INDICATIONS:

Treatment of mixed infections caused by pathogens (microorganisms and protozoa) sensitive to the preparation components: – urogenital system diseases: acute and chronic pyelonephritis; prostatitis; cystitis; epididymitis; complicated or recurrent urinary tracts infections; – sexually transmitted diseases.

DOSAGE:

Oflavin-OZ should be used orally without chewing and with water following. It is allowed to use the preparation before and after meal. Oflavin-OZ dosage and duration of the treatment are depended on microorganism sensitivity, severity and type of infectious process. The dose for adults is 1 tablet two times per day during 5 days, then the treatment is prolonged for 2–5 days using ofloxacin tablets. The treatment should be prolonged not less than 3 days after disappearing of clinical symptoms.

ADVERSE REACTIONS:

Gastrointestinal tract: Nausea; vomiting, abdominal pain, metal taste, diarrhea (sometimes it may be a symptom of enterocolitis and in some cases it can be hemorrhagic one), appetite loss, dry mouth, anorexia, hypoglycemia in diabetes patients, who use hypoglycemic agents. Central nervous system: agitation; dizziness; headache; sleep disorders (insomnia or somnolence), anxiety, inquietude, mental confusion, tremor, convulsions, rigidity, temporal loss of consciousness, peripheral sensitivity disorders (paresthesia, incoordination, taste disorders, olfaction, visual impairment; hearing impairment (tinnitus or loss of hearing), photophobia, extrapyramidal disorders, intracranial pressure increase; in patients with decreased myoclonic threshold convulsive attacks are possible; nightmare, hallucinations, unsteady gait and tremor (caused by muscle disbalance), neuropathy; in isolated cases – psychotic reactions and depression, which are dangerous, especially suicidal idea or actions; it may be exacerbation of myasthenia gravis and dysphasia. Haemopoiesis: anaemia; hemolytic anemia, leucopenia, eosinophilia, thrombocytopenia, pancytopenia, agranulocytosis, granulocytopenia, depression of bone marrow formation, in isolated cases hemolytic anemia development is possible. Kidney: kidney dysfunction; in isolated cases – acute interstitial nephritis or increase of creatinine level in serum that can lead to severe kidney insufficiency, anuria, polyuria, kidney concrements, hematuria. Liver: increase of liver enzymes (ASAT, AvusuLAT, LDG, GTH, alkaline phosphatase and gamma-glutamyl transferase) and bilirubin activity, cholestatic jaundice, in isolated cases – hepatitits, even of high degree one. Specific form of enterocolitis that can be observed in antibiotics usage – pseudomembranous colitis (in most cases it is caused by Clostridiu difficile). In case of suspicion of Clostridium difficile the preparation treatment should be immediately stopped and an adequate treatment should be carried out. Medicines, which depress peristalsis, should not be used in such cases. Cardio-vascular system: arterial hypotension, tachycardia; rarely – collapse (caused by arterial pressure decreasing), cerebral thrombosis, lungs edema, torsades de pointes. Muscular-skeletal system: tendinitis (especially in elderly patients), arthralgia, myalgia, tendon and muscle pain (in isolated cases it may be as symptoms of rabdomyolysis). Skin: skin rash, itch, photosensitization, edema, Quincke’s edema, edema of tongue and/or larunx with possible asphyxia, rash after influence of long-term intensive solar radiation, multiform erythema, Steven-Johnson syndrome, Lyell’s syndrome and vasculitis (in isolated cases vasculitis can lead to skin lesions that is accompanied with necrolysis, and viscera may be included). Allergic reactions: anaphylaxis, for example, tachycardia, fever, short breath, shock, angioneurotic edema, vascular reactions, eosinophilia. In such cases it is necessary to withdraw the treatment immediately and to carry out a replacement therapy if there is a need. In isolated cases pneumonitis may occur. Reproductive system: vaginal candidiasis. Respiratory system: short breath, bronchospasm, allergic pneumonitis, stridor. Others: asthenia, fever, vaginitis, level increase of triglyceride, cholesterol, lethargy, excessive increase or decrease of sugar level in blood, tendon discomfort, including tendon inflammation and tear (for example, Achilles tendon), especially in patients, which are concurrently treated by corticosteroids. In presence of signs of tendon inflammation the preparation therapy should be immediately discontinued and appropriate treatment for affected tendon should be administered. It is not excluded a possibility of that Oflavin-OZ can cause porphyria attack in inclined patients. In addition, in isolated cases (for example, impairment of taste, hearing and olfaction) side effects disappeared after Oflavin-OZ therapy withdrawal. It is also possible a hiccup, tunica mucosa of mouth painfulness, heartburn, increase of triglyceride, cholesterol and calcium levels in serum, petechia, ecchymosis/fruise, prothrombin time lengthening, thrombotic and thrombocytopenic purpura.

Drug interactions:

The preparation should be used not earlier than 4 hours after use of medicines, which contain magnesium, aluminum, iron, zinc and sucralfate. In concurrent use of the preparation with probenecid, cimetidine, furosemide and methotrexate the excretion of Oflavin-OZ with urine is slowed, and a half life period and a risk of its toxic action are increased. NSAIDs can intensify the preparation stimulating effect on central nervous system. It intensifies coumarin anticoagulants action and prolonges myorelaxation, caused by vecuronium bromide. In concurrent use of warfarin it is necessary to control coagulation parameters. In concurrent use of peroral antidiabetic drugs glycemia parameters should be checked. Concomitant administration of phenobarbital and other enzyme inductors decreases a period of ornidazol circulation in serum, while enzyme inductors (for example, cimetidine) increase it. Theophylline concentration in blood and its half-life period can be increased in concurrent use of Oflavin-OZ.

Administration during pregnancy and lactation:

It is not administered.

Children:

It is not administered.

Overdose:

Symptoms: dizziness; mental confusion; somnolence, lethargy, disorientation; convulsions; gastro-intestinal tract reactions – nausea and vomiting, erosive lesions of stomach mucosa. Treatment: gastric lavage; enterosorbates, magnesium sulfate, antacids are used for protection of mucous coat of stomach. In case of convulsions it is recommended an intravenous introduction of diazepam. Hemodialysis and peritoneal dialysis accelerate the preparation excretion. The treatment is symptomatic. There is no special antidote.

Ability to influence on reaction rate while driving cars and operating other machines:

It is necessary to avoid driving a motor transport and operating other mechanisms during Oflavin-OZ treatment.

PRECAUTIONS:

The preparation should be used with caution in patients with CNS disorders that causes myoclonic threshold decreasing (epilepsy). During the preparation treatment it may be observed enhancement of central nervous or peripheral nervous system disorders. In case of peripheral neuropathy, incoordination (ataxia), dizziness or consciousness disturbance the treatment should be stopped. Patients should use enough water to avoid crystalluria. It is necessary to adjust the dose and excretion time of the preparation in patients with kidney insufficiency and elderly patients to compensate slow excretion. It is not recommended to use the preparation within 4 hours after use of medicines, which contain magnesium, aluminum, iron, zinc and sucralfate. If there is no need then patients who use Oflavin-OZ should not be under the influence of the sunbeam; it is necessary to avoid ultraviolet irradiation (mercury quartz lamp, solarium) due to a high risk of photosensitization occurrence. Except very rare single cases (for example, impairment of taste, hearing and olfaction) all side effects of Oflavin-OZ disappear after the preparation withdrawal. In case of side effects development, especially CNS side effects, allergic reactions, which may appear immediately after the first intake, the preparation should be withdrawn. Diarrhea occurrence may be a manifestation of pseudomembranous colitis. In suspicion of this complication development the preparation treatment should be immediately withdrawn and urgent antibacterial therapy must be administered (orally – vancomicin or metronidazole). Medicines, which depress peristalsis, are contraindicated. Patients with kidney dysfunction and severe hepatic lesion (cirrhosis) should not exceed an average dosage (2 tablets). In case of tendinitis occurrence a consultation of orthopaedist is necessary for decision of a question about treatment continuation. Fluoroquinolones, including ofloxacin, increase a risk of tendonitis and tendon tear in any age. This side effect most of all concerns Achilles tendon, tendon of which may require a surgical intervention. A distant risk of tendonitis and tendon tear is increased in patients over 60 years old, in patients who use corticosteroids and in patients after transplantation of kidney, heart and lungs. Apart from age and corticosteroids use, there are factors, which independently increase a risk of tendon tears – intense physical activity, kidney insufficiency and previous tendon disorders, such as rheumatoid arthritis. Some quinolones, including ofloxacin, can prolong QT interval on electrocardiogram and cause single cases of arrhythmia. It is necessary to avoid Oflavin-OZ administration with known QT interval. It is recommended to carry out clinical and laboratory monitoring in usage of high doses of the preparation and in case of the treatment more than 10 days. Leucocyte control is necessary for patients with blood disorders in anamnesis, especially in repeated courses of the treatment. It may be observed candidiasis exacerbation that will require an appropriate treatment. In case of hemodialysis it is necessary to take into account elimination of half-life period and to administer additional doses of the preparation before and after hemodialysis. It is necessary to control concentrations of lithium salts, creatinine and electrolytes during lithium therapy. Effects of other drugs can be enhanced or weakened during preparation treatment. Long-term use of Oflavin-OZ preparation can cause a secondary infection related to the growth of microorganisms resistant to the preparation. Appropriate measures should be applied in case of secondary infection occurrence during the therapy. It is incompatible with alcohol.

CONTRAINDICATIONS:

– hypersensitivity to the preparation components; – hypersensitivity to fluoroquinolones derivatives; – epilepsy; disseminated sclerosis; – central nervous system lesions with decreased myoclonic threshold (after craniocerebral trauma, insult, inflammation process in cerebrum and meninges), – patients with tendon tear after usage of fluoroquinolones in anamnesis; – children age under 18 years old; – pregnancy; – lactation.

PHARMACOLOGICAL PROPERTIES: Pharmacodynamics: In most of mixed infections, when it is present more than one kind of causative agent, it is necessary to carry out a combined therapy for full-fledged treatment. Combination of ofloxacin and ornidazole is the most effective in these cases. Ofloxacin belongs to fluoroquinolones group. It has a wide spectrum of action. Bactericidal action of ofloxacin, as of other fluoroquinolones, is caused by its possibility to block bacterial DNA-hydrase enzyme. Ofloxacin has a wide antibiotic spectrum against microorganisms resistant to penicillins, aminoglycosides, cephalosporins and bacteria with multiresistance. Spectrum of action of Ofloxacin includes such kinds of microorganisms:  aerobic gramnegative bacteria: E. coli, Klebsiella spp., Salmonella spp., Proteus spp., Shigella spp., Yersinia spp., Enterobacter spp., Morganella morganii, Providencia spp., Vibrio spp., Citrobacter spp., Campylobacter spp., Ps. cepacia, Neisseria gonorrhoeae, N. meningitides, Haemophilus influenzae, Acinetobacter spp., Moraxella catarrhalis;  aerobic grampositive bacteria: staphylococcus, including strains producing and non-producing penicillinase, Streptococcus spp. (especially beta-haemolytic ones);  Enterococcus faecalis, Streptococcus pneumoniae, Pseudomonas spp., Legionella spp., Serratia spp., Bacteriodes spp., Fusobacterium spp., Gardnerella vaqinalis, Ureaplasma urealiticum, Bruccella spp., M. tuberculosis, which are moderately sensitive to ofloxacin; Anaerobic bacteria (except В.urealiticus), Тrероnеmа раllidum, viruses, fungi and protozoa are non-sensitive to ofloxacin. Оrnidazole is an antiprotozoal and antibacterial agent, it is a derivative of 5-nitroimidazole. It is active against Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis) and against some anaerobic bacteria such as Bacteroides and Clostridium spp., and anaerobic coccus. By mechanism of action ornidazole is a DNA-tropic preparation with selective action against microorganisms, which have enzyme systems able to renew nitro group and to catalyze an interaction of proteins of ferredoxin group and nitro compounds. After preparation penetration into microbial cell it mechanism of action is caused by renewal of nitro group by influence of microorganism nitroreductase and by activity of having renewed nitroimidazole. Products of renewal form complexes with DNA, causing its degradation, and disturb processes of replication and transcription of DNA. In addition, products of metabolism of the preparation have cytotoxic properties and disturb process of cell respiration. Pharmacokinetics: It was not studied.

PHARMACEUTICAL CHARACTERISTICS:

General physical-chemical properties: Orange coloured, elongated film coated tablets break line on one side & plain on other side.

Shelf-life:

3 years.

Storage conditions:

Store below 25°C in dry place. Protect from direct sunlight. Keep out of reach of children.

Package:

There are 10 tablets in a blister; 1 blister is in a carton box.

Conditions of supply:

By prescription.