Allergoferon^® beta (Drops) Instructions for Use

Marketing Authorization Holder

Firn M, LLC (Russia)

ATC Code

S01GX (Other antiallergic agents)

Active Substances

Betamethasone sodium phosphate

Interferon alfa-2b

Dosage Form

Allergoferon® beta

Eye and nasal drops 1 mg+5000 IU/1 ml: 5 ml or 10 ml bottle with dropper dispenser

Dosage Form, Packaging, and Composition

Eye and nasal drops as a transparent, colorless or slightly yellowish solution, with a slight specific odor.

Excipients: benzalkonium chloride – 0.1 mg, disodium edetate dihydrate – 0.5 mg, sodium chloride – 3.2 mg, hypromellose – 3 mg, potassium dihydrogen phosphate – 3.63 mg, sodium phosphate dibasic dodecahydrate – 7.13 mg, povidone 8000 – 5 mg, macrogol 4000 – 30 mg, macrogol 400 – 10 mg, purified water – up to 1 ml.

5 ml – plastic bottles (1) with a dropper dispenser – cardboard boxes.
10 ml – plastic bottles (1) with a dropper dispenser – cardboard boxes.

Clinical-Pharmacological Group

A drug with anti-inflammatory and immunomodulatory action for topical use in ENT practice and ophthalmology

Pharmacotherapeutic Group

Topical glucocorticosteroid + cytokine

Pharmacological Action

A combined preparation for topical use. It has a pronounced local anti-inflammatory, anti-allergic, and immunomodulatory effect. Possesses an anti-exudative effect.

Betamethasone sodium phosphate is a glucocorticosteroid that exerts local anti-inflammatory, anti-allergic, and anti-exudative action.

Interferon alfa-2b human recombinant is a cytokine that exerts anti-inflammatory, immunomodulatory, and antiproliferative action.

Pharmacokinetics

Systemic absorption of the drug after topical application is low. After instillation into the conjunctival sac, betamethasone sodium phosphate penetrates well into the corneal epithelium and conjunctiva; therapeutic concentrations are achieved in the aqueous humor of the eye; the rate of penetration increases with inflammation or damage to the mucous membrane.

The concentration achieved in plasma is so low that it cannot be determined by modern analytical methods and has no clinical significance. The concentration of interferon alfa-2b achieved in blood plasma is significantly below the detection limit (the detection limit for interferon alfa-2b is 1-2 IU/ml), which has no clinical significance.

Indications

Seasonal allergic rhinitis and conjunctivitis (hay fever), of moderate severity in the acute stage.

ICD codes

Dosage Regimen

Use topically for conjunctival or intranasal administration only.

For seasonal allergic conjunctivitis, instill one drop into the conjunctival sac of the affected eye(s) three times a day.

For seasonal allergic rhinitis, instill two drops into each nasal passage three times a day.

Initiate treatment upon the onset of acute allergy symptoms.

The maximum duration of continuous treatment is 10 days.

Do not use for prophylaxis or for extended periods without medical supervision.

Before use, ensure the dropper tip and solution are uncontaminated; avoid contact with eyelids, nasal skin, or other surfaces.

Shake the bottle gently if the solution appears cloudy or contains visible particles.

If wearing contact lenses, remove them before instillation and reinsert no sooner than 15 minutes later.

When using both eye and nasal routes, administer the nasal drops first.

If a dose is missed, apply it as soon as remembered; if it is almost time for the next dose, skip the missed dose and continue the regular schedule.

Do not exceed the prescribed dosage and frequency.

Discontinue use and consult a physician if no improvement is observed within 48 hours or if symptoms worsen.

Adverse Reactions

From the organ of vision: increased intraocular pressure, glaucoma, optic nerve damage, decreased visual acuity and narrowing of visual fields, cataract development, delayed wound healing, development of secondary eye infection, anterior uveitis, perforation of the cornea and sclera, mydriasis, accommodation disturbance, ptosis, transient burning sensation, eye irritation, conjunctival hyperemia.

From ENT organs: ulceration and atrophy of the nasal mucosa, perforation of the nasal septum, rhinorrhea, sneezing, irritation of the nasal mucosa, epistaxis, anosmia.

Other: lacrimation, allergic reactions, headache.

Contraindications

Hypersensitivity to interferon alfa-2b, betamethasone; viral (including herpetic), bacterial, fungal, mycobacterial infections; trachoma; glaucoma, cataract, diabetic retinopathy; damage to the corneal epithelium (including conditions after foreign body removal); ulcerative lesions of the nasal mucosa and nasal trauma; recent surgical interventions in the nasal cavity; children under 18 years of age; pregnancy, breastfeeding period.

With caution

Arterial hypertension, severe hepatic insufficiency.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is contraindicated.

Use in Hepatic Impairment

Use with caution in patients with severe hepatic insufficiency.

Pediatric Use

Contraindicated for use in children under 18 years of age.

Geriatric Use

Use with caution in elderly patients to avoid exacerbation of chronic diseases.

Special Precautions

During the use of this combination, intraocular pressure, the condition of the cornea and lens should be monitored, as the development of steroid-induced glaucoma and cataract is possible.

Effect on the ability to drive vehicles and machinery

Due to possible lacrimation after instillation of the drug, for 30 minutes after instillation, it is necessary to refrain from potentially hazardous activities requiring increased attention, including driving vehicles.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.