Dancil, eye and ear drops 0.3%, 5ml

Composition

1 ml-ofloxacin 3 mg

Auxiliary substances:

benzalkonium chloride-0.1 mg;

sodium chloride-8 mg;

disodium edetate-1 mg;

hypromellose-2 mg;

sodium hydroxide-q. s. ;

hydrochloric acid-q. s. ;

water for injection-up to 1 ml

Pharmacological action

Danzil is an antimicrobial agent. It belongs to the group of broad-spectrum fluoroquinolones. The bactericidal effect of ofloxacin is associated with the blockade of the 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., as well as Chlamydia spp.

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

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

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

Resistant to beta-lactamases.

Pharmacokinetics

After oral use, it is rapidly and completely absorbed from the gastrointestinal tract. Food intake does not significantly affect the degree of absorption, but it can slow down its rate. Cmax in blood plasma is reached after 2 hours.

Protein binding – 25%. Ofloxacin is widely distributed in tissues and body fluids (urinary system, genitals, prostate, lungs, ENT organs, gallbladder, bones, skin).

It is excreted unchanged in the urine (about 80% in 24 hours). Urinary concentrations of ofloxacin significantly exceeded MPC 90 for most microorganisms after the last dose (300 mg twice daily for 14 days).

A small part of the Active ingredient (about 4%) is excreted in the faeces. T1 / 2 is 6 h. In senile patients, with an average creatinine clearance of 50 ml / min, T1/2 may increase to 13.3 h.

Indications

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

Use during pregnancy and lactation

Use during pregnancy is possible (including in the form of dosage forms for topical use), if the expected effect of therapy exceeds the potential risk to the fetus (adequate and strictly controlled studies of the safety of use in pregnant women have not been conducted).

Teratogenic effects. Ofloxacin did not have a teratogenic effect when administered to pregnant animals during organogenesis: rats in doses over 810 mg / kg / day, which is 11 times higher than the MRDH when taken orally and 9000 times – when used as eye drops; rabbits in doses over 160 mg / kg/day, which exceeds the MRDH by 4 and 1800 times, respectively.

Doses equivalent to 50 and 10 MRDH when taken orally were fetotoxic — there was a decrease in fetal body weight and an increase in fetal mortality in rats and rabbits.

Category of action on the fetus according to the FDA-C.

With a single dose of 200 mg of ofloxacin in nursing women, its concentrations in breast milk are similar to those in plasma.

Since ofloxacin can potentially cause serious adverse reactions in children who are breastfed, nursing women should stop either breastfeeding or taking ofloxacin (given the importance of the drug for the mother).

Contraindications

• hypersensitivity to ofloxacin or other quinolone derivatives.
• pregnancy and lactation.
• children and adolescents under 18 years of age.

Side effects

From the gastrointestinal tract:

• nausea, vomiting, diarrhoea, pain and cramps, appetite loss, dry mouth, flatulence, gastrointestinal dysfunction, constipation;
• rarely – liver function abnormalities, liver necrosis, jaundice, hepatitis, intestinal perforation, pseudomembranous colitis, bleeding from the gastrointestinal tract, disorders of the mucous membrane of the mouth, heartburn, increased activity of liver enzymes, including GGT and LDH, increased levels of bilirubin in the blood serum.

Central and peripheral nervous system disorders:  

• insomnia, dizziness, fatigue, drowsiness, nervousness;
• rarely – convulsions, anxiety, cognitive changes, depression, abnormal dreams, euphoria, hallucinations, paresthesia, syncope, tremor, confusion, nystagmus, suicidal thoughts or attempts, disorientation, psychotic reactions, paranoia, phobia, agitation, aggressiveness, emotional instability, peripheral neuropathy, ataxia, impaired coordination, exacerbation of extrapyramidal disorders, speech disorder.

Allergic reactions:  

• skin rash, pruritus;
• rarely-angioedema, urticaria, vasculitis, allergic pneumonitis, anaphylactic shock, erythema multiforme, Stevens-Johnson syndrome, erythema nodosum, exfoliative dermatitis, toxic epidermal necrolysis, conjunctivitis.

From the side of the reproductive system:  

• itching in the external genital area in women, vaginitis, vaginal discharge;
• rarely-burning, irritation, pain and rash in the genital area in women, dysmenorrhea, menorrhagia, metrorrhagia, vaginal candidiasis.

From the side of metabolism:

• rarely-thirst, weight loss, hyper-or hypoglycemia (especially in diabetic patients receiving insulin or oral hypoglycemic agents), acidosis, increased serum TG, cholesterol, and potassium.

Respiratory system disorders:

• rarely-cough, nasal discharge, respiratory arrest, dyspnoea, bronchospasm, stridor.

From the cardiovascular system:

• rarely-cardiac arrest, edema, hypertension, hypotension, palpitation, vasodilation, cerebral thrombosis, pulmonary edema, tachycardia.

From the urinary system:

• rarely-dysuria, increased urination, urinary retention, anuria, polyuria of kidney stones, renal failure, nephritis, hematuria, albuminuria, candiduria.

Musculoskeletal disorders:  

• rarely-arthralgia, myalgia, tendinitis, muscle weakness, exacerbation of myasthenia gravis.

From the side of the senses:

• rarely – hearing impairment, tinnitus, diplopia, nystagmus, visual clarity disorders, taste and smell disorders, photophobia.

Dermatological reactions:

• rarely-photosensitization, hyperpigmentation, vesiculobullous rashes.

From the hematopoietic system:  

• rarely-anemia, bleeding, pancytopenia, agranulocytosis, leukopenia, reversible suppression of bone marrow hematopoiesis, thrombocytopenia, thrombocytopenic purpura, petechiae, ecchymosis, increased prothrombin time.

Other services:  chest pain, pharyngitis, fever, body aches; rarely-asthenia, chills, general malaise, nosebleeds, increased sweating.

Interaction

When used concomitantly with antacids containing calcium, magnesium or aluminum, with sucralfate, with preparations containing divalent and trivalent cations, such as iron, or with multivitamins containing zinc, it is possible to disrupt the absorption of quinolones, leading to a decrease in their concentration in the body. These drugs should not be used for 2 hours before or for 2 hours after taking ofloxacin.

Concomitant use of ofloxacin and NSAIDs increases the risk of developing a stimulating effect on the central nervous system and seizures.

When used concomitantly with theophylline, it is possible to increase its concentration in blood plasma (including in the equilibrium state), increase the half-life. This increases the risk of side effects associated with theophylline.

An additive interaction was observed when ofloxacin was co-administered with beta-lactam antibiotics, aminoglycosides, and metronidazole.

How to take it, course of use and dosage

Infectious eye diseases

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

Treatment of conjunctivitis, blepharitis, keratoconjunctivitis, keratitis, meibomitis, dacryocystitis and prevention of infections in ophthalmic surgery after eye trauma and surgical interventions. Ofloxacin in the form of eye drops is usually used only during the waking period. For adults and children aged 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 (during wakefulness) for 2 days, then 1-2 drops 4 times a day for no more than 5 days.

Ear infections

Adults and children over 12 years of age

External otitis — 10 drops in the affected ear 1 time a day for 10 days.

Chronic purulent otitis media with chronic perforation of the eardrum — 10 drops in the affected ear 2 times a day for 14 days.

Otitis media with a tympanostomy tube installed — 5 drops in the affected ear 2 times a day for 10 days.

Children from 1 to 11 years old

The doctor should specifically prescribe the use of the drug and determine the dosage. All treatment should take place under his outpatient supervision.

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

Before instillation, warm the bottle in your hand for 1-2 minutes to avoid dizziness (possibly when using a cold solution). Instillation is performed in the patient’s lying position on his side. After instillation, the patient should maintain this position for 5 minutes to facilitate the passage of the solution through the external ear canal. If necessary, instillations in the other ear work in the same way.

Overdose

After topical application of an excessive dose of Danzil, the eyes should be rinsed with clean water at room temperature.

There are no data on systemic manifestations of overdose.

Special instructions

Use with caution in patients with impaired renal and hepatic function.

During the treatment period, it is necessary to monitor the level of glucose in the blood. With long-term therapy, it is necessary to periodically monitor the functions of the kidneys, liver, and peripheral blood picture.

When using ofloxacin, it is necessary to ensure sufficient hydration of the body, the patient should not be exposed to ultraviolet radiation.

No mutagenic potential was detected 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.

Safety and efficacy in children and adolescents under 18 years of age have not been established.

Influence on the ability to drive motor vehicles and manage mechanisms

Use with caution in patients whose activity is associated with the need for high concentration of attention and speed of psychomotor reactions.

Form of production

Eye and ear drops 0.3%

Storage conditions

In a dark place, at a temperature not exceeding 25 °C (do not freeze)

Shelf life

2 years

Active ingredient

Ofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Purpose

For adults as directed by your doctor

Indications

Inflammatory eye diseases, Otitis media