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Ofloxacin Dancil drops eye/ear 0.3% 5 ml x1

Trade name: Dancil International name: Ofloxacin Pharmacological group: antimicrobial agent - fluoroquinolone Pharmacological group according to ATC: J01MA01. Ofloxacin Pharmacological action: antimicrobial, antituberculosis, fluoroquinolone Storage conditions: List B Pharmacodynamics: SOLUTION FOR INFUSION, COAT-COATED TABLETS A broad-spectrum antimicrobial agent from the group of fluoroquinolones, acts on the bacterial enzyme DNA gyrase, which ensures supercoiling, etc. stability of bacterial DNA (destabilization of DNA chains leads to their death). Has a bactericidal effect. Active against microorganisms producing beta-lactamases and fast-growing atypical mycobacteria. Sensitive: Staphylococcus aureus, Staphylococcus epidermidis, Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Citrobacter, Klebsiella spp. (including Klebsiella pneumonia), Enterobacter spp., Hafnia, Proteus spp. (including Proteus mirabilis, Proteus vulgaris - indole-positive and indole-negative), Salmonella spp., Shigella spp. (including Shigella sonnei), Yersinia enterocolitica, Campylobacter jejuni, Aeromonas hydrophila, Vibrio cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Chlamydia spp., Legionella spp., Serratia spp., Providencia spp., Haemophilus ducreyi, Bordetella parapertussis, Bordetella pertussis, Moraxella catarrhalis, Propionibacterium acne, Brucella spp. The following have varying sensitivity to the drug: Enterococcus faecalis, Streptococcus pyogenes, pneumoniae and viridans, Serratia marcescens, Pseudomonas aeruginosa, Acinetobacter, Mycoplasma hominis, Mycoplasma pneumoniae, Mycobacterium tuberculosis, Mycobacterium fortuitum, Ureaplasma urealyticum, Clostridium perfringens, Corynebacterium spp. , Helicobacter pylori, Listeria monocytogenes, Gardnerella vaginalis. In most cases insensitive: Nocardia asteroides, anaerobic bacteria (e.g. Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacter spp., Fusobacterium spp., Clostridium difficile). Does not affect Treponema pallidum.

EYE DROPS, EYE AND EAR DROPS, EYE OINTMENT Broad-spectrum antimicrobial agent from the group of fluoroquinolones, acts on the bacterial enzyme DNA gyrase, which ensures supercoiling, etc. stability of bacterial DNA (destabilization of DNA chains leads to their death). Has a bactericidal effect. In ophthalmology and ENT practice, it is used to treat eye and ear infections caused by sensitive strains: Chlamydia trachomatis, Enterobacter cloacae, Haemophilus influenzae, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae. Pharmacokinetics: SOLUTION FOR INFUSION, COIL-COATED TABLETS Absorption after oral administration is rapid and complete (95%). Bioavailability - over 96%, binding to plasma proteins - 25%, TCmax after oral administration - 1-2 hours, Cmax after administration at a dose of 100, 300 and 600 mg is 1, 3, 4 and 6.9 mg/l, respectively, and depends on dose: after a single dose of 200 and 400 mg, it is 2.5 and 5 mcg/ml, respectively. Food may slow absorption but does not significantly affect bioavailability. The apparent volume of distribution is 100 l. Distribution: cells (leukocytes, alveolar macrophages), skin, soft tissues, bones, abdominal and pelvic organs, respiratory system, urine, saliva, bile, prostate secretion, penetrates well through the blood-brain barrier, placental barrier, secreted into breast milk. Penetrates into the CSF (14-60%). Metabolized in the liver (about 5%) to form N-oxide ofloxacin and dimethylofloxacin. T1/2 - 4.5-7 hours (regardless of dose). Excreted by the kidneys - 75-90% (unchanged), about 4% - with bile. Extrarenal clearance is less than 20%. After a single dose of 200 mg, it is detected in the urine within 20-24 hours. In case of renal/liver failure, excretion may slow down. Does not accumulate. Hemodialysis removes 10-30% of the drug. Indications for use: SOLUTION FOR INFUSION, COATED TABLETS Infections of the respiratory tract (bronchitis, pneumonia), ENT organs (sinusitis, pharyngitis, otitis media, laryngitis, tracheitis), skin, soft tissues, bones, joints, infectious and inflammatory diseases of the abdominal cavity and biliary tract, kidneys (pyelonephritis), urinary tract (cystitis, urethritis), pelvic organs (endometritis, salpingitis, oophoritis, cervicitis, parametritis, prostatitis), genital organs (colpitis, orchitis, epididymitis), gonorrhea, chlamydia, sepsis (only for intravenous administration), meningitis, prevention of infections in patients with impaired immune status (including neutropenia).

EYE DROPS, EYE AND EAR DROPS, EYE OINTMENT Ophthalmology: bacterial corneal ulcers, conjunctivitis, blepharitis, meibomitis (styre), dacryocystitis, keratitis, chlamydial eye infections, prevention of infectious complications in the postoperative period after surgical interventions for removal of a foreign body and eye injury . ENT practice: acute and chronic bacterial external and internal otitis, otitis with perforation of the tympanic membrane or tympanopuncture, prevention of infectious complications during surgical interventions. Contraindications: SOLUTION FOR INFUSION, COAT-COATED TABLETS Hypersensitivity, glucose-6-phosphate dehydrogenase deficiency, epilepsy (including history), decreased seizure threshold (including after TBI, stroke or inflammatory processes in the central nervous system), damage tendons with previous treatment with fluoroquinolones, age up to 18 years (skeletal growth has not yet been completed), pregnancy, lactation.

EYE DROPS, EYE AND EAR DROPS, EYE OINTMENT Hypersensitivity (including to other quinolone derivatives), chronic non-bacterial conjunctivitis or otitis, pregnancy, lactation. Dosage regimen: SOLUTION FOR INFUSION, COIL-COATED TABLETS Orally, i.v. Doses are selected individually depending on the location, severity of the infection, sensitivity of microorganisms, as well as the general condition of the patient and liver and kidney function. SOLUTION FOR INFUSION: IV administration begins with a single dose of 200 mg, which is administered drip-wise slowly over 30-60 minutes. If the patient's condition improves, the patient is transferred to oral administration of the drug in the same daily dose. IV: urinary tract infections - 100 mg 1-2 times a day, kidney and genital infections - from 100 mg 2 times a day to 200 mg 2 times a day, respiratory tract infections, as well as ENT organs, skin infections and soft tissues, infections of bones and joints, infections of the abdominal cavity, septic infections - 200 mg 2 times a day. If necessary, the dose is increased to 400 mg 2 times a day. For the prevention of infections in patients with a pronounced decrease in immunity - 400-600 mg/day. If necessary, 200 mg intravenously in a 5% dextrose solution. Duration of infusion - 30 minutes. Only freshly prepared solutions should be used. COAT-COATED TABLETS: Orally: adults - 200-800 mg/day, course of treatment - 7-10 days, frequency of use - 2 times a day. Doses up to 400 mg/day can be given in one dose, preferably in the morning. For gonorrhea - 400 mg once. In patients with impaired renal function (with CC 50-20 ml/min) 100-200 mg/day. For CC less than 20 ml/min - 100 mg every 24 hours, for hemodialysis and peritoneal dialysis - 100 mg every 24 hours. The maximum daily dose for liver failure is 400 mg/day. The tablets are taken whole with water, before or during meals. The duration of treatment is determined by the sensitivity of the pathogen and the clinical picture; treatment should be continued for at least another 3 days after the symptoms of the disease disappear and body temperature completely normalizes. When treating salmonellosis, the course of treatment is 7-8 days; for uncomplicated lower urinary tract infections, the course of treatment is 3-5 days.

EYE DROPS, EYE AND EAR DROPS, EYE OINTMENT: Locally. Floxal: drops are instilled into the conjunctival sac of the affected eye, 1 drop 2-4 times a day for no more than 2 weeks, eye ointment - 1.5 cm strips of ointment are placed behind the lower eyelid 2-3 times a day, for chlamydial infections - 5 times a day day. The course of treatment is no more than 2 weeks. Uniflox: 1-2 drops into the conjunctival sac every hour for the first 2 days, in the next 2-3 days - 6-7 times a day for 7 days (within 3 days after the cessation of purulent discharge). The course of treatment is no more than 2 weeks. In ENT practice: 10 drops are instilled into the ear canal of the affected ear 2 times a day for 10 days, for chronic purulent otitis and perforation of the eardrum - for 14 days. The bottle with drops is preheated in your hand for 1-2 minutes (to prevent dizziness). The patient should be and remain for 5 minutes after instillation in a position lying on his side. Side effects: SOLUTION FOR INFUSION, COATED TABLETS From the digestive system: gastralgia, loss of appetite, nausea, vomiting, diarrhea, flatulence, abdominal pain, increased activity of liver transaminases, hyperbilirubinemia, cholestatic jaundice, pseudomembranous enterocolitis. From the nervous system: headache, dizziness, uncertainty of movements, tremors, convulsions, numbness and paresthesia of the extremities, intense dreams, nightmares, psychotic reactions, anxiety, agitation, phobias, depression, confusion, hallucinations, increased intracranial pressure. From the musculoskeletal system: tendinitis, myalgia, arthralgia, tenosynovitis, tendon rupture. From the senses: impaired color vision, diplopia, disorders of taste, smell, hearing and balance. From the cardiovascular system: tachycardia, decreased blood pressure, collapse (with intravenous administration, with a sharp decrease in blood pressure, the administration is stopped). Allergic reactions: skin rash, itching, urticaria, allergic pneumonitis, allergic nephritis, eosinophilia, fever, angioedema, bronchospasm, erythema multiforme (including Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell's syndrome), photosensitivity, vasculitis, anaphylactic shock. From the skin: pinpoint hemorrhages (petechiae), bullous hemorrhagic dermatitis, papular rash with crust, indicating vascular damage (vasculitis). From the hematopoietic organs: leukopenia, agranulocytosis, anemia, thrombocytopenia, pancytopenia, hemolytic and aplastic anemia. From the urinary system: acute interstitial nephritis, impaired renal function, hypercreatininemia, increased urea concentration. Other: intestinal dysbiosis, superinfection, hypoglycemia (in patients with diabetes), vaginitis. Local reactions: pain, hyperemia at the injection site, thrombophlebitis (with intravenous administration).

Overdose Symptoms: dizziness, confusion, lethargy, disorientation, drowsiness, vomiting. Treatment: gastric lavage, symptomatic therapy.

EYE DROPS, EYE AND EAR DROPS, EYE OINTMENT Allergic reactions. Eye drops (optional): burning sensation and discomfort in the eyes, hyperemia, itching and dryness of the conjunctiva, photophobia, lacrimation. After instillation into the ear canal (additionally): itching in the ear canal area, a feeling of bitter taste in the mouth, rarely - eczema, dizziness, tinnitus, ear pain, dry mouth. Interaction: SOLUTION FOR INFUSION, COIL-COATED TABLETS Reduces the clearance of theophylline by 25% (with simultaneous use, the dose of theophylline should be reduced). Increases the concentration of glibenclamide in plasma. Cimetidine, furosemide, methotrexate and drugs that block tubular secretion increase the concentration of ofloxacin in plasma. When taken simultaneously with vitamin K antagonists, it is necessary to monitor the blood coagulation system. When prescribed with NSAIDs, nitroimidazole derivatives and methylxanthines, the risk of developing neurotoxic effects increases. When administered simultaneously with GCS, the risk of tendon rupture increases, especially in older people. When prescribed with drugs that alkalinize urine (carbonic anhydrase inhibitors, citrates, sodium bicarbonate), the risk of crystalluria and nephrotoxic effects increases. Compatible with the following infusion solutions: 0.9% NaCl solution, Ringer's solution, 5% fructose solution, 5% dextrose solution. Do not mix with heparin (risk of precipitation). Food products, antacids containing Al3+, Ca2+, Mg2+ or Fe salts reduce the absorption of ofloxacin, forming insoluble complexes (the time interval between the administration of these drugs should be at least 2 hours). Special instructions: SOLUTION FOR INFUSION, COIL-COATED TABLETS It is not the drug of choice for pneumonia caused by pneumococci. Not indicated for the treatment of acute tonsillitis. It is not recommended to use for more than 2 months, to be exposed to sunlight, exposure to UV rays (mercury-quartz lamps, solarium). In case of side effects from the central nervous system, allergic reactions, pseudomembranous colitis, discontinuation of the drug is necessary. For pseudomembranous colitis confirmed by colonoscopy and/or histology, oral administration of vancomycin and metronidazole is indicated. Rarely, tendinitis can lead to tendon rupture (mostly the Achilles tendon), especially in older patients. If signs of tendinitis occur, you should immediately stop treatment, immobilize the Achilles tendon and consult an orthopedist. During the treatment period, ethanol should not be consumed. When using the drug, women are not recommended to use sanitary tampons due to the increased risk of developing thrush. During treatment, the course of myasthenia gravis may worsen and attacks of porphyria may increase in predisposed patients. May lead to false negative results in the bacteriological diagnosis of tuberculosis (prevents the isolation of Mycobacterium tuberculosis). In patients with impaired liver or kidney function, monitoring of plasma concentrations of ofloxacin is necessary. In case of severe renal and hepatic insufficiency, the risk of developing toxic effects increases (reducing dose adjustment is required). During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

With caution: Atherosclerosis of cerebral vessels, cerebrovascular accidents (history), chronic renal failure, organic lesions of the central nervous system.

EYE DROPS, EYE AND EAR DROPS, EYE OINTMENT Should not be administered subconjunctivally or into the anterior chamber of the eye. You should wear sunglasses (due to the possible development of photophobia) and avoid prolonged exposure to bright light. Immediately after using eye drops or ointments, blurred visual perception is possible, which can lead to difficulties when driving a car and when working with machinery; it is recommended to start working (driving) 15 minutes after using the drug. Soft contact lenses should not be worn during treatment with the drug; hard contact lenses are removed before instillation and reinserted 20 minutes after instillation. The combined use of eye drops and eye ointment is possible, with the ointment being used last.

Manufacturer: Promed Exports Pvt Ltd, India Registration certificate holder: Promed Exports Pvt Ltd, India Release form: eye and ear drops 0.3% (plastic dropper bottle) 5 ml Composition: ofloxacin 3 mg, excipients (benzalkonium chloride 100 mcg, water for injection, hypromellose 2 mg, disodium edetate 1 mg, sodium hydroxide to pH 6.0-6.8, sodium chloride 8 mg, hydrochloric acid to pH 6.0-6.8) - 1 ml Shelf life: 2 years, after opening - 1 month Registration information : LSR-009895/09 dated 12/04/2009 Registration certificate status: valid HS codes: 3004 90 190 9