Ofloxacin tablet form. Ofloxacin shtada - instructions for use. What is Ofloxacin

Antibacterial drug fluoroquinolone groups Drug: OFLOKSACIN (OFLOXACIN)Active ingredient: ofloxacin
ATX Code: J01MA01
CFG: Antibacterial drug of the fluoroquinolone group
ICD-10 codes (indications): A39, A54, A56.0, A56.1, A56.4, G00, H66, J01, J02, J03, J04, J15, J20, J31, J32, J35.0, J37, J42, K81.0, K81.1, K83.0, L01, L02, L03, L08.0, M00, M86, N10, N11, N30, N34, N41, N45, N70, N71, N72, Z29.2
Reg. number: R No. 002204/01
Date of registration: 07.08.08
The owner of the reg. Award: SYNTHESIS (Russia)
PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING almost white color, round, biconvex; an almost white layer is visible on the cross section. Excipients: corn starch, microcrystalline cellulose, talc, povidone, calcium stearate, aerosil (colloidal silicon dioxide). Shell composition: hypromellose (hydroxypropyl methylcellulose), talc, titanium dioxide, propylene glycol, macrogol 4000 ( polyethylene oxide 4000).10 pcs. - cellular contour packings (1) - packs of cardboard. Film-coated tablets almost white, round, biconvex; an almost white layer is visible on the cross section. Excipients: corn starch, microcrystalline cellulose, talc, povidone (low molecular weight polyvinylpyrrolidone), calcium stearate, aerosil (colloidal silicon dioxide). Shell composition: hypromellose (hydroxypropyl methylcellulose), talc, titanium dioxide, propylene glycol , macrogol 4000 (polyethylene oxide 4000).10 pcs. - cellular contour packings (1) - packs of cardboard. INSTRUCTIONS FOR USE FOR THE SPECIALIST.
The description of the drug was approved by the manufacturer in 2005.

PHARMACHOLOGIC EFFECT

Antimicrobial a wide range actions from the group of fluoroquinolones. It acts on the bacterial enzyme DNA gyrase, which ensures supercoiling and, thus, the stability of bacterial DNA (destabilization of DNA chains leads to their death). It has a bactericidal effect.

The drug is active against microorganisms producing?-lactamase and fast-growing atypical mycobacteria.

Sensitive to the drug: 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 aeruginosa, Vibrio cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Chlamydia spp., Legionella spp., Serratia spp., Providencia spp., Haemophilus ducreyi, Bordetella parapertussis, Bordetella pertussis, Moraxella catarrhalis, Propionibacterium acnes, Brucella spp.


Different sensitivity to the drug have: Enterococcus faecalis, Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus viridans, Serrratia marcescens, Pseudomonas aeruginosa, Acinetobacter spp., Mycoplasma hominis, Mycoplasma pneumoniae, Mycobacterium tuberculosis, Mycobacteriurn fortuitum, Ureaplasma urealyticum, Clostridium perfringens, Corynebacterium spp., Helicobacter pylori, Listeria monocytogenes, Gardnerella vaginalis.

Nocardia asteroides, anaerobic bacteria (Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile) are resistant to the drug.

The drug is inactive against Treponema pallidum.

After taking the drug inside, absorption is fast and complete (95%). Bioavailability - more than 96%.

Plasma protein binding - 25%. 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 the drug at a dose of 200 mg and 400 mg Cmax is 2.5 µg/ml and 5 µg/ml, respectively. Eating may slow down absorption, but does not significantly affect bioavailability.

Apparent Vd - 100 l. Ofloxacin is distributed in leukocytes, alveolar macrophages, skin, soft tissues, bones, organs abdominal cavity and small pelvis respiratory system, urine, saliva, bile, secret prostate. It penetrates well through the BBB, the placental barrier, is excreted with breast milk. Penetrates into the cerebrospinal fluid with inflamed and non-inflamed meninges (14-60%). Does not accumulate.

Metabolized in the liver (about 5%) with the formation of N-oxide ofloxacin and dimethylofloxacin.

T1 / 2 - 4.5-7 hours (regardless of dose). Excreted by the kidneys unchanged - 75-90%, with bile - about 4%. Extrarenal clearance - less than 20%.

After a single application at a dose of 200 mg, it is detected in the urine within 20-24 hours.

Pharmacokinetics in special clinical situations

With renal or hepatic insufficiency, excretion may slow down.

Infectious and inflammatory diseases respiratory tract(bronchitis, pneumonia);

Infectious and inflammatory diseases of the ENT organs (sinusitis, pharyngitis, otitis media, laryngitis);

Infectious and inflammatory diseases of the skin and soft tissues;

Infectious and inflammatory diseases of bones and joints;

Infectious and inflammatory diseases of the abdominal cavity (including infections of the gastrointestinal tract) and biliary tract;

Infectious and inflammatory diseases of the kidneys (pyelonephritis) and urinary tract(cystitis, urethritis);

Infectious and inflammatory diseases of the pelvic organs (endometritis, salpingitis, oophoritis, cervicitis, parametritis, prostatitis) and genital organs (colpitis, orchitis, epididymitis);

Prevention of infections in patients with immune status(including with neutropenia).

DOSING MODE

Doses are selected individually depending on the location and severity of the infection, as well as the sensitivity of microorganisms, general condition patient and liver and kidney function.

The drug is administered orally adults- 200-800 mg / day, frequency of use - 2 times / day. The course of treatment is 7-10 days. Doses up to 400 mg/day may be given as a single dose, preferably in the morning.

In acute gonorrhea - 400 mg once.

At patients with impaired renal function (with CC from 50 to 20 ml / min) a single dose should be 50% of the average dose with a multiplicity of appointments 2 times / day, or full single dose appoint 1 time / day. At QC<20 мл/мин single dose - 200 mg, then - 100 mg / day every other day.

At hemodialysis and peritoneal dialysis the drug is prescribed 100 mg every 24 hours.

The maximum daily dose for liver failure- 400 mg / day.

The average daily dose for children in severe infections - 7.5 mg / kg of body weight, the maximum dose is 15 mg / kg.

Tablets should be taken whole with water, before or during a meal.

The duration of the course of treatment is determined by the sensitivity of the pathogen and the clinical picture; treatment should be continued for another 3 days after the disappearance of the symptoms of the disease and the complete normalization of the temperature.

In the treatment of salmonellosis, the course of treatment is 7-8 days, with uncomplicated infections of the lower urinary tract - 3-5 days.

SIDE EFFECT

From the digestive system: anorexia, nausea, vomiting, diarrhea, flatulence, abdominal pain (including gastralgia), increased activity of hepatic transaminases, hyperbilirubinemia, cholestatic jaundice, pseudomembranous enterocolitis.

From the side of the central nervous system: headache, dizziness, uncertainty of movements, tremor, convulsions, numbness and paresthesia of the extremities, intense dreams, nightmares, psychotic reactions, anxiety, irritability, phobias, depression, confusion, hallucinations, increased intracranial pressure; violation of color perception, diplopia, violations of taste, smell, hearing and balance.

From the musculoskeletal system: tendinitis, myalgia, arthralgia, tendosynovitis, tendon rupture.

From the side of the cardiovascular system: tachycardia, vasculitis, collapse.

On the part of the skin: pinpoint hemorrhages (petechiae), bullous hemorrhagic dermatitis, papular rash, vasculitis.

On the part of 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.

Allergic reactions: skin rash, itching, urticaria, allergic pneumonitis, allergic nephritis, eosinophilia, fever, angioedema, bronchospasm, Stevens-Johnson syndrome, Lyell's syndrome, photosensitivity, erythema multiforme; rarely - anaphylactic shock.

Others: dysbacteriosis, superinfection, hypoglycemia (in diabetic patients), vaginitis.

Deficiency of glucose-6-phosphate dehydrogenase;

Epilepsy (including history);

Decrease in the convulsive threshold (including after a traumatic brain injury, stroke or inflammatory processes in the central nervous system);

Age up to 18 years (because the growth of the skeleton is not completed);

lactation (breastfeeding);

Hypersensitivity to the components of the drug.

With caution, the drug should be prescribed for atherosclerosis of cerebral vessels, cerebrovascular accidents (in history), chronic renal failure, organic lesions of the central nervous system.

PREGNANCY AND LACTATION

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

SPECIAL INSTRUCTIONS

It is not the drug of choice for pneumonia caused by pneumococci. Not indicated in the treatment of acute tonsillitis.

In case of side effects from the central nervous system, allergic reactions, pseudomembranous colitis, the drug should be discontinued. 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-AKOS, rarely occurring tendinitis can lead to tendon rupture (mainly the Achilles tendon), especially in elderly patients. In the event of symptoms of tendinitis, it is necessary to immediately stop treatment, immobilize the Achilles tendon and consult an orthopedist.

Against the background of treatment, the course of myasthenia gravis may worsen, more frequent attacks of porphyria 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, it is necessary to control the concentration of ofloxacin in plasma. In severe renal and hepatic insufficiency, the risk of developing toxic effects increases (dose adjustment is required).

Alcohol should be avoided during treatment with the drug.

Pediatric use

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

Influence on the ability to drive vehicles and control mechanisms

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

Symptoms: dizziness, confusion, lethargy, disorientation, drowsiness, vomiting.

Treatment: gastric lavage, symptomatic therapy.

DRUG INTERACTIONS

Food products, antacids containing aluminum, calcium, magnesium, or iron salts reduce the absorption of ofloxacin, forming insoluble complexes (therefore, the interval between the appointment of Ofloxacin-AKOS and these drugs should be at least 2 hours).

Ofloxacin reduces the clearance of theophylline by 25%. Therefore, with simultaneous use, the dose of theophylline should be reduced.

Cimetidine, furosemide, methotrexate and drugs that block tubular secretion increase plasma concentrations of ofloxacin.

Ofloxacin increases the plasma concentration of glibenclamide.

When taking ofloxacin with vitamin K antagonists, it is necessary to control the blood coagulation system.

When prescribing Ofloxacin-AKOS with NSAIDs, nitroimidazole derivatives and methylxanthines, the risk of developing neurotoxic effects increases.

With the simultaneous appointment of Ofloxacin-AKOS with glucocorticosteroids, the risk of tendon rupture increases, especially in the elderly.

When prescribing Ofloxacin-AKOS with drugs that alkalinize urine (carbonic anhydrase inhibitors, citrates, sodium bicarbonate), the risk of developing crystalluria and nephrotoxic effects increases.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored in a dry, dark place, out of the reach of children, at a temperature not exceeding 25°C. Shelf life - 2 years.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Ofloxacin is a broad-spectrum antimicrobial drug. The drug belongs to fluoroquinlones, therefore, before proceeding with its use for therapeutic purposes, the patient must be examined. This medicine is able to affect bacterial enzymes, blocking their activity in the body, and as an addition it has bactericidal properties. If the doctor has prescribed Ofloxacin, the instructions for use should be carefully read to avoid the development of unwanted reactions due to improper use.

The drug is produced in various dosage forms. The type of remedy that the doctor prescribes is due to the diagnosed disease. The medicine is released in the form of:

  • Film-coated tablets, round, biconvex, white. The drug is packaged in 10 tablets in a blister, which is placed in a cardboard box.
  • Ointment for the eyes, which is represented by a homogeneous substance with a white or yellowish-white tint. The product is packaged in an aluminum tube with a volume of 5 grams, and then put into a cardboard box.
  • Solution for infusion. The drug is a greenish-yellow, clear liquid. It is poured into glass vials (dark or colorless), each of which contains 100 ml of the product. Then the vial is placed in a cardboard box.

As part of the tablets, the active ingredient is represented by ofloxacin. As additional components used: microcrystalline cellulose, starch, talc, calcium stearate. The shell consists of polypropylene glycol, titanium dioxide, hydroxypropyl methylcellulose.

The liquid for infusion also contains ofloxacin as an active ingredient. And the auxiliary ingredients are sodium chloride and distilled water.

As part of the ointment, the active substance is ofloxacin, and vaseline and methyl parahydroxybenzoate were used as additional ingredients.

Pharmacological effect

Ofloxacin has a wide spectrum of action. For the most part, it has an effect on gram-negative bacteria. It can easily cope with organisms that are resistant to treatment with antibiotics and sulfonamides.

It has a good effect when taken orally. When the tablet enters the body, the agent is quickly and completely absorbed. It is possible to slow down absorption when the drug was taken simultaneously with food.

The active component quickly spreads throughout the body, it is worth noting that it easily passes through any placental and blood-brain barrier, is able to penetrate into mother's milk and the spinal canal. The maximum concentration of the active ingredient in the bloodstream is observed after 30 minutes. Removal of ofloxacin in its original form by 75-90% is carried out by the renal system.

The drug, even after a single use, is contained in urine for about a day.

In what cases is the drug prescribed

This medication is effective for various pathologies, but which dosage form will be prescribed depends on the diagnosis. The most convenient form in each case is selected by the doctor. If the remedy is chosen correctly, the therapy will be as effective as possible.

Treatment with tablets, as well as an infusion solution, is prescribed for diseases of various organs and systems of infectious etiology:

  1. with ENT pathologies - sinusitis, pharyngitis, otitis media and others;
  2. with pneumonia and bronchitis;
  3. with infection of the digestive system, problems in the biliary tract;
  4. with problems with the condition of the skin and soft tissues;
  5. with diseases of bone and joint tissue, damage to the skeletal structure;
  6. with pyelonephritis (renal pathology), urethritis and cystitis - disorders in the urinary tract;
  7. with infection of the reproductive system and the entire pelvic area.

Fluid for infusion can be prescribed in the treatment of septicemia, chlamydia and meningitis to prevent the development of diseases of an infectious nature in patients with impaired immune status.

The drug in the form of an ointment can be prescribed when an infectious pathology provoked by bacteria is detected, in which the cornea, eyelids, and conjunctiva were affected.

Also, treatment with Ofloxacin in the form of an ointment is prescribed:

  • with ocular chlamydia;
  • with barley (dacryocystitis);
  • with complications of an infectious nature after surgical intervention in case of injury to the eye (such consequences are possible even after the foreign body has been removed).

Application restrictions

Different dosage forms of Ofloxacin have slightly different contraindications. Although there are general restrictions on use. The drug in any form should not be used:

  • with hypersensitivity to the composition of this medication;
  • pregnant and lactating mothers.

As for the drug in tablets and infusion solution, they cannot be used:

  • when detecting deficiency of glucose-6-phosphate dehydrogenase;
  • if diagnosed with epilepsy;
  • with a tendency to convulsive conditions;
  • persons under the age of 18, whose skeleton continues to form.

Treatment with ointment is contraindicated against the background of chronic conjunctivitis, the cause of which was not bacteria. The tool is prohibited to persons under 15 years of age.

The use of tablets should be abandoned if atherosclerosis of the cerebral vessels is diagnosed, the central nervous system is affected, there are problems with blood circulation in the brain, and kidney failure is detected.

If these requirements are not met immediately after using the drug, there is a high probability of problems with visual reception. Additional difficulties may arise when a person needs to drive a vehicle or work on equipment that requires precise movements.

Any work that requires attention can be started at least 15 minutes after taking the drug.

How to use the medicine

The dosage and frequency of use of the drug is determined by the attending physician on an individual basis. When developing a therapeutic regimen, the doctor takes into account the severity of the infectious disease, the location of the affected area, and the state of the patient's body. Pathogen susceptibility, renal and hepatic functions are then assessed. If problems with renal functionality are detected, the dosage is calculated especially carefully.

If the patient has liver failure, the daily dosage should not exceed 0.4 g. The duration of the course of treatment is due to the sensitivity of pathogens to the drug and the symptoms that were noted during the initial consultation.

When it was possible to overcome the disease, its signs finally disappeared, and the temperature returned to normal, the remedy should be applied for about 3 more days.

How to take pills

The tablets are taken orally. The dosage of the drug is selected by the doctor individually for each patient, it depends on the location of the lesion. The doctor also takes into account the severity of the infectious disease, the patient's well-being, the ability of the excretory organs. For an adult, the daily dosage is 200-800 mg, and the duration of treatment is 7-10 days.

You need to take the medicine twice a day. When determining the dosage is less than 400 mg, the tablet can be drunk once (preferably in the morning). If Ofloxacin is prescribed for gonorrhea, the dosage is 400 mg for a single dose throughout the day.

If renal functionality is impaired, the daily dosage of the drug should not exceed 100-200 mg. If liver problems are found, the daily amount is 400 mg.

Tablets should be taken without chewing, drinking plenty of water so that the medicine dissolves better. You can use the drug before meals or in the process of eating. The duration of therapy is determined by the sensitivity of the pathogenic microorganism and some concomitant factors.

With infection of the urinary canal, the duration of treatment is 7-10 days, with lesions in the pelvic organs - 10-14 days, with inflammation of the prostate - 1.5 months, with infection of the skin and respiratory system - 10 days.

Application of infusion solution

The introduction of Ofloxacin can be carried out intravenously through a dropper. The volume of the therapeutic substance is determined on an individual basis - it is determined by the localization of the infectious focus, the severity of the course and other factors.

Initially, the drug is administered parenterally drip for 30 minutes. A single dose is 200 mg. After the patient feels better, they are transferred to treatment with tablets in the same amount.

In case of infection of the urinary canal, the drug is administered 1-2 times a day at a dose of 100 mg. In infectious diseases of the kidneys and reproductive system, the dosage of the drug is 100-200 mg 2 times a day. If the ENT organs and respiratory tract, soft tissues are affected, skin and septic infections are detected, the agent is administered 2 times a day at a dosage of 200 mg. If the doctor deems it necessary, the medicine will be administered once during the day at once in an amount of 400 mg.

In order to prevent against the background of a serious weakening of the immune system, a daily dosage of 400-600 mg is prescribed.

Ointment treatment

Ofloxacin in the form of an ointment is intended for topical use. Twice or thrice a day for the eyelid of the affected eye, you need to lay 1 cm of the product, initially it should be squeezed onto the finger. This volume of the drug contains approximately 0.12 mg of the active ingredient. In case of infection with chlamydia, the ointment will have to be applied up to 5-6 times a day.

To introduce the ointment, you need to gently pull the lower eyelid down, then take an open tube with your free hand, squeeze it a little so as to squeeze out a strip of 1 cm.

The duration of therapy is a maximum of 14 days. When infected with chlamydia, the course of treatment is approximately 4-5 weeks.

Adverse reactions

Usually patients tolerate Ofloxacin well. Although in case of non-compliance with the prescribed dose or with individual intolerance, there is the possibility of developing negative pathological reactions. When treating with tablets and infusion solution, the following side effects may occur:

  • in relation to GICT - nausea with vomiting, diarrhea, anorexia, bloating;
  • in relation to the central nervous system - headache, feeling of stiffness when moving, anxiety, increased irritability, disturbances in taste, color and sound sensations;
  • in relation to the skeletal and muscular system - myalgia, tendonitis, tendon damage
  • in relation to the cardiovascular system - tachycardia, vasculitis, lowering blood pressure;
  • in relation to the urinary organs - disturbances in renal function, elevated levels of urea, acute nephritis;
  • skin irritations, rashes, itching, angioedema, feverish conditions;
  • vaginitis, dysbacteriosis, in patients with diabetes - hypoglycemia.

Therapy with an infusion solution can provoke a local reaction in the form of pain and redness at the injection site of the needle, thrombophlebitis.

When treated with ointment, local irritation may develop. Patients complain of burning and discomfort near the eye, itching and redness, lacrimation, photophobia, and occasionally an allergic reaction. Most of the time, the symptoms go away quickly.

Precautionary measures

When treating with Ofloxacin in the form of tablets and solution, some rules must be observed:

  • Do not use Ofloxacin for acute tonsillitis and pneumonia.
  • It is not necessary to be treated with such medicines for more than 2 months. During this period, it is recommended to avoid the influence of ultraviolet radiation, not only natural, but also artificial.
  • If side effects occur regarding the central nervous system, an allergic reaction, pseudomembranous colitis, the drug should be immediately abandoned. During the use of Ofloxacin for therapeutic purposes, women should refrain from using sanitary tampons during menstruation, as this can provoke vaginal candidiasis.
  • Due to tendinitis, which may develop during therapy, the integrity of the tendons may be impaired, especially in elderly patients. If symptoms of tendonitis are detected, the drug should be abandoned, the affected area should be immobilized and an orthopedist should be consulted for advice.
  • Treatment with Ofloxacin can cause complications of myasthenia gravis.
  • If a person has problems with the excretory system, it is necessary to monitor the level of the active component in the blood. Sometimes a dosage reduction may be required. During treatment, it is better to stop drinking alcohol.

In pediatrics, this drug is used for therapeutic purposes only if the risk is justified and the expected benefit will be significantly greater than the likely harm caused by the drug.

When using Ofloxacin, care must be taken to perform any activity that requires concentration. It is not recommended to drive a car, perform work that requires a quick reaction.

When using the ointment for the duration of treatment, you should stop wearing contact lenses. To protect the eyes, dark glasses should be used so as not to provoke photophobia. The introduction of the drug into the region of the anterior eye chamber is not recommended.

Interaction with other medicines

Within 2 hours after the use of Ofloxacin, products with sulfates, iron, calcium and zinc should not be used, as this makes it difficult to absorb the active substance.

In the presence of diabetes, it is necessary to carefully monitor the level of sugar in the blood when using Ofloxacin for therapeutic purposes. It should not be used simultaneously with anti-inflammatory drugs, since with this combination additional treatment will have to be carried out to restore the functioning of the central nervous system.

Ofloxacin in the form of eye drops can be prescribed simultaneously with other means in this form. In such a situation, it is necessary to instill an eye with an interval of at least 15 minutes between drugs, and the last one should be Ofloxacin.

In order to avoid the occurrence of unwanted reactions, it is necessary to inform the doctor about the medications that the patient is already taking.

Analogues

If for some reason treatment with Ofloxacin is not possible, the doctor may prescribe medications with a similar active substance:

  • Ofloxacin-SOLOpharm;
  • Uniflox;
  • Dancila;
  • Phloxala;
  • Ofloxacin Zentiva;
  • Zanotsina;
  • Ofloksina;
  • Ofloxacin-Teva;
  • Zanotsina OD;
  • Tarivid;
  • Oflomaka;
  • Tariferida;
  • Ofloks;
  • Glaufos;
  • Taricina;
  • Flosiprina and others.


Treatment with analogues of Ofloxacin can also be prescribed according to the effect:

  • Tsiprolet;
  • Ecocyfol;
  • Cyprobay;
  • Tsiprinol;
  • Cifran;
  • Ciprofloxacin;
  • Oftocypro;
  • Abaktalom;
  • Tsipromed;
  • Gentamicin;
  • Vilprafen;
  • Zinacef;
  • Askosef and others.

It is worth considering that any remedy has its own contraindications for use, and can also provoke the development of pathological reactions. Therefore, it is forbidden to replace the drug on your own. For this purpose, you need to contact your doctor.

Storage and holiday conditions

Keep the medicine out of the reach of children, dry and dark place. Tablets should be stored at a temperature of 22-25 degrees, solution for infusion and ointment - 15-25 degrees. Freezing the solution is prohibited.

The drug in the form of tablets and solution is suitable for use for 2 years from the date of manufacture, and in the form of an ointment - for 3 years.

The medication can be purchased at the pharmacy network with a prescription.

The price of the drug

Ofloxacin is worth depending on the dosage form and dosage:

  • tablets with a dosage of 200 mg in the amount of 10 pieces - 26-30 rubles;
  • tablets with a dosage of 400 mg in the amount of 10 pieces - 53-59 rubles;
  • remedy in the form of an ointment - 38-64 rubles;
  • solution for infusion - 30-42 rubles per 1 vial.

In this article, you can read the instructions for using the drug Ofloxacin. Reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of the antibiotic Ofloxacin in their practice are presented. We kindly ask you to actively add your reviews about the drug: the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Ofloxacin analogues in the presence of existing structural analogues. Use for the treatment of bronchitis and pneumonia in adults, children, as well as during pregnancy and lactation. Interaction of the drug with alcohol.

Ofloxacin- a broad-spectrum antimicrobial agent from the group of fluoroquinolones, acts on the bacterial enzyme DNA gyrase, which provides supercoiling, and so on. stability of bacterial DNA (destabilization of DNA chains leads to their death). It has a bactericidal effect.

The antimicrobial spectrum includes gram-positive and gram-negative aerobes, anaerobes.

Others: Chlamydia trachomatis, Chlamydia pneumoniae, Gardnerella vaginalis, Legionella pneumophila, Mycoplasma hominis, Mycoplasma pneumoniae, Ureaplasma urealyticum. Mostly insensitive: Nocardia asteroides, anaerobic bacteria (including Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile), Enterococcus spp., most Streptococcus spp., not acts on Treponema pallidum.

Pharmacokinetics

Absorption after oral administration is fast and complete (95%). Food may delay absorption but does not significantly affect bioavailability. Distribution: cells (leukocytes, alveolar macrophages), skin, soft tissues, bones, abdominal and pelvic organs, respiratory system, urine, saliva, bile, prostate secretion; well gets through a blood-brain barrier, a placental barrier, is secreted with mother's milk. Penetrates into the cerebrospinal fluid (14-60%). Metabolized in the liver (about 5%) with the formation of N-oxide ofloxacin and dimethylofloxacin. Excreted by the kidneys - 75-90% (unchanged), about 4% - with bile. Extrarenal clearance - less than 20%.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to ofloxacin:

  • respiratory tract (bronchitis, pneumonia);
  • ENT organs (sinusitis, pharyngitis, otitis media, laryngitis, tracheitis);
  • skin, soft tissues (boils, carbuncles);
  • bones, joints;
  • organs of the abdominal cavity and biliary tract (cholecystitis, cholangitis);
  • kidneys (pyelonephritis);
  • uncomplicated infections of the lower urinary tract (cystitis, urethritis);
  • genital and pelvic organs (endometritis, salpingitis, oophoritis, cervicitis, parametritis, prostatitis, colpitis, orchitis, epididymitis);
  • gonorrhea;
  • chlamydia;
  • ureaplasmosis;
  • prevention of infections in patients with impaired immune status (including with neutropenia).

Release form

Film-coated tablets 100 mg, 200 mg and 400 mg.

Solution for infusion (injections in ampoules for injection).

Eye ointment 0.3%.

Other forms of release, whether it be drops or capsules, the antibiotic Ofloxacin does not exist.

Instructions for use and dosage

Pills

inside. The dose is selected individually depending on the location, severity of the infection, the sensitivity of microorganisms, as well as 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. Doses up to 400 mg per day can be given as a single dose, preferably in the morning. With gonorrhea - 400 mg once.

In patients with impaired renal function (with creatinine clearance 50-20 ml / min) 100-200 mg per day. With creatinine clearance less than 20 ml / min - 100 mg every 24 hours; with hemodialysis and peritoneal dialysis - 100 mg every 24 hours.

The maximum daily dose for liver failure is 400 mg per day. 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 3 more days after the disappearance of the symptoms of the disease and the complete normalization of body temperature. In the treatment of uncomplicated and complicated infections of the lower urinary tract, the course of treatment is 7 and 10 days, respectively, with prostatitis - up to 6 weeks, with infections of the pelvic organs - 10-14 days, with infections of the respiratory organs and skin - 10 days.

Ampoules

The drug is administered intravenously by drip (dropper). 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.

Therapy begins with intravenous drip (within 30-60 minutes) administration of the drug at a dose of 200 mg. When the patient's condition improves, they are transferred to oral administration of the drug in the same daily dose.

For urinary tract infections, the drug is prescribed 100 mg 1-2 times a day, for infections of the kidneys and genital organs - from 100 to 200 mg 2 times a day; with 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.

For the prevention of infections in patients with a pronounced decrease in immunity - 400-600 mg per day.

Ointment

locally. For the lower eyelid of the affected eye 2-3 times a day lay 1 cm strips of ointment (0.12 mg ofloxacin). With chlamydial infections, the ointment is applied 5-6 times a day.

To administer the ointment, gently pull the lower eyelid down and, gently pressing the tube, insert a 1 cm long strip of ointment into the conjunctival sac. Then close the eyelid and move the eyeball to evenly distribute the ointment.

The duration of the course of treatment is no more than 2 weeks (for chlamydial infections, the course is extended to 4-5 weeks).

Side effect

  • gastralgia;
  • anorexia;
  • nausea, vomiting;
  • diarrhea;
  • flatulence;
  • abdominal pain;
  • pseudomembranous enterocolitis;
  • headache;
  • dizziness;
  • uncertainty of movements;
  • tremor;
  • convulsions;
  • numbness and paresthesia of the extremities;
  • nightmares;
  • anxiety;
  • psychomotor agitation;
  • depression;
  • confusion;
  • hallucinations;
  • increased intracranial pressure;
  • violation of color perception;
  • violation of taste, smell and balance;
  • myalgia;
  • arthralgia;
  • tendon rupture;
  • tachycardia;
  • decrease in blood pressure (with a sharp decrease in blood pressure, the administration is stopped);
  • vasculitis;
  • collapse;
  • leukopenia, agranulocytosis, anemia, thrombocytopenia, pancytopenia, hemolytic and aplastic anemia;
  • acute interstitial nephritis;
  • impaired renal function;
  • point hemorrhages;
  • bullous hemorrhagic dermatitis;
  • papular rash indicating vascular damage (vasculitis);
  • skin rash;
  • skin itching;
  • hives;
  • allergic pneumonitis;
  • allergic nephritis;
  • fever;
  • angioedema;
  • bronchospasm;
  • Stevens-Johnson syndrome and Lyell's syndrome;
  • photosensitivity;
  • multiform exudative erythema;
  • anaphylactic shock;
  • dysbacteriosis;
  • superinfection;
  • hypoglycemia (in diabetic patients);
  • vaginitis;
  • pain and redness at the injection site;
  • thrombophlebitis.

Contraindications

  • deficiency of glucose-6-phosphate dehydrogenase;
  • epilepsy (including history);
  • lowering the threshold for convulsive readiness (including after a traumatic brain injury, stroke, or inflammatory processes in the central nervous system);
  • age up to 18 years (until the growth of the bones of the skeleton is completed);
  • pregnancy;
  • lactation;
  • hypersensitivity to the drug.

Use during pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation.

Use in children

The drug is contraindicated in children and adolescents under 18 years of age, because. skeletal growth has not been completed.

In children, the drug is used only for life-threatening infections, taking into account the expected clinical efficacy and the potential risk of side effects when less toxic drugs cannot be used. The average daily dose in this case is 7.5 mg/kg of body weight, the maximum is 15 mg/kg.

special instructions

Ofloxacin is not the drug of choice for pneumonia caused by pneumococci and is not indicated for the treatment of acute tonsillitis.

If side effects from the central nervous system, allergic reactions, pseudomembranous colitis occur, the drug should be discontinued.

Rarely, tendonitis can lead to tendon rupture (mainly the Achilles tendon), especially in older patients. In case of signs of tendinitis, it is necessary to immediately stop treatment, immobilize the Achilles tendon and consult an orthopedist.

Against the background of treatment, the course of myasthenia gravis may worsen, more frequent attacks of porphyria in predisposed patients.

False-negative results may occur in the bacteriological diagnosis of tuberculosis (prevents the isolation of Mycobacterium tuberculosis).

In case of impaired liver or kidney function, it is necessary to control the concentration of ofloxacin in the blood plasma. In severe renal and hepatic insufficiency, the risk of developing toxic effects increases (reducing dose adjustment is required).

Against the background of the use of the drug, ethanol (alcohol) should not be consumed.

Influence on the ability to drive vehicles and control mechanisms

When using the drug, one should refrain from engaging in potentially hazardous activities that require increased attention and a high speed of psychomotor reactions.

drug interaction

With simultaneous use ofloxacin reduces the clearance of theophylline by 25% (with simultaneous use, the dose of theophylline should be reduced).

With the simultaneous use of cimetidine, furosemide, methotrexate and drugs that block tubular secretion, increase the concentration of ofloxacin in plasma.

Ofloxacin increases the plasma concentration of glibenclamide.

When taken simultaneously with indirect anticoagulants-vitamin K antagonists, it is necessary to monitor the state of the blood coagulation system.

When combined with non-steroidal anti-inflammatory drugs (NSAIDs), nitroimidazole and methylxanthin derivatives, the risk of developing neurotoxic effects increases.

With simultaneous appointment with glucocorticosteroids (GCS), the risk of tendon rupture increases, especially in the elderly.

When administered with drugs that alkalinize urine (carbonic anhydrase inhibitors, citrates, sodium bicarbonate), the risk of crystalluria and nephrotoxic effects increases.

Pharmaceutical interaction

Ofloxacin solution is compatible with the following infusion solutions: isotonic sodium chloride solution, Ringer's solution, 5% fructose solution, 5% dextrose (glucose) solution.

Analogues of the drug Ofloxacin

Structural analogues for the active substance:

  • Vero Ofloxacin;
  • Glaufos;
  • Dancil;
  • Zanocin;
  • Zoflox;
  • Oflo;
  • Ofloks;
  • Ofloxabol;
  • Ofloxacin DS;
  • Ofloxacin Protech;
  • Ofloxacin Stada;
  • Ofloxacin Promed;
  • Ofloxacin Teva;
  • Ofloksin;
  • Ofloksin 200;
  • Oflomak;
  • Oflocid;
  • Oflocid forte;
  • Tarivid;
  • Tariferid;
  • Taricin;
  • Uniflox;
  • Phloxal.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.

Catad_tema Genitourinary infections - articles

Ofloxacin in urological practice

V.E. Ohrits, E.I. Veliyev
Department of Urology and Surgical Andrology, RMAPE

Antibacterial drugs(ABP) class fluoroquinolones(PC), united by a common mechanism of action (inhibition of the synthesis of a key enzyme of a bacterial cell - DNA gyrase), currently occupy one of the leading positions in the chemotherapy of bacterial infectious diseases. The first quinolone was obtained by accident during the purification of the antimalarial drug chloroquine. It was nalidixic acid, which has been used for over 40 years to treat urinary tract infections(IMP). Subsequently, the introduction of a fluorine atom into the structure of nalidixic acid marked the beginning of a new class of ABP, PC. Further improvement of PC led to the appearance in the mid-1980s of monofluoroquinolones (containing one fluorine atom per molecule): norfloxacin, pefloxacin, ofloxacin and ciprofloxacin.

The spectrum of action of FH

All PCs are drugs with a wide spectrum of action, which includes bacteria (aerobic and anaerobic, gram-positive and gram-negative), mycobacteria, chlamydia, mycoplasma, rickettsia, borrelia, some protozoa.

PCs are characterized by activity against predominantly Gram-negative bacteria: families Enterobacteriaceae (Citrobacter, Enterobacter, Escherichia coli, Klebsiella, Proteus, Providencia, Salmonella, Shigella, Yersinia), Neisseriae, Haemophilus, Moraxella, for which the minimum inhibitory concentration (MIC90)

PC in most cases is Among PC there are differences in activity against different groups of microorganisms and certain types of bacteria. The most active in vitro PCs are ciprofloxacin (against Enterobacteriaceae and Pseudomonas aeruginosa) and ofloxacin (against gram-positive cocci and chlamydia).

resistance bacteria to PC develops relatively slowly, it is mainly associated with mutations in the genes encoding DNA gyrase or topoisomerase IV. Other mechanisms of bacterial resistance to PC are associated with impaired transport of drugs through porin channels in the outer cell membrane of the microbial cell or with the activation of release proteins that lead to the removal of PC from the cell.

Pharmacokinetics of PC

All PCs are well absorbed in the gastrointestinal tract, reaching maximum concentrations in the blood after 1–3 hours; food intake somewhat slows down absorption, but does not affect its completeness. PCs are characterized by high oral bioavailability, which reaches 80–100% for most drugs (with the exception of norfloxacin, 35–45%).

All PCs circulate in the body for a long time at therapeutic concentrations (half-life 5-10 hours), due to which they are used 1-2 times a day.

Concentrations of PC in most tissues of the body are comparable to serum levels or exceed them; high concentrations of PC accumulate in the renal parenchyma and in the prostate tissue. There is a good penetration of PC into cells - polymorphonuclear leukocytes, macrophages, which is important in the treatment of intracellular infections.

There are differences in the severity of metabolism, which are subjected to PC in the body. Pefloxacin is most susceptible to biotransformation (50–85%), and ofloxacin is least biotransformed (less than 10%, while 75–90% of ofloxacin unchanged is excreted by the kidneys).

An important advantage of PC is that a number of drugs (ofloxacin, pefloxacin, ciprofloxacin) have two dosage forms - for oral administration and for parenteral use. This makes it possible to apply them sequentially (step therapy), starting with intravenous administration and then switching to oral administration of drugs, which, of course, increases the compliance and economic feasibility of treatment.

PC tolerance

In general, PCs are well tolerated, although they may cause adverse effects in 4-8% of patients (most commonly in the gastrointestinal tract, central nervous system, and skin).

Approximately 20 years ago, animal studies revealed the ability of PC to cause arthropathy, which led to a virtual ban on the use of PC in pregnant women and children under 12 years of age. The appointment of FH to patients of these categories is possible only for health reasons. In publications concerning the use of PC in seriously ill children, data on the frequent development of an arthrotoxic effect have not been confirmed. It was observed in less than 1% of children and depended on age and gender: it was more common in adolescents than in young children, and in girls more often than in boys.

One of the safest FH is considered ofloxacin. According to some researchers, no cases of arthrotoxicity (both acute and cumulative) were identified during long-term follow-up of children and adolescents who received ofloxacin for health reasons. In addition, in patients with concomitant joint diseases, there was no exacerbation while taking ofloxacin.

Features of ofloxacin

Ofloxacin can be considered as one of the most highly active early PC drugs for the treatment of UTIs. Due to its structure and mechanism of action, ofloxacin has a high bactericidal activity. The drug is active against gram-negative and gram-positive microorganisms (including strains resistant to other antibiotics), as well as intracellular pathogens.

Ofloxacin can be administered simultaneously with many ABPs (macrolides, b-lactams). Due to this property, the drug is widely used as part of combination therapy for infectious diseases. Ofloxacin, unlike ciprofloxacin, retains its activity with simultaneous use of RNA polymerase synthesis inhibitors (chloramphenicol and rifampicin), since it is practically not metabolized in the liver.

The bioavailability of ofloxacin when administered orally and parenterally is identical. Due to this, when replacing the injection route of administration of the drug with oral dose adjustment is not required (one of the significant differences between ofloxacin and ciprofloxacin). Ofloxacin is prescribed 1-2 times a day. Eating does not affect its absorption, however, when eating fatty foods, the absorption of ofloxacin slows down.

Ofloxacin penetrates well into target organs (for example, in chronic prostatitis - into the prostate tissue). There is a linear relationship between the dose of ofloxacin used and its concentration in tissues. The drug is excreted mainly by the kidneys (more than 80%) unchanged.

Ofloxacin, to a lesser extent than ciprofloxacin, interacts with other drugs, practically does not affect the pharmacokinetics of theophylline and caffeine.

The activity of ofloxacin is most pronounced against gram-negative bacteria and intracellular pathogens (chlamydia, mycoplasmas, ureaplasmas), against gram-positive flora and Pseudomonas aeruginosa, ofloxacin is less active. The bactericidal effect of ofloxacin appears quite quickly, and the resistance of microorganisms to it develops slowly. This is due to its influence on one DNA gyrase gene and on topoisomerase IV. The main differences of ofloxacin from other PCs(Yakovlev V.P., 1996):

1. Microbiological:

  • the most active drug among FH II generation against chlamydia, mycoplasmas and pneumococci;
  • equal activity with ciprofloxacin against gram-positive bacteria;
  • no effect on lacto- and bifidobacteria.

2. Pharmacokinetic:

  • high oral bioavailability (95-100%);
  • high concentrations in tissues and cells, equal to or exceeding serum levels;
  • low level of metabolism in the liver (5-6%);
  • activity does not depend on the pH of the medium;
  • excretion unchanged in the urine;
  • elimination half-life 5-7 hours.

3. Clinical:

  • most favorable safety profile: no serious adverse effects in controlled studies;
  • no clinically significant phototoxic effect;
  • does not interact with theophylline.

PC in urological practice

Perhaps, PCs are most actively used in urological practice for antibacterial prophylaxis and treatment of UTIs. The drug for antibiotic therapy (ABT) UTI should be characterized by the following properties:

  • proven clinical and microbiological efficacy;
  • high activity against major uropathogens, low level of microbial resistance in the region;
  • the ability to create high concentrations in the urine;
  • high security;
  • convenience of reception, good compliance of patients.

It is important to distinguish between ambulatory and nosocomial UTIs. With UTI that occurred outside the hospital, the main causative agent is E. coli (up to 86%), while other microorganisms are much less common: Klebsiella pneumoniae - 6%, Proteus spp. – 1.8%, Staphylococcus spp. - 1.6%, P. aeruginosa - 1.2%, Enterococcus spp. - 1%. In nosocomial UTIs, E. coli also leads, but the role of other microorganisms and microbial associations increases significantly, multi-resistant pathogens are much more common, and sensitivity to ABP varies between hospitals.

According to multicenter studies conducted in Russia, the resistance of uropathogens to widely used ABPs, such as ampicillin and co-trimoxazole, reaches 30%. If the level of resistance of uropathogenic strains of E. coli to an antibiotic in the region is more than 10-20%, this drug should not be used for empirical antibiotic therapy. Ofloxacin, ciprofloxacin, and norfloxacin have the highest activity against E. coli among PCs. On average, 4.3% of E. coli strains resistant to PC are isolated in Russia. Comparable data are obtained in the USA and most European countries. At the same time, for example, in Spain, the level of E. coli resistance to PC is much higher - 14-22%. Regions with a higher level of E. coli resistance to PC exist in Russia as well - these are St. Petersburg (13% of strains are resistant) and Rostov-on-Don (9.4%).

Analyzing the resistance of E. coli, the main causative agent of outpatient and inpatient UTIs in Russia, it can be argued that PCs (ofloxacin, ciprofloxacin, etc.) can serve as the drugs of choice for empirical treatment of uncomplicated and, in some cases, complicated UTIs.

The use of ofloxacin for the prevention and treatment of UTIs

Acute cystitis

Acute cystitis is the most common manifestation of UTI. The frequency of acute cystitis in women is 0.5–0.7 episodes of the disease per 1 woman per year, and in men aged 21–50 years, the incidence is extremely low (6–8 cases per 10 thousand per year). The prevalence of acute cystitis in Russia, according to estimates, is 26–36 million cases per year.

In acute uncomplicated cystitis, it is advisable to prescribe short (3-5-day) courses of ABT.

However, in chronic recurrent cystitis, short courses of therapy are unacceptable - the duration of ABT for complete eradication of the pathogen should be at least 7-10 days.

For cystitis, ofloxacin is prescribed 100 mg 2 times a day or 200 mg 1 time a day. In chronic cystitis in young people, especially in the presence of concomitant sexually transmitted infections (in 20-40% of cases caused by chlamydia, mycoplasmas or ureaplasmas), ofloxacin is a priority among other PCs.

Acute pyelonephritis

Acute pyelonephritis is the most common kidney disease in all age groups; women predominate among patients. The incidence of acute pyelonephritis in Russia is estimated at 0.9-1.3 million cases per year.

Treatment of pyelonephritis is based on the use of effective antibiotic therapy, subject to the restoration of urodynamics and, if possible, the correction of other complicating factors (endocrine disorders, immunodeficiency, etc.). Initially, empiric ABT is carried out, which, if necessary, is changed after receiving the antibiogram; ABT should be long-term.

Ofloxacin can be used to treat pyelonephritis, taking into account its accumulation in the kidney parenchyma and high concentrations in the urine, the drug is prescribed 200 mg 2 times a day for 10-14 days.

Prostatitis

Despite the advances in modern urology, the treatment of chronic prostatitis is still an unresolved problem. Etiopathogenetic ideas about chronic prostatitis suggest that infection and inflammation trigger a cascade of pathological reactions: morphological changes in the tissue of the prostate (PG) with a violation of its angioarchitectonics, persistent immune inflammation, hypersensitization of the autonomic nervous system, etc. Even after the elimination of the infectious agent, the listed pathological processes can persist with severe clinical symptoms. Long-term ABT is recommended by many researchers as a component of complex treatment of chronic prostatitis of categories II, III, IV according to the classification of the US National Institutes of Health (NIH, 1995).

Acute prostatitis (category I according to NIH, 1995) in 90% of cases develops without previous urological manipulations, and in about 10% of cases it becomes a complication of urological interventions (prostate biopsy, bladder catheterization, urodynamic study, etc.). The basis of treatment is gradual ABT for 2-4 weeks.

The vast majority of pathogens of bacterial prostatitis are gram-negative microbes of the intestinal group (E. coli, Klebsiella spp., Proteus spp., Enterobacter spp., etc.). C. trachomatis, U. urealiticum, S. aureus, S. saprophyticus, Trichomonas spp., Pseudomonas spp., anaerobes, etc. can also be etiological factors. PCs are the drugs of choice for the treatment of prostatitis, which best penetrate into the tissue and secretion of the pancreas and overlap the main spectrum of prostatitis pathogens. The condition for successful ABT in prostatitis is its sufficient duration - for at least 4 weeks, followed by bacteriological control.

Ofloxacin can be successfully used for the treatment of prostatitis, as it is highly active against chlamydia, and against mycoplasmas and ureaplasmas, its effectiveness is comparable to other PCs and doxycycline. In chronic prostatitis, ofloxacin is prescribed orally at 400 mg 2 times a day for 3-4 weeks. In acute prostatitis, gradual therapy is carried out: the drug is first prescribed intravenously at 400 mg 2 times a day, switching to oral administration after normalization of body temperature and clinical improvement.

Pancreatic cancer and UTI

Molecular and genetic studies in recent years indicate that prostatitis can initiate the development of pancreatic cancer. Chronic inflammation activates carcinogenesis by damaging the cell genome, stimulating cell proliferation and angiogenesis. Studies of the effectiveness of antibacterial and anti-inflammatory therapy in the prevention of pancreatic cancer are being actively conducted.

Inflammatory changes in the pancreas can lead to an increase in the level of prostate-specific antigen (PSA) in the blood. According to current recommendations, an increase in PSA levels above age norms is an indication for a biopsy of the pancreas. However, in the absence of changes suspicious of pancreatic cancer on digital rectal examination, it is possible to use antibacterial and anti-inflammatory therapy for 3–4 weeks, followed by monitoring of PSA levels. In the case of its normalization, a biopsy of the pancreas is not performed.

Benign pancreatic hyperplasia and UTI

benign prostatic hyperplasia

(BPH) and lower urinary tract infection symptoms are very common among men. The basis of medical treatment of BPH are α-blockers and 5α-reductase inhibitors. However, it is well known that BPH is almost always accompanied by prostatitis, which often contributes significantly to clinical symptoms. Therefore, ABT in some cases is appropriate for BPH. With a confirmed inflammatory process, it is necessary to prescribe ABT for a period of 3-4 weeks. PCs are the drugs of choice, taking into account the spectrum of their antimicrobial action and pharmacokinetic features.

Prevention in urological interventions

UTIs most often become a complication of such interventions as transrectal pancreatic biopsy, bladder catheterization, complex urodynamic study, etc. According to modern standards, antibacterial prophylaxis of UTIs is mandatory before invasive urological interventions. This is because the cost and associated risks of antibiotic prophylaxis are much less than the risk and cost of treating UTIs. For the prevention of infectious complications in most transurethral manipulations, as well as in transrectal biopsy of the pancreas, it is sufficient to prescribe a single dose of PC 2 hours before the intervention (for example, 400 mg ofloxacin).

An unresolved urological problem is catheter-associated infection. Colonies of microorganisms form the so-called biofilms on foreign materials, inaccessible to the action of ABP and antiseptics. Antibiotics cannot eliminate an already formed biofilm, but there is evidence that the prophylactic administration of PC (for example, ofloxacin, ciprofloxacin, or levofloxacin) can prevent or slow down its formation.

Conclusion

Fluoroquinolones have been used successfully for many years to treat urinary tract infections. Ofloxacin meets the principles of rational antibacterial therapy for UTIs, its use is advisable for the treatment and prevention of UTIs - cystitis, pyelonephritis, prostatitis. The presence of oral and parenteral dosage forms of ofloxacin makes its use convenient in outpatient practice and in the hospital.

Recommended reading
Loran O.B., Sinyakova L.A., Kosova I.V. Treatment and prevention of chronic recurrent cystitis in women // Consilium medicum. 2004. T 6. No. 7. S. 460–465.
Modern clinical guidelines for antimicrobial therapy / Ed. Strachunsky L.S. Smolensk, 2004.
Padeyskaya E.N., Yakovlev V.P. Antimicrobials of the fluoroquinolone group in clinical practice. M., 1998.
Yakovlev V.P. Place of ofloxacin in outpatient practice: experience of 15 years of use // Infections and antimicrobial therapy. 2000. V. 2. No. 5. S. 154–156.
Yakovlev V.P. Pharmacokinetic properties of ofloxacin // Antibiotics and chemotherapy. 1996. V. 41. No. 9. S. 24–32.
Granier N. Evaluation de la toxicite des quinolones en pediatrie // Les Quinolones en Pediatrie. Paris, 1994, pp. 117–121.
Kahlmeter G. An international survey of the antimicrobial susceptibility of pathogens from uncomplicated urinary tract infections: the ECO-SENS project // J. Antimicrob. Chemother. 2003. V. 51. No. 1. P. 69–76.
Karlowsky J.A., Kelly L.J., Thornsberry C. et al. Trends in antimicrobial resistance among urinary tract infection isolates of Escherichia coli from female outpatients in the United States // Antimicrob. Agents Chemother. 2002. V. 46. No. 8. R. 2540–2545.
Kaygisiz O., Ugurlu O., Kosan M. et al. Effects of antibacterial therapy on PSA change in the presence and absence of prostatic inflammation in patients with PSA levels between 4 and 10 ng/ml // Prostate Cancer Prostatic Dis. 2006. V. 9. No. 3. R. 235–238.
Sugar L.M. Inflammation and prostate cancer // Can. J. Urol. 2006. V. 13. No. 1. R. 46–47.
Terris M. Recommendations for prophylactic antibiotic use in genitourinary surgery // Contemp. Urology 2001. No. 9. P. 12–27.
Warren J.W., Abrutyn E., Hebel J.R. et al. Guidelines for antimicrobial treatment of uncomplicated acute bacterial cystitis and acute pyelonephritis in women. Infectious Diseases Society of America (IDSA) // Clin. Infect. Dis. 1999. V. 29. No. 4. R. 745–758.

Ofloxacin is an antimicrobial drug with a wide spectrum of bactericidal action. Belongs to the group of fluoroquinolones.

It has an effect on a wide range of microorganisms. The therapeutic effect is aimed at blocking bacterial enzymes, which causes a violation in the formation of the structural components of the bacterium and leads to the death of the microorganism. After administration, it is completely absorbed in the gastrointestinal tract and completely metabolized in the liver.

Usually tablets are prescribed in a dose of 200-800 mg. If the dosage is less than 400 mg, then it should be taken in the morning before meals, and above - in the morning and evening. The course of treatment is about one week.

Clinical and pharmacological group

Antibacterial drug of the fluoroquinolone group.

Terms of dispensing from pharmacies

Released by prescription.

Prices

How much do Ofloxacin tablets cost in pharmacies? The average price is at the level of 50 rubles.

Release form and composition

Ofloxacin is available in the following forms:

  • Film-coated tablets: biconvex, round, almost white; a layer on a transverse section of almost white color (10 pieces in blister packs, in a cardboard bundle 1 pack);
  • Solution for infusion: transparent, greenish-yellow (100 ml in colorless or dark glass bottles, 1 bottle in a carton box);
  • Eye ointment 0.3%: white, white with a yellowish tinge or yellow (5 g each in aluminum tubes, 1 tube in a cardboard bundle).

Active ingredient: ofloxacin - 200 mg or 400 mg in 1 tablet; 2 mg in 1 ml of solution; 3 mg in 1 g of ointment.

Auxiliary components:

  • Film-coated tablets: talc, corn starch, colloidal silicon dioxide, calcium stearate, microcrystalline cellulose, povidone; film shell: titanium dioxide, macrogol 4000, hypromellose, propylene glycol, talc;
  • Solution for infusion: distilled water and sodium chloride;
  • Eye ointment: propyl parahydroxybenzoate, methyl parahydroxybenzoate, petroleum jelly.

Pharmacological effect

The presented drug is very effective against gram-negative pathogens, it is often included in the course of therapy even in cases where other drugs of the same group have not given a therapeutic effect.

Ofloxacin is taken orally and at the same time it still remains very effective, it is absorbed very quickly in the organs of the gastrointestinal tract and enters tissues, organs, bile, sputum, skin, saliva in almost full concentration. The maximum concentration of the main active agent in the blood (in plasma) is observed within an hour after ingestion.

Ofloxacin is excreted unchanged, more than half of the received dose is excreted from the body after 6 hours, but the presence of the main active substance in the urine can be detected even a day after administration (it can be single).

Indications for use

Ofloxacin indications include various infectious diseases, such as:

  • infectious and inflammatory diseases of the kidneys () and urinary tract (,);
  • infectious and inflammatory diseases of the biliary tract and abdominal cavity (except for bacterial enteritis);
  • infections of ENT organs (,);
  • respiratory tract infections ( , );
  • infectious diseases of soft tissues, joints, bones, skin;
  • infections of the pelvic organs and genital organs (salpingitis, endometritis, colpitis, parametritis, oophoritis, epididymitis, orchitis);
  • meningitis.

Ofloxacin is effective in the treatment of infectious eye diseases (blepharitis, bacterial corneal ulcers, keratitis, meibomitis, dacryocystitis, chlamydial eye infections).

In addition to the use for the listed indications, the drug can also be used to prevent infectious diseases in patients with impaired immune status. In the treatment of gonorrhea, septicemia and chlamydia, intravenous use is provided.

Contraindications

Absolute for all forms of release:

  • The period of pregnancy and breastfeeding (lactation);
  • Hypersensitivity to the components of Ofloxacin and other quinolone derivatives.

Additionally for tablets and solution:

  • Deficiency of glucose-6-phosphate dehydrogenase;
  • Epilepsy, including data in history;
  • Children and adolescents up to 18 years of age (since the growth of the skeleton has not yet been completed);
  • Lowering the threshold for seizure activity, including the period after a stroke, traumatic brain injury, or inflammatory diseases of the central nervous system (CNS).

Additionally for ointment:

  • Chronic conjunctivitis of non-bacterial etiology;
  • Age up to 15 years.

Caution is required to take pills in case of atherosclerosis of the cerebral vessels, cerebrovascular accidents (data in the anamnesis), organic lesions of the central nervous system, chronic renal failure.

Use during pregnancy and lactation

Pregnant women are prescribed the drug only as a local treatment, under the supervision of a physician. Taking the drug in the form of tablets and drip is contraindicated.

When treating lactating women with Ofloxacin, breastfeeding is stopped for the duration of the entire course of treatment and until the drug is completely removed from the body.

Use in children

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

Dosage and method of application

The instructions for use indicate that the exact dose and regimen of taking the drug in the form of tablets and solution for infusion is selected individually by the attending physician, depending on the severity of the infection and its localization, as well as on the general condition of the patient, the sensitivity of microorganisms, and liver and kidney function.

Ofloxacin tablets

Tablets are taken orally, whole, before meals or during meals, washed down with water.

In the case of acute gonorrhea, the tablets are taken once at a dose of 0.4 g.

The duration of the course of therapy: salmonellosis - 7-8 days, uncomplicated infections of the lower urinary tract - 3-5 days.

Ointment Ofloxacin

Apply topically, laying a strip of the drug (1 cm long) into the lower eyelid up to three times a day. The standard course of therapy is 2 weeks. With chlamydial infections, the frequency of application of the ointment is increased to 5-6 times a day, the duration of treatment is up to 5 weeks.

Ofloxacin solution

Injections are done intravenously, by drip. The dose of the drug is selected by the doctor individually, taking into account the patient's condition and possible contraindications. The initial dose is 200 mg administered over 30-60 minutes. After the patient's condition improves, Ofloxacin tablets are prescribed in the same daily dose.

For urinary tract infections, the drug is administered at a dose of 100 mg, injections are made twice a day. In the treatment of ENT organs, soft tissues, joints, abdominal organs, two infusions of 200 mg are prescribed per day. If necessary, this dose is doubled. In case of kidney diseases, 100 ml of solution is administered using a dropper, 1-2 times a day.

Side effects

Taking Ofloxacin tablets can lead to the development of adverse reactions from various organs and systems:

  • Skin - petechiae (pinpoint hemorrhages in the skin), dermatitis (reactive inflammation of the skin), papular rash.
  • Digestive system - nausea, periodic vomiting, loss of appetite, up to its complete absence (anorexia), diarrhea, flatulence (bloating), abdominal pain, increased activity of liver transaminase enzymes (ALT, AST) in the blood, indicating damage to liver cells , cholestatic jaundice, provoked by stagnation of bile in the structures of the hepatobiliary system, hyperbilirubinemia (increased concentration of bilirubin in the blood), pseudomembranous enterocolitis (inflammatory pathology caused by the anaerobic bacterium Clostridium difficile).
  • Blood and red bone marrow - a decrease in the number of red blood cells (hemolytic or aplastic anemia), white blood cells (leukopenia), platelets (thrombocytopenia), as well as the virtual absence of granulocytes (agranulocytosis).
  • Cardiovascular system - tachycardia (increased heart rate), vasculitis (inflammatory reaction of blood vessels), collapse (marked decrease in the tone of arterial vessels).
  • Musculoskeletal system - pain in the joints (arthralgia), skeletal muscles (myalgia), reactive inflammation of the ligaments (tendivitis), synovial bags of the joints (synovitis), pathological tendon ruptures.
  • Urinary system - interstitial nephritis (reactive inflammation of the tissues of the kidneys), a violation of the functional activity of the kidneys, an increase in the level of urea and creatinine in the blood, which indicates the development of renal failure.
  • Allergic reactions - skin rash, itching, urticaria (characteristic rash and swelling of the skin, resembling a nettle burn), bronchospasm (allergic narrowing of the bronchi due to their spasm), allergic pneumonitis (allergic pneumonia), allergic fever (fever), angioedema Quincke's edema (pronounced swelling of the tissues of the face and external genital organs), severe necrotic allergic skin reactions (Lyell's syndrome, Stevens-Johnson syndrome), anaphylactic shock (severe systemic allergic reaction with a pronounced decrease in blood pressure and the development of multiple organ failure).
  • Nervous system and sensory organs - headache, dizziness, uncertainty in movements, especially those associated with the need for fine motor skills, tremor (trembling) of the hands, periodic convulsions of various groups of skeletal muscles, numbness of the skin and its paresthesia (impaired sensitivity), nightmares, various phobias (severe fear of objects or various situations), anxiety, increased excitability of the cerebral cortex, depression (prolonged mood decline), confusion, visual or auditory hallucinations, psychotic reactions, diplopia (double vision), impaired vision (color perception), taste, sense of smell, hearing, balance, increased intracranial pressure.

If side effects develop after the start of the use of Ofloxacin tablets, they should be discontinued and consult a doctor. The possibility of further use of the drug, he determines individually, depending on the nature and severity of side effects.

Overdose

Manifested by dizziness, lethargy, drowsiness, confusion, disorientation, convulsions, vomiting. Treatment consists of gastric lavage, forced diuresis and symptomatic therapy. Diazepam is used for convulsive syndrome.

special instructions

Before you start using the drug, read the special instructions:

  1. Alcohol should be avoided during treatment with the drug.
  2. It is not the drug of choice for pneumonia caused by pneumococci. Not indicated in the treatment of acute tonsillitis.
  3. Against the background of treatment, the course of myasthenia gravis may worsen, more frequent attacks of porphyria in predisposed patients.
  4. It is not recommended to use the drug for more than 2 months. Avoid exposure to sunlight, exposure to UV rays (mercury-quartz lamps, solarium).
  5. When using the drug, women are not recommended to use tampax-type tampons, due to an increased risk of developing vaginal candidiasis.
  6. When using the drug, false-negative results are possible in the bacteriological diagnosis of tuberculosis (prevents the isolation of Mycobacterium tuberculosis).
  7. In case of side effects from the central nervous system, allergic reactions, pseudomembranous colitis, the drug should be discontinued. For pseudomembranous colitis confirmed by colonoscopy and/or histology, oral administration of vancomycin and metronidazole is indicated.
  8. In patients with impaired liver or kidney function, it is necessary to control the concentration of ofloxacin in plasma. In severe renal and hepatic insufficiency, the risk of developing toxic effects increases (dose adjustment is required).
  9. It should be borne in mind that when using Ofloxacin-AKOS, rarely occurring tendinitis can lead to tendon rupture (mainly the Achilles tendon), especially in elderly patients. In the event of symptoms of tendinitis, it is necessary to immediately stop treatment, immobilize the Achilles tendon and consult an orthopedist.

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

drug interaction

When using the drug, it is necessary to take into account the interaction with other drugs:

  1. Ofloxacin increases the plasma concentration of glibenclamide.
  2. When taking ofloxacin with vitamin K antagonists, it is necessary to control the blood coagulation system.
  3. Ofloxacin reduces the clearance of theophylline by 25%. Therefore, with simultaneous use, the dose of theophylline should be reduced.
  4. Cimetidine, furosemide, methotrexate and drugs that block tubular secretion increase plasma concentrations of ofloxacin.
  5. When prescribing Ofloxacin-AKOS with NSAIDs, nitroimidazole derivatives and methylxanthines, the risk of developing neurotoxic effects increases.
  6. With the simultaneous appointment of Ofloxacin-AKOS with glucocorticosteroids, the risk of tendon rupture increases, especially in the elderly.
  7. Food products, antacids containing aluminum, calcium, magnesium, or iron salts reduce the absorption of ofloxacin, forming insoluble complexes (therefore, the interval between the appointment of Ofloxacin-AKOS and these drugs should be at least 2 hours).
  8. When prescribing Ofloxacin-AKOS with drugs that alkalinize urine (carbonic anhydrase inhibitors, citrates, sodium bicarbonate), the risk of developing crystalluria and nephrotoxic effects increases.