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

Indications

The drug is prescribed when symptoms of infectious diseases affecting:

• Respiratory tract: bronchitis, pneumonia, pneumonia
• ENT organs: sinusitis, pharyngitis, otitis media
• Kidneys: pyelonephritis
• Urinary tract: urethritis, cystitis
• Genital organs: orchitis, epidermitis
• Pelvic organs: endometritis, cervicitis, prostatitis.

The medicine is effective in the fight against skin infections, as well as those affecting bone tissue, joints and soft tissues.

Medicinal properties

Absorption of the drug is 95%, occurs quickly and completely from the gastrointestinal tract. Bioavailability - more than 95%, binding to plasma proteins - 25%, metabolization in the liver - 5%.

Eating may slightly affect the absorption of the medicine, slowing down its rate. The maximum concentration in blood plasma is observed after two hours.

Ofloxacin has the ability to quickly enter body tissues and fluids. It is distributed in the organs of the urinary system, genitals, lungs, prostate gland, gall bladder, ENT organs, bones, skin.

80% of ofloxacin is excreted from the body through urine, and 4% through feces.

Directions for use and doses

Regardless of the form of use of the drug, the daily dose of the active substance must be taken into account. Tablets - orally, before or directly with food. The number of medication doses is 1 or 2 times a day. The maximum amount of medication is 800 mg. per day.

Zoflox 400 mg 5 pcs. film-coated tablets

pharmachologic effect

Antimicrobial agent of the fluoroquinolone group with a broad spectrum of action.
The bactericidal effect of ofloxacin is associated with the blockade of the DNA gyrase enzyme in bacterial cells. Highly active against most gram-negative bacteria: Escherichia coli, Salmonella spp., Shigella spp., Proteus spp., Morganella morganii, Klebsiella spp. (including Klebsiella pneumoniae), Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Mycoplasma spp., Legionella pneumophila, Acinetobacter spp., as well as Chlamydia spp.

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

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

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

Resistant to β-lactamases.

Composition and release form Zoflox 400 mg 5 pcs. film-coated tablets

Tablets - 1 tablet: ofloxacin 400 mg.

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

Directions for use and doses

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

Pharmacokinetics

After oral administration, it is quickly and completely absorbed from the gastrointestinal tract. Food intake has little effect on the extent of absorption, but may slow its rate. Cmax in blood plasma is reached after 2 hours.

Protein binding - 25%. Ofloxacin is widely distributed in tissues and body fluids (urinary system, genital organs, prostate gland, lungs, ENT organs, gall bladder, bones, skin).

It is excreted unchanged in the urine (about 80% in 24 hours). Concentrations of ofloxacin in urine significantly exceeded the MIC90 for most microorganisms after taking the last dose (300 mg 2 times a day for 14 days). A small part of the active substance (about 4%) is excreted in the feces. T1/2 is 6 hours. In elderly patients with CC on average 50 ml/min, T1/2 may increase to 13.3 hours.

Indications for use Zoflox 400 mg 5 pcs. film-coated tablets

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

Contraindications

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

Application of Zoflox 400 mg 5 pcs. film-coated tablets during pregnancy and breastfeeding

Contraindicated for use during pregnancy and lactation.

Experimental studies showed no negative effects on fertility in rats.

Use in children

Contraindicated in children and adolescents under 18 years of age.

special instructions

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

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

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

In ;experimental studies ;mutagenic potential was not revealed. Long-term studies to determine the carcinogenicity of ofloxacin have not been conducted.

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

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

Impact on the ability to drive vehicles and operate machinery

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

Side effects Zoflox 400 mg 5 pcs. film-coated tablets

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

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

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

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

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

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

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

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

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

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

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

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

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

Drug interactions

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

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

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

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

Precautionary measures

There are several warnings for taking the drug correctly.

1. The simultaneous use of an antacid and Zoflox leads to a decrease in the effectiveness of ofloxacin
2. Patients who suffer from cerebral atherosclerosis or have impaired renal function should take the medication with caution and under the supervision of a physician.
3. When using Zoflox, you need to provide the necessary hydration to the body
4. During treatment, it is necessary to constantly monitor blood glucose levels

Mofloks® 400 (Mofloks® 400)

In some cases, after the first use of the drug, hypersensitivity and allergic reactions may develop, which should be reported to your doctor immediately. Very rarely, even after the first use of the drug, anaphylactic reactions can progress to life-threatening anaphylactic shock. In these cases, treatment with moxifloxacin should be stopped and the necessary therapeutic measures (including anti-shock) should be started immediately.

QT interval prolongation may occur in some patients when using moxifloxacin. Because women have a longer QT interval than men, they may be more sensitive to drugs that prolong the QT interval. Elderly patients are also more susceptible to drugs that affect the QT interval. The degree of QT interval prolongation may increase with increasing drug concentrations, so the recommended dose should not be exceeded. However, in patients with pneumonia, no correlation was observed between moxifloxacin plasma concentrations and QT interval prolongation. Prolongation of the QT interval is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia. None of the 9,000 patients treated with moxifloxacin experienced cardiovascular complications or deaths associated with QT prolongation.

When using moxifloxacin, the risk of developing ventricular arrhythmias may increase in patients with conditions predisposing to arrhythmias. In this regard, moxifloxacin is contraindicated in:

- changes in electrophysiological parameters of the heart, expressed in prolongation of the QT interval: congenital or acquired documented prolongation of the QT interval, electrolyte disturbances, especially uncorrected hypokalemia, clinically significant bradycardia; clinically significant heart failure with reduced left ventricular ejection fraction; if there is a history of rhythm disturbances accompanied by clinical symptoms (since the risk of developing a prolongation of the QT interval cannot be excluded);

- use with other drugs that prolong the QT interval (see section “Interaction with other drugs”).

The drug should be used with caution in patients with potentially proarrhythmic conditions (especially women and elderly patients), such as acute myocardial ischemia and cardiac arrest; in patients with liver cirrhosis (since in this category of patients the risk of developing QT prolongation cannot be excluded).

Cases of fulminant hepatitis, potentially leading to liver failure (including fatal cases), have been reported with the use of moxifloxacin (see section "Side effects"). The patient should be informed that if symptoms of liver failure occur (anorexia, jaundice, dark urine, itching, abdominal pain), consult a doctor before continuing treatment with moxifloxacin.

Cases of bullous skin lesions such as Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with the use of moxifloxacin. The patient should be informed that if symptoms of skin or mucous membrane lesions occur, they should consult a doctor before continuing treatment with moxifloxacin.

The use of quinolone drugs is associated with a possible risk of developing seizures. Moxifloxacin should be used with caution in patients with central nervous system diseases and central nervous system disorders that predispose to seizures or lower the threshold for seizure activity.

The use of broad-spectrum antibacterial drugs, including moxifloxacin, is associated with a risk of developing pseudomembranous colitis. This diagnosis should be considered in patients who experience severe diarrhea during treatment with moxifloxacin. In this case, appropriate therapy should be prescribed immediately. Drugs that inhibit intestinal motility are contraindicated in the development of severe diarrhea.

Moxifloxacin should be used with caution in patients with myasthenia gravis due to possible exacerbation of the disease.

During therapy with quinolones, including moxifloxacin, tendonitis and tendon rupture may develop, especially in the elderly and patients receiving glucocorticosteroids. Cases have been described that occurred within several months after completion of treatment. At the first symptoms of pain or inflammation at the site of injury, the use of the drug should be stopped and the affected limb should be unloaded.

If visual disturbances occur, consultation with an ophthalmologist is necessary.

When using quinolones, photosensitivity reactions are observed. However, during preclinical and clinical studies, as well as with the use of moxifloxacin in practice, no photosensitivity reactions were observed. However, patients using moxifloxacin should avoid exposure to direct sunlight and ultraviolet light.

The use of moxifloxacin is not recommended to treat infections caused by methicillin-resistant Staphylococcus aureus (MRSA). In cases of suspected or confirmed infections caused by MRS A, treatment with appropriate antibacterial drugs should be prescribed.

The use of the drug in the form of tablets for oral administration is not recommended in patients with complicated inflammatory diseases of the pelvic organs (for example, associated with tubo-ovarian or pelvic abscesses).

The ability of moxifloxacin to inhibit the growth of mycobacteria may cause in vitro interaction between moxifloxacin and the test for Mycobacterium spp., leading to false-negative results when analyzing samples from patients who are being treated with moxifloxacin during this period.

In patients treated with quinolones, including moxifloxacin, cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons and leading to paresthesia, hypoesthesia, dysesthesia and weakness have been described. Symptoms may appear shortly after starting use and may be irreversible. Patients being treated with moxifloxacin should be warned to seek immediate medical attention if symptoms of neuropathy occur, including pain, burning, tingling, numbness, and/or weakness or other sensory disturbances, including touch, pain, temperature, vibration, and sensation. position (see section "Side effects"). Moxifloxacin should be discontinued immediately.

Psychiatric reactions may occur even after the first use of fluoroquinolones, including moxifloxacin. In very rare cases, depression or psychotic reactions progress to the occurrence of suicidal thoughts and behavior with a tendency to self-harm, including suicide attempts (see section "Side effects"). In case of development of any side effects from the central nervous system, including mental disorders, you must immediately discontinue the drug Moflox® 400 and begin appropriate therapy. In these cases, it is recommended to switch to therapy with another antibiotic other than fluoroquinolones. if possible. Caution must be exercised when using Moflox® 400 in patients with a history of psychosis and/or psychiatric illness.

Due to the widespread and increasing incidence of infections caused by fluoroquinolone-resistant Neisseria gonorrhoeae, moxifloxacin monotherapy should not be used in the treatment of patients with pelvic inflammatory disease. Unless the presence of fluoroquinolone-resistant Neisseria gonorrhoeae is excluded. If the presence of fluoroquinolone-resistant Neisseria gonorrhoeae cannot be excluded, consideration should be given to supplementing empirical therapy with moxifloxacin, an appropriate antibacterial drug that is active against Neisseria gonorrhoeae.

As with other fluoroquinolones, changes in blood glucose concentrations, including cases of hypo- and hyperglycemia, were observed with the use of moxifloxacin. During therapy with moxifloxacin, dysglycemia occurred more often in elderly patients and patients with diabetes mellitus receiving concomitant therapy with oral hypoglycemic drugs (for example, sulfonylureas) or insulin. When using moxifloxacin in such patients, the risk of developing hypoglycemia, including hypoglycemic coma, increases. It is necessary to inform patients about the symptoms of hypoglycemia (confusion, dizziness, ravenous appetite, headache, nervousness, palpitations or increased heart rate, pale skin, perspiration, trembling, weakness). If the patient develops hypoglycemia, treatment with moxifloxacin should be immediately discontinued and concomitant therapy initiated. In these cases, it is recommended to switch to therapy with another antibiotic other than fluoroquinolones, if possible. When treating moxifloxacin in elderly patients and patients with diabetes mellitus, careful monitoring of blood glucose concentrations is recommended.

The use of moxifloxacin in the form of oral tablets is not recommended in patients with complicated pelvic inflammatory diseases (for example, associated with tubo-ovarian or pelvic abscesses).

Cross-drug interactions

The simultaneous use of Zoflox and other medications can cause unwanted processes in the body.

1. Precipitation - when mixed with heparin
2. Hypoglycemia and hyperglycemia – upon contact in the body with hypoglycemic agents
3. Crystalluria and nephrotic effects - combined use of carbonic anhydrase inhibitors, citrates and sodium bicarbonate
4. Tendon rupture - simultaneous treatment with corticosteroids
5. Neurotoxic effects, seizures – in combination with NSAIDs
6. Reduced theophylline clearance by up to 25% - when taken together, the dose of theophylline is reduced
7. Increased plasma concentrations of glibenclamide
8. Increasing the daily concentration of cyclosporine.

Side effect

Treatment with Zoflox may cause side effects affecting:

• Organs of the digestive system: the appearance of diarrhea, nausea, constipation, flatulence, heartburn, abdominal pain and cramps, intestinal perforation
• Liver: development of necrosis, jaundice, hepatitis, increased activity of liver enzymes
• Central and peripheral nervous system: symptoms of sleep disturbances, dizziness, increased drowsiness, nervousness, depression, impaired coordination and speech appear
• Cardiovascular system: possibility of cardiac arrest, the appearance of edema, pulmonary edema
• Reproductive system: development of vaginitis, vaginal candidiasis, dysmenorrhea, itching and rash on the genitals
• Urinary system: the appearance of dysuria, anuria, kidney stones, renal failure.

Conditions and shelf life

The drug must be stored in its original packaging in a cool place, out of direct sunlight. Children's access to medicine must be strictly controlled.

Shelf life – 3 years from the date of issue.
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