Prenacid (Drops) Instructions for Use

Marketing Authorization Holder

SIFI, S.p.A. (Italy)

ATC Code

S01BA11 (Desonide)

Active Substance

Desonide (Rec.INN registered by WHO)

Dosage Forms

	Prenacid	Eye drops 0.25%: 10 ml bottle, 1 pc. in a set with a dropper cap
		Eye ointment 0.25%: 10 g tube, 1 pc.

Dosage Form, Packaging, and Composition

Eye drops colorless, transparent.

Excipients: potassium dihydrogen phosphate, sodium hydrogen phosphate dodecahydrate, sodium chloride, polysorbate 80, benzalkonium chloride, purified water.

10 ml – dark glass bottles (1) in a set with a dropper cap – cardboard packs.

Eye ointment 0.25% homogeneous, light yellow in color.

Excipients: vaseline oil, lanolin, petrolatum.

10 g – aluminum tubes (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, vasoconstrictive, and anti-allergic effects.

It reduces vascular permeability, chemotaxis, and promotes lysosome stabilization.

Indications

Acute and chronic allergic and inflammatory processes of the eyes

• Inflammation of the anterior segment of the eye (blepharitis, conjunctivitis, scleritis, deep keratitis without epithelial damage, iritis, iridocyclitis);
• Inflammation of the posterior segment of the eye (choroioditis, chorioretinitis, optic neuritis).

Prevention and treatment of inflammatory processes in the postoperative and post-traumatic periods.

ICD codes

Dosage Regimen

For eye drops, instill 1-2 drops into the lower conjunctival sac of the affected eye(s).

Administer drops 3-4 times daily for acute inflammatory conditions.

For eye ointment, apply a small amount (approximately 1 cm ribbon) into the lower conjunctival sac.

Apply ointment 3-4 times daily or use once at night when concurrently using eye drops during the day.

Adjust the frequency of administration based on the severity of inflammation; reduce to 1-2 times daily for maintenance therapy.

Do not allow the dropper tip or tube nozzle to contact any surface to prevent contamination.

The maximum duration of continuous treatment is 4 weeks.

Discontinue treatment if no clinical improvement is observed within 48 hours; re-evaluate the diagnosis.

For post-operative or post-traumatic inflammation, initiate therapy as directed and taper the dose according to clinical response.

Adverse Reactions

Local reactions: tingling, burning sensation.

With prolonged use, an increase in intraocular pressure with the development of a glaucoma symptom complex with optic nerve atrophy and narrowing of the visual fields is possible (therefore, when using drugs containing glucocorticosteroids for more than 10 days, intraocular pressure should be measured regularly), corneal perforation, and the addition of a fungal infection.

With continuous use for more than 3 months, cataract development is possible.

Contraindications

• Keratitis caused by herpes zoster (dendritic keratitis), chickenpox and other viral diseases of the eyelids, conjunctiva and cornea;
• Mycobacterial eye infections;
• Fungal eye diseases;
• Acute purulent eye diseases (including stye);
• Corneal epitheliopathy;
• Increased intraocular pressure;
• Glaucoma;
• Hypersensitivity to the components of the drug.

Use with caution during pregnancy, during lactation (breastfeeding), and in childhood.

Use in Pregnancy and Lactation

The drug should be used with caution during pregnancy and during lactation (breastfeeding).

Pediatric Use

The drug should be used with caution in childhood.

Special Precautions

Patients using contact lenses should be informed that before using Prenacid, contact lenses should be removed and reinserted no earlier than 20-30 minutes after the procedure.

As a result of long-term use of Prenacid in the form of eye drops, an increase in intraocular pressure is possible. Therefore, when using the drug for more than 10 days, intraocular pressure should be measured regularly.

Glucocorticosteroid therapy can mask the development of a bacterial or fungal infection. Therefore, if an infection develops, the use of Prenacid should be combined with specific antibiotic therapy.

If allergic reactions occur, treatment should be stopped immediately.

Effect on the ability to drive vehicles and operate machinery

Due to possible lacrimation after instillation of the drug, it is not recommended to use it immediately before driving vehicles or operating machinery.

Overdose

An increase in the manifestations of the described side effects is possible.

Drug Interactions

Drug interactions of Prenacid 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).

Pharmacy supply conditions

The drug is dispensed by prescription.

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.