Ofloxin - description of the drug, instructions for use, reviews

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Manufacturers: Fresenius Kabi

Active ingredients

• Ofloxacin

Disease class

• Blepharitis
• Acute and unspecified inflammation of the tear ducts
• Conjunctivitis, unspecified
• Keratitis
• Corneal ulcer
• Otitis externa
• Purulent and unspecified otitis media
• Otitis media, unspecified
• Acute sinusitis
• Acute pharyngitis, unspecified
• Acute laryngitis
• Acute tracheitis
• Pneumonia without specifying the pathogen
• Chronic pharyngitis
• Chronic sinusitis
• Chronic laryngitis and laryngotracheitis
• Chronic laryngitis
• Bronchitis, not specified as acute or chronic
• Peritonitis
• Local infection of skin and subcutaneous tissue, unspecified
• Pyogenic arthritis, unspecified
• Bone disease, unspecified
• Trauma to the eye and orbit
• Respiratory tuberculosis, not confirmed bacteriologically or histologically
• Septicemia, unspecified
• Bacterial infection, unspecified
• Gonococcal infection, unspecified
• Other chlamydial sexually transmitted diseases
• Other diseases caused by chlamydia
• Chlamydial conjunctivitis (H13.1*)
• Chlamydial infection, unspecified
• Foreign body in the outer part of the eye
• Surgical practice
• Cystitis
• Urethritis and urethral syndrome
• Urinary tract infection without established localization
• Inflammatory disease of the prostate, unspecified
• Inflammatory diseases of the female pelvic organs, unspecified
• Gonococcal inflammatory diseases of the female pelvic organs
• Inflammatory diseases of the female pelvic organs caused by chlamydia (A56.1)

Clinical and pharmacological group

• Not indicated. See instructions

Pharmacological action

• Antibacterial
• Bactericidal

Pharmacological group

• Quinolones/fluoroquinolones

Compound

Ofloxin 200 mg

1 tablet of the drug contains 200 mg ofloxacin .
Excipients include: corn starch, poloxamer, magnesium stearate, lactose monohydrate, crospovidone, povidone, talc; The shell shell contains hypromellose, macrogol, titanium dioxide, talc.

Ofloxin 400 mg

1 tablet of the drug contains 400 mg ofloxacin .

Excipients include: corn starch, magnesium stearate, poloxamer, lactose monohydrate, crospovidone, povidone, talc; The shell shell contains hypromellose, macrogol, titanium dioxide, talc.

Pharmacodynamics and pharmacokinetics

Ofloxacin is an antimicrobial drug with a broad spectrum of bactericidal action. It belongs to the group of fluoroquinolones . The main effect of ofloxacin is on the enzyme DNA gyrase, which ensures supercoiling of bacterial DNA. The drug destabilizes DNA chains, which leads to the death of microorganisms.

Ofloxacin has high activity against microorganisms that produce β-lactamases, and is also used to combat such fast-growing atypical microbacteria as Enterobacteriaceae (Salmonella, Serratia, Citrobacter, Klebsiella, Yersinia) , Escherichia coli, Enterobacter spp., Shigella spp., Providencia spp., Proteus spp.

The drug is also effective against staphylococci (including penicillinase-producing and methicillin-resistant strains (Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycobacterium tuberculosis, Mycobacterium leprae, Ureaplasma urealyticum).

The drug also shows good results in the treatment of diseases caused by the following microbacteria: Pasteurella multocida, Pseudomonas spp., Brucella melitensis, Haemophilus influenzae, Campylobacter spp., Neisseria meningitidis, Branhamella catarrhalis, Vibrio spp., Pseudomonas aeruginosa.

It is advisable to use this antibiotic during active reproduction of Helicobacter pylori, Acinetobacter spp., Neisseria gonorrhoeae, Haemophilus ducreyi, Gardnerella vaginalis.

Ofloxin is less active against infectious diseases caused by streptococci of groups A, B, C. Also, anaerobes with the exception of Clostridium perfringens are not significantly sensitive to the drug. In these cases, ofloxacin has minimal effect and, if possible, it is better to use other drugs to slow down the proliferation of these bacteria.

Anaerobic bacteria Fusobacterium spp., Bacteroides spp., Peptococcus spp., and Peptostreptococcus spp. are completely insensitive to the drug.

Ofloxin is also inactive against Treponema pallidum.

Suction

When taking the drug, absorption is complete (95%) and rapid. Bioavailability exceeds 96%. Cmax when taking the drug in dosages of 100 mg, 300 mg and 600 mg reaches 1 mg/l, 3.4 mg/l and 6.9 mg/l, respectively. With a single dose of the drug in a dosage of 200 mg and 400 mg, Cmax reaches 2.5 μg/ml and 5 μg/ml. Please note that food intake significantly slows down absorption, but does not significantly affect bioavailability.

Distribution

The binding of ofloxacin to plasma proteins is 20-25%. The apparent Vd reaches 100 liters. The drug easily penetrates into many liquid environments and tissues of the body (tear and cerebrospinal fluid, urine, saliva, bronchial secretions, etc.). Ofloxacin also easily penetrates the placental barrier and the blood-brain barrier, and is also excreted in breast milk. The penetrating ability of the drug into the cerebrospinal fluid varies from 14 to 60%. Ofloxacin does not accumulate.

Metabolism

Metabolism occurs in the liver. Dimethylofloxacin and ofloxacin N-oxide are formed.

Removal

T1/2 when taken orally, regardless of the dose, is excreted after 4.5-7 hours. Excretion is carried out by the kidneys (75-90%) and bile (4%). Extrarenal clearance is about 20%. Patients with renal or hepatic insufficiency should remember that T1/2 of the drug increases. With a single dose of 200 mg, ofloxacin can be detected in the urine for 20-24 hours.

Ofloxin 400 mg 10 pcs. film-coated tablets

pharmachologic effect

Antimicrobial agent of the fluoroquinolone group with a broad spectrum of action.
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.

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

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

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

Resistant to β-lactamases.

Composition and release form Ofloxin 400 mg 10 pcs. film-coated tablets

1 tablet contains the active substance: ofloxacin 400 mg.

10 pieces. — cellular contour packages (1) — cardboard packs.

Directions for use and doses

Individual. The daily dose is 200-800 mg, the frequency of use is 2 times a day. For patients with impaired renal function (creatinine clearance 20-50 ml/min), the first dose is 200 mg, then 100 mg every 24 hours. For creatinine clearance less than 20 ml/min, the first dose is 200 mg, then 100 mg every 48 hours.

Pharmacokinetics

After oral administration, it is quickly and completely absorbed from the gastrointestinal tract. Food intake has little effect on the extent of absorption, but may slow 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, genital organs, prostate gland, lungs, ENT organs, gall bladder, bones, skin).

It is excreted unchanged in the urine (about 80% in 24 hours). Concentrations of ofloxacin in urine significantly exceeded the MIC90 for most microorganisms after the last dose (300 mg 2 times a day 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 CC on average 50 ml/min, T1/2 may increase to 13.3 hours.

Indications for use Ofloxin 400 mg 10 pcs. film-coated tablets

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

Contraindications

Pregnancy, lactation, childhood and adolescence under 18 years of age, hypersensitivity to ofloxacin or other quinolone derivatives.

Application Ofloxin 400 mg 10 pcs. film-coated tablets during pregnancy and breastfeeding

Contraindicated for use during pregnancy and lactation.

Experimental studies have not revealed any negative effects on fertility in rats.

Use in children

Contraindicated in children and adolescents under 18 years of age.

special instructions

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

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

When using ofloxacin, the body should be sufficiently hydrated and the patient should not be exposed to ultraviolet radiation.

Experimental studies have not revealed any mutagenic potential. Long-term studies to determine the carcinogenicity of ofloxacin have not been conducted.

In studies in juvenile animals of several species, ofloxacin caused arthropathy and osteochondrosis.

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

Impact on the ability to drive vehicles and operate machinery

Use with caution in patients whose activities require a high concentration of attention and speed of psychomotor reactions.

Side effects Ofloxin 400 mg 10 pcs. film-coated tablets

From the digestive system: nausea, vomiting, diarrhea, abdominal pain and cramps, loss of appetite, dry mouth, flatulence, gastrointestinal dysfunction, constipation; rarely - liver dysfunction, liver necrosis, jaundice, hepatitis, intestinal perforation, pseudomembranous colitis, bleeding from the gastrointestinal tract, disorders of the oral mucosa, heartburn, increased activity of liver enzymes, including GGT and LDH, increased bilirubin levels in the blood serum.

From the nervous system: insomnia, dizziness, fatigue, drowsiness, nervousness; rarely - convulsions, anxiety, cognitive changes, depression, pathological dreams, euphoria, hallucinations, paresthesia, syncope, tremor, confusion, nystagmus, suicidal thoughts or attempts, disorientation, psychotic reactions, paranoia, phobia, agitation, aggressiveness, emotional lability, peripheral neuropathy, ataxia, coordination disorders, exacerbation of extrapyramidal disorders, speech impairment.

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

From the reproductive system: itching in the area of ​​the external genitalia in women, vaginitis, vaginal discharge; rarely - burning, irritation, pain and rash in the genital area in women, dysmenorrhea, menorrhagia, metrorrhagia, vaginal candidiasis.

From the cardiovascular system: rarely - cardiac arrest, edema, arterial hypertension, arterial hypotension, palpitation, vasodilation, cerebral thrombosis, pulmonary edema, tachycardia.

From the urinary system: rarely - dysuria, increased frequency of urination, urinary retention, anuria, polyuria, kidney stone formation, renal failure, nephritis, hematuria, albuminuria, candiduria.

From the musculoskeletal system: rarely - arthralgia, myalgia, tendinitis, muscle weakness, exacerbation of myasthenia gravis.

Metabolic: rarely - thirst, weight loss, hyper- or hypoglycemia (especially in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents), acidosis, increase in serum TG, cholesterol, potassium.

From the respiratory system: rarely - cough, nasal discharge, respiratory arrest, dyspnea, bronchospasm, stridor.

From the senses: rarely - hearing impairment, tinnitus, diplopia, nystagmus, impaired clarity of visual perception, impaired taste, smell, photophobia.

Dermatological reactions: rarely - photosensitivity, hyperpigmentation, vesiculobullous rashes.

From the hematopoietic system: rarely - anemia, bleeding, pancytopenia, agranulocytosis, leukopenia, reversible inhibition of bone marrow hematopoiesis, thrombocytopenia, thrombocytopenic purpura, petechiae, ecchymosis, increased prothrombin time.

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

Drug interactions

When used simultaneously with antacids containing calcium, magnesium or aluminum, with sucralfate, with drugs containing di- and trivalent cations such as iron, or with multivitamins containing zinc, the absorption of quinolones may be impaired, leading to a decrease in their concentration in the body. These drugs should not be used within 2 hours before or within 2 hours after taking ofloxacin.

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

When used simultaneously with theophylline, it is possible to increase its concentration in the blood plasma (including at steady state), and increase T1/2. This increases the risk of developing adverse reactions associated with theophylline.

With simultaneous use of ofloxacin with beta-lactam antibiotics, aminoglycosides and metronidazole, additive interactions were observed.

Indications for use

Ofloxin has proven itself in the treatment of:

• severe respiratory tract infections ( bronchiectasis , lung abscess , pneumonia );
• infections of the ENT organs ( otitis media, sinusitis, pharyngitis, laryngitis /except acute tonsillitis /);
• infections of bones and joints;
• soft tissue and skin infections;
• infectious and inflammatory diseases of the abdominal cavity (infections of the gastrointestinal tract; biliary tract /except for bacterial enteritis /);
• kidney infections ( pyelonephritis );
• urinary tract infections ( urethritis, cystitis );
• infections of the pelvic organs ( endometritis, salpingitis, cervicitis, parametritis, prostatitis );
• severe infections of the genital organs ( orchitis, colpitis, epididymitis, gonorrhea, prostatitis );
• meningitis;
• chlamydia;
• concomitant infections with AIDS ;
• eye infections ( conjunctivitis , bacterial corneal ulcers, blepharitis, dacryocystitis, meibomitis, keratitis ).

Ofloxin is also actively used:

• in the prevention of infectious complications after surgical interventions due to the removal of a foreign body or eye injury;
• for complex therapy of tuberculosis ;
• in the prevention of infections in patients with immunodeficiency ( neutropenia ).

Ofloxacin

Kidney failure

Since ofloxacin is excreted primarily by the kidneys, dosage adjustments are required in patients with impaired renal function.

Prevention of photosensitivity

When using ofloxacin, due to the risk of photosensitization, exposure to strong solar or artificial ultraviolet radiation should be avoided.

Superinfection

As with the use of other antimicrobial drugs, the use of ofloxacin, especially for a long time, can lead to increased proliferation of microorganisms that are insensitive to it (bacteria and fungi). Therefore, during treatment, it is imperative to re-evaluate the patient’s condition, and if superinfection develops during treatment, appropriate measures should be taken to treat it.

Peripheral neuropathy

Sensory and sensorimotor peripheral neuropathy, which may have a rapid onset, has been reported in patients receiving fluoroquinolones, including ofloxacin. If the patient develops symptoms of neuropathy, ofloxacin should be discontinued. This minimizes the possible risk of developing irreversible changes.

Patients with glucose-6-phosphate dehydrogenase deficiency

Patients diagnosed with glucose-6-phosphate dehydrogenase deficiency are predisposed to hemolytic reactions when treated with quinolones. Therefore, caution should be exercised when using ofloxacin in such patients.

Pseudomembrane colitis caused by Clostridium difficile

The appearance of diarrhea, especially severe, persistent and/or bloody diarrhea, during or after treatment, may be a manifestation of pseudomembranous colitis. If the development of pseudomembranous colitis is suspected, treatment with ofloxacin should be stopped immediately, and appropriate specific therapy (Vancomycin orally, teicoplanin orally or metronidazole orally) should be immediately prescribed. If this clinical situation occurs, drugs that inhibit intestinal motility are contraindicated.

Patients predisposed to developing seizures

Like other fluoroquinolones, ofloxacin should be used with caution in patients with a predisposition to the development of seizures: in patients with previous lesions of the central nervous system, in patients simultaneously receiving drugs that lower the seizure threshold of the brain (theophylline, fenbufen and other similar non-steroidal anti-inflammatory drugs). If seizures develop, treatment with ofloxacin should be discontinued.

Tendinitis

Tendinitis, which occurs rarely with quinolones, can sometimes lead to rupture of tendons, including the Achilles tendon, especially in elderly patients and in patients concomitantly taking corticosteroids. This side effect may develop within 48 hours of starting treatment and may be bilateral. If signs of tendinitis (inflammation of the tendon) appear, it is recommended to immediately stop treatment with the drug. The affected tendon may need to be treated appropriately, for example by providing sufficient immobilization.

QT prolongation

Some caution is required when using fluoroquinolones, including ofloxacin, in patients with known risk factors for QT prolongation, such as: advanced age; uncorrected electrolyte disturbances (hypokalemia, hypomagnesemia); congenital prolongation of the QT interval; diseases of the cardiovascular system (heart failure, myocardial infarction, bradycardia); simultaneous use with other drugs that prolong the QT interval (class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).

Exacerbation of pseudoparalytic myasthenia gravis (myasthenia gravis)

Fluoroquinolones, including ofloxacin, can block neuromuscular activity and increase muscle weakness in patients with myasthenia gravis. In the post-marketing period, serious adverse reactions, including pulmonary failure requiring mechanical ventilation and death, have been observed with the use of fluoroquinolones in patients with myasthenia gravis. The use of ofloxacin in patients with an established diagnosis of pseudoparalytic myasthenia gravis is not recommended.

Severe skin reactions

When using ofloxacin, cases of severe bullous reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been observed. Patients should be informed that if any reactions from the skin or mucous membranes develop, the patient should immediately consult a doctor and not continue treatment until his consultation.

Hypersensitivity reactions and allergic reactions

With the use of fluoroquinolones, the development of hypersensitivity reactions and allergic reactions (anaphylactic shock and anaphylactoid reactions, which can progress to a life-threatening condition) has been reported. In these cases, treatment with ofloxacin should be stopped and the necessary therapeutic measures should be initiated.

Psychotic reactions

Psychotic reactions, including suicidal thoughts/attempts, have been reported in patients taking fluoroquinolones, including ofloxacin. If patients develop such reactions, ofloxacin should be discontinued and appropriate treatment should be prescribed. Ofloxacin should be used with caution in patients with psychotic disorders, including a history of psychotic disorders.

Liver dysfunction

Ofloxacin should be used with caution in patients with impaired liver function as liver damage may occur. Cases of fulminant hepatitis leading to liver failure (including fatal cases) have been reported with the use of fluoroquinolones. Patients should be advised to stop treatment and consult a doctor if symptoms and signs of liver disease are observed, such as anorexia, jaundice, dark urine, itching, abdominal pain.

Dysglycemia (hypo- and hyperglycemia)

Both hypoglycemia and hyperglycemia have been reported with fluoroquinolones, including ofloxacin. Hypoglycemic coma has been reported in patients with diabetes mellitus receiving concomitant treatment with oral hypoglycemic drugs (eg, glibenclamide) or insulin drugs. In patients with diabetes mellitus, careful monitoring of blood glucose concentrations is required.

Patients taking vitamin K antagonists

Due to the possible increase in prothrombin time/international normalized ratio and/or bleeding in patients taking both ofloxacin and vitamin K antagonists (for example, warfarin), regular monitoring of blood clotting parameters is necessary.

Risk of developing resistance

The prevalence of acquired resistance may vary geographically and over time for individual microorganism species. Therefore, local information on resistance is required; Microbiological diagnostics should be carried out with isolation of the pathogen and determination of its sensitivity, especially in severe infections or lack of response to treatment.

Escherichia coli infections

Resistance to fluoroquinolones in Escherichia coli, the most common causative agent of urinary tract infections, varies across geographic regions. Physicians are advised to take into account the local resistance of Escherichia coli to fluoroquinolones.

Infections caused by Neisseria gonorrhoeae

Due to increasing resistance in Neisseria gonorrhoeae, ofloxacin should not be used as empirical treatment for suspected gonococcal urinary tract infection. Susceptibility testing of the pathogen to ofloxacin should be performed to guide targeted therapy.

Methicillin-resistant Staphylococcus aureus

There is a high likelihood that Staphylococcus aureus (methicillin-resistant strains) will be resistant to fluoroquinolones, including ofloxacin. Therefore, ofloxacin is not recommended for the treatment of established or suspected infections caused by Staphylococcus aureus (methicillin-resistant strains) unless laboratory tests have confirmed the sensitivity of this microorganism to ofloxacin.

Bone and joint infections

For infections of bones and joints, the need for combined use of ofloxacin with other antibacterial drugs should be considered.

Effect on laboratory parameters and diagnostic tests

Ofloxacin may inhibit the growth of Mycobacterium tuberculosis, leading to false-negative results in the microbiological diagnosis of tuberculosis.

Contraindications

You should stop taking Ofloxin:

• with deficiency of glucose-6-phosphate dehydrogenase ;
• with epilepsy (including a history);
• when the convulsive threshold is reduced (including after a stroke , traumatic brain injury or any inflammatory processes in the central nervous system).

Ofloxin is contraindicated:

• persons under the age of 18;
• persons who have hypersensitivity to the components of the drug.
• pregnant women;
• women during lactation.

The drug should be used with caution by people with diseases associated with cerebrovascular accidents and cerebral atherosclerosis . In case of chronic renal failure and organic lesions of the central nervous system, it is advisable to select drugs for treatment with a similar spectrum of action, but less dangerous.

Instructions for use OFLOXACIN

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 the drug for more than 2 months. Avoid exposure to sunlight and 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.

It should be borne in mind that when using Ofloxacin-Borimed, rare tendinitis can lead to tendon rupture (mainly the Achilles tendon), especially in elderly patients. If symptoms of tendinitis occur, you should immediately stop treatment, immobilize the Achilles tendon and consult an orthopedist.

When using the drug, women are not recommended to use Tampax-type tampons, due to the increased risk of developing vaginal candidiasis.

During treatment, the course of myasthenia gravis may worsen and attacks of porphyria may increase in predisposed patients.

When using the drug, false negative results are possible 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 treatment with the drug, you should avoid drinking alcohol.

Use in pediatrics

In children, Ofloxacin-Borimed is prescribed only when there is a threat to life, taking into account the expected benefits and the potential risk of side effects, when it is impossible to use other, less toxic drugs.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

The drug should be prescribed with caution in case of atherosclerosis of cerebral vessels, cerebrovascular accidents (history), chronic renal failure, QT prolongation, organic lesions of the central nervous system.

Side effects

During treatment with Ofloxin, the patient may feel discomfort and suffer from:

• From the digestive system: nausea, vomiting, diarrhea, flatulence, abdominal pain (including gastralgia ), increased activity of liver transaminases , hyperbilirubinemia, cholestatic jaundice, pseudomembranous enterocolitis.
• From the peripheral nervous system and central nervous system: headache, dizziness, uncertainty of movements, tremors, convulsions, numbness and paresthesia of the extremities, intense dreams, nightmares, psychotic reactions, anxiety, increased excitability, phobias, depression, confusion, hallucinations , increased intracranial pressure.
• From the senses: disturbances of color perception, diplopia, disturbances of taste, hearing, smell and balance.
• From the cardiovascular system: tachycardia, vasculitis, collapse.
• From the musculoskeletal system: tendonitis, myalgia, arthralgia, tenosynovitis, tendon rupture.
• From the hematopoietic system: leukopenia, agranulocytosis, anemia, thrombocytopenia, pancytopenia, hemolytic and aplastic anemia.
• From the urinary system: acute interstitial nephritis, renal dysfunction, hypercreatininemia, increased urea content.
• Allergic reactions: skin rash, itching, urticaria, allergic pneumonitis, allergic nephritis, eosinophilia, fever, Quincke's edema, bronchospasm, Stevens-Johnson syndrome, Lyell's syndrome, photosensitivity, erythema multiforme, anaphylactic shock.
• Dermatological reactions: pinpoint hemorrhages (petechiae), bullous hemorrhagic dermatitis, papular rash, vasculitis.
• And also: dysbiosis, superinfection, hypoglycemia (in patients with diabetes ), vaginitis .

Solution for infusion Ofloxin (Ofloxin)

Instructions for medical use of the drug

Description of pharmacological action

Inhibits DNA gyrase (topoisomerase II and IV), disrupts the process of supercoiling and cross-linking of DNA breaks, inhibits cell division, causes structural changes in the cytoplasm and death of microorganisms. Has a wide spectrum of action. Affects mainly gram-negative and some gram-positive microorganisms. Effective against microorganisms resistant to most antibiotics and sulfonamide drugs. Cross-resistance of bacteria to ofloxacin and other fluoroquinolones is possible. The spectrum of action includes: E. coli, Salmonella spp., Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Haemophilus influenzae, Haemophilus ducreyi, Proteus mirabilis, Proteus vulgaris, Pseudomonas spp., incl. Pseudomonas aeruginosa, Acinetobacter spp., Aeromonas hydrophilia, Bordetella parapertussis, Bordetella pertussis, Klebsiella spp., incl. Klebsiella pneumoniae, Moraxella (Branhamella) Catarrhalis, Morganella Morganii, Providencia spp., Neisseria gonorrhoeae, neisseria meningitidis, shigella Sonnei, Helicobacter pylori, m YCoplasma spp., Ureaplasma urealyticum, Vibrio spp., Gardnerella vaginalis, Chlamydia spp., Legionella pneumophila, Staphylococcus spp., Streptococcus spp., Enterococcus faecalis, Listeria monocytogenes, Propionibacterium acnes, Clostridium perfringens, Mycobacterium tuberculosis (including multi-resistant strains). When taken orally, it is completely absorbed from the gastrointestinal tract (about 95%), absolute bioavailability is 96%. After taking ofloxacin in the dosage form of regular tablets, Cmax in plasma is achieved within 1-2 hours, after taking extended-release tablets - within 6-8 hours. Plasma protein binding is 32%. Apparent volume of distribution 100 l. T1/2 when taking conventional tablets - 4.5–7 hours. Penetrates the cells (leukocytes, alveolar macrophages) of most organs and tissues, creates high concentrations in urine, bile, saliva, sputum, prostate secretions, kidneys, liver, bile bladder, skin, lungs, passes through the BBB and placental barrier. In the liver (about 5%) it is converted to ofloxacin N-oxide and demethylofloxacin. Excreted primarily by the kidneys unchanged (80–90%); a small part is excreted in bile, feces, and breast milk (extrarenal clearance is less than 20%). After a single oral dose of 200 mg is detectable in the urine for 20–24 hours. In case of liver and/or kidney diseases, excretion may slow down. Re-appointment does not lead to cumulation.

Indications for use

Infectious and inflammatory diseases caused by sensitive microorganisms, incl. infections of the respiratory tract (pneumonia, exacerbation of bronchitis), ENT organs (sinusitis, pharyngitis, otitis media, laryngitis, tracheitis), skin and soft tissues, bones and joints, abdominal cavity, pelvic organs, kidneys and urinary tract (pyelonephritis, cystitis , urethritis), genital organs (including gonorrhea, prostatitis), chlamydial infections, septicemia, tuberculosis (as part of complex therapy), prevention of infections in patients with immunodeficiency. In ophthalmology: bacterial corneal ulcers, conjunctivitis, blepharitis, meibomitis, dacryocystitis, keratitis, chlamydial eye infections, prevention of infectious complications in the postoperative period after surgery to remove a foreign body and eye injury. ENT practice: acute and chronic bacterial external and otitis media, otitis with perforation of the tympanic membrane or tympanopuncture; prevention of infectious complications during surgical interventions.

Release form

solution for infusion 2 mg/ml; bottle (bottle) 100 ml cardboard pack 1; composition and packaging White or almost white, film-coated tablets, oblong, biconvex, scored on both sides and engraved “400” on one side. 1 tab. ofloxacin 400 mg Excipients: lactose monohydrate, corn starch, povidone, crospovidone, poloxamer, magnesium stearate, talc. Shell composition: hypromellose, macrogol, titanium dioxide, talc. 10 pieces. - blisters (1) - cardboard packs.

Pharmacodynamics

Antimicrobial drug with a broad spectrum of bactericidal action from the group of fluoroquinolones. Acts on the enzyme DNA gyrase, which ensures supercoiling and, thus, stability of bacterial DNA (destabilization of DNA chains leads to the death of microorganisms). Active against microorganisms producing β-lactamases and fast-growing atypical mycobacteria, incl. Staphylococcus aureus, Staphylococcus epidermidis, Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Citrobacter spp., Klebsiella spp. (including Klebsiella pneumoniae), Enterobacter spp., Hafnia spp., Proteus spp. (including Proteus mirabilis, Proteus vulgaris /indole-positive and indole-negative strains/), Salmonella spp., Shigella spp. (including Shigella sonnei), Yersinia enterocolitica, Campylobacter jejuni, Aeromonas hydrophila, Plesiomonas shigelloides, Vibrio cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Haemophilus ducreyi, Chlamydia spp., Legionella spp., Serratia spp., Providencia spp., Bordetella parapertussis, Bor detella pertussis, Moraxella catarrhalis, Propionibacterium acnes, Brucella spp. Enterococcus faecalis, Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus viridans, Serratia marcescens, Pseudomonas aeruginosa, Acinetobacter spp., Mycoplasma hominis, Mycoplasma pneumoniae, Mycobacterium tuberculosis, as well as Mycobacterium fortuitum, Ureaplasma urealyticum, Clo stridium perfringens, Corynebacterium spp. , Helicobacter pylori, Listeria monocytogenes, Gardnerella vaginalis. In most cases, the following are insensitive to the drug: Nocardia asteroides, anaerobic bacteria (Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile). Inactive against Treponema pallidum.

Pharmacokinetics

Absorption After taking the drug orally, absorption is rapid and complete (95%). Bioavailability - more than 96%. Cmax after taking the drug orally at a dose of 100 mg, 300 mg and 600 mg is 1 mg/l, 3.4 mg/l and 6.9 mg/l, respectively, and is achieved after 1-2 hours. After a single dose of 200 mg and 400 mg Cmax is 2.5 μg/ml and 5 μg/ml, respectively. Food intake may slow absorption but does not significantly affect bioavailability. Distribution Plasma protein binding - 20-25%. Apparent Vd - 100 l. Ofloxacin penetrates into many tissues and fluids of the body, incl. into saliva, bronchial secretions, bile, urine, lacrimal and cerebrospinal fluid, pus, into the lungs, prostate gland, skin, leukocytes, alveolar macrophages, soft tissues, bones, abdominal and pelvic organs. Penetrates well through the BBB, placental barrier, and is excreted in breast milk. Penetrates into the cerebrospinal fluid in inflamed and non-inflamed meninges (14-60%). Does not accumulate. Metabolism Metabolized in the liver (about 5%) to form N-oxide ofloxacin and dimethylofloxacin. Elimination T1/2 after oral administration is 4.5-7 hours (regardless of dose). Excreted unchanged by the kidneys - 75-90%, with bile - about 4%. Extrarenal clearance is less than 20%. After a single dose of 200 mg, it is detected in the urine within 20-24 hours. Pharmacokinetics in special clinical cases In patients with renal failure (creatinine clearance 50 ml/min or less) or liver failure, T1/2 of ofloxacin increases.

Use during pregnancy

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Use for renal impairment

In patients with impaired renal function (with CC from 50 to 20 ml/min), a single dose should be 50% of the average recommended dose with a frequency of administration of 2 times a day. You can administer the full single dose 1 time/day. For CC less than 20 ml/min, the single initial dose is 200 mg, then 100 mg/day every other day. For peritoneal dialysis and hemodialysis, the drug is administered at a dose of 100 mg every 24 hours.

Other special occasions at reception

For liver failure, the maximum daily dose is 400 mg.

Contraindications for use

- deficiency of glucose-6-phosphate dehydrogenase; — epilepsy (including history); — reduction of the convulsive threshold (including after traumatic brain injury, stroke or inflammatory processes in the central nervous system); - age up to 18 years (since skeletal growth is not complete); - pregnancy; - lactation (breastfeeding); - hypersensitivity to the components of the drug. The drug should be prescribed with caution in case of atherosclerosis of cerebral vessels, cerebrovascular accidents (history), chronic renal failure, organic lesions of the central nervous system.

Side effects

From the digestive system: anorexia, nausea, vomiting, diarrhea, flatulence, abdominal pain (including gastralgia), increased activity of liver transaminases, hyperbilirubinemia, cholestatic jaundice, pseudomembranous enterocolitis. From the central nervous system and peripheral nervous system: headache, dizziness, uncertainty of movements, tremor, convulsions, numbness and paresthesia of the extremities, intense dreams, nightmares, psychotic reactions, anxiety, increased excitability, phobias, depression, confusion, hallucinations, increased intracranial pressure. From the senses: impaired color vision, diplopia, disorders of taste, smell, hearing and balance. From the cardiovascular system: tachycardia, vasculitis, collapse. From the musculoskeletal system: tendonitis, myalgia, arthralgia, tenosynovitis, tendon rupture. From the hematopoietic system: leukopenia, agranulocytosis, anemia, thrombocytopenia, pancytopenia, hemolytic and aplastic anemia. Dermatological reactions: pinpoint hemorrhages (petechiae), bullous hemorrhagic dermatitis, papular rash, vasculitis. From the urinary system: acute interstitial nephritis, impaired renal function, hypercreatininemia, increased urea content. Allergic reactions: skin rash, itching, urticaria, allergic pneumonitis, allergic nephritis, eosinophilia, fever, Quincke's edema, bronchospasm, Stevens-Johnson syndrome, Lyell's syndrome, photosensitivity, erythema multiforme, anaphylactic shock. Other: dysbacteriosis, superinfection, hypoglycemia (in patients with diabetes), vaginitis.

Directions for use and doses

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. Orally, adults are prescribed a daily dose of 200-800 mg (divided into 2 doses), the course of treatment is 7-10 days. Doses up to 400 mg/day can be taken in 1 dose, preferably in the morning. For gonorrhea, 400 mg is prescribed once. For urinary tract infections, the drug is prescribed at a dose of 100 mg 1-2 times a day. For infections of the kidneys and genital organs - 100-200 mg 2 times a day. For infections of the respiratory tract, as well as ENT organs, infections of the skin and soft tissues, 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. 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 of the disease. Treatment should be continued for another 3 days after the symptoms of the disease disappear and the temperature completely normalizes. For salmonellosis, the course of treatment is 7-8 days, for uncomplicated infections of the lower urinary tract - 3-5 days. For the prevention of infections in patients with a pronounced decrease in immunity - 400-600 mg/day. In patients with impaired renal function (with CC from 50 to 20 ml/min), a single dose should be 50% of the average recommended dose with a frequency of administration of 2 times a day. You can administer the full single dose 1 time/day. For CC less than 20 ml/min, the single initial dose is 200 mg, then 100 mg/day every other day. For peritoneal dialysis and hemodialysis, the drug is prescribed at a dose of 100 mg every 24 hours. For liver failure, the maximum daily dose is 400 mg.

Overdose

Symptoms: dizziness, confusion, lethargy, disorientation, drowsiness, vomiting. Treatment: gastric lavage, symptomatic therapy. Hemodialysis removes 10-30% of the drug.

Interactions with other drugs

When prescribing the drug orally, it should be taken into account that foods, antacids containing aluminum, calcium, magnesium, or iron salts reduce the absorption of ofloxacin, forming insoluble complexes (therefore, the interval between the administration of Ofloxin and these drugs should be at least 2 hours). With simultaneous use, ofloxacin reduces the clearance of theophylline by 25% (in this case, the dose of theophylline should be reduced). With simultaneous use of cimetidine, furosemide, methotrexate and drugs that block tubular secretion, the concentration of ofloxacin in plasma increases. Ofloxacin increases plasma concentrations of glibenclamide. When taken simultaneously with indirect anticoagulants - vitamin K antagonists, it is necessary to monitor the state of the blood coagulation system. When used together 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 developing crystalluria and nephrotoxic effects increases.

Storage conditions

List B. The drug should be stored in a dry place, out of reach of children, at a temperature of 10° to 25°C.

Best before date

36 months

Instructions for use of Ofloxin (Method and dosage)

Due to the fact that Ofloxin is used to treat a wide range of diseases, the dosage of this antibiotic is selected individually and depends not only on the severity and localization of the infection, but also on the general condition of the patient. Particular attention in the instructions for Ofloxin 400 mg should be paid to the functions of the liver and kidneys.

Adults are prescribed a dose of 200 mg 2 times a day, or 400 mg 1 time a day. The maximum dose per day should not exceed 800 mg. The course of treatment is determined by the sensitivity of the pathogen and most often lasts 7-10 days. It is preferable to take the drug in the morning 30-60 minutes before meals. Take the tablets with a small amount of water.

Before you start taking the drug, you must consult your doctor, since the dosage for the treatment of various diseases may vary.

Overdose

In case of overdose, the patient may experience the following symptoms:

• confusion;
• disorientation;
• lethargy;
• severe vomiting;
• drowsiness;
• dizziness.

To eliminate these symptoms, it is necessary to rinse the stomach as soon as possible and use symptomatic therapy .

Interaction

When taking the drug orally, you should remember that the absorption of ofloxacin by foods that contain large amounts of calcium, aluminum, magnesium, as well as iron salts, since they form insoluble complexes. You should ensure that the interval between taking Ofloxin and these substances is at least 2 hours.

When taking ofloxacin, the clearance of theophylline is reduced by 25% and it is advisable in this situation to reduce the dose of theophylline .

Particular attention should be paid to drugs that block tubular secretion , since their simultaneous use with Ofloxin can significantly increase the concentration of ofloxacin in plasma.

The concentration of Glibenclamide in plasma is also dependent on Ofloxin.

Ofloxin should not be taken simultaneously with vitamin K antagonists , as this may negatively affect the state of the blood coagulation system .

Derivatives of nitroimidazole and methylxanthines , when taken together, can cause the development of neurotoxic effects , and GCS increases the risk of tendon rupture, which is especially dangerous for older people.

Taking Ofloxin with drugs that alkalinize the urine can lead to an increased risk of the occurrence and development of nephrotoxic effects and crystalluria .

Analogs

Level 4 ATX code matches:
Siflox

Hyleflox

Leflobakt

Lefoccin

Gatifloxacin

Ofloxacin

Faktiv

Tigeron

Lebel

Zanotsin

Lomefloxacin

Eleflox

Lomflox

Pefloxacin

Tsiprobay

Sparflo

Tariwid

Zoflox

Abaktal

Moxifloxacin

At the moment, Ofloxin has about 20 analogues from both domestic and foreign manufacturers. The most popular drugs today are: Zanotsin, Ofloxacin, Oflocid and Loflox .

Also structural analogues of the active substance are: Vero Ofloxacin, Glaufos, Dancil, Uniflox, Floxal.

Reviews about Ofloxin

Ratings of Ofloxin on forums range from 1 to 5 on a 5-point scale.

After analyzing reviews from visitors to medical forums, we can conclude that patients who completed the full course of treatment were completely satisfied with the results of treatment. Low ratings for the drug were most often given by visitors for whom Ofloxin caused severe side effects. Most often on forums, patients complain of severe stomach pain, loss of appetite , the appearance of thrush, lethargy, drowsiness and even nighttime hallucinations .

Is Ofloxin an antibiotic or not?

Many discussions on forums are devoted to this issue. And here experts give a clear answer that Ofloxin is a fairly powerful antibiotic, and advise patients in whom this drug causes a strong feeling of discomfort to choose less toxic medications for treatment.

There is no information about the drug Ofloxin on Wikipedia.

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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use Ofloxin, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.

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** Attention! The information presented in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Ofloxin is provided for informational purposes and is not intended for prescribing treatment without the participation of a doctor. Patients need to consult a specialist!

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