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Additional ingredients: microcrystalline cellulose, sodium starchglycolate, Povidon К-30, magnesium stearate, color Opadry orange.
Pharmaceutical Form: Film coated tablets.
Pharmacotherapeutic group:
antibacterial agents for system usage. Code АТС: J01R A04
Pharmacological properties
Pharmacodynamic
It is a combined medicine; its action is caused by the components which are in composition. Ofloxacin is belonged to fluoroquinolones group. It has a wide antibiotic spectrum. Bactericidal action of ofloxacin, as all of other fluoroquinolones, is due to the possibility to block the bacterial enzyme DNA-hydrase
Ofloxacin has the wide antibiotic spectrum against bacteria, which are resistant to penicillins, aminoglycosides, cephalosporins and bacteria with polyresistance. Bacterial specter 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 cultures, which produce penicillinase and nonproducing ones, Streptococcus spp. (especially beta-haemolytic streptococcus).
·Enterococcus faecalis, Streptococcus pneumoniae, Pseudomonas spp., Legionella spp., Serratia spp., Bacteriodes spp., Fusobacterium spp., Gardnerella vaqinalis, Ureaplasma urealiticum, Bruccella spp., M.tuberculosis are moderate sensitive to ofloxacin.
· Anaerobic bacteria (except В.urealiticus, Тгероnеmа раllidum, viruses, fungi, protozoa are not sensitive to ofloxacin.
Оrnidazole is highly effective in treatment of protozoa and mixed diseases, namely caused by Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis), and by some of anaerobic bacteria, such as Bacteroides and Clostridium spp., Fusobacterium spp.,and anaerobic coccus.
Pharmacokinetics
After the internal usage ofloxacin is absorbed from the gastro-intestinal tract almost fully (bioavailability is almost 100%), maximum concentration is reached in plasma for 30 – 60 minutes, depending on the dosage. It is excreted mainly with the urine (90%) in unchanged form.
In ornidazole usage approximately 90% of it is absorbed quickly. Maximum concentration is reached in plasma for 3 hours. The binding with the plasma proteins is about 13 %, it penetrates into the liquor. It metabolizes in the liver, the period of half-life is 13 hours. The excretion way is the urine (63%) and the faeces (22%).
Indications:
The treatment of the mixed infections, which caused by pathogens (bacteria and protozoa), which are sensitive to the drug:
- Urogenital system diseases: acute and chronic pyelonephritis; prostatitis; cystitis; epididymite; surgical infections; complicated or recurrent urinary tracts infections; gynecological diseases;
- Illnesses transmitted by a sexual way, caused by penicillin resistant gonococcus, clamydia, trichomonads and others bacteria;
- Abdominal cavity and biliary tracts infections; amebiasis - amebic dysentery; abenteric forms of the amebiasis, especially amebic abscess of the liver; lambliasis and others infected diseases, such as typhoid, salmonellosis, shigellosis;
- Orodental infections, acute necrotic ulcerative gingivitis.
Prophylaxis of the infected diseases complications in immunodeficiency patients or in patients with the granulocytopenia; preoperative prophylaxis; afteroperative treatment of surgery infections, especially in gastroenterology.
Administration and Dosage:
Polymic™ should be used oral without the chewing and with the drinking after water. It is allowed to use the medicine before and after the meal.
Dosage of Polymic™ and duration of the treatment is depended on the sensitivity of bacteria, kind and severity of the infection. The average dose for adults is 1 – 2 tablets two times per day during 7 – 10 days. The treatment should be prolonged not less then 3 days after the disappearing of clinical symptoms.
Side effects:
Gastrointestinal tract: gastric pain; diarrhoea; nausea; vomiting; anorexia; enterocolitis, hypoglycaemia in pancreatic diabetic patients, which received hypoglycemic agents.
Nervous system: agitation; dizziness; headache; sleep disorders (insomnia or drowse); peripheral sensitivity disorders; coordination disorders.
Haemopoiesis: anaemia; leukopenia, eosinophilia, thrombocytopenia, pancytopenia.
Kidney: the increasing of creatinine in the plasma.
Liver: the increasing of the activity of the liver enzymes and bilirubin.
Cardio-vascular system: hypotension, tachycardia.
Muscular – skeletal system: tendonitis, especially in old patients, It could be also arthralgia, myalgia.
Allergic reactions: skin rush, itch, photosensitization, angioneurotic edema.
Contraindications:
• Hypersensitivity to the drug components;
• epilepsy;
•central nervous system lesions with the readiness for convulsions (after the craniocerebral trauma, insult, meningitis and inflammation process in cerebrum);
• age under the 16 years;
• pregnancy;
• lactation.
Overdosage:
The most important overdosage symptoms are dizziness; mental confusion; convulsions, nausea; vomiting; erosive lesions of stomach mucosa.
It is no special antidote. The treatment is symptomatic.
Special indications:
POLYMIC should be used internally, without chewing, taking a drink after the drug usage. It could be used before the meal or after the meal. It is not recommended to use the drug more then 2 months.
Because of the big risk of the photosensitization it is not recommended for patients, using POLYMIC to be under the direct sunlight, UV-light (mercury quartz lamp, solarium).
Inasmuch as the pneumonia in the ambulatory practice is caused by pneumococcus in most cases POLYMIC is not the drug of the drug of the first choice.
All of the side effects of POLYMIC are disappeared after the cessation of therapy, except of the very rare cases, for example the smell disorders, taste or ear disorders. In a case of the side effects after the first usage of the drug, especially from the direction of nervous system, or allergic reactions, it is necessary to stop the drug usage. The diarrhoea during the treatment by POLYMIC could be the symptom of the pseudomembranous colitis. In a case of suspicion of such complication it is necessary to stop the treatment by POLYMIC and administer the urgent treatment by antibiotics (Vancomycin or metronidazole – internally). The drugs, which decreased the intestinal peristalsis, are contraindicated! For patients with kidney disorders or with severe liver lesions (cirrhosis) it is not allowed to exceed the average daily dose (2 tablets). The patients, who drive the cars and operate any other machines and mechanisms, should take into consideration the possible side effects of the drug from the direction of nervous system (dizziness, drowse, mental confusion, vision and ear and coordination disorders). The prolonged usage of POLYMIC could cause the secondary infections appearance, associated with bacteria, which are resistant to the drug. In this case it is necessary to administer the according therapy. The drug is not compatible with the alcohol!
Drug interactions:
The effectiveness of POLYMIC is decreased in a case of the synchronous usage with antacids and drugs, which contain the iron, thus POLYMIC should be taken in two hours before or in two hours later on the usage of these drugs. In a case of the synchronous usage with NSAID the risk of stimulative influence on the CNS and convulsions appearance is increased. In synchronous usage of the drug with probenecid, cimetidine, furosemide and methotrexate the excretion of POLYMIC is slowed down and the period of half life and the risk of toxic effects are increased. POLYMIC intensifies the action of anticoagulants of coumarin line, prolonges the myorelaxation, caused by vecuronium bromide.
Storage and Shelf-life:
Keep out of reach of children, in protected from light place at the temperature not more than 25oC. Shelf-life – 2 years.
Conditions of supply: On prescription.
Package 10 tablets are in the blister; 1 blister is in carton box.
Manufacturer: Kusum Healthcare
Pvt. Ltd., India
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