Betasone^® (Drops) Instructions for Use

Marketing Authorization Holder

Masterlek, CJS (Russia)

Manufactured By

Pharmaceutical Firm LECKO, CJS (Russia)

ATC Code

S02BA07 (Betamethasone)

Active Substance

Betamethasone sodium phosphate (BAN accepted for use in the United Kingdom)

Dosage Form

Betasone®

Eye/ear drops 0.1%: bottle 5 ml with dropper cap included

Dosage Form, Packaging, and Composition

Eye/ear drops in the form of a transparent, colorless or with a slight yellowish tint liquid.

Auxiliary substances : sodium phosphate dibasic, sodium chloride, disodium salt of EDTA (trilon B), benzalkonium chloride, orthophosphoric acid (to pH 7.0-8.5), sodium hydroxide solution 1M, water for injections.

5 ml – bottles of dark glass (1) in a set with a dropper cap – carton packs.

Clinical-Pharmacological Group

Topical corticosteroid for use in ophthalmology and ENT practice

Pharmacotherapeutic Group

Topical glucocorticosteroid

Indications

• Ophthalmic Use: Treatment of steroid-responsive inflammatory conditions of the eye, including non-infectious conjunctivitis, keratitis, anterior uveitis (iritis, iridocyclitis), and inflammation following ocular surgery or trauma.
• Otic Use: Treatment of steroid-responsive inflammatory conditions of the external auditory canal, such as otitis externa, and for the symptomatic relief of eczematous and allergic conditions affecting the ear.

The decision to use Betasone drops should be made by a qualified healthcare professional after a thorough evaluation to confirm the diagnosis and rule out contraindications, particularly latent or active ocular or otic infections.

Contraindications

• Absolute Contraindications: Hypersensitivity to betamethasone, any other component of the formulation, or other corticosteroids. Active, untreated viral (e.g., herpes simplex, vaccinia, varicella), fungal, or mycobacterial infections of the eye or ear. Purulent, untreated bacterial infections.
• Relative Contraindications (Use with Extreme Caution): Glaucoma or a history of elevated intraocular pressure. A history of herpes simplex keratitis. Corneal or scleral thinning (perforation risk). Perforation of the tympanic membrane (for otic use). Pregnancy and lactation, as the potential risks must be weighed against the benefits. Use in pediatric patients requires close supervision due to a higher susceptibility to systemic absorption and adrenal suppression.

Self-diagnosis and treatment are strongly discouraged. This medication should not be used for the red, irritated eye of unknown origin without a comprehensive ophthalmological examination.

Dosage Regimen

For Ophthalmic Use: Instill one to two drops into the conjunctival sac of the affected eye(s) every one to two hours during the initial 24 to 48 hours. As the inflammation subsides, the frequency of administration should be gradually reduced to one drop three to four times daily. The duration of treatment is determined by the clinical response and the severity of the condition. Treatment should not be discontinued abruptly; a gradual tapering of the dose is recommended to prevent rebound inflammation.

For Otic Use: Instill two to three drops into the affected ear canal two to three times daily. The canal may be lightly plugged with a cotton wick soaked in the medication for enhanced contact. The duration of therapy is typically short-term, as directed by a physician.

Administration Instructions: Wash hands thoroughly before use. Avoid touching the dropper tip to any surface, including the eye, ear, or fingers, to prevent contamination. Tilt the head back (for eyes) or to the side (for ear). Gently pull down the lower eyelid or pull the ear lobe upward and backward to straighten the canal. Apply the prescribed number of drops. Close the eye gently for 1-2 minutes after ophthalmic administration; apply gentle pressure to the nasolacrimal duct (inner corner of the eye) for one minute to minimize systemic absorption. For ear drops, remain in position for several minutes. Replace the cap securely after use.

Adverse Reactions

Ophthalmic Use: Common local reactions may include transient stinging or burning upon instillation, blurred vision, and mild irritation. More serious adverse effects require immediate medical attention and include: increased intraocular pressure (IOP) leading to glaucoma and optic nerve damage, posterior subcapsular cataract formation, delayed wound healing, secondary ocular infections from viruses, fungi, or bacteria suppressed by the steroid, corneal or scleral perforation in susceptible individuals, and mydriasis.

Otic Use: Local reactions can include transient stinging or burning sensation, itching, and irritation within the ear canal. Hypersensitivity reactions, such as contact dermatitis, are possible. With prolonged use or application to large denuded areas, systemic absorption of corticosteroids can occur, potentially leading to symptoms of hypercortisolism, including adrenal suppression, especially in children.

Patients should be monitored regularly by an ophthalmologist or otolaryngologist during prolonged therapy to check for signs of increased IOP, cataract formation, and secondary infections.

Drug Interactions

Formal specific interaction studies have not been conducted with Betasone drops. However, concomitant use with other corticosteroid preparations, either systemic or topical, may result in an additive effect, increasing the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing’s syndrome.

Concurrent use of drugs known to be toxic to the eye or ear, or medications that may delay wound healing, should be approached with caution. The preservative benzalkonium chloride may be incompatible with certain ionic contact lens solutions; soft contact lenses should not be worn during treatment with this medication. Patients should inform their physician about all other medications they are using, including over-the-counter products and herbal supplements.

Overdose

Acute overdose with topical ophthalmic or otic preparations is unlikely to cause life-threatening symptoms. However, accidental ingestion of the contents of the bottle could lead to systemic corticosteroid effects, such as hypercortisolism. In case of accidental ingestion, symptomatic and supportive care is recommended.

Prolonged or excessive topical application can lead to significant systemic absorption, manifesting as symptoms of steroid excess, including moon face, central obesity, hypertension, hyperglycemia, and adrenal suppression. In such cases, the medication should be withdrawn gradually. Treatment is supportive and should include evaluation of adrenal function if indicated. There is no specific antidote.

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

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.