ALERON [Sodium cromoglycate] 40 mg Eye drops
instructions for the medical use of the medicinal product
ALERON
Tradename: Aleron, Алерон
International non-proprietary name or generic name: sodium cromoglycate, кромогликат натрия
Dosage form: eye drops.
1 ml of the preparation
contains:
active substance: sodium cromoglycate 40 mg;
excipients: benzalkonium chloride, disodium edetate, montanox 80,
water for injection.
Pharmacotherapeutic group: Antiallergic drugs for topical
use in ophthalmology.
Code АТХ: S01GX01
Pharmacological properties
Pharmacodynamics
An antiallergic agent that prevents mast cell
degranulation and the release of allergic reaction mediators—histamine and
leukotrienes (especially SRS-A). Its mechanism of action likely involves
stabilizing mast cell membranes and blocking calcium channels, which inhibits
mediator release. Sodium cromoglycate blocks both early and late allergic
reactions.
The drug does not have antihistamine or
vasoconstrictor effects.
Pharmacokinetics
Absorption through the mucous membrane
of the eye is insignificant. Systemic bioavailability is less than 0.03%. The
half-life is 5-10 minutes. Plasma protein binding is 65%. It is not
metabolized. It is excreted unchanged in urine and feces in approximately equal
amounts.
Indications for use
• allergic
conjunctivitis;
• allergic keratitis
and keratoconjunctivitis;
• irritation of the
mucous membrane of the eye caused by allergic reactions (environmental factors,
occupational hazards, household chemicals, cosmetics, ophthalmic medications,
plants, and pets).
Contraindications
• hypersensitivity to any of the drug's
components;
• children under 4 years of age.
Use with caution during pregnancy and
breastfeeding.
Method of administration
and dosage
Adults and children over 4 years: Instill 1-2 drops into
each conjunctival sac 4 times daily at 4-6 hour intervals. If necessary, the
dose can be increased to 6 drops.
After achieving a therapeutic effect, the frequency of application can
be reduced and the medication can be used only in cases of contact with
allergens (house dust, fungal spores, pollen).
Instructions for use:
Wash your
hands thoroughly before using the medication.
Avoid
contact of the tip of the opened bottle with the eye or your hands.
Tilt your
head back, place the tip of the bottle over your eye, and pull down your lower
eyelid with the index finger of your other hand. Apply gentle pressure to the
bottle and instill the required amount of medication into the conjunctival sac.
If the
drop does not reach the conjunctival sac, repeat the instillation.
After
instillation, close your eyes and do not blink or open them for approximately 2
minutes to ensure optimal contact between the mucous membrane and the
medication.
Close the
bottle tightly after each use.
Special instructions and precautions
If conjunctival
hyperemia persists or worsens after using eye drops, discontinue use and
consult a doctor.
If you wear contact
lenses, remove them before using the drops and reinsert them 15-20 minutes
after using the drops.
Influence on the
ability to drive vehicles and mechanisms
Immediately after
instillation, blurred vision may occur, which may lead to difficulties in
driving a car and operating machinery.
Side effect
Eye disorders: transient blurred vision, short-term
burning sensation, foreign body sensation, dry eye, conjunctival edema,
lacrimation, meibomitis.
Other: allergic reactions (itching, mild
conjunctival soreness, conjunctival injection), taste changes.
If
any of the side effects listed in the instructions get worse, or you notice any
other side effects not listed in the instructions, tell your doctor.
Interaction with other medicinal
products
Reduces the need for ophthalmic drugs containing glucocorticosteroids.
There are no data on overdose.
Storage conditions
Store at a temperature not exceeding 30°C. Keep out
of reach of children.
Shelf life
3 years.
Once
opened, the medicine can be used within 28 days.
Do not
use after the expiration date.
Vacation conditions
Over the counter.
Release form
10 ml of the product in LDPE dropper bottles
with a screw-on protective cap.
1 bottle with instructions for use in a cardboard box.