Instructions for use Kromofarm eye drops 2% bottle 10 ml
Composition
active ingredient: cromoglycic acid;
1 ml of solution contains sodium cromoglicate, calculated on 100% dry matter, 20 mg;
Excipients: benzalkonium chloride; sodium chloride; disodium edetate; polysorbate 80; sodium dihydrogen phosphate, dihydrate; sodium hydrogen phosphate, dodecahydrate; water for injections.
Dosage form
Eye drops.
Main physicochemical properties: clear colorless or slightly yellowish liquid.
Pharmacotherapeutic group
Drugs used in ophthalmology. Antiedematous and antiallergic drugs. ATX code S01G X01.
Pharmacological properties
Pharmacodynamics
The active ingredient in Cromopharm® eye drops - sodium cromoglycate - stabilizes the membranes of mast cells after they have been exposed to antigens, and thus prevents degranulation and the release of various inflammatory mediators.
In addition, sodium cromoglicate blocks calcium channels associated with IgE receptors, thus blocking the entry of calcium into mast cells, thereby preventing their degranulation. This mechanism of action is the same for all mucous membranes (bronchi, nose, eyes and intestines).
Pharmacokinetics
Sodium cromoglycate is poorly soluble in lipids, therefore it is unable to penetrate most biological membranes, for example, the blood-brain barrier. To achieve an optimal therapeutic effect, it is not necessary to maintain certain levels of the active substance in the blood. The therapeutic effect of sodium cromoglycate after topical application depends only on its concentration in the target organ.
The metabolism of sodium cromoglicate has not yet been studied. Sodium cromoglicate is excreted in bile and urine in approximately the same proportion.
Indication
Acute and chronic allergic conjunctivitis, including seasonal keratoconjunctivitis.
Contraindication
Hypersensitivity to the active substance or to any other components of the drug.
Interaction with other medicinal products and other types of interactions
No specific drug interaction studies have been conducted.
When using Cromopharm® simultaneously with other topical ophthalmic drugs, a 15-minute interval should be maintained between instillations.
Application features
In general, wearing contact lenses is not recommended for allergic conjunctivitis. If in exceptional circumstances the ophthalmologist has allowed the patient to wear contact lenses, they should be removed before instilling Kromopharm® eye drops and reinserted no earlier than 15 minutes after using the drug.
Cromopharm® contains benzalkonium chloride, which may cause eye irritation. Benzalkonium chloride may discolor soft contact lenses.
When instilling eye drops, avoid any contact of the dropper tip with the eye or skin.
The shelf life after opening the bottle is 28 days.
Ability to influence reaction speed when driving vehicles or other mechanisms
Immediately after using the drug, short-term blurred vision is possible, therefore, before driving or working with other mechanisms, after instilling the drug, the patient should wait until visual clarity is restored.
Use during pregnancy or breastfeeding
Pregnancy
Although animal studies do not indicate direct or indirect harmful effects of sodium cromoglicate with respect to pregnancy, embryonal/fetal development, parturition or postnatal development, there are no clinical data on the use of the drug in pregnant women. The drug should be prescribed to pregnant women with caution after careful assessment of the benefits and risks of such use.
Breast-feeding
Since sodium cromoglicate passes into breast milk in very small quantities, any toxic effects in breastfed infants are unlikely. However, for safety reasons, the drug should be used during breastfeeding only if the potential benefit to the mother outweighs the potential risk to the child.
Method of administration and doses
Adults and children over 4 years of age should instill 1 drop in each eye 4 times a day. In some acute cases, the drug can be instilled more often - 1 drop up to 6-8 times a day. If the condition improves, the frequency of instillation can be reduced, but treatment should be continued as long as the patient is in contact with allergens (pollen, household dust, mold spores and food allergens).
Cromopharm® is intended for long-term therapy. Treatment with Cromopharm® must be continued until the patient's contact with the allergen that caused the disease is stopped.
For seasonal allergic conjunctivitis, treatment should be started immediately after the first symptoms appear or used prophylactically before the appearance of pollen.
Attention! Do not screw the cap tightly before use. Before the first use, screw the bottle cap as tightly as possible. In this case, the spike located on the inside of the cap pierces the hole. Immediately before use, hold the bottle with the drug in the palm of your hand to warm it to body temperature. Unscrew the cap, remove it and, slightly pressing on the bottle body, drip the solution into the eye. After instilling the drug, screw the cap tightly and store the drug according to the recommendations given in the instructions.
During long-term therapy, the therapeutic effect of treatment should be monitored regularly. After adequate stabilization of clinical symptoms, the dose of the drug can be reduced by the doctor's decision.
Children
The drug is not recommended for use in children under 4 years of age.
Overdose
Since there are no reports of overdose, specific treatment methods are unknown.
Adverse reactions
In isolated cases, local reactions such as burning, foreign body sensation, chemosis, conjunctival hyperemia, irritation, lacrimation, temporary blurred vision and hypersensitivity reactions may occur. There are isolated reports of severe generalized anaphylactic reactions with bronchospasm that have been associated with the use of sodium cromoglicate.
The drug contains benzalkonium chloride as a preservative, which can also cause adverse reactions, such as allergic reactions or taste disturbances.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 ml in a bottle. 1 bottle in a pack.
Vacation category
According to the recipe.
Producer
JSC "Farmak".
Location of the manufacturer and its business address
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
