Oftasait^® (Drops) Instructions for Use

Marketing Authorization Holder

Micro Labs Limited (India)

ATC Code

S01GX07 (Azelastine)

Active Substance

Azelastine (Rec.INN registered by WHO)

Dosage Form

Oftasait®

Eye drops 0.05%: dropper bottle 10 ml

Dosage Form, Packaging, and Composition

Eye drops as a clear, colorless solution.

Excipients: benzalkonium chloride 50% solution calculated as benzalkonium chloride – 0.125 mg, hypromellose 4000 – 1 mg, disodium edetate – 0.5 mg, sorbitol (Neosorb 70/20 crystallized type) – 66.666 mg, sodium hydroxide – q.s. to pH 5.5-6.5, purified water – up to 1 ml.

10 ml – polyethylene dropper bottles (1) – cardboard packs.

Clinical-Pharmacological Group

An antiallergic drug for topical use in ophthalmology

Pharmacotherapeutic Group

Antiallergic agent – H₁-histamine receptor blocker

Pharmacological Action

H₁-histamine receptor blocker, a phthalazinone derivative. It has a pronounced antiallergic effect. In addition, it inhibits the release of inflammatory mediators from mast cells.

Pharmacokinetics

When applied topically in ophthalmology, C_max values were very low and were detected at or below the limit of quantification.

Indications

Prevention and treatment of seasonal allergic conjunctivitis; treatment of non-seasonal (perennial) allergic conjunctivitis.

ICD codes

Dosage Regimen

Instill one drop into the affected eye(s) twice daily, in the morning and evening.

For prevention of seasonal allergic conjunctivitis, initiate treatment upon anticipated exposure to allergens.

For treatment of active symptoms, continue administration for the duration of allergen exposure.

Wash hands thoroughly before use.

Avoid allowing the dropper tip to contact any surface, including the eye, to prevent contamination.

If using other topical ophthalmic agents, administer them at least 10-15 minutes apart.

Do not wear contact lenses during treatment if eyes are red.

Remove contact lenses prior to instillation and reinsert no sooner than 15 minutes afterward.

Immediately after instillation, apply gentle pressure to the lacrimal sac (inner corner of the eye) for one to two minutes to reduce systemic absorption.

This technique is particularly important for pediatric patients and individuals with systemic health conditions.

Discard the container and any remaining solution four weeks after first opening.

Adverse Reactions

From the organ of vision common – transient blurred vision, conjunctivitis; rare – sensation of burning in the eye.

Systemic reactions uncommon – bitter taste in the mouth; very rare – allergic reactions, headache, asthma, dyspnea, fatigue, flu-like symptoms, pharyngitis, pruritus, rhinitis.

Contraindications

Hypersensitivity to azelastine, first trimester of pregnancy, children under 4 years of age.

Use in Pregnancy and Lactation

Use is contraindicated in the first trimester of pregnancy.

In the second and third trimesters of pregnancy, use is possible only in cases of extreme necessity, when the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

During breastfeeding, use is possible only in cases of extreme necessity, when the expected benefit of therapy for the mother outweighs the risk for the breastfed infant.

Pediatric Use

Use is contraindicated in children under 4 years of age.

Special Precautions

It is not recommended to wear contact lenses during treatment.

Effect on ability to drive vehicles and operate machinery

In case of blurred vision immediately after instillation of this product, you should refrain from driving a car and engaging in activities requiring increased attention until vision is restored.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.