Ofloxacin, 400 mg, film-coated tablets, 10 pcs.
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 be exposed to sunlight or exposure to UV rays (mercury-quartz lamps, solarium).
To prevent urine hyperconcentration and subsequent crystalluria, adequate hydration is recommended during treatment.
The appearance of diarrhea, especially severe, persistent and/or bloody diarrhea, during or after treatment with ofloxacin may be a manifestation of pseudomembranous colitis. If pseudomembranous colitis is suspected, treatment with ofloxacin should be discontinued immediately and appropriate specific antibacterial therapy (eg, oral vancomycin, oral teicoplanin, or metronidazole) should be instituted without delay. Drugs that inhibit intestinal motility are contraindicated.
If side effects from the central nervous system or allergic reactions occur, discontinuation of the drug is necessary.
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 become more frequent.
May lead to false negative results in the bacteriological diagnosis of tuberculosis (prevents the isolation of Mycobacterium tuberculosis).
In patients with impaired liver function, monitoring of plasma concentrations of ofloxacin is necessary. In severe liver failure, the risk of toxic effects increases (reducing dose adjustment is required).
In patients using fluoroquinolones, including ofloxacin, cases of sensory and sensorimotor axonal polyneuropathy affecting small and (or) large axons and leading to paresthesia and hypoesthesia have been reported. dysesthesia and weakness. Symptoms may appear soon after starting use and may be irreversible. If the patient develops symptoms of neuropathy, including pain, burning, tingling, numbness and/or weakness or other sensory disturbances, including touch, pain, temperature, vibration and position sense, ofloxacin should be discontinued immediately.
Taking ofloxacin, especially long-term, can cause a secondary infection associated with the growth of drug-resistant microorganisms. Re-evaluation of the patient's condition is necessary.
Impact on the ability to drive vehicles and operate machinery
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. If undesirable effects such as dizziness or drowsiness occur, you should refrain from performing these activities.
Ofloxacin film-coated tablets 200 mg No. 10
Ofloxacin film-coated tablets 200 mg No. 10
Latin name Ofloxacin
Release form Tablets
Pharmacological action Ofloxacin DS is a broad-spectrum antimicrobial agent from the group of fluoroquinolones that acts on the bacterial enzyme DNA gyrase, which ensures supercoiling and, thus, 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, Campilobacter jejuni, Aeromonas hydrophila, Plesiomonas aeruginosa, Vibrio cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Chlamydia spp., Legionella spp., Serratia spp., Providencia spp., Haemophilus ducreyi, Bordetella parapertussis, Bor detella pertussis, Moraxella catarrhalis, Propionibacterium acnes, Staphylococcus spp., Brucella spp. The following have varying sensitivity to the drug: Enterococcus faecalis, Streptococcus pyogenes, pneumoniae and viridans, Serratio marcescens, Pseudomonas aeruginosa, Acinetobacter, Mycoplasma hominis and pneumoniae, Mycobacterium tuberculosis, as well as Mycobacterium fortuim, Ureaplasma urealyticum, Clostridium perfringens, Corynebacterium spp., Helico bacter pylori Listeria monocytogenes, Gardnerella vaginalis. Generally insensitive: Nocardia asteroides, anaerobic bacteria (eg Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile). Does not affect Treponema pallidu.
Pharmacokinetics: Absorption after oral administration is rapid and complete (95%). Bioavailability - over 96%, binding to plasma proteins - 25%, time to reach maximum concentration (TCmax) when taken orally - 1-2 hours, maximum concentration (Cmax) after taking a dose of 100 mg, 300 mg, 600 mg is 1.3. 4 and 6.9 mg/l and depends on the dose: after a single dose of 200 mg and 400 mg it is 2.5 μg/ml and 5 μg/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 cerebrospinal fluid in inflamed and non-inflamed meninges (14-60%). Metabolized in the liver (about 5%) to form N-oxide ofloxacin and dimethylofloxacin. The half-life is 4.5-7 hours (regardless of the 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 Infections of the respiratory tract (bronchitis, pneumonia), ENT organs (sinusitis, pharyngitis, otitis media, laryngitis), skin, soft tissues, bones, joints, infectious and inflammatory diseases of the abdominal cavity and biliary tract (except for bacterial enteritis), kidneys (pyelonephritis), urinary tract (cystitis, urethritis), pelvic organs (endometritis, salpingitis, oophoritis, cervicitis, parametritis, prostatitis), genital organs (colpitis, orchitis, epididymitis), gonorrhea, chlamydia; meningitis; prevention of infections in patients with impaired immune status (including neutropenia).
Contraindications Hypersensitivity, glucose-6-phosphate dehydrogenase deficiency, epilepsy (including a history), decreased seizure threshold (including after traumatic brain injury, stroke or inflammatory processes in the central nervous system); age up to 18 years (skeletal growth is not yet completed), pregnancy, lactation. With caution - atherosclerosis of cerebral vessels, cerebrovascular accidents (history), chronic renal failure, organic lesions of the central nervous system.
Special instructions 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, ultraviolet 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 must immediately stop treatment, immobilize the Achilles tendon and consult an orthopedist. When using the drug, women are not recommended to use 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 (dose adjustment is required). During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions; you should not consume ethanol.
Composition 1 tablet contains: Active substance: ofloxacin – 200 mg; Excipients: corn starch, lactose, povidone, croscarmellose sodium, magnesium stearate. Shell: hypromellose (hydroxypropylymethylcellulose), macrogol 6000 (polyethylene glycol 6000), titanium dioxide, talc, polysorbate 80.
Directions for use and dosage: Inside. Doses are selected individually depending on the location and severity of the infection, as well as the sensitivity of microorganisms, the general condition of the patient and the function of the liver and kidneys. Adults - 200-800 mg per day, course of treatment - 7-10 days, frequency of use - 2 times a day. A dose of up to 400 mg per day can be given in one dose, preferably in the morning. For gonorrhea - 400 mg once. In patients with impaired renal function (with a creatinine clearance of 50-20 ml/min), a single dose should be 50% of the average dose with a frequency of administration 2 times a day, or the full single dose is administered 1 time a day. When creatinine clearance is less than 20 ml/min, a single dose is 200 mg, then 100 mg per day every other day. For hemodialysis and peritoneal dialysis - 100 mg every 24 hours. The maximum daily dose for liver failure is 400 mg per 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 the 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.
Drug interactions Food products, antacids containing aluminum, calcium, magnesium or iron salts reduce the absorption of ofloxacin, forming insoluble complexes (the time interval between the administration of these drugs should be at least 2 hours). Reduces the clearance of theophylline by 25% (with simultaneous use, the dose of theophylline should be reduced). Cimetidine, furosemide, methotrexate and drugs that block tubular secretion increase the concentration of ofloxacin in plasma. Increases the concentration of glibenclamide in plasma. When taken simultaneously with vitamin K antagonists, it is necessary to monitor the blood coagulation system. When prescribed with nonsteroidal anti-inflammatory drugs, nitroimidazole derivatives and methylxanthines, the risk of developing neurotoxic effects increases. When administered concomitantly with glucocorticosteroids, the risk of tendon rupture increases, especially in the elderly. When prescribed with drugs that alkalinize urine (carbonic anhydrase inhibitors, citrates, sodium bicarbonate), the risk of crystalluria and nephrotoxic effects increases.
Overdose Symptoms: dizziness, confusion, lethargy, disorientation, drowsiness, vomiting. Treatment: gastric lavage, symptomatic therapy. Hemodialysis removes 10–30% of the drug.
Storage conditions: In a dry place, at a temperature of 15 to 25 °C. Keep out of the reach of children.
Shelf life 3 years
