Danzil - instructions for use, dose, side effects, contraindications

Benzalkonium chloride 0.1 mg, sodium chloride 8.0 mg, disodium edetate 1.0 mg, hypromellose 2.0 mg, sodium hydroxide q.s., hydrochloric acid q.s., water for injection up to 1.0 ml.

Description:Transparent light yellowish solution.

Pharmacotherapeutic group:Antimicrobial agent, fluoroquinolone

ATX: & nbsp

S.01.A.E.01 Ofloxacin

J.01.M.A.01 Ofloxacin

Pharmacodynamics:

The mechanism of action is due to the inhibition of bacterial DNA gyrase, which ensures super-convoliation and, thus, the stability of bacterial DNA (destabilization of DNA chains leads to their death). Has a bactericidal effect.

Ofloxacin is not destroyed by beta-lactamases and is not affected by enzymes such as aminoglycoside adenylase, phosphorylase or chloramphenicol acetyltransferase.

Ofloxacin - synthetic fluorinated 4-quinolone, which has antibacterial properties for a wide range of gram-negative and to a lesser extent Gram-positive microorganisms, is active against most strains of the following pathogens of eye infections:

In ophthalmology and ENT-practice they are used to treat infections of the eyes and the ear caused by sensitive strains: Chlamydia trachomatis, Enterobacter cloacae, Haemophilus influenzae, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae.

Pharmacokinetics:

The average concentration of ofloxacin in the lacrimal fluid after 4 hours after topical application is greater than 2 μg / ml, the minimum concentration necessary to inhibit by 90% growth in vitro (MIC90) of the most common strains of infectious diseases of the eye.

Inhibition of ofloxacin in the ear in the case of an intact tympanic membrane is accompanied by a minimum absorption in the middle ear. However, the absorption of ofloxacin is enhanced by perforations of the tympanic membrane. After instillation of a 0.3% solution of ofloxacin to an adult with perforation of the tympanic membrane, the peak serum concentration was 10 ng / ml.

The maximum concentration of ofloxacin in the serum after 10 days of regular topical application is 1000 times less than with the use of standard doses of ofloxacin inside.

Indications:

- Infectious diseases of the adnexa of the eye and anterior segment of the eye, caused by microorganisms sensitive to ofloxacin in adults and children aged 1 year and older.

- Prevention of infections in ophthalmic surgery.

Ear infections

Ofloxacin is indicated for the treatment of the following conditions in adults and children aged 1 year and older:

- External otitis media caused by Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus.

- Chronic purulent otitis media, incl. with perforation of the tympanic membrane caused by Proteus mirabilis, Pseudomonas aeruginosa or Staphylococcus aureus.

- Acute otitis media with an established tympanostomy tube caused by Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus and Streptococcus pneumoniae.

Contraindications:Hypersensitivity to components (including other derivatives of quinolones), non-bacterial diseases of the adnexa of the eye, anterior and posterior segments of the eye, non-bacterial otitis, pregnancy, lactation, children (up to 1 year).

Pregnancy and lactation:Contraindicated.

Dosing and Administration:

Infectious Diseases of the Eyes:

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

- For the 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 wakefulness. 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:

In the case of external otitis, 10 drops are dropped into the affected ear 2 times a day for 10 days.

In the treatment of chronic purulent otitis media with chronic perforation of the tympanic membrane, the recommended dose is 10 drops per affected ear twice a day for 14 days.

For the treatment of otitis with an established tympanostomy tube, the recommended dose is 5 drops 2 times a day for 10 days.

Children from 1 to 11 years:

The doctor should specifically prescribe the use of the drug and determine the dosage. All treatment should be carried out under his outpatient supervision.

For the treatment of external otitis and acute otitis media with a tympanostomy tube, the recommended dose is 5 drops per affected ear 3 times a day for 10 days. Before instillation, you should warm the bottle in your hand for 1-2 minutes to avoid the development of dizziness (possibly with a cold solution). The instillation is performed in the patient's position lying on its side. After instillation, the patient should maintain this position for 5 minutes to facilitate passage of the solution through the external auditory meatus. If necessary, instillation in the other ear works in a similar way.

Overdose:

After topical application of an excessive dose of Dancil®, the eyes should be washed with clean water at room temperature. There are no data on systemic manifestations of an overdose.

Special instructions:

As with other antimicrobial agents, prolonged use of ofloxacin can lead to an increase in insensitive flora. Therefore, in the absence of clinical improvement during the standard treatment period or worsening of the condition, it is necessary to cancel the drug and begin alternative therapy.

Soft contact lenses should not be worn during drug treatment; hard contact lenses are removed before instillation and set again 20 minutes after instillation. Do not inject subconjunctival or into the anterior chamber of the eye. It is necessary to wear sunglasses (because of the possible development of photophobia) and avoid prolonged exposure to bright light.

Form release / dosage:

Eye and ear drops 0,3%.

Packaging:5 ml each in a plastic dropper bottle with a screw cap or in a plastic bottle sealed with a stopper capper, closed with a plastic screw cap with the control of the first autopsy.Each vial-dropper or plastic bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:

List B.

At a temperature of no higher than 25 ° C in a dark place. Do not freeze. Keep out of the reach of children.

Shelf life:

3 years. Drops should be used within 45 days after opening the vial. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-009895/09

Date of registration:04.12.2009 / 05.12.2013

Expiration Date:Unlimited

The owner of the registration certificate:Sentiss Pharma Pvt. Ltd.Sentiss Pharma Pvt. Ltd. India

Manufacturer: & nbsp

SENTISS PHARMA Pvt. Ltd India

Representation: & nbspSENTISS RUSS LLCSENTISS RUSS LLCRussia

Information update date: & nbsp18.03.2017

Illustrated instructions

Instructions

Dancyl® (Dancil®)