Ophor
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT OFOR® (OFOR®)
Composition:
Active substances: ofloxacinum, ornidazolum;
One tablet contains ofloxacin 200 mg and ornidazole 500 mg;
Excipients: maize starch, povidone (K-30), magnesium stearate, sodium croscarmellose, colloidal anhydrous silicon dioxide, Opadry white*, titanium dioxide (E 171), polyethylene glycols, talc, "sunset yellow" colour (E 110).
* Composition of Opadry white film coating: hypromellose, titanium dioxide (E 171), lactose monohydrate, polyethylene glycol, talc.
Pharmaceutical form. Film-coated tablets.
Main physicochemical properties: orange-colored, oblong-shaped, biconvex tablets with a score line on one side, coated with a film layer.
Pharmacotherapeutic group.
Combined antibacterial agents. ATC code J01RA09.
Pharmacological properties.
Pharmacodynamics.
The pharmacological effect of ofloxacin is antibacterial (bactericidal). It inhibits DNA gyrase (topoisomerase II and IV), disrupts the process of DNA supercoiling and repair of DNA breaks, suppresses cell division, causes structural changes in the cytoplasm, and leads to the death of microorganisms.
It has a broad spectrum of activity. It acts primarily against Gram-negative and some Gram-positive microorganisms: Citrobacter diversus, Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Neisseria gonorrhoeae, Chlamydia trachomatis, Staphylococcus aureus, Streptococcus pyogenes. It is effective against microorganisms resistant to most antibiotics and sulfonamides.
The pharmacological effect of ornidazole is antibacterial and antiprotozoal. It is active against Trichomonas vaginalis, Entamoeba histolytica, and Giardia lamblia (Giardia intestinalis), as well as certain anaerobic bacteria (Clostridium spp., Bacteroides spp., Fusobacterium) and anaerobic cocci. Ornidazole acts as a DNA-targeting agent with selective activity against microorganisms possessing enzymatic systems capable of reducing the nitro group and catalyzing the interaction of ferredoxin-group proteins with nitro compounds. After the drug penetrates into the microbial cell, its mechanism of action involves the reduction of the nitro group under the influence of microbial nitroreductases and the activity of the already reduced nitroimidazole. The reduction products form complexes with DNA, causing DNA degradation and disrupting DNA replication and transcription processes. Additionally, the metabolites of the drug exhibit cytotoxic properties and interfere with cellular respiration.
Pharmacokinetics.
Not studied.
Clinical characteristics.
Indications.
To be used for the treatment of mixed infections caused by pathogens (microorganisms and protozoa) sensitive to the components of the medicinal product:
- complicated urinary tract infections: cystitis, acute pyelonephritis, bacterial prostatitis, epididymitis;
- sexually transmitted infections.
Official recommendations regarding the appropriate use of antibacterial agents should be taken into account.
Contraindications.
Hypersensitivity to ofloxacin, ornidazole, other derivatives of fluoroquinolones, nitroimidazole derivatives, or to any other components of the medicinal product.
Central nervous system disorders with a lowered seizure threshold, including multiple sclerosis (following head trauma, stroke, inflammatory processes of the brain and meninges); epilepsy, including in medical history; glucose-6-phosphate dehydrogenase deficiency; history of tendinitis; blood disorders, dyscrasia, or other hematological abnormalities; QT interval prolongation; uncompensated hypoglycemia, childhood (under 18 years of age), pregnancy, breastfeeding.
The medicinal product is contraindicated in patients receiving class IA antiarrhythmic agents (quinidine, procainamide) or class III (amiodarone, sotalol), tricyclic antidepressants, macrolides; in patients with tendon rupture following previous fluoroquinolone use.
The use of the medicinal product should be avoided in patients with a history of serious adverse reactions to drugs containing quinolones or fluoroquinolones. Administration of the medicinal product to such patients should only be initiated if no alternative treatment options are available and after careful assessment of the benefit-risk ratio (see section "Special precautions for use").
Interaction with other medicinal products and other types of interactions.
Interactions related to ofloxacin
Antihypertensive medicinal products
Concomitant use of ofloxacin with antihypertensive agents or under barbiturate anesthesia may lead to sudden drop in blood pressure. In such cases, cardiovascular function should be monitored.
Medicinal products that prolong the QT interval
Concomitant use of ofloxacin with drugs that prolong the QT interval (class IA antiarrhythmics – quinidine, procainamide, and class III – amiodarone, sotalol, tricyclic antidepressants, macrolides) is contraindicated.
Ofloxacin, like other fluoroquinolones, should be used with caution in patients receiving antipsychotic agents.
Non-steroidal anti-inflammatory drugs (NSAIDs), nitroimidazole derivatives, and methylxanthines
Concomitant use of ofloxacin with NSAIDs (including phenylpropionic acid derivatives), nitroimidazole derivatives, and methylxanthines increases the risk of nephrotoxic effects and enhances the stimulatory effect on the central nervous system, leading to a reduced seizure threshold. If seizures occur, the medicinal product should be discontinued.
Medicinal products that reduce the seizure threshold
When quinolones are used concomitantly with other medicinal products that reduce the seizure threshold, such as theophylline, an additional decrease in the brain seizure threshold may occur.
Medicinal products excreted via tubular secretion
Concomitant administration of high doses of ofloxacin with medicinal products excreted via tubular secretion may lead to increased plasma concentrations due to reduced elimination.
Medicinal products metabolized via cytochrome P450
Since concomitant use of most quinolones, including ofloxacin, inhibits the enzymatic activity of cytochrome P450, concomitant administration of ofloxacin with drugs metabolized by this system (cyclosporine, theophylline, methylxanthine, caffeine, warfarin, etc.) prolongs the elimination half-life of these medicinal products.
Anticoagulants, including vitamin K antagonists
Prolonged bleeding time has been reported with concomitant use of ofloxacin and anticoagulants.
When ofloxacin is used concomitantly with vitamin K antagonists (e.g., warfarin), increased values in coagulation tests (prothrombin time (PT)/international normalized ratio (INR)) and/or bleeding, which may be severe, have been observed. Therefore, coagulation parameters should be monitored in patients receiving concomitant vitamin K antagonists due to a possible increase in the activity of coumarin derivatives.
Medicinal products that reduce ofloxacin absorption
Concomitant use of the medicinal product with antacids containing calcium, magnesium, or aluminum, sucralfate, divalent or trivalent iron, multivitamins containing zinc reduces the absorption of ofloxacin. Therefore, the interval between administration of these drugs should be at least 4 hours.
Hypoglycemic medicinal products
Hypoglycemia or hyperglycemia may occur with concomitant use of ofloxacin and oral hypoglycemic agents or insulin; therefore, monitoring of parameters is necessary for compensation. When used concomitantly with glyburide, increased serum levels of glyburide may occur; careful monitoring of patients receiving this combination is required.
Medicinal products that increase urine pH
When used with drugs that alkalinize urine (carbonic anhydrase inhibitors, citrates, sodium bicarbonate), the risk of crystalluria and nephrotic effects increases.
Probenecid, cimetidine, furosemide, and methotrexate
Concomitant use of ofloxacin with probenecid, cimetidine, furosemide, or methotrexate leads to increased plasma concentrations of ofloxacin and an increased risk of its toxic effects.
Theophylline
No pharmacokinetic interaction between ofloxacin and theophylline has been detected.
However, the steady-state serum concentration of theophylline, elimination half-life, and the risk of theophylline-related adverse reactions may increase during concomitant use. Serum theophylline levels should be carefully monitored and dosage adjusted if necessary. Adverse reactions (including seizures) may occur with or without increased serum theophylline levels.
During laboratory tests
Pseudo-positive results may occur during ofloxacin therapy when testing for opiates or porphyrins in urine. Therefore, more specific methods should be used.
Ofloxacin may inhibit the growth of Mycobacterium tuberculosis and produce false-negative results in bacteriological testing for tuberculosis diagnosis.
Interactions related to ornidazole
Anticoagulants
Ornidazole enhances the effect of oral anticoagulants of the coumarin group, increasing the risk of hemorrhage. When used concomitantly, prothrombin time or appropriate coagulation tests should be carefully monitored for appropriate dose adjustment of anticoagulants.
Vecuronium bromide
Ornidazole prolongs the muscle-relaxant effect of vecuronium bromide.
Hepatic enzyme inducers
Concomitant use of phenobarbital and other microsomal enzyme inducers reduces the serum half-life of ornidazole, whereas enzyme inhibitors (e.g., cimetidine) increase it.
Hepatic enzyme inhibitors
Concomitant use of enzyme inhibitors (e.g., cimetidine) with ornidazole increases its serum half-life.
Alcohol
Although ornidazole (unlike other nitroimidazole derivatives) does not inhibit aldehyde dehydrogenase, alcohol consumption should be avoided throughout the course of treatment with the medicinal product and for at least 3 days after its discontinuation.
Lithium
Concomitant use of ornidazole with medicinal products containing lithium salts should be accompanied by monitoring of lithium and electrolyte concentrations, as well as serum creatinine levels.
Special precautions for use.
Before starting treatment, the following tests should be performed: culture for microflora and determination of sensitivity to ofloxacin and ornidazole.
Avoid using the medicinal product in patients who have previously experienced serious adverse reactions to quinolones or fluoroquinolones. Treatment of such patients should be initiated only if there are no alternative treatment options and after careful assessment of the benefit-risk ratio.
When using high doses of the drug or treatment lasting more than 10 days, clinical and laboratory monitoring is recommended.
If adverse effects occur, especially those affecting the nervous system, allergic reactions, or severe arterial hypotension—which may appear immediately after the first dose—the medicinal product must be discontinued.
The effects of other medicinal products may be enhanced or diminished during concomitant use of this medicinal product.
Use the medicinal product with caution in patients with cerebral atherosclerosis.
Special precautions related to ofloxacin
Long-term, disabling, and potentially irreversible serious adverse reactions
Very rarely, patients receiving quinolones and fluoroquinolones, regardless of age or presence of risk factors, have experienced long-term (lasting several months or years), disabling, and potentially irreversible serious adverse reactions affecting various systems of the body, sometimes simultaneously (e.g., musculoskeletal, nervous, psychiatric, and sensory systems). The medicinal product should be discontinued immediately upon the first signs or symptoms of any serious adverse reaction, and medical advice should be sought.
Renal function impairment
When using Oflo® medicinal product, adequate hydration should be maintained (patients should drink sufficient amounts of water) to prevent crystalluria.
The medicinal product should be administered with caution in patients with impaired renal function (do not exceed the average daily dose), and laboratory parameters of renal function should be monitored. Dose adjustment of ofloxacin is required in patients with reduced renal function, as ofloxacin is primarily excreted by the kidneys.
Hepatic function impairment
The medicinal product should be administered with caution in patients with impaired liver function (due to the possibility of worsening liver function), and laboratory parameters of liver function should be monitored. Fulminant hepatitis, potentially leading to liver failure and fatal outcomes, may occur during fluoroquinolone therapy. Patients should discontinue treatment and seek immediate medical attention if signs of liver disease develop, such as anorexia, jaundice, dark-colored urine, pruritus, or abdominal tenderness upon palpation (see section "Adverse reactions").
Patients with severe liver disease (cirrhosis) should not exceed the average daily dose.
Clostridium difficile-associated disease
Diarrhea, especially severe, persistent, and/or hemorrhagic, during or after ofloxacin therapy (including several days after treatment) may be a symptom of pseudomembranous colitis (Clostridium difficile-associated disease [CDAD]). The severity of CDAD may range from mild to life-threatening; the most severe form is pseudomembranous colitis (see section "Adverse reactions"). Therefore, this diagnosis should be considered in patients who develop severe diarrhea during or after treatment. If pseudomembranous colitis is suspected, the medicinal product should be discontinued immediately, and appropriate symptomatic antibiotic therapy should be initiated without delay (e.g., oral vancomycin, oral teicoplanin, or metronidazole). Medicinal products that inhibit intestinal peristalsis are contraindicated in such cases.
Hypersensitivity to fluoroquinolones
Hypersensitivity and allergic reactions to fluoroquinolones have been reported after the first dose. Anaphylactic and anaphylactoid reactions may progress to life-threatening shock, even after the first dose. In such cases, the medicinal product should be discontinued and appropriate treatment initiated (e.g., shock management).
Severe bullous reactions
Cases of severe bullous reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, have been reported during ofloxacin use (see section "Adverse reactions"). Patients should be advised to seek immediate medical attention if skin and/or mucosal reactions occur before continuing therapy.
Tendinitis and tendon rupture
Tendinitis and tendon rupture (including of the Achilles tendon), sometimes bilateral, may occur within 48 hours of starting quinolone or fluoroquinolone therapy or even several months after discontinuation. The risk of tendinitis and tendon rupture is increased in elderly patients, patients with impaired renal function, organ transplant recipients, and patients receiving concomitant corticosteroid therapy. Therefore, concomitant use of corticosteroids with this medicinal product should be avoided. In addition to age and corticosteroid use, other factors independently increasing the risk of tendon rupture include intense physical activity, renal insufficiency, and prior tendon disorders such as rheumatoid arthritis.
Treatment with the drug should be discontinued at the first signs of tendinitis (e.g., painful swelling, inflammation), and alternative treatment should be considered. Affected limbs should be properly managed (e.g., immobilization), and orthopedic consultation should be sought to determine whether to continue treatment. Corticosteroids should not be used if signs of tendinopathy occur.
QT interval prolongation
Very rare cases of QT interval prolongation and isolated cases of arrhythmias have been reported with fluoroquinolone use. The medicinal product is contraindicated in patients with QT interval prolongation (see section "Contraindications"). Caution should be exercised when administering fluoroquinolones, including ofloxacin, to patients with known risk factors for QT interval prolongation, elderly patients, patients with uncorrected electrolyte imbalances (hypokalemia, hypomagnesemia), congenital or acquired long QT syndrome, or cardiac conditions (heart failure, myocardial infarction, bradycardia).
Patients receiving vitamin K antagonists
Due to the potential for increased coagulation test results (INR/PT) and/or bleeding in patients receiving fluoroquinolones in combination with vitamin K antagonists (e.g., warfarin), monitoring of coagulation parameters is required when these two groups of medicinal products are used concomitantly (see section "Interaction with other medicinal products and other forms of interaction").
Phototoxicity prevention
Patients using the medicinal product Oflo® should avoid exposure to sunlight and UV radiation due to the potential for phototoxicity. To prevent phototoxicity, patients are advised to avoid strong sunlight or artificial UV radiation (e.g., UV lamps, tanning beds) during treatment and for 48 hours after discontinuation. If photosensitivity reactions (e.g., sunburn-like) occur, treatment with the drug should be discontinued.
Superinfections
As with other antibiotics, prolonged use of ofloxacin may lead to overgrowth of resistant microorganisms; therefore, patients should be monitored regularly during treatment. If a secondary infection develops during therapy, appropriate measures should be taken.
Arterial hypotension
If severe arterial hypotension occurs, use of the medicinal product Oflo® should be discontinued.
Patients with history of psychotic or psychiatric disorders
Psychotic reactions have been reported in patients taking fluoroquinolones. In isolated cases, these progressed to suicidal ideation and self-destructive behavior, including suicide attempts, sometimes after only a single dose. If such reactions occur, the medicinal product should be discontinued and appropriate therapeutic measures initiated. The medicinal product should be used with caution in patients with a history of psychotic disorders or psychiatric conditions.
Peripheral neuropathy
The medicinal product should be used with caution in patients with central nervous system disorders that lower the seizure threshold (e.g., epilepsy).
If seizures occur, the drug should be discontinued.
During treatment, worsening of central or peripheral nervous system disorders may occur. Cases of sensory or sensorimotor polyneuropathy, leading to paresthesia, hypaesthesia, dysesthesia, or weakness, have been reported in patients receiving quinolones and fluoroquinolones. Patients should be advised to inform their physician immediately if symptoms of neuropathy occur (e.g., pain, burning, tingling, numbness, or weakness) to prevent potentially irreversible damage. If peripheral neuropathy occurs, treatment should be discontinued.
Patients with seizure predisposition
Quinolones may lower the seizure threshold and provoke seizures. The medicinal product is contraindicated in patients with epilepsy (including history) or lowered seizure threshold.
Concomitant use of ofloxacin with NSAIDs (including phenylpropionic acid derivatives), nitroimidazole derivatives, and methylxanthines enhances the stimulatory effect on the central nervous system, leading to a lowered seizure threshold (see section "Interaction with other medicinal products and other forms of interaction").
If seizures occur, the medicinal product should be discontinued.
Diabetes mellitus
Ofloxacin may potentiate the hypoglycemic effect of insulin and oral hypoglycemic agents (including glibenclamide); changes in blood glucose levels (including both hyperglycemia and hypoglycemia) have been reported. Cases of hypoglycemic coma have been documented. Blood glucose levels should be monitored in these patients.
Development of secondary infection
Prolonged or repeated antibiotic therapy may lead to opportunistic infections and overgrowth of resistant microorganisms. If a secondary infection develops, appropriate measures should be taken. Exacerbation of candidiasis may occur, requiring appropriate treatment.
Resistance of some Pseudomonas aeruginosa strains
During treatment with this drug, as with other fluoroquinolone agents, resistance in some strains of Pseudomonas aeruginosa may develop rapidly.
Methicillin-resistant Staphylococcus aureus (MRSA)
Methicillin-resistant Staphylococcus aureus (MRSA) is highly likely to be resistant to fluoroquinolones, including ofloxacin. Therefore, the medicinal product is not recommended for treatment of infections caused by or suspected to be caused by MRSA, except when laboratory tests confirm susceptibility to ofloxacin (and use of antibacterial agents typically recommended for MRSA infections is considered inappropriate).
Infections caused by Escherichia coli (E. coli)
Resistance to fluoroquinolones in E. coli (the most common cause of urinary tract infections) varies across European Union countries. Local prevalence of E. coli resistance to fluoroquinolones should be considered when prescribing fluoroquinolones.
Pneumococcal or mycoplasma pneumonia, tonsillar angina caused by β-hemolytic streptococci
The medicinal product Oflo® is not the drug of choice for treating patients with these conditions.
Infections caused by Neisseria gonorrhoeae
Due to increasing resistance of Neisseria gonorrhoeae, the medicinal product should not be used as empirical antibacterial therapy for suspected gonococcal infection (gonococcal urethritis, pelvic inflammatory disease, epididymo-orchitis), except when the pathogen has been identified and its sensitivity to ofloxacin confirmed. If no clinical improvement is observed after 3 days of treatment, therapy should be reevaluated.
Medicinal products containing magnesium, aluminum, iron, zinc, and sucralfate
The medicinal product Oflo® should not be taken within 4 hours after administration of products containing magnesium, aluminum, iron, zinc, or sucralfate.
Myasthenia gravis
Fluoroquinolones, including ofloxacin, block neuromuscular transmission and may provoke muscle weakness in patients with myasthenia gravis. Serious adverse reactions reported in the post-marketing period, including fatal cases and the need for respiratory support, have been associated with fluoroquinolone use in patients with myasthenia gravis. The medicinal product Oflo® should be used with caution in patients with a history of myasthenia gravis.
Glucose-6-phosphate dehydrogenase deficiency
Patients with latent or confirmed glucose-6-phosphate dehydrogenase deficiency may be susceptible to hemolytic reactions during quinolone therapy. The medicinal product Oflo® should be administered with caution in such patients.
Aneurysm/aortic dissection, valvular regurgitation/insufficiency
Epidemiological studies have shown an increased risk of aortic aneurysm and dissection, particularly in elderly patients, and aortic and mitral valve regurgitation following fluoroquinolone use.
Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal cases), and valvular regurgitation/insufficiency of any heart valve have been reported in patients receiving fluoroquinolones (see section "Adverse reactions").
Therefore, fluoroquinolones should be used only after careful benefit-risk assessment and consideration of alternative treatment options in patients with a positive family history of aneurysm or congenital heart valve defects, or in patients with an existing diagnosis of aneurysm and/or aortic dissection, or heart valve disease, or in the presence of other risk factors, namely:
- Risk factors for both aneurysm/aortic dissection and valvular regurgitation/insufficiency (e.g., connective tissue disorders such as Marfan syndrome or vascular Ehlers-Danlos syndrome, Turner syndrome, Behçet’s disease, hypertension, rheumatoid arthritis);
- Risk factors for aneurysm/aortic dissection (e.g., vascular diseases such as Takayasu arteritis or giant cell arteritis, atherosclerosis, or Sjögren’s syndrome);
- Risk factor for valvular regurgitation/insufficiency (e.g., infective endocarditis).
The risk of aortic aneurysm, dissection, and rupture is increased in patients receiving concomitant corticosteroids.
In case of sudden abdominal, chest, or back pain, patients should seek immediate emergency medical help.
Patients should be advised to seek immediate medical help in case of acute dyspnea, new-onset palpitations, abdominal swelling, or lower limb edema.
Visual disturbances
If any visual disturbances occur, patients should immediately consult an ophthalmologist.
During laboratory tests
Pseudopositive results in urine tests for opioids or porphyrins may occur during treatment. Therefore, more specific methods should be used.
Other special precautions
Except for very rare cases (e.g., isolated disturbances of smell, taste, or hearing), all adverse effects of the medicinal product resolve immediately after discontinuation.
Special precautions related to ornidazole
Blood disorders
In patients with a history of blood disorders, leukocyte monitoring is recommended, especially during repeated treatment courses.
Central and peripheral nervous system disorders
During ornidazole therapy, disorders of the central or peripheral nervous system may worsen. The medicinal product is contraindicated in patients with central nervous system disorders, including multiple sclerosis.
If peripheral neuropathy, motor coordination disturbances (ataxia), dizziness, or confusion occur, treatment should be discontinued.
Candidiasis
Exacerbation of candidiasis may occur, requiring appropriate treatment.
Hemodialysis
In patients undergoing hemodialysis, the shortened half-life of ornidazole should be considered, and additional doses of the medicinal product should be administered before or after hemodialysis.
Lithium therapy
Serum concentrations of lithium salts, creatinine, and electrolytes should be monitored during concomitant lithium therapy.
The effects of other medicinal products may be enhanced or diminished during treatment with Oflo®.
Patients with hepatic impairment
Use with caution in patients with impaired liver function.
Alcohol consumption
Alcoholic beverages should not be consumed during treatment with Oflo®.
Excipients
The medicinal product contains the azo dye "sunset yellow" (E 110), which may cause allergic reactions.
Use during pregnancy or breastfeeding
The medicinal product is contraindicated during pregnancy or breastfeeding.
If use of the medicinal product is necessary, breastfeeding should be discontinued during the treatment period.
Ability to affect reaction speed when driving or operating machinery
Adverse effects on the nervous system may occur during use of the medicinal product. Patients who drive or operate machinery should take this into account.
Method of Administration and Dosage
Ofor® should be taken orally, without chewing, with water. The medication may be taken either before or after meals.
The dosage and duration of treatment depend on the susceptibility of microorganisms, the severity and type of infectious process. The recommended dose for adults is 1 tablet twice daily for 5 days, followed by continuation of therapy for another 2–5 days with ofloxacin tablets. Treatment should continue for at least 3 days after the disappearance of clinical symptoms of the disease.
Children
The medication is contraindicated in children (under 18 years of age) because skeletal growth has not yet been completed in this age group.
Overdose
Symptoms
Related to ofloxacin
The most significant expected signs of acute ofloxacin overdose include symptoms related to the central nervous system, particularly confusion, dizziness, impaired consciousness, seizures, QT interval prolongation, as well as gastrointestinal reactions such as nausea and erosive mucosal damage.
During post-marketing surveillance, the following adverse reactions related to the central nervous system have been observed: confusion, convulsions, hallucinations, and tremor.
Related to ornidazole
Overdose may result in loss of consciousness, headache, dizziness, tremor, seizures, peripheral neuritis, dyspeptic disorders, and exacerbation of symptoms of other adverse reactions.
Treatment. In case of overdose, appropriate measures should be taken, such as gastric lavage and administration of adsorbents and sodium sulfate, if possible within the first 30 minutes after overdose. To protect the gastric mucosa, antacids are recommended. Fractions of ofloxacin may be removed from the body by hemodialysis.
Peritoneal dialysis and continuous ambulatory peritoneal dialysis are not effective for eliminating ofloxacin from the body. There is no specific antidote for this medication. Ofloxacin elimination can be enhanced by forced diuresis.
In cases of overdose, symptomatic treatment is required. ECG monitoring should be performed due to the potential for QT interval prolongation. In the event of seizures, diazepam is indicated.
Adverse reactions.
Skin disorders: pruritus, skin rashes including urticaria, blistering, hyperhidrosis, pustular rashes; erythema multiforme, vasculitic purpura, acute generalized exanthematous pustulosis, photosensitivity reactions, photo-sensitization, photosensitivity (in the form of sunburn), skin discoloration, nail splitting, skin hyperemia, exfoliative dermatitis.
Immune system disorders: hypersensitivity reactions, including manifestations of skin allergic reactions; anaphylactic/anaphylactoid reactions, angioneurotic edema (including tongue, larynx, pharynx swelling, facial swelling/edema), anaphylactic/anaphylactoid shock, tachycardia, fever, dyspnea; Stevens-Johnson syndrome; Lyell's syndrome; drug-induced dermatitis; vasculitis (which in rare cases may lead to skin necrosis), eosinophilia, pneumonitis. In such cases, the drug should be discontinued and alternative therapy initiated.
Cardiovascular system disorders*:* flushing, tachycardia, transient arterial hypotension, collapse (if severe arterial hypotension develops, treatment with the drug should be discontinued), collapse; QT interval prolongation on ECG, torsades de pointes arrhythmia, ventricular arrhythmia, ventricular flutter/fibrillation (predominantly in patients with risk factors for QT interval prolongation), cerebral vessel thrombosis, pulmonary edema, cardiovascular disorders.
Central nervous system disorders*: headache, dizziness (vertigo), depression, sleep disturbances (insomnia or somnolence), restlessness, psychomotor agitation, seizures, confusion, transient loss of consciousness, nightmares, slowed reaction time, increased intracranial pressure, paresthesia; sensory or sensorimotor neuropathy, tremor and other extrapyramidal disorders, impaired muscle coordination (disturbance of balance sensation, unsteady gait), ataxia, psychotic reactions, suicidal thoughts/actions, hallucinations, salivation, anxiety, rigidity, peripheral sensory disturbances, peripheral neuropathy, taste disturbances; photophobia, exacerbation of myasthenia gravis, olfactory disturbances, parosmia, dysphasia, dyskinesia, syncope, fatigue, spatial disorientation.
Gastrointestinal disorders: anorexia (loss of appetite), nausea, vomiting, heartburn, gastralgia (abdominal pain), abdominal pain or cramps, epigastric pain, diarrhea, frequent loose stools, enterocolitis, sometimes hemorrhagic enterocolitis, flatulence; dysbiosis, altered taste sensations (dysgeusia), taste disturbances, agueusia, including metallic taste in the mouth, gastrointestinal distress, constipation, dry mouth, oral mucosal tenderness, increased salivation, coated tongue; stomatitis, dyspepsia, pancreatitis. A specific form of enterocolitis that may occur during antibiotic use — pseudomembranous colitis (in most cases caused by Clostridium difficile). In suspected Clostridium difficile infection, the drug should be discontinued immediately and appropriate treatment initiated. Antiperistaltic agents should not be used in such cases.
Hepatic disorders: manifestations of hepatotoxicity, including changes in liver function tests, elevated liver enzyme activity [alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT)], increased blood bilirubin levels, jaundice, including cholestatic jaundice, elevated triglyceride and cholesterol levels, and in isolated cases — hepatitis, even of severe degree, severe liver injury, including cases of acute liver failure, sometimes fatal, primarily in patients with impaired liver function.
Urinary system disorders: renal function impairment, including urinary retention, acute interstitial nephritis, darkening of urine color, renal failure, acute renal failure, anuria, polyuria, kidney stones, hematuria.
Reproductive system disorders: genital pruritus in women, vaginitis, vaginal candidiasis.
Musculoskeletal system disorders*: tendinitis (especially in elderly patients); muscle cramps, myalgia, muscle strains, arthritis, arthralgia; muscle rupture, ligament rupture, tendon rupture (including Achilles tendon), which may be bilateral and occur within 48 hours of starting treatment; rhabdomyolysis and/or myopathy, muscle weakness. If signs of tendon inflammation occur, treatment with the drug should be discontinued immediately and appropriate treatment for the affected tendon initiated.
Blood and lymphatic system disorders: neutropenia, leukopenia, anemia, hemolytic anemia, eosinophilia, thrombocytopenia, pancytopenia; agranulocytosis, bone marrow suppression, blood dyscrasia of medullary aplasia type, petechiae, ecchymoses/bruising, prolonged prothrombin time, thrombocytopenic purpura, manifestations of bone marrow toxicity, bone marrow suppression.
Psychiatric disorders*: psychomotor agitation, psychotic disorders, delirium, anxiety, nervousness, depression with self-destructive behavior, including suicidal thoughts or suicide attempts, epileptic seizures, hallucinations.
Eye disorders*: visual disturbances (e.g., blurred vision, eye irritation), photophobia, color blindness, uveitis, transient vision loss.
Ear disorders*: vertigo, tinnitus, ear ringing, hearing loss, hearing disturbances.
Respiratory system disorders: cough, nasopharyngitis, pharyngitis, bronchospasm; allergic pneumonitis, severe wheezing, dyspnea (shortness of breath), including severe dyspnea, stridor, pulmonary edema.
Metabolic disorders: hypoglycemia (in diabetic patients taking antidiabetic drugs), hyperglycemia, hypoglycemic coma.
Infections: fungal infections, exacerbation of candidiasis, resistance of pathogenic microorganisms, proliferation of other resistant microorganisms.
Laboratory test abnormalities: elevated liver enzyme activity (ALT, AST, LDH, GGT, ALP, GGT), increased bilirubin, cholesterol, triglycerides, potassium levels, excessive increase or decrease in glucose levels; prolonged prothrombin time; elevated urea and creatinine levels.
Other: fatigue, chest pain, elevated body temperature (pyrexia), feeling of warmth, nasal pain, back pain, limb pain, weakness, fever, malaise, chills.
It cannot be ruled out that the medicinal product Ofor® may trigger an attack of porphyria in susceptible patients. Hiccups and oral mucosal tenderness are also possible.
* In very rare cases, patients receiving quinolones and fluoroquinolones, regardless of the presence of risk factors, have experienced prolonged (lasting several months or years), disabling, and potentially irreversible serious adverse reactions affecting various, and sometimes multiple simultaneously, organ systems and sensory organs (including reactions such as tendinitis, tendon rupture, arthralgia, limb pain, gait disturbances, neuropathies associated with paresthesia, depression, fatigue, memory impairment, sleep disturbances, hearing, vision, taste, and smell disturbances).
** Cases of aneurysm and aortic dissection, sometimes complicated by rupture (including fatal cases), and regurgitation/insufficiency of any heart valve have been reported in patients receiving fluoroquinolones (see section "Special precautions").
Reporting adverse reactions after drug registration is highly important. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and their legal representatives should report all suspected adverse reactions and lack of drug efficacy via the automated pharmacovigilance information system at: https://aisf.dec.gov.ua
Shelf life. 3 years.
Storage conditions.
Store in the original packaging, protected from light, in a place inaccessible to children, at a temperature not exceeding 30 °C.
Packaging.
10 tablets per blister, 1 blister per cardboard pack.
Prescription category. Prescription only.
Manufacturer.
Evertogen Life Sciences Limited.
Manufacturer's address and location of business activity.
Plot No: S-8, S-9, S-13/P & S-14/P TSIIC, Pharma SEZ, Green Industrial Park, Polepally (V), Jadcherla (M), Mahabubnagar, Telangana, IN-509 301, India.