Composition, form of production and packaging
? Eye drops 2% in the form of a clear, colorless to slightly yellowish solution without mechanical inclusions.
1 ml
sodium cromoglicate 20 mg
Excipients: benzalkonium chloride 0.1 mg, sodium chloride 4 mg, disodium edetate 1.5 mg, sorbitol liquid uncrystallized 20 mg, sodium dihydrogen phosphate dihydrate 1 mg, disodium hydrogen phosphate dodecahydrate 5 mg, sodium hydroxide to pH 7.0, water d / u - 0.9661 mg.
10 ml - a bottle-droppers polyethylene (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Anti-allergic drug. Stabilizer of membranes of mast cells.
It has a membrane-stabilizing effect, blocks the entry of calcium ions into the mast cell, preventing its degranulation and release of histamine, bradykinin, prostaglandins, leukotrienes (including slowly reacting substances) and other biologically active substances.
The drug is most effective as a means of prevention. A noticeable clinical effect occurs within a few days or weeks after admission.
PHARMACOKINETICS
Suction and distribution
Absorption through the mucous membrane of the eye is negligible. Systemic bioavailability is less than 0.03%. Relationship with plasma proteins - 65% .
Metabolism and excretion
It is not metabolized. It is excreted by the kidneys and through the intestine in unchanged form (approximately in equal amounts within 24 hours after application). T1/2 - 5-10 minutes.
INDICATIONS
Prevention and treatment:
- allergic conjunctivitis;
- allergic keratitis, keratoconjunctivitis;
- irritation of the mucous membrane of the eyes, due to allergic reactions (environmental factors, occupational hazards, household chemicals, cosmetics, ophthalmic medicinal forms, plants and domestic animals).
DOSING MODE
Adults and children over the age of 2 years instilled 1-2 drops in each conjunctival sac 4 times / day with an interval of 4-6 hours. If necessary, the dose can be increased to 6-8 instillations.
After achieving therapeutic effect, the frequency of application of the drug can be reduced and used Kromogeksal В® only in contact with allergens (house dust, spores of fungi, pollen).
SIDE EFFECT
From the side of the organ of vision: violation of the clarity of visual perception, burning in the eye, edema of the conjunctiva, sensation of foreign body, dry eyes, lacrimation, meibomite (barley); superficial lesion of the corneal epithelium.
CONTRAINDICATIONS
- Children under 2 years;
- Hypersensitivity to sodium cromoglycate or to any other component of the drug.
Caution should be used in children under 4 years of age, during pregnancy and lactation.
PREGNANCY AND LACTATION
Caution should be used drug Kromogeksal В® during pregnancy and lactation.
APPLICATION FOR CHILDREN
Contraindicated for children under 2 years, with caution - children under 4 years.
SPECIAL INSTRUCTIONS
The use of the drug Kromogeksal В® reduces the need for the use of ophthalmic preparations containing glucocorticoids.
When using KromohexalВ® drops, due to the content of benzalkonium chloride, one should avoid wearing soft contact lenses; Strict contact lenses should be removed 15 minutes before instillation and dress after 15 minutes.
The bottle must be closed after each use. Do not touch the tip of the pipette to the eye.
Impact on the ability to drive vehicles and manage mechanisms
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.
OVERDOSE
Data on drug overdose are absent.
DRUG INTERACTION
Until now, no interaction with other drugs has been identified.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a place protected from light, inaccessible to children, at a temperature of no higher than 25 В° C. Shelf life - 3 years.
Open vials should be used within 6 weeks.
