Dexapos^® (Drops) Instructions for Use

Marketing Authorization Holder

Ursapharm Arzneimittel, GmbH & Co. KG (Germany)

ATC Code

S01BA01 (Dexamethasone)

Active Substance

Dexamethasone (Rec.INN registered by WHO)

Dosage Form

Dexapos®

Ophthalmic drops 0.1%: dropper bottle 5 ml

Dosage Form, Packaging, and Composition

Ophthalmic drops 0.1% colorless, transparent.

Excipients: methylhydroxypropylcellulose, dextrose, thiomersal (thimerosal), purified water.

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

Clinical-Pharmacological Group

Topical corticosteroids for ophthalmology

Pharmacotherapeutic Group

Topical glucocorticosteroid

Pharmacological Action

Glucocorticosteroid for topical use in ophthalmology. It has anti-inflammatory, anti-allergic, and anti-exudative effects.

The active substance of the drug Dexapos^® – Dexamethasone – stabilizes cell membranes, reduces capillary permeability, causes an anti-exudative effect by stabilizing lysosomal membranes. It has antiproliferative and immunosuppressive activity. It inhibits the expression of genes encoding the synthesis of proteins involved in the development of inflammation. The anti-inflammatory and anti-allergic action of dexamethasone is 25 times greater than that of cortisol, which is a natural endogenous glucocorticosteroid.

The methylhydroxypropylcellulose included in Dexapos^® as an auxiliary component promotes prolonged retention of the active substance on the anterior surface of the eye, thereby increasing the efficacy and duration of action of the drug.

With topical application, systemic absorption is low.

Pharmacokinetics

Dexamethasone penetrates through the cornea with intact epithelium into the aqueous humor of the anterior chamber of the eye.

In case of eye inflammation or damage to the mucous membrane and cornea, the rate of dexamethasone penetration significantly increases.

With topical application, systemic absorption is low.

Indications

Acute and chronic inflammatory processes

• Conjunctivitis;
• Scleritis;
• Deep keratitis without epithelial damage;
• Iritis;
• Iridocyclitis;
• Choroiditis;
• Chorioretinitis;
• Sympathetic ophthalmia.

Allergic eye diseases

• Allergic conjunctivitis;
• Allergic keratoconjunctivitis;
• Hay fever.

Prevention and treatment of inflammatory phenomena in the postoperative and post-traumatic period.

ICD codes

Dosage Regimen

Instill one to two drops into the conjunctival sac of the affected eye(s).

Administer three to five times daily. The frequency depends on the severity of the inflammatory condition.

For severe inflammation, initiate therapy with a higher frequency (e.g., every 1-2 hours). Taper the frequency as the clinical response permits.

Do not use the preparation for more than two to three weeks. The duration of therapy must not exceed this period without re-evaluation.

Base the final treatment duration on therapeutic efficacy, symptom resolution, and the risk of adverse effects.

Monitor intraocular pressure regularly if treatment extends beyond two weeks, especially in patients with a history of glaucoma.

Remove contact lenses prior to instillation. Reinsert lenses no sooner than 20 minutes after application.

Discontinue use immediately and consult an ophthalmologist if ocular pain, vision changes, or other signs of potential adverse reactions occur.

Adverse Reactions

From the organ of vision: burning sensation (occurs immediately after instillation and quickly passes); with prolonged use – development of secondary glaucoma, steroid cataract.

Contraindications

• Keratitis caused by Herpes simplex or Varicella zoster (dendritic keratitis);
• Viral lesions of the cornea and conjunctiva (including chickenpox);
• Mycobacterial eye infections;
• Fungal eye diseases;
• Acute purulent eye diseases with damage to the corneal epithelium;
• Corneal epitheliopathy;
• Increased intraocular pressure;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Adequate and strictly controlled clinical studies on the safety of the drug Dexapos^® during pregnancy and lactation have not been conducted.

Prescription of Dexapos^® is possible only if the intended therapeutic benefit for the mother outweighs the potential risk to the fetus or child.

Pediatric Use

To date, clinical studies on the safety and efficacy of the drug Dexapos^® in children have not been conducted. The use of the drug in pediatrics is possible if the expected therapeutic effect outweighs the potential risk of developing side effects.

Special Precautions

If the duration of drug use exceeds 2 weeks, as well as in patients with a history of open-angle and closed-angle glaucoma, it is recommended to regularly monitor intraocular pressure.

If the use of contact lenses is necessary, they should be removed before instillation of the drug Dexapos^® and reinserted no earlier than 20 minutes later.

The patient should be informed that if side effects occur, treatment should be stopped immediately and an ophthalmologist should be consulted.

Use in pediatrics

To date, clinical studies on the safety and efficacy of the drug Dexapos^® in children have not been conducted. The use of the drug in pediatrics is possible if the expected therapeutic effect outweighs the potential risk of developing side effects.

Effect on ability to drive vehicles and machinery

Immediately after application of the drug Dexapos^®, a short-term impairment of visual acuity may occur, leading to a slowdown in psychomotor reactions. Therefore, it is not recommended to use the drug immediately before working with machinery and driving vehicles.

Overdose

Overdose is unlikely when using the drug Dexapos^®.

Drug Interactions

Drug interactions of the drug Dexapos^® have not been described.

Storage Conditions

List B. The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

After opening the bottle, the drug should be used within 6 weeks.

Dispensing Status

The drug is dispensed by prescription.

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.