Dancil^® (Drops) Instructions for Use

Marketing Authorization Holder

Sentiss Pharma, Pvt. Ltd. (India)

ATC Codes

S01AE01 (Ofloxacin)

S02AA16 (Ofloxacin)

Active Substance

Ofloxacin (Rec.INN registered by WHO)

Dosage Form

Dancil®

Eye and ear drops 0.3%: bottle or dropper bottle 5 ml 1 pc.

Dosage Form, Packaging, and Composition

Eye and ear drops in the form of a clear, light yellowish solution.

Excipients: benzalkonium chloride – 0.1 mg, sodium chloride – 8 mg, disodium edetate – 1 mg, hypromellose – 2 mg, sodium hydroxide – q.s., hydrochloric acid – q.s., purified water – up to 1 ml.

5 ml – LDPE bottles (1) with a dropper cap – cardboard boxes.
5 ml – LDPE dropper bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Antibacterial drug of the fluoroquinolone group for topical use in ophthalmology and ENT practice

Pharmacotherapeutic Group

Antimicrobial agent – fluoroquinolone

Pharmacological Action

Broad-spectrum antimicrobial drug from the fluoroquinolone group. The bactericidal action is associated with the blockade of the DNA gyrase enzyme in bacterial cells.

Highly active against most gram-negative microorganisms: Escherichia coli, Salmonella spp., Proteus spp., Morganella morganii, Shigella spp., Klebsiella spp., Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Mycoplasma spp., Legionella pneumophila, Acinetobacter spp., Chlamydia spp.

Active against some gram-positive microorganisms, in particular Staphylococcus spp., Streptococcus spp.

Moderately sensitive to ofloxacin are Enterococcus faecalis, Streptococcus pneumoniae, Pseudomonas spp.

Microorganisms producing beta-lactamase are sensitive to ofloxacin.

Not sensitive are anaerobic bacteria (except for Bacteroides urealyticus).

Pharmacokinetics

4 hours after topical application, the average concentration in the tear fluid exceeds 2 µg/ml.

Instillation into the ear in the case of an intact tympanic membrane is accompanied by minimal absorption into the middle ear. However, absorption increases with perforations of the tympanic membrane.

Indications

Blepharitis; stye; conjunctivitis; dacryocystitis; keratitis; corneal ulcer; chlamydial eye infection; prevention and treatment of bacterial infections after eye injuries and surgical interventions; external otitis, chronic purulent otitis media, including with perforation of the tympanic membrane; prevention of infectious complications during surgical interventions in adults; external otitis and acute otitis media with a tympanostomy tube in children from 1 to 11 years old.

ICD codes

Dosage Regimen

For infectious eye diseases including conjunctivitis, keratitis, and blepharitis, instill 1 to 2 drops into the affected eye(s) every 2 to 6 hours, typically four times daily.

For severe infections, the frequency may be increased to every 30 minutes to 2 hours during the initial treatment phase, as directed.

For ear infections such as otitis externa, instill 10 drops into the affected ear twice daily.

Administer ear drops for a full 10-day course, even if symptoms improve earlier.

In cases of chronic suppurative otitis media with a perforated tympanic membrane, use the same regimen of 10 drops twice daily for 10 days.

For surgical prophylaxis in adults, follow the specific pre- and post-operative instillation schedule provided by the surgeon.

For children aged 1 to 11 years with acute otitis media and tympanostomy tubes, instill 5 drops into the affected ear twice daily for 10 days.

Do not use for more than 14 days for ophthalmic indications without re-evaluation.

Avoid allowing the dropper tip to contact any surface to prevent contamination of the solution.

Adverse Reactions

Local reactions: transient burning or discomfort in the eye, conjunctival hyperemia, blurred vision, eye pain, itching sensation, ear pain, ringing sensation in the ears, dry mouth.

Systemic reactions: eczema, paresthesia, dizziness.

Contraindications

Non-bacterial diseases of the eye adnexa, anterior and posterior segments of the eye; non-bacterial otitis; pregnancy; lactation period (breastfeeding); children’s age (under 1 year).

Use in Pregnancy and Lactation

Use during pregnancy is only possible if the intended benefit to the mother outweighs the potential risk to the fetus. It is not recommended for use during the lactation period (breastfeeding).

Pediatric Use

Use is contraindicated in children under 1 year of age.

Special Precautions

It is not recommended to wear contact lenses during use.

You should wear sunglasses (due to the possible development of photophobia) and avoid prolonged exposure to sunlight.

Effect on the ability to drive vehicles and mechanisms

After application (after instillation into the conjunctival sac), visual acuity is temporarily impaired, which must be taken into account when driving a car and working with mechanisms.

Drug Interactions

During use, it should be taken into account that magnesium, aluminum, iron, and zinc reduce the absorption of ofloxacin.

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.