Ofloxacin Welfarm, 200 mg 10 pcs

Pharmacotherapeutic group: antimicrobial agent – fluoroquinolone

ATX code: J01MA01

Pharmacological properties

Pharmacodynamics

Ofloxacin is a synthetic broad spectrum antibacterial drug from the group of fluoroquinolones with bactericidal action. The main mechanism of action of quinolones is specific inhibition of bacterial DNA-gyrase. DNA-gyrase is necessary for replication, transcription, repair and recombination of bacterial DNA. Its inhibition leads to unwinding and destabilization of bacterial DNA and, consequently, to the death of the microbial cell.

Highly active against most gram-negative and gram-positive microorganisms.

Fluoroquinolones have concentration-dependent bactericidal activity and moderate postantibacterial action. The ratio of AUC to minimum inhibitory concentration (MIC) or the ratio of maximum concentration to MIC is a predictive factor for successful clinical treatment.

Sensitive microorganisms

Non-sensitive microorganisms (possibly due to acquired resistance): Citrobacter freundii, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Neisseria gonorrhoeae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia spp, Staphylococcus spp. (coagulazonegative strains), Staphylococcus aureus (methicillin-sensitive strains), Staphylococcus epidermidis, Campylobacter jejuni, Enterococcus faecalis, Streptococcus pneumoniae. Resistant microorganisms

Acinetobacter baumannii, Bacteroides spp., Clostridium difficile, Enterococci (including Enterococcus faecium), Listeria monocytogenes, Staphylococcus aureus (methicillin-resistant strains), Nocardia spp.

Resistance

Resistance to ofloxacin develops as a result of a stepwise process of mutations in the genes encoding both type II topoisomerases: DNA-Gyrase and topoisomerase IV. Other mechanisms of resistance, such as a mechanism of influence on the permeability of the external structures of the microbial cell (a mechanism characteristic of Pseudomonas aeruginosa) and the mechanism of efflux (active excretion of the antimicrobial agent from the microbial cell), can also affect the sensitivity of microorganisms to ofloxacin.

MPC limit values

MPC limit values (mg/L) ofloxacin as approved by the European Committee on Antibiotic Susceptibility Testing (EUCAST).

Moraxella catarrhalis

species of microorganism

Pharmacokinetics

After oral administration, ofloxacin is rapidly and almost completely absorbed from the gastrointestinal tract. Bioavailability is almost 100%. Maximum blood plasma concentration ofloxacin after a single dose of 200 mg is 2.5-3 mcg/ml and is reached after 1 hour. Binding with plasma proteins is 25%. The volume of distribution is about 120 l. Less than 5% of Ofloxacin undergoes biotransformation.

It is mainly excreted by the kidneys (80-90% of the dose is unchanged). Two main metabolites are detected in the urine: N-desmethylofloxacin and ofloxacin N-oxide. About 4% ofloxacin is excreted with bile as glucuronides. The elimination half-life is 6-7 hours. Concentrations of ofloxacin in urine and in infected urinary tract are 5-100 times higher than those ofloxacin in blood serum.

Special patient groups Elderly patients

Elderly patients have an increased half-life, but the maximum concentration does not change.

Renal failure

In renal failure, the half-life is prolonged; total and renal clearance decrease in proportion to the decrease in creatinine clearance.

Indications

Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to ofloxacin:

– pyelonephritis;

– prostatitis, epididymitis, orchitis;

– infections of the pelvic organs;

– cystitis.

As an alternative to other antimicrobial drugs, ofloxacin can be used to treat the following infectious and inflammatory diseases:

– uncomplicated urinary tract infections;

– infections of the skin and soft tissues;

– infections of bones and joints;

– acute sinusitis;

– exacerbation of chronic bronchitis, community-acquired pneumonia;

– prevention of infections caused by microorganisms sensitive to ofloxacin in patients with a significant decrease in immune status (for example, with neutropenia).

When using the drug, official national recommendations should be taken into account

on the appropriate use of antibacterial drugs, as well as the sensitivity of pathogenic microorganisms in a particular country.

Pharmacological effect

Pharmacotherapeutic group: antimicrobial agent – fluoroquinolone

ATX code: J01MA01

Pharmacological properties

Pharmacodynamics

Ofloxacin is a synthetic broad-spectrum antibacterial drug from the group of fluoroquinolones that has a bactericidal effect. The main mechanism of action of quinolones is the specific inhibition of bacterial DNA gyrase. DNA gyrase is necessary for replication, transcription, repair and recombination of bacterial DNA. Its inhibition leads to unwinding and destabilization of bacterial DNA and, as a result, to the death of the microbial cell.

Highly active against most gram-negative and gram-positive microorganisms.

Fluoroquinolones have concentration-dependent bactericidal activity and moderate post-antibacterial activity. The ratio of AUC to minimum inhibitory concentration (MIC) or the ratio of maximum concentration to MIC is a predictive factor for successful clinical treatment.

Sensitive microorganisms

Variably sensitive microorganisms (possibly due to acquired resistance): Citrobacter freundii, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Neisseria gonorrhoeae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia spp., Staphylococcus spp. (coagulase-negative strains), Staphylococcus aureus (methicillin-sensitive strains), Staphylococcus epidermidis, Campylobacter jejuni, Enterococcus faecalis, Streptococcus pneumoniae. Resistant microorganisms

Acinetobacter baumannii, Bacteroides spp., Clostridium difficile, Enterococci (including Enterococcus faecium), Listeria monocytogenes, Staphylococcus aureus (methicillin-resistant strains), Nocardia spp.

Resistance

Resistance to ofloxacin develops as a result of a stepwise process of mutations in the genes encoding both type II topoisomerases: DNA gyrase and topoisomerase IV. Other mechanisms of resistance, such as the mechanism of influencing the permeability of the external structures of the microbial cell (a mechanism characteristic of Pseudomonas aeruginosa) and the mechanism of efflux (active removal of the antimicrobial agent from the microbial cell), may also affect the sensitivity of microorganisms to ofloxacin.

MPC boundary values

MIC breakpoint values ​​(mg/l) of ofloxacin approved by the European Committee on Antimicrobial Susceptibility Testing (EUCAST).

Microorganisms

Sensitive (mg/l)

Resistant (mg/l)

Enterobacteriaceae

≤0.5

>1

Staphylococcus spp.

≤1

>1

Streptococcus pneumoniae

≤0.12

>4

Haemophilus influenzae

≤0.5

>0.5

Moraxella catarrhalis

≤0.5

>0.5

Neisseria gonorrhoeae

≤0.12

>0.25

IPC boundary values ​​not related to a specific

type of microorganisms

≤0.5

>1

Pharmacokinetics

After oral administration, ofloxacin is rapidly and almost completely absorbed from the gastrointestinal tract. Bioavailability is almost 100%. The maximum concentration of ofloxacin in blood plasma after taking a single dose of 200 mg is 2.5-3 mcg/ml and is achieved after 1 hour. Plasma protein binding is 25%. Distribution volume – approximately 120 l. Less than 5% of ofloxacin undergoes biotransformation.

It is excreted mainly by the kidneys (80-90% of the dose – unchanged). Two main metabolites are found in urine: N-desmethylofloxacin and ofloxacin N-oxide. About 4% of ofloxacin is excreted in the bile in the form of glucuronides. The half-life is 6-7 hours. Concentrations of ofloxacin in urine and in infected urinary tracts exceed the concentrations of ofloxacin in serum by 5-100 times.

Special patient groups Elderly patients

In elderly patients, an increase in half-life is observed, but the maximum concentration does not change.

Kidney failure

In renal failure, the half-life increases; total and renal clearance decrease in proportion to the decrease in creatinine clearance.

Special instructions

Kidney failure

Due to the fact that ofloxacin is excreted mainly by the kidneys, dosage adjustment of ofloxacin is necessary in patients with renal failure (see sections “Precautions”, “Dosage and Administration”).

Prevention of photosensitivity

During treatment with ofloxacin, due to the risk of photosensitivity, exposure to bright sunlight and ultraviolet rays should be avoided.

Secondary infection

As with the use of other antimicrobial drugs, when taking ofloxacin, especially long-term, it is possible to develop a secondary infection associated with the growth of drug-resistant microorganisms, to exclude and confirm which the patient’s condition should be re-evaluated. If a secondary infection develops during therapy, the necessary measures should be taken to treat it.

Peripheral neuropathy

Sensory and sensorimotor neuropathy, which may have a rapid onset, has been reported in patients receiving fluoroquinolones, including ofloxacin. If patients develop symptoms of neuropathy, treatment with ofloxacin should be discontinued to help minimize the possible risk of developing irreversible conditions (see section “Caution”).

Patients with glucose-6-phosphate dehydrogenase deficiency

Patients diagnosed with glucose-6-phosphate dehydrogenase deficiency may be predisposed to hemolytic reactions when treated with quinolones. Therefore, caution should be exercised when using ofloxacin in such patients (see section “Caution”).

Pseudomembranous colitis caused by Clostridium difficile

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

Patients predisposed to developing seizures

Like other quinolones, ofloxacin should be used with caution in patients predisposed to the development of seizures (patients with a history of central nervous system lesions, in patients concomitantly receiving drugs that lower the threshold for seizure activity of the brain (theophylline, fenbufen [and other similar non-steroidal anti-inflammatory drugs]), (see section “With caution”). If seizures develop, treatment with ofloxacin should be discontinued.

Tendinitis

Tendinitis, which rarely occurs with quinolones, can sometimes lead to rupture of tendons, including the Achilles tendon, especially in elderly patients and in patients concomitantly taking corticosteroids. This undesirable effect may develop within 48 hours after the start of treatment and be bilateral. If signs of tendonitis (inflammation of the tendon) appear, it is recommended to immediately stop treatment with ofloxacin. Appropriate treatment (eg, immobilization) of the injured tendon may be required.

QT prolongation

Some caution is warranted when taking fluoroquinolones, including ofloxacin, in patients with known risk factors for QT prolongation, such as:

– old age;

– uncorrected electrolyte imbalance (eg, hypokalemia, hypomagnesemia);

– congenital prolongation of the QT interval;

– diseases of the cardiovascular system (heart failure, myocardial infarction, bradycardia);

– simultaneous use of drugs that prolong the QT interval (classes IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics).

Pseudoparalytic myasthenia gravis (myasthenia gravis)

Fluoroquinolones, including ofloxacin, have neuromuscular blocking activity and may increase muscle weakness in patients with myasthenia gravis. In the post-marketing period, serious adverse reactions, including pulmonary failure requiring mechanical ventilation and death, have been observed with the use of fluoroquinolones in patients with myasthenia gravis. The use of ofloxacin in a patient with an established diagnosis of pseudoparalytic myasthenia gravis is not recommended (see section “Side Effects”).

Severe skin reactions

Severe bullous reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported when taking ofloxacin. Patients should be informed that if skin reactions and/or mucosal lesions develop, they should immediately consult a physician before continuing treatment with ofloxacin.

Hypersensitivity reactions and allergic reactions

Hypersensitivity reactions and allergic reactions (anaphylactic shock and anaphylactoid reactions, which can progress to a life-threatening condition) have been reported with the use of fluoroquinolones. In these cases, ofloxacin should be discontinued and appropriate treatment should be initiated.

Psychotic reactions

Psychotic reactions, including suicidal thoughts/attempts, have been reported in patients taking fluoroquinolones, including ofloxacin. Ofloxacin should be used with caution in patients with psychotic disorders (including a history) (see section

“With caution”) Psychiatric adverse reactions may occur even after a single dose. If such reactions occur, treatment with ofloxacin should be discontinued immediately and appropriate treatment should be initiated immediately and switched to an antibiotic other than a fluoroquinolone if possible.

Liver dysfunction

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

Dysglycemia (hypo- and hyperglycemia)

When using fluoroquinolones, including ofloxacin, the development of both hyperglycemia and hypoglycemia, as well as severe hypoglycemia, including the development of hypoglycemic coma, has been reported, especially in elderly patients, patients with diabetes mellitus, taking oral hypoglycemic drugs or insulin (signs of hypoglycemia: confusion, dizziness, ravenous appetite, headache, nervousness, feeling palpitations or increased pulse rate, pale skin, perspiration, trembling, weakness). Plasma glucose concentrations should be carefully monitored in these patients. If adverse reactions occur, such as a decrease in glucose concentration, treatment with ofloxacin should be stopped immediately and appropriate treatment should be immediately initiated and therapy switched to an antibiotic other than a fluoroquinolone, if possible.

Patients taking vitamin K antagonists

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

Risk of developing resistance

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

Escherichia coli infections

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

Infections caused by Neisseria gonorrhoeae

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

Methicillin-resistant Staphylococcus aureus

There is a high likelihood that methicillin-resistant Staphylococcus aureus will be resistant to fluoroquinolones, including ofloxacin. Therefore, ofloxacin is not recommended for the treatment of known or suspected infections caused by methicillin-resistant Staphylococcus aureus unless laboratory tests have confirmed the organism’s sensitivity to ofloxacin.

Bone and joint infections

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

Effect on laboratory parameters and diagnostic tests

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

When determining opiates and porphyrins in urine during treatment with ofloxacin, a false positive result is possible. It may be necessary to confirm positive results using more specific methods.

Other

During the treatment period, it is not recommended to consume ethanol.

Impact on the ability to drive vehicles and machinery

Some adverse reactions, such as dizziness/vertigo, drowsiness and blurred vision, may reduce psychomotor response and ability to concentrate and therefore increase the risk in situations in which the presence of these abilities is especially important (for example, when driving a car or other machinery).

Active ingredient

Ofloxacin

Composition

For one tablet:

Pregnancy

Pregnancy

Ofloxacin should not be used during pregnancy (see section “Contraindications”).

Breastfeeding period

Since ofloxacin is excreted into breast milk,
then due to the risk to the child,
Women who are breastfeeding should not take ofloxacin, or
if its use is necessary, breastfeeding should be stopped
feeding.

Contraindications

– hypersensitivity to ofloxacin, other quinolones or excipients of the drug;

– epilepsy;

– pseudoparalytic myasthenia gravis (myasthenia gravis) (see sections “Side effects”, “Special instructions”);

– tendon damage due to a history of taking fluoroquinolones;

– childhood and adolescence under 18 years of age (the risk of damage to the cartilaginous growth zones of bones in a child cannot be completely excluded);

– pregnancy (the risk of damage to the cartilaginous growth zones of the fetus cannot be completely excluded);

– the period of breastfeeding (the risk of damage to the child’s cartilaginous growth plates cannot be completely eliminated).

With caution

– in patients predisposed to the development of seizures (in patients with previous lesions of the central nervous system (CNS), such as severe cerebral atherosclerosis, a history of cerebrovascular accidents, organic lesions of the central nervous system, a history of brain injury; in patients simultaneously receiving drugs that lower the threshold of convulsive activity of the brain, such as fenbufen or other non-steroidal anti-inflammatory drugs, theophylline);

– in patients with latent or manifest deficiency of glucose-6-phosphate dehydrogenase (increased risk of hemolytic reactions when treated with quinolones);

– in patients with impaired renal function (mandatory monitoring of renal function is required, as well as correction of the dosage regimen, see section “Dosage and Administration”);

– in patients with liver failure (monitoring liver function indicators);

– in patients with porphyria (risk of exacerbation of porphyria);

– in patients with risk factors for prolongation of the QT interval: in elderly patients; with uncorrected electrolyte disturbances (hypokalemia, hypomagnesemia); with congenital long QT syndrome; for heart diseases (heart failure, myocardial infarction, bradycardia); while taking medications that can prolong QT (class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics);

– in patients with diabetes mellitus receiving oral hypoglycemic agents (for example, glibenclamide) or insulin (the risk of hypoglycemia increases);

– in patients with severe adverse reactions to other quinolones, such as severe neurological reactions (increased risk of similar adverse reactions when using ofloxacin);

– in patients with a history of psychosis and other mental disorders.

Side Effects

The information presented below is based on data obtained from clinical studies and extensive post-marketing experience with ofloxacin. The side effects listed below are presented in accordance with the following gradations of frequency of their occurrence: very often (>1/10); often (>1/100, 1/1000, 1/10000, <1/1000); very rare (< 1/10000) (including isolated reports); frequency is unknown (it is not possible to determine the frequency of occurrence based on available data).

Cardiac disorders: rarely – tachycardia; infrequently – feeling of heartbeat; frequency unknown – prolongation of the QT interval, ventricular arrhythmia of the “pirouette” type (especially in patients with risk factors for prolongation of the QT interval).

Vascular disorders: rarely – increased blood pressure, decreased blood pressure.

Disorders of the blood and lymphatic system: very rarely – anemia, hemolytic anemia, leukopenia, eosinophilia, thrombocytopenia; frequency unknown – agranulocytosis, pancytopenia, suppression of bone marrow hematopoiesis.

Nervous system disorders: uncommon – dizziness, headache; rarely – drowsiness, paresthesia, dysgeusia (disorder of taste perception), parosmia (disorder of smell perception); very rarely – peripheral sensory neuropathy, peripheral sensory-motor neuropathy, seizures, extrapyramidal symptoms, including tremor, and other disorders of muscle coordination; frequency unknown – ageusia, increased intracranial pressure.

Mental disorders: infrequently – agitation, sleep disturbances, insomnia; rarely – psychotic disorders (for example, hallucinations), anxiety, nervousness, confusion, nightmares, depression; frequency unknown – psychotic disorders and depression with self-harm, in rare cases, even suicidal thoughts or attempts, impaired attention, disorientation, memory impairment, delirium.

Violations of the organ of vision: infrequently – irritation of the mucous membrane of the eye, conjunctivitis; rarely – visual impairment (diplopia, impaired color vision); frequency unknown – uveitis.

Hearing and labyrinthine disorders: uncommon – vertigo; very rarely – hearing impairment (tinnitus), hearing loss.

Disorders of the respiratory system, chest and mediastinal organs: uncommon – cough, nasopharyngitis; rarely – shortness of breath, bronchospasm; frequency unknown – allergic pneumonitis, severe shortness of breath.

Disorders of the digestive system: infrequently – abdominal pain, diarrhea, nausea, vomiting, loss of appetite; rarely – enterocolitis (sometimes hemorrhagic); very rarely – pseudomembranous colitis; frequency unknown – dyspepsia, constipation, flatulence, pancreatitis, stomatitis.

Disorders of the liver and biliary tract: rarely – increased activity of liver enzymes such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), gamma-glutamyltransferase (GGT) and/or alkaline phosphatase (ALP) and/or bilirubin concentration in the blood; very rarely – cholestatic jaundice; frequency unknown – hepatitis, which can be severe; When using ofloxacin (mainly in patients with impaired liver function), cases of severe liver failure, including acute liver failure, sometimes fatal, have been reported.

Renal and urinary tract disorders: rarely – increased serum creatinine concentration; very rarely – acute renal failure; frequency unknown – acute interstitial nephritis, increased urea concentration in the blood.

Disorders of the skin and subcutaneous tissues: infrequently – itching, rash; rarely – urticaria, hyperhidrosis, pustular rash, “flushes” of blood to the skin; very rarely – exudative erythema multiforme, toxic epidermal necrolysis, photosensitivity reactions, drug rash, vascular purpura, vasculitis, which in exceptional cases can lead to skin necrosis; frequency unknown – Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis.

Musculoskeletal and connective tissue disorders: rarely – tendonitis; very rarely – arthralgia, myalgia, tendon rupture (for example, Achilles tendon) (as with other fluoroquinolones, this side effect can develop within 48 hours after the start of treatment and can be bilateral); frequency unknown – rhabdomyolysis and/or myopathy, muscle weakness, which is especially important for patients with pseudoparalytic myasthenia, muscle tear, muscle rupture, ligament rupture, arthritis.

Metabolic and nutritional disorders: rarely – anorexia; frequency unknown – hyperglycemia, hypoglycemia, severe hypoglycemia, up to the development of hypoglycemic coma, especially in elderly patients, patients with diabetes mellitus, taking oral hypoglycemic drugs or insulin.

Infectious and parasitic diseases: infrequently – fungal infections, resistance of pathogenic microorganisms.

Immune system disorders: rarely – anaphylactic reactions, anaphylactoid reactions, angioedema; very rarely – anaphylactic shock, anaphylactoid shock.

Congenital, hereditary and genetic disorders: frequency unknown – exacerbation of porphyria in patients with porphyria.

General disorders and disorders at the injection site: frequency unknown – asthenia, increased body temperature, pain in the back, chest, limbs.

Interaction

With antacids containing aluminum hydroxide, sucralfate, magnesium hydroxide, aluminum phosphate, or preparations containing zinc, iron

Antacids containing aluminum hydroxide, sucralfate, magnesium hydroxide, aluminum phosphate, or preparations containing zinc or iron reduce the absorption of ofloxacin. When using the above drugs and ofloxacin, an approximately two-hour interval should be maintained between their doses.

With vitamin K antagonists

An increase in prothrombin time/international normalized ratio and/or the development of bleeding (including severe) was observed in patients with simultaneous use of ofloxacin and vitamin K antagonists (for example, warfarin). With the simultaneous use of vitamin K antagonists, control of the blood coagulation system is necessary.

With glibenclamide

Ofloxacin may slightly increase serum concentrations of glibenclamide when administered concomitantly. When using ofloxacin and glibenclamide simultaneously, it is recommended to carefully monitor the patient’s condition and blood glucose concentrations.

With other hypoglycemic agents for oral administration and insulin

Ofloxacin increases the risk of hypoglycemia; more careful monitoring of blood glucose concentrations is required.

With probenecid, cimetidine, furosemide or methotrexate

When quinolones are used together with drugs that are eliminated from the body by renal tubular secretion (such as probenecid, cimetidine, furosemide, methotrexate), a mutual slowdown in elimination and an increase in serum concentrations are possible (especially when high doses are used).

With drugs that may lower the seizure threshold of the brain, such as theophylline, fenbufen (and other similar non-steroidal anti-inflammatory drugs)

In clinical studies, no pharmacokinetic interactions of ofloxacin with theophylline were established. However, a significant decrease in the threshold of convulsive activity of the brain is possible with simultaneous use of quinolones with drugs that lower the threshold of convulsive activity of the brain (theophylline, fenbufen [and other similar non-steroidal anti-inflammatory drugs]).

With glucocorticosteroids

When used simultaneously with glucocorticosteroids, the risk of tendon rupture increases, especially in elderly patients.

With drugs that can prolong the QT interval

Ofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs that can prolong the QT interval (class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics).

With drugs that alkalinize urine (carbonic anhydrase inhibitors, citrates, sodium bicarbonate)

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

Overdose

Symptoms

The most important symptoms of overdose are central nervous system symptoms (such as dizziness, confusion, impaired consciousness, convulsions), prolongation of the QT interval, and gastrointestinal reactions (such as nausea and erosions of the gastrointestinal mucous membranes).

Treatment

In case of overdose, it is recommended to perform gastric lavage and
symptomatic therapy. For protection
antacids can be used in the gastric mucosa. ECG monitoring is necessary as it may
prolongation of the QT interval. Ofloxacin fractions can be
removed from the body by hemodialysis. There is no specific antidote.

Storage conditions

In a place protected from light at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life

3 years.

Do not use after expiration date.

Manufacturer

Velfarm LLC, Russia