-10 minutes. Me metabolized, excreted by the kidneys and through the intestine in unchanged form (approximately in equal amounts within 24 hours after application).

Indications:Allergic conjunctivitis (seasonal and chronic).

Contraindications:

Hypersensitivity to cromoglycic acid or other components of the drug; children under 4 years.

Pregnancy and lactation:

Use during pregnancy is only possible if the intended benefit to the mother exceeds the potential risk to the fetus.

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

Dosing and Administration:

Locally, in the conjunctival sac.

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. With seasonal allergic conjunctivitis, treatment should begin immediately after the onset of the first symptoms or be 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. In case 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 in each case.

Side effects:

Undesirable effects are classified according to the recommendations of the World Health Organization: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000 <1/100), rarely (> 1 / 10 000, <1/1000), very rarely (<1/10 000); frequency is unknown (insufficient data to estimate the frequency of development).

From the side of the organ of vision: very rarely - a rapid violation of the clearness of visual perception, a brief burning sensation, a foreign body, dryness in the eye, conjunctival edema, lacrimation, meibomite, superficial injury of the corneal epithelium.

Other: very rarely - allergic reactions (itching, mild tenderness and congestion hyperemia), a change in taste sensations; frequency unknown - severe anaphylactic reactions (bronchospasm).

Overdose:

Cases of an overdose have not been revealed.

Interaction with other medicinal products

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.

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:

Benzalkonium chloride, which is part of the drug, can cause eye irritation and change the color of soft contact lenses. Before using eye drops, contact lenses should be removed, and they can be installed again not less than 15-20 minutes after application of the drug.

Do not touch the tip of the pipette to the eye.

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

As with any other eye drops, after instillation of the drug, a transient visual impairment is possible.Do not drive vehicles and engage in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions, until the disappearance of symptoms of reduced visual acuity.

Form release / dosage:

Eye drops 2 %.

5 ml are packed in a polyethylene bottle with a dropper, closed with a cover with a warranty ring. 2 bottles along with instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Shelf life after opening the bottle is 4 weeks.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-002960

Date of registration:16.04.2015

The owner of the registration certificate:Warsaw Pharmaceutical Plant Polfa, JSCWarsaw Pharmaceutical Plant Polfa, JSC Poland

Manufacturer: & nbsp

WARSAW PHARMACEUTICAL WORK POLFA, S.A. Poland

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp16.04.2015

Illustrated instructions

Instructions

Dipolkrom® (DIPOLCROM®)