Dilaterol^® (Drops) Instructions for Use

Marketing Authorization Holder

Promed Exports, Pvt. Ltd. (India)

ATC Code

S01AA12 (Tobramycin)

Active Substance

Tobramycin (Rec.INN registered by WHO)

Dosage Form

Dilaterol®

Eye drops 0.3%: 5 ml dropper bottle

Dosage Form, Packaging, and Composition

Excipients: benzalkonium chloride 100 mcg, hypromellose 2.5 mg, disodium edetate 1 mg, sodium chloride 9 mg, hydrochloric acid or sodium hydroxide (to adjust pH to 7.5), purified water up to 1 ml.

5 ml – dropper bottle (1) with dispenser – carton packs.

Clinical-Pharmacological Group

Antibiotic for topical use in ophthalmology

Pharmacotherapeutic Group

Antibiotic-aminoglycoside

Pharmacological Action

A broad-spectrum antibiotic from the aminoglycoside group. In low concentrations, it acts bacteriostatically (blocks the 30S ribosomal subunit and disrupts protein synthesis), and in higher concentrations, it acts bactericidally (disrupts protein synthesis and the permeability of the cytoplasmic membrane of the microbial cell, causing its death).

In vitro, it is active against Staphylococcus spp., including Staphylococcus aureus and Staphylococcus epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains; against Streptococcus spp., including some hemolytic Streptococcus spp. of group A, some non-hemolytic species, and some Streptococcus pneumoniae; Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most strains of Proteus vulgaris, Haemophilus influenzae and Haemophilus aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus, and some Neisseria spp.

Some gentamicin-resistant strains remain highly sensitive to tobramycin. It is not effective against most strains of group D streptococci.

Pharmacokinetics

With topical application, systemic absorption is low.

Tobramycin penetrates the cornea poorly, and its concentration in the aqueous humor after topical application of a 0.3% solution is not detected.

Increasing the frequency of application may contribute to an increase in the concentration of tobramycin in the aqueous humor.

Indications

Infections of the eye and its adnexa: blepharitis, blepharoconjunctivitis, dacryocystitis, meibomitis, conjunctivitis, keratoconjunctivitis, keratitis, endophthalmitis, iridocyclitis caused by pathogens sensitive to the drug.

Prevention of infectious complications after ophthalmic surgical interventions.

ICD codes

Dosage Regimen

For mild and moderate severity of the disease, instill 1-2 drops into the affected eye every four hours for 7-10 days.

For severe infections, instill two drops into the eye every hour until the inflammatory phenomena decrease.

For the prevention of infectious complications after ophthalmic surgical interventions, the drug is instilled 3-4 times a day for one month after the operation.

Adverse Reactions

Lacrimation, burning, itching and pain in the eye, photophobia, eyelid edema, conjunctival hyperemia, chemosis, punctate epithelial erosions of the cornea, allergic conjunctivitis, blepharitis and contact dermatitis.

Contraindications

Hypersensitivity to the components of the drug, breastfeeding period, children under 2 months of age.

Use in Pregnancy and Lactation

In studies of the effect on fetal development in animals, no negative effect on the fetus or the course of pregnancy was revealed.

However, given the lack of sufficient experience with the use of the drug Dilaterol^® during pregnancy, prescribing the drug in this category is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding is recommended to be discontinued during treatment, as there is a risk of developing adverse reactions in the child due to the use of tobramycin.

Pediatric Use

Contraindicated in children under 2 months of age.

Special Precautions

Long-term use of Dilaterol^® eye drops, as in the case of using other antibiotics, can lead to increased growth of non-susceptible microorganisms (including fungi).

It is recommended to conduct a bacteriological examination of the eye microflora before starting and after completion of treatment if the clinical result is unsatisfactory.

Wearing contact lenses during treatment with the drug is not allowed.

Effect on the ability to drive vehicles and mechanisms

If after application of the drops patients experience temporary blurred vision, it is not recommended to drive vehicles or engage in activities requiring increased attention and reaction until vision is restored.

Overdose

Symptoms: itching and swelling of the eyelids, punctate keratitis, erythema of the eyelids, increased lacrimation.

The total amount of tobramycin contained in one bottle of eye drops is too small to cause toxic reactions even after accidental ingestion.

After topical application of an excessive dose of Dilaterol^® eye drops, the eyes should be rinsed with clean water at room temperature.

Drug Interactions

In case of simultaneous use of Dilaterol^® eye drops with systemic antibiotics from the aminoglycoside group, an increase in systemic side effects (nephrotoxic, ototoxic effects, disorders of mineral metabolism and hematopoiesis) is possible.

Storage Conditions

Store the drug at a temperature not exceeding 30°C (86°F) in a place protected from light. Do not freeze. Keep out of the reach of children.

Shelf life – 2 years. After opening the bottle, the drug should be used within 30 days.

Do not use after the expiration date printed on the packaging.

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.