Ofloxin
Ofloxin: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Ofloxin
ATX code: J01MA01
Active ingredient: ofloxacin (Ofloxacin)
Manufacturer: Zentiva, as (Zentiva, as) (Czech Republic)
Description and photo update: 2019-26-08
Prices in pharmacies: from 179 rubles.
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Ofloxin is an antibacterial agent of the fluoroquinolone group.
Release form and composition
Dosage forms:
- Film-coated tablets: almost white or white, round biconvex, engraved "200" on one side and a dividing line on the other; internal structure when broken - white or almost white (in blisters: 7 pcs., in a cardboard box 2 blisters; 10 pcs., in a cardboard box 1 or 2 blisters);
- Solution for infusion: clear light liquid with a yellow-green tint (100 ml in glass colorless bottles, 1 bottle in a cardboard box).
The cardboard box also contains instructions for the use of Ofloxin.
The active ingredient is ofloxacin:
- 1 tablet - 0.2 g;
- 1 bottle of solution - 0.2 g.
Auxiliary components:
- Tablets: povidone 25, lactose monohydrate, crospovidone, corn starch, magnesium stearate, poloxamer, talc;
- Solution: disodium edetate dihydrate, concentrated hydrochloric acid, sodium chloride, water for injection.
Additionally, as part of the tablet shell: macrogol 6000, hypromellose 2910/5, titanium dioxide, talc.
Pharmacological properties
Pharmacodynamics
The active component of Ofloxin, ofloxacin, is a broad-spectrum antibacterial substance with bactericidal efficacy. Refers to the group of fluoroquinolones. The mechanism of its action is due to the ability to block the DNA gyrase of microorganisms - an enzyme involved in the processes of transcription and replication of deoxyribonucleic acid (DNA) of bacteria.
Ofloxacin has antibacterial activity against Gram-positive and Gram-negative microorganisms such as Proteus spp., Enterobacteriaceae (Citrobacter spp., Enterobacter spp., Escherichia coli, Klebsiella spp., Providencia spp., Salmonella spp., Shigella spp., Yersinia spp.). It is effective for infections caused by the following bacteria: Acinetobacter spp., Branhamella catarrhalis, Brucella melitensis, Campylobacter spp., Gardnerella vaginalis, Haemophilus influenzae, Haemophilus ducreyi, Helicobacter pylori, Pylori. Pylori. Vibrio spp.
Ofloxin is also active against staphylococci, including penicillinase-producing and methicillin-resistant strains of various bacteria (Chlamydia trachomatis, Chlamydia pneumoniae, Mycobacterium tuberculosis, Mycobacterium leprae, Mycoplasma pneumoniae, Ureaplasma ureaplasma).
Ofloxacin has limited efficacy against group A, B and C streptococcal infections.
Anaerobes (with the exception of Clostridium perfringens) and the causative agent of syphilis are resistant to Ofloxin.
Pharmacokinetics
After oral administration of Ofloxin, ofloxacin is rapidly absorbed from the gastrointestinal tract. The maximum concentration in the blood (Cmax) reaches within 60-120 minutes.
Plasma proteins bind 25%. Bioavailability is 96-100%. It penetrates well into all tissues, is distributed in all body fluids, including the spinal cord. In high concentrations, it is determined in bile and gallbladder. Penetrates through the placental barrier and into breast milk.
It is metabolized to ofloxacin-N-oxide and ofloxacin-desmethyl. The half-life is 5-8 hours, it can significantly increase with renal failure - up to 15-60 hours. About 80% of the dose received is excreted by the kidneys by tubular secretion and filtration, of which no more than 5% are metabolites, the rest is unchanged drug. Another 4–8% of the dose is excreted through the intestines. Excretion is slowed down in patients with severe liver disease.
Total clearance is 214 ml / min, renal clearance is 173 ml / min. It is excreted in small amounts during hemodialysis. The half-life for hemodialysis is 8-12 hours, for peritoneal dialysis - 22 hours.
After intravenous administration of 200 mg ofloxin Cmax ofloxacin is observed after about 1 hour. Equilibrium concentrations of the drug are observed after the introduction of 4 infusions. The half-life is 6-7 hours.
Indications for use
The use of Ofloxin is indicated in the treatment of infectious and inflammatory pathologies caused by microorganisms sensitive to the drug:
- Bronchitis, pneumonia;
- Meningitis;
- Sinusitis, otitis media, pharyngitis, laryngitis;
- Joint and bone infections;
- Infectious diseases of the skin, soft tissues;
- Infectious and inflammatory diseases of the gastrointestinal tract, biliary tract and other organs of the abdominal cavity;
- Endometritis, oophoritis, salpingitis, cervicitis, prostatitis, parametritis;
- Pyelonephritis, cystitis, urethritis;
- Gonorrhea;
- Genital infections (orchitis, colpitis, epididymitis);
- Chlamydia.
For patients with neutropenia and other disorders of the immune status, Ofloxin is prescribed for the prevention of infections.
In addition, the solution is used in the treatment of septicemia.
Contraindications
- Epilepsy (including history);
- Deficiency of glucose-6-phosphate dehydrogenase;
- Decrease in the threshold of seizure activity of the brain, including conditions after a stroke, traumatic brain injury or inflammation in the central nervous system (CNS);
- Age under 18;
- The period of pregnancy and breastfeeding;
- Hypersensitivity to drug components.
With caution, it is recommended to prescribe Ofloxin to patients with atherosclerosis of the cerebral vessels, indicating a history of cerebrovascular accidents, organic lesions of the central nervous system, chronic renal failure.
In addition, Ofloxin tablets are contraindicated in patients with tendon lesions after previous therapy with quinolones, and should be taken with caution if the QT interval is prolonged on electrocardiography.
Ofloxin, instructions for use: method and dosage
Film-coated tablets
Ofloxin tablets are taken before meals or during meals, by mouth, swallowing whole and drinking plenty of water.
The doctor prescribes the dose and duration of the drug taking on the basis of clinical indications, taking into account the severity of the patient's condition, the type of infection and the functional parameters of the liver and kidneys.
The recommended daily dose of Ofloxin can range from 0.2 to 0.6 g, therefore, a dose of up to 0.4 g per day is taken 1 time, preferably in the morning, and a dose of more than 0.4 g is divided into two equal parts and taken at regular intervals time 2 times a day. The duration of therapy is 7-10 days.
In severe forms of infectious pathologies or with an overweight patient, the daily dose can be increased to 0.8 g.
In the treatment of uncomplicated infections of the lower urinary tract, 0.2 g per day is prescribed for 3-5 days, with gonorrhea - 0.4 g once.
The initial treatment with Ofloxin in the form of a solution for infusion after improvement of the patient's condition can be continued by taking the tablets in the same dose.
Concomitant use with antacids is contraindicated.
Solution for infusion
Ofloxin solution is injected intravenously.
The dose is prescribed individually, taking into account the severity of the course and localization of the infection, the sensitivity of microorganisms, the clinical condition of the patient, kidney and liver function.
Treatment begins with a single slow injection of 0.2 g of the drug for 0.5-1 hour. After improving the patient's condition, they are transferred to taking pills in the same daily dose.
Recommended dosage of Ofloxin:
- Urinary tract infections: 0.1 g 1-2 times a day;
- Genital and kidney infections: 0.1-0.2 g 2 times a day;
- Infections of the respiratory tract, ear, throat and nose (pharyngitis, sinusitis, otitis media, laryngitis), soft tissues and skin, bones and joints, abdominal cavity, septic infections: 0.2 g 2 times a day, to achieve a therapeutic effect, dose can be increased to 0.4 g 2 times a day;
- Prevention of infections with a pronounced decrease in immunity: 0.2 g mixed with 5% glucose solution, duration of infusion - 0.5 hours (it is necessary to mix solutions immediately before administration).
A single dose of Ofloxin for the treatment of patients with functional disorders of the kidneys (creatinine clearance (CC) 50-20 ml / min) should correspond to 1/2 of the average recommended and should be applied 1-2 times a day. When CC is less than 20 ml / min, a single dose of 0.2 g is prescribed, then every other day, 0.1 g per day.
With hemodialysis and peritoneal dialysis - 0.1 g 1 time per day.
For patients with hepatic insufficiency, the daily dose should not exceed 0.4 g.
Side effects
- Digestive system: nausea, vomiting, anorexia, diarrhea, flatulence, gastralgia and other abdominal pains, pseudomembranous enterocolitis, increased activity of liver enzymes, cholestatic jaundice, hyperbilirubinemia;
- Cardiovascular system: lowering blood pressure (BP), vasculitis, tachycardia, collapse;
- Nervous system: headache, convulsions, uncertainty of movement, dizziness, tremors, paresthesias and numbness of the extremities, increased intracranial pressure, intense and / or nightmares, anxiety, psychotic reactions, phobias, increased excitability, depression, hallucinations, confusion;
- Hematopoietic system: anemia, agranulocytosis, leukopenia, pancytopenia, thrombocytopenia, aplastic and hemolytic anemia;
- Sense organs: impairment of smell, taste, hearing, balance, diplopia, impaired color perception;
- Musculoskeletal system: tendosynovitis, myalgia, tendonitis, arthralgia, tendon rupture;
- Urinary system: impaired renal function, increased levels of urea in the blood, acute interstitial nephritis, hypercreatininemia;
- Dermatological reactions: petechiae (punctate hemorrhages), bullous hemorrhagic dermatitis, photosensitivity, papular rash;
- Allergic reactions: fever, pruritus, skin rash, urticaria, allergic pneumonitis, eosinophilia, allergic nephritis, Quincke's edema, Stevens-Johnson syndrome, bronchospasm, exudative erythema multiforme, Lyell's syndrome, anaphylactic shock;
- Others: superinfection, dysbiosis, with diabetes mellitus - hypoglycemia, vaginitis.
In addition, Ofloxin can cause side effects characteristic of one of the forms of the drug:
- Tablets: from the digestive system - hepatitis, from the musculoskeletal system - muscle weakness, rhabdomyolysis;
- Solution for infusion: reactions at the injection site in the form of pain, redness, thrombophlebitis.
Overdose
Symptoms: vomiting, dizziness, drowsiness, lethargy, confusion, disorientation.
Gastric lavage is recommended. Further treatment is symptomatic.
special instructions
In pneumococcal pneumonia and acute tonsillitis, Ofloxin is not indicated for use.
The duration of drug treatment should not exceed 2 months.
The patient must avoid exposure to direct sunlight and exposure to ultraviolet rays.
When symptoms of side effects from the central nervous system, pseudomembranous colitis, the development of allergic reactions appear, therapy should be canceled. For the treatment of laboratory-confirmed pseudomembranous colitis, oral vancomycin and metronidazole are indicated.
The use of Ofloxin in rare cases causes the development of tendonitis, which can lead to rupture of the tendons (Achilles tendon), more often in elderly patients. Therefore, when tendonitis occurs, immobilization of the Achilles tendon and consultation with an orthopedist are required.
During treatment, women are not recommended to use vaginal tampons due to the high risk of candidiasis.
The action of Ofloxin can worsen the course of myasthenia gravis, in patients prone to porphyria - contribute to an increase in the frequency of attacks, in the bacteriological diagnosis of tuberculosis - give false negative results.
In case of impaired renal or liver function, regular monitoring of the level of ofloxacin in the blood plasma is required. Due to the risk of toxic effects, dose adjustment is required in patients with severe renal and hepatic impairment.
Drinking alcohol during the treatment with Ofloxin is contraindicated.
The use of a solution for infusion in pediatrics is possible only when the child's life is threatened, when it is impossible to use other, less toxic drugs, after a careful assessment of the intended benefits and the potential threat of side effects. When prescribing, the average daily dose is recommended in the amount of 0.0075 g per 1 kg of the child's weight, the maximum dose should not exceed 0.015 g per 1 kg.
Influence on the ability to drive vehicles and complex mechanisms
During the period of using Ofloxin, the patient should not engage in potentially hazardous activities, including driving vehicles and mechanisms.
Application during pregnancy and lactation
Ofloxin is contraindicated for pregnant and breastfeeding women.
Pediatric use
Ofloxin is not used in children and adolescents (up to 18 years).
With impaired renal function
In case of impaired renal function, Ofloxin can be used, but with extreme caution. Dose adjustment required.
For violations of liver function
For violations of liver function Ofloxin can be used, but with extreme caution. Dose adjustment required.
Use in the elderly
Elderly patients are prescribed the drug with caution.
Drug interactions
With the simultaneous use of Ofloxin:
- Cimetidine, methotrexate, furosemide and drugs that block tubular secretion - increase the concentration of ofloxacin in the blood plasma;
- Non-steroidal anti-inflammatory drugs, derivatives of methylxanthines and nitroimidazole - increase the risk of neurotoxic effects;
- Glucocorticosteroids - increase the risk of tendon rupture, especially in elderly patients;
- Inhibitors of carbonic anhydrase, sodium bicarbonate, citrates (drugs that alkalinize urine) - increase the likelihood of developing nephrotoxic effects, crystalluria.
When combined with ofloxacin, theophylline clearance decreases by 25%, and the level of glibenclamide in blood plasma increases.
It is required to control the state of the blood coagulation system with concomitant therapy with indirect anticoagulants - vitamin K antagonists.
Foods and antacids containing calcium, aluminum, iron or magnesium salts reduce the absorption of ofloxacin, so the interval between taking them and taking Ofloxin should be 2 or more hours.
The risk of lengthening the QT interval increases when Ophloxin tablets are combined with class IA and III antiarrhythmic drugs, macrolides, tricyclic antidepressants (drugs that prolong the QT interval).
Ofloxin solution is pharmaceutically compatible with 0.9% sodium chloride solution, 5% fructose solution, Ringer's solution, 5% glucose (dextrose) solution, but it cannot be mixed with heparin.
Analogs
Ofloxin analogues are: Zanocin, Zoflox, Ofloxacin, Ofloxacin Protekh, Oflocid, Loflox, Vero Ofloxacin, Glaufos, Dancil, Tarivid, Uniflox, Floxal.
Terms and conditions of storage
Keep out of the reach of children, in a dry place at a temperature of 10-25 ° C, the solution should be protected from direct sunlight.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews of Ofloxin
According to most reviews, Ofloxin is a strong antibiotic that is effective for infectious diseases caused by microorganisms that are sensitive to it.
In some negative messages, side effects are described, including decreased appetite, severe pain in the stomach, drowsiness, lethargy, nocturnal hallucinations, development of candidiasis.
The price of Ofloxin in pharmacies
Approximate prices for Ofloxin: solution for infusion 2 mg / ml - 127-163 rubles. for 1 bottle 100 ml; film-coated tablets 200 mg - 172-180 rubles. per pack of 10
Ofloxin: prices in online pharmacies
Drug name Price Pharmacy |
Ofloxin 200 mg film-coated tablets 10 pcs. 179 r Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!