Dancil, eye and ear drops 0.3% 5 ml

Dancil is an antimicrobial agent. It belongs to the group of fluoroquinolones of broad spectrum. Bactericidal effect of Ofloxacin is associated with blockade of DNA-gyrase enzyme in bacterial cells.

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

Active against some Gram-positive microorganisms (including Staphylococcus spp., Streptococcus spp. /especially beta-hemolytic streptococci/).

Ofloxacin is moderately sensitive to Enterococcus faecalis, Streptococcus pneumoniae, Pseudomonas spp.

The anaerobic bacteria (except Bacteroides ureolyticus) are not sensitive to ofloxacin.

Resistant to the action of β-lactamases.

Pharmacokinetics

After oral administration, it is quickly and completely absorbed from the gastrointestinal tract. Food intake has little effect on the degree of absorption, but may slow down its rate. Cmax in plasma is reached after 2 hours.

Protein binding is 25%. Ofloxacin is widely distributed in the tissues and body fluids (organs of the urinary system, genital organs, prostate, lungs, ENT organs, gall bladder, bones, skin).

It is excreted unchanged in the urine (about 80% within 24 hours). Urinary concentrations of ofloxacin were significantly higher than MPK90 for most microorganisms after the last dose (300 mg twice daily for 14 days).

A small part of the active substance (about 4%) is excreted in the feces. T1/2 is 6 hours. In elderly patients with an average CK of 50 ml/min may increase T1/2 to 13.3 h.

Indications

Infectious inflammatory diseases caused by microorganisms sensitive to Ofloxacin: diseases of the lower respiratory tract, ear, throat, nose, skin, soft tissue, bone, joints, infectious and inflammatory diseases of the abdominal cavity (except bacterial enteritis) and the pelvis, kidney and urinary tract infections, prostate, gonorrhea.

Active ingredient

Composition

1 ml – ofloxacin3 mg

Supplementary substances:

benzalkonium chloride – 0.1 mg;

sodium chloride – 8 mg;

p>dinatrium edetate – 1 mg;

hypromellose – 2 mg;

sodium hydroxide – q.s.;

Hydrochloric acid – q.s.;

Injection water – up to 1 ml.

How to take, the dosage

Infectious eye diseases

The treatment of bacterial corneal ulcers. The recommended dose of Ofloxacin for adults and children 1 year and older is 1-2 drops of 0.3% solution in the affected eye (or both eyes) every 30 minutes while awake, then 4 and 6 hours after falling asleep, for 2 days. Starting on the 3rd day of treatment and for the next 4-6 days, the solution may be injected 1-2 drops every hour while awake, then 1-2 drops 4 times a day for another 3 days or until clinical cure is achieved.

The treatment of conjunctivitis, blepharitis, keratoconjunctivitis, keratitis, meibomitis, dacryocystitis and prevention of infection in ophthalmosurgery after eye injury and surgery.Ofloxacin in the form of eye drops is usually used only during waking hours. For adults and children 1 year and older, the recommended dose of Ofloxacin is 1-2 drops of 0.3% solution in the affected eye (or both eyes) every 2-4 hours (while awake) for 2 days, then 1-2 drops 4 times daily for no more than 5 days.

Ear infections

Adults and children over 12 years of age

Outer otitis media – 10 drops in the affected ear once daily for 10 days.

Chronic purulent media otitis with chronic tympanic membrane perforation – 10 drops in the affected ear 2 times a day for 14 days.

Oatitis with a tympanostomy tube inserted – 5 drops in the affected ear 2 times a day for 10 days.

In children from 1 to 11 years of age

The doctor must specifically prescribe the drug and determine the dosage. All treatment should be under his or her outpatient care.

The treatment of external otitis media and acute otitis media with a tympanostomy tube placed.The recommended dose is 5 drops in the affected ear 3 times a day for 10 days.

Before instillation, warm the bottle in the hand for 1-2 minutes to avoid dizziness (possible with a cold solution). The instillation is done while the patient is lying on his or her side. After the injection the patient should remain in this position for 5 min to facilitate passage of the solution through the external auditory canal. If instillation in the other ear is necessary, proceed in a similar manner.

Interaction

In concomitant use with antacids containing calcium, magnesium or aluminum, with sucralfate, with drugs containing bivalent and trivalent cations, such as iron, or with multivitamins containing zinc, quinolones absorption disorders are possible, leading to a decrease of their concentration in the body. These drugs should not be used within 2 hours before or within 2 hours after taking ofloxacin.

Concomitant use ofloxacin and NSAIDs increases the risk of CNS stimulation and seizures.

Concomitant use with theophylline may increase its plasma concentrations (including equilibrium) and increase the elimination half-life. This increases the risk of adverse reactions associated with the action of theophylline.

In concomitant use ofloxacin with beta-lactam antibiotics, aminoglycosides and metronidazole an additive interaction was noted.

Special Instructions

Cautiously use in patients with impaired renal and hepatic function.

Blood glucose levels should be monitored during treatment. During long-term therapy, renal function, liver function and peripheral blood picture should be periodically monitored.

When using ofloxacin sufficient hydration of the body must be provided, the patient must not be exposed to ultraviolet radiation.

There has been no mutagenic potential in experimental studies. Long-term studies to determine the carcinogenicity of Ofloxacin have not been conducted.

In studies on young animals of several species, ofloxacin caused arthropathy and osteochondrosis.

The safety and efficacy in children and adolescents under 18 years of age has not been established.

Influence on the ability to drive and operate machinery

With caution, use in patients whose activities require high concentration and rapid psychomotor reactions.

Contraindications

Side effects

Gastrointestinal disorders:

Overdose

After topical application of an overdose of Dancil, the eyes should be rinsed with clean room temperature water.

There is no evidence of systemic manifestations of overdose.

Pregnancy use

Pregnant use is possible (including topical dosage forms) if the expected effects of therapy exceed the potential risk to the fetus (no adequate and strictly controlled safety studies have been conducted in pregnant women).

Teratogenic effects. Ofloxacin had no teratogenic effect when administered to pregnant animals during organogenesis: to rats in doses over 810 mg/kg/day, which is 11 times higher than MRDH when administered orally and 9000 times higher than MRDH when administered as eye drops; to rabbits in doses over 160 mg/kg/day, which are 4 and 1800 times higher than MRDH respectively.

Doses equivalent to 50 and 10 MRDH when administered orally were fetotoxic – decreased fetal body weight and increased fetal mortality in rats and rabbits were observed.

The FDA fetal action category is C.

On a single administration of 200 mg ofloxacin to lactating women, its concentrations in breast milk are similar to those in plasma.

Because ofloxacin can potentially cause serious adverse reactions in breastfed infants, breastfeeding women should stop either breastfeeding or taking ofloxacin (given the importance of the drug to the mother).

Similarities