Each mL of isotonic solution contains sodium cromoglycate 20 mg. It also contains the following: Benzalkonium chloride (preservative) 0.05 mg/mL, sodium edetate, glucose and water for injections.
Pharmacology: Antiallergic eye drops. Cromolyn sodium stabilizes membranes of mast cells after they have been exposed to antigens and thus, prevents degranulation and with this the release of various chemical mediators. The mediators are biologically active molecules. They are either preformed and stored in the mast cells (ie, histamine, kinins) and mediate type I immediate allergic reactions through their release, or they are synthesized after provocative stimulation (ie, prostaglandins, leukotrienes) and mediate late type IV inflammatory reactions. Beside other mechanisms of action, cromolyn possesses calcium antagonist features. Cromolyn blocks the IgE-receptor linked calcium channel and therefore, blocks the flow of calcium into the cell normally occurring after IgE-binding. As a result, mast cell degranulation is suppressed and histamine release is avoided. Cromolyn sodium is effective in prophylaxis and therapy of an allergic reaction of the eye.
After single topical eye application to rabbits, cromolyn was shown to be present in aqueous humor for at least 7 hrs; 24 hrs after application, no remaining drug was found in the eye. Due to its very low lipid solubility, cromolyn sodium has almost no systemic absorption (in humans approximately 0.03%, in rabbits approximately 0.02%). This explains the lack of systemic side effects.
Prophylaxis and treatment of allergic conditions of the eye including acute and chronic conjunctivitis, hay fever conjunctivitis, vernal keratoconjunctivitis.
Adult and children: Instill 1 drop 4 times daily into the conjunctival sac.
Instructions for Use: Unscrew the cap covering the nozzle, with a finger retract the lower eyelid until the inner red, moist surface is exposed. Tilt the head back, invert the bottle and gently squeeze out the prescribed number of drops onto the exposed surface of the lower lid avoiding any contact of the bottle with eye or skin. The exact duration of Allergocrom therapy should be based on the physician's judgement. The treatment with Allergocrom should not be stopped after symptoms improve. Rather, its use should be continued until the patient is no longer in contact with the allergen (pollen, house dust, mold).
Overdosing or intoxications are not to be expected when Allergocrom is used properly. Due to its very low lipid solubility, cromolyn sodium has almost no systemic absorption (in humans approximately 0.03% in rabbits approximately 0.02%). This explains the lack of systemic side effects.
Hypersensitivity to sodium cromoglycate or to any of the ingredients of Allergocrom.
Users of soft (hydrophilic) contact lens should refrain from wearing lenses while under treatment with Allergocrom. Wear can be reinserted within a few hours after discontinuation of Allergocrom. A direct contact between contact lens and eye drops should be avoided.
Effects on the Ability to Drive or Operate Machinery: Immediately after applying Allergocrom, vision will be impaired for a short time. During this time, the patient will not be able to react rapidly and purposefully in the case of unexpected and suddenly occurring events. Do not drive any vehicle or operate machines during this time.
Use in pregnancy & lactation: Although there is no indication of teratogenic effect, Allergocrom is not recommended for use during the first 3 months of pregnancy.
Use in children: Safety and effectiveness in children <4 years has not been established.
Although there is no indication of teratogenic effect, Allergocrom is not recommended for use during the first 3 months of pregnancy.
Hypersensitivity and allergic reaction to benzalkonium chloride may occur.
In rare cases, the sensation of temporary burning, foreign body sensation and chemosis have been reported.
Discontinue use if side effects occur and consult ophthalmologist soon.
Do not store above 25°C.
Do not use Allergocrom >4 weeks after the bottle has been opened.
S01GX01 - cromoglicic acid ; Belongs to the class of other ophthalmologic antiallergics.
Eye drops (sterile, clear, colourless to slightly yellow solution) 20 mg/mL x 10 mL x 1's.