Zoflox
Zoflox: 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. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Zoflox
ATX code: J01MA01
Active ingredient: Ofloxacin (Ofloxacin)
Producer: AS Mustafa Nevzat Ilac Sanayii, Turkey
Description and photo update: 18.10.2018
Zoflox is a drug that has an antimicrobial effect.
Release form and composition
Dosage forms of release:
- film-coated tablets: white, oblong, with a transverse score; at the break - white, uniform consistency (5 or 10 pcs. in blisters, in a cardboard box 1 blister);
- solution for infusion: transparent, from light yellow to colorless (in colorless glass bottles of 100 ml, 1 bottle in a cardboard box).
Composition of 1 tablet:
- active substance: ofloxacin - 200 or 400 mg;
- additional components: lactose, hydroxypropyl cellulose, starch, sodium carboxymethyl cellulose, magnesium stearate;
- sheath: OPADRY (Y-1-7000) (film coating).
Composition of 100 ml infusion solution:
- active substance: ofloxacin - 200 mg;
- additional components: sodium chloride, hydrochloric acid, water for injection.
Pharmacological properties
Pharmacodynamics
Zoflox is a broad-spectrum antimicrobial agent from the group of fluoroquinolones, which acts on the bacterial enzyme DNA gyrase. Produces a bactericidal effect.
Ofloxacin is active against beta-lactamase-producing microorganisms and atypical fast-growing mycobacteria.
The following are susceptible to the drug's action: Escherichia coli, Staphylococcus aureus, Bordetella pertussis, Staphylococcus epidermidis, Providencia spp., Neisseria meningitidis, Neisseria gonorrhoeae, Citrobacter, Klebsiella spp., Enterobacter spp., Paraemolytic spp., Enterobacter spp., Bordetella parapertussis, Staphylococcus spp., Propionibacterium acnes, Salmonella spp., Shigella spp., Campylobacter jejuni, Yersinia enterocolitica, Aeromonas hydrophila, Plesiomonas aeruginosa, Vibrio cholerae, Haemophilus influenza., Ch. Spp., Haemophilus influenza. catarrhalis, Haemophilus ducreyi.
Different sensitivities to ofloxacin are possessed by: pneumoniae and viridans, Mycoplasma hominis and pneumoniae, Pseudomonas aeruginosa, Acinetobacter, Enterococcus faecalis, Streptococcus pyogenes, Serratia marcescens, Mycobacterium tuberculosis, Ureaplasma urealyticum, Fortunocytosis, Ureaplasma urealyticum, perflutero-vaginosum, Ureaplasma urealyticum, perflutericum Corynebacterium spp.
Insensitive in most cases: Nocardia asteroides, anaerobic bacteria (for example, Peptococcus spp., Bacteroides spp., Peptostreptococcus spp., Fusobacterium spp., Eubacterium spp., Clostridium difficile).
Treponema pallidum has no effect.
Pharmacokinetics
After oral administration, complete (95%) and rapid absorption of ofloxacin is observed. Communication with plasma proteins - 25%, bioavailability - more than 96%, the time to reach the maximum concentration - from 1 to 2 hours.
The maximum concentration depends on the dose, after a single dose of 200 and 400 mg, it is 2.5 and 5 μg / ml, respectively. Food has no significant effect on bioavailability, but may slow absorption.
After a single intravenous infusion for 60 minutes at a dose of 200 mg ofloxacin, the average maximum plasma concentration is 2.7 μg / ml; 12 hours after administration - 0.3 μg / ml. Equilibrium concentrations are reached after 4 doses.
The apparent volume of distribution is 100 liters. Distribution: cells (leukocytes, alveolar macrophages), respiratory system, soft tissues, skin, bones, bile, pelvic and abdominal organs, urine, prostate secretions, saliva; well penetrates the placental and blood-brain barriers, is secreted with breast milk. Penetrates into the cerebrospinal fluid with non-inflamed / inflamed meninges (14-60%).
Metabolism occurs in the liver (about 5%) with the formation of dimethylofloxacin and ofloxacin N-oxide. The half-life is independent of dose and ranges from 4.5 to 7 hours. It is excreted unchanged by the kidneys (75–90%) and with bile (about 4%). Extrarenal clearance is less than 20%.
After a single dose, 200 mg is detected in the urine within 20-24 hours. Deceleration can occur with hepatic / renal failure. Hemodialysis removes 10–30% of the drug. Does not cumulate.
Indications for use
- infectious and inflammatory diseases of the kidneys, biliary and urinary tract, pelvic organs, abdominal cavity, genitals, including pyelonephritis, cystitis, urethritis, endometritis, salpingitis, colpitis, orchitis, oophoritis, cervicitis, epididymitis, parametritis, prostatitis (except for bacterial enteritis);
- infections of the ENT organs, respiratory tract, joints, skin, bones, soft tissues, including bronchitis, laryngitis, pneumonia, pharyngitis, sinusitis, otitis media;
- meningitis;
- septicemia (infusion solution);
- chlamydia, gonorrhea;
- prevention of infections in patients with impaired immune status (including with neutropenia).
Contraindications
Absolute:
- deficiency of glucose-6-phosphate dehydrogenase;
- lowering the seizure threshold, including conditions after suffering craniocerebral trauma, stroke, or inflammatory processes localized in the central nervous system;
- epilepsy (including a burdened history);
- pregnancy and the period of breastfeeding;
- the presence of individual intolerance to the components of the drug.
Relative (diseases / conditions in the presence of which caution is required):
- organic lesions of the central nervous system;
- cerebral atherosclerosis;
- chronic renal failure;
- burdened history of cerebral circulation disorders;
- age up to 18 years.
Instructions for the use of Zoflox: method and dosage
The dosage regimen of Zoflox is determined individually. The drug is prescribed taking into account the course of the infection (severity and localization), the sensitivity of microorganisms to the action of the drug, hepatic / renal function and the general condition of the patient.
Application methods:
- tablets: orally whole with water, preferably before / during meals; adults are usually prescribed 200-800 mg per day, the frequency of use is 2 times a day, a dose of up to 400 mg can be used once a day (preferably in the morning), the course is 7-10 days; in the treatment of gonorrhea, 400 mg is prescribed once;
- infusion solution: intravenous drip; initial dose - 200 mg (in 5% glucose solution), duration of infusion - 30-60 minutes; only freshly prepared solutions can be introduced. Urinary tract infections - 100 mg 1-2 times a day, genital and kidney infections - 100-200 mg 2 times a day, infections of the respiratory tract, skin and soft tissues, ENT organs, joints, bones, abdominal cavity, septic infections, bacterial enteritis - 200 mg (if necessary - 400 mg) 2 times a day; when the patient's condition improves, they are transferred to taking the drug inside. The daily dose for the prevention of infections with reduced immunity is 400-600 mg.
After the symptoms of the disease disappear and the temperature is completely normalized, therapy must be continued for at least 3 more days. The duration of the course for salmonellosis is 7–8 days, for uncomplicated infections of the lower urinary tract - from 3 to 5 days.
Recommendations for the use of ofloxacin in patients with impaired renal function (depending on creatinine clearance):
- 20-50 ml / min: with a frequency of application 2 times a day, a single dose is reduced by 2 times, or the drug is prescribed 1 time a day in a full single dose;
- <20 ml / min: a single dose of 200 mg, then 100 mg is used every other day.
For peritoneal dialysis / hemodialysis, the drug is prescribed every 24 hours at 100 mg.
In liver failure, the maximum daily dose is 400 mg.
In children, the drug can be used only if there is a threat to life, after assessing the benefit / risk ratio if it is impossible to use other, less toxic drugs. In this case, the daily dose is: average - 7.5 mg / kg, maximum - 15 mg / kg.
Side effects
- urinary system: hypercreatininemia, increased urea content, acute interstitial nephritis, impaired renal function;
- nervous system: increased intracranial pressure, confusion, intense dreams, headache, tremors, dizziness, lack of confidence in movements, psychomotor agitation, nightmares, phobias, hallucinations, depression, psychotic reactions, convulsions, numbness and paresthesias of the extremities, anxiety;
- digestive system: pseudomembranous enterocolitis, gastralgia, nausea, anorexia, vomiting, diarrhea, increased activity of hepatic transaminases, flatulence, abdominal pain, hyperbilirubinemia, cholestatic jaundice;
- musculoskeletal system: myalgia, tendonitis, tendosynovitis, arthralgia, tendon rupture;
- cardiovascular system: tachycardia, collapse, vasculitis, decrease in blood pressure (with the introduction of an infusion solution; with a sharp decrease in blood pressure, the administration must be stopped);
- skin: bullous hemorrhagic dermatitis, petechiae, papular rash with a crust, indicating vascular lesions;
- senses: diplopia, disturbances in balance, taste, hearing, color perception and smell;
- hematopoietic organs: aplastic / hemolytic anemia, leukopenia, agranulocytosis, anemia, thrombocytopenia, pancytopenia;
- allergic reactions: fever, eosinophilia, pruritus / rash, urticaria, allergic pneumonitis / nephritis, anaphylactic shock, Quincke's edema, photosensitivity, bronchospasm, Stevens-Johnson and Lyell syndromes, exudative erythema multiforme;
- others: vaginitis, superinfection, dysbiosis, hypoglycemia (against the background of diabetes mellitus);
- local reactions (for infusion solution): thrombophlebitis, redness / pain at the injection site.
Overdose
The main symptoms are vomiting, drowsiness, confusion, dizziness, lethargy, disorientation.
Therapy: symptomatic, gastric lavage.
special instructions
Zoflox is not the drug of choice for pneumococcal pneumonia. The drug is not indicated for the treatment of acute tonsillitis.
It is not recommended to use Zoflox for more than 2 months.
Avoid exposure to sunlight and ultraviolet rays (tanning beds, mercury-quartz lamps).
If during the period of therapy the development of side reactions from the central nervous system, pseudomembranous colitis and allergic reactions is observed, Zoflox is canceled. In cases of histologic / colonoscopic confirmation of pseudomembranous colitis, vancomycin and metronidazole (orally) are prescribed.
Tendinitis, the development of which is rarely observed during the use of Zoflox, can lead to rupture of tendons (mainly the Achilles tendon), especially in elderly patients. In cases of signs of illness, therapy is immediately canceled and the Achilles tendon is immobilized (orthopedic consultation may be required).
It is not recommended for women to use tampons during the treatment course (due to the increased likelihood of thrush).
In predisposed patients, there may be a worsening of the course of myasthenia gravis, an increase in the frequency of attacks of porphyria.
When conducting bacteriological diagnostics of tuberculosis, the use of Zoflox can cause false negative results.
Influence on the ability to drive vehicles and complex mechanisms
Patients during the period of therapy are advised to refrain from driving, ethanol should not be consumed.
Application during pregnancy and lactation
The drug is contraindicated for women during pregnancy and breastfeeding.
Pediatric use
In children under 18 years of age (until the growth of the skeleton is complete) Zoflox can be used only for health reasons in cases where the use of less toxic drugs is impossible.
With impaired renal function
In patients with impaired renal function, the dose is adjusted. Monitoring of the plasma concentration of ofloxacin is required. The likelihood of toxic effects increases.
For violations of liver function
In patients with impaired hepatic function, the dose is adjusted. Monitoring of the plasma concentration of ofloxacin is required. The likelihood of toxic effects increases.
Drug interactions
According to the instructions, Zoflox in the form of an infusion solution is compatible with sodium chloride solution, 5% fructose and dextrose solution, Ringer's solution. Due to the likelihood of precipitation, it should not be mixed with heparin.
With the combined use of ofloxacin with certain drugs / substances, the following effects may develop:
- furosemide, cimetidine, methotrexate and drugs that block tubular secretion: the plasma concentration of ofloxacin increases;
- antacids containing Ca2 +, A13 +, Mg2 + or iron salts, food products: the absorption of ofloxacin decreases with the formation of insoluble complexes (the interval between the use of these drugs should be at least 2 hours);
- glibenclamide: its plasma concentration increases;
- vitamin K antagonists: measures are required to control the blood coagulation system;
- theophylline: its clearance decreases (its dose when combined with Zoflox should be reduced);
- nonsteroidal anti-inflammatory drugs, derivatives of nitroimidazole and methylxanthines: the likelihood of neurotoxic effects increases;
- glucocorticosteroids: the likelihood of tendon rupture increases, especially in elderly patients;
- urine alkalizing drugs, including citrates, carbonic anhydrase inhibitors, sodium bicarbonate: increases the likelihood of crystalluria and nephrotoxic reactions.
Analogs
Analogs of Zoflox are: Ashof, Tarivid, Ofloxacin, Zanocin, Ofloxabol, Dancil, Oflox, Oflo, Tariferid, Roflo, Floxal and others.
Terms and conditions of storage
Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Zoflox
In most cases, reviews of Zoflox are positive. If the drug is used without first consulting a doctor and confirming the sensitivity of the pathogen to its action, its effectiveness may be insufficient.
The most common adverse reactions were loss of appetite, nausea, weakness, and low blood pressure. As a rule, these disorders go away on their own after the end of the course / discontinuation of the drug; additional treatment is not required.
The price of Zoflox in pharmacies
Approximate price for Zoflox tablets:
- 200 mg each (10 pcs. per package) - 170-220 rubles;
- 400 mg each (5 pcs. in a package) - 150-220 rubles.
The price of the infusion solution is unknown as it is not available in pharmacies.
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, 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!
