Active substanceOrnidazole + OfloxacinOrnidazole + Ofloxacin
Similar drugsTo uncover
  • Combiflox
    pills inwards 
  • Dosage form: & nbsptablets, film-coated.
    Composition:

    Each tablet contains:

    Active substances: Ornidazole-500 mg, ofloxacin-200 mg

    Excipients: cellulose microcrystalline - 238.00 mg, sodium carboxymethyl starch -15.00 mg, croscarmellose sodium-10.00 mg, silicon dioxide colloid-10.00 mg, talc-9.00 mg, magnesium stearate-12.00 mg, hypromellose -3,500 mg, opadrai orange -27,000 (hypromellose 40%, lactose monohydrate 22% titanium dioxide 18.2% macrogol 8.0% triacetin 6.0% dye sunset yellow 5, 8%), dye quinoline yellow - 0.100 mg.

    Description:

    Orange capsule capsules coated with a film sheath, with a dividing risk on one side. On the fracture, the mass of the tablet is a yellowish cream color.

    Pharmacotherapeutic group:antimicrobials in combination.
    ATX: & nbsp

    J.01.R.A.09   Ofloxacin and ornidazole

    Pharmacodynamics:

    Combined drug, the effect of which is due to the components that make up its composition.

    Ornidazole is an antiprotozoal and antimicrobial agent derived from 5-nitroimidazole. The mechanism of action is the biochemical reduction of the 5-nitro group of ornidazole by intracellular transport proteins of anaerobic bacteria and protozoa.The recovered 5-nitro ornidazole interacts with DNA microbial cells by inhibiting synthesis of nucleic acids, which leads to the death of the bacteria.

    Active with respect to Trichomonas vaginalis, Giardia lamblia, Entamoeba histolytica, as well as anaerobes Bacteroides spp. (incl. Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Clostridium spp.

    Orniferous microorganisms are not sensitive to ornidazole.

    Ofloksatsin - a broad-spectrum antimicrobial agent from the group of fluoroquinolones, acts on the bacterial DNA-gyrase enzyme, which provides supercoiling, and so on. stability of bacterial DNA (destabilization of DNA chains leads to their death). Has a bactericidal effect.

    The antimicrobial spectrum includes Gram-positive aerobes: Staphylococcus aureus (methicillin-sensitive), Staphylococcus epidermidis (methicillin-sensitive), Staphylococcus saprophyticus, Streptococcus pneumoniae (penicillin-sensitive), Streptococcus pyogenes.

    Gram-negative aerobes: Acinetobacter calcoaceticus, Bordetella pertussis, Citrobacter freundii, Citrobacter koseri, Enterobacter aerobes, Enterobacter cloacae, Escherichia coli, Haemophilus ducreyi, Haemophilus influenzae, Klebsiella oxytoca, Moraxella catarrhalis, Morganella morganii, Klebsiella pneumoniae, Neisseria gonorrhoeae, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri , Providencia stuartii, Pseudomonas aeruginosa (quickly develop resistance), Serratia marcescens.

    Anaerobes: Clostridium perfringens.

    Other: Chlamydia trachomatis, Chlamydia pneumoniae, Gardnerella vaginalis, Legionella pneumophila, Mycoplasma hominis, Mycoplasma pneumoniae, Ureaplasma urealyticum.

    In most cases, they are insensitive: Nocardia asteroides, anaerobic bacteria (incl. Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile), Enterococcus spp., most Streptococcus spp., does not apply to Treponema pallidum.

    Pharmacokinetics:

    Suction:

    how ofloxacin, and ornidazole well absorbed in the gastrointestinal tract after oral administration. Bioavailability - 90% (ornidazole) - 95% (ofloxacin). Connection with plasma proteins - 13% (ornidazole) - 25% (ofloxacin). Time-reaching maximum concentration for ofloxacin (TSmah) -1-2 hours, for ornidazole - 3 hours.

    Distribution:

    Ofloxacin: apparent volume of distribution is 100 liters. Distribution: cells

    (leukocytes, alveolar macrophages), skin, soft tissues, bones, abdominal and pelvic organs, respiratory system, urine, saliva, bile, the secret of the prostate gland; well penetrates the blood-brain barrier (GEB), the placental barrier, is secreted with the mother's milk. It penetrates into the cerebrospinal fluid (CSF) -14-60%.

    Ornidazole: penetrates most tissues, passes through the GEB and the placenta, penetrates into breast milk.

    Metabolism and excretion:

    Ofloxacin: metabolized in the liver (about 5%) with formation N-oxidofloxacin and dimethylofloxacin. The half-life (T1 / 2) is 4.5-7 hours (regardless of the dose). It is excreted by the kidneys - 75-90% (unchanged), about 4% - with bile.The extrarenal clearance is less than 20%. After a single application in a dose of 200 mg in urine is detected within 20-24 hours. In renal / hepatic insufficiency, excretion can be slowed down. Do not cumulate. With hemodialysis, 10-30% of the drug is removed.

    Ornidazole: metabolized in the liver by hydroxylation, oxidation and

    glucuronation. T1 / 2 -. 12-14 hours is derived as metabolites (60-70%) and unchanged (4%) kidneys and intestine (20-25%), cumulates.


    Indications:

    Mixed bacterial infections caused by sensitive Gram-positive and Gram-negative microorganisms, in association with anaerobic microorganisms and / or protozoa:

    Infectious - inflammatory diseases of the abdominal cavity and biliary tract, kidney (pyelonephritis), lower urinary tracts (cystitis, urethritis), genitals and pelvic organs (endometritis, salpingitis, oophoritis, cervicitis, parametritis, prostatitis, colpitis, orchitis, epididymitis) .

    Contraindications:

    Hypersensitivity to ofloxacin, ornidazole, and other fluoroquinolone derivatives of imidazole, the drug component, epilepsy (including history), decrease the seizure threshold (includingafter traumatic brain injury, stroke, or inflammatory processes in the central nervous system (CNS) lesion tendons at the previously held treatment fluoroquinolones; age to 18 years, pregnancy, lactation.

    Carefully:

    Cerebral atherosclerosis, cerebrovascular disease (disorder), chronic renal failure (CRF), liver disease, liver failure, organic CNS diseases (including multiple sclerosis), a predisposition to convulsive reactions, myasthenia, hepatic porphyria, deficits glucose-6-phosphate dehydrogenase, diabetes, congenital syndrome interval lengthening Q-T, heart disease (heart failure (HF), myocardial infarction, bradycardia), psychosis and other mental disorders in history.; simultaneous reception of AC, extending the interval Q-T (antiarrhythmic IA and class III, tricyclic and tetracyclic antidepressants, antipsychotics, macrolides, antifungals, antihistamines, some, including astemizole, terfenadine, ebastine), for general anesthesia from the barbiturate group, drugs (LC), lowering blood pressure (BP), electrolyte imbalance (eg, hypokalemia, hypomagnesemia), elderly age, alcoholism.


    Pregnancy and lactation:

    The use of the drug during pregnancy and during lactation is contraindicated. If it is necessary to use the drug during lactation, breastfeeding should be stopped.

    Dosing and Administration:

    Inside, 1 hour before meals or 2 hours after meals, with enough water. Do not break, chew or destroy the pill.

    The recommended dose is 1 tablet 2 times a day for 7-10 days.

    Dosing regimen for CRF (calculation of the dose of ofloxacin): with creatinine clearance (CC) 50-20 ml / min 200 mg 1 time every 24 hours, with CC less than 20 ml / min, with hemodialysis, peritoneal dialysis - 200 mg 1 time every 48 hours.

    In liver failure, the maximum daily dose is 2 tablets (400 mg ofloxacin).

    Side effects:

    From the digestive system: gastralgia, decreased appetite, nausea, vomiting, diarrhea, constipation, flatulence, abdominal pain, increased activity of "liver" transaminases, hyperbilirubinemia, cholestatic jaundice, pseudomembranous colitis, dryness of the oral mucosa, colitis (including hemorrhagic) , hepatitis.

    From the nervous system: headache, dizziness, insomnia, nervousness, motion uncertainty, tremor, convulsions, numbness and paresthesia of the extremities, intense dreams, nightmares, anxiety, state of arousal, phobias, depression, confusion, hallucinations, increased intracranial pressure, insomnia, nervousness , drowsiness, epileptic seizures, extrapyramidal disorders, psychotic reactions with suicidal tendencies, sensory or sensory-motor peripheral neuropathy, impaired coordination of motion, temporary loss of consciousness.

    From the side of the musculoskeletal system: tendonitis, myalgia, arthralgia,

    tendosynovitis, tendon rupture, pain in the limbs, rigidity of muscles, rhabdomyolysis, muscle weakness.

    From the sense organs: violation of color perception, diplopia, taste disorders, perversion of taste sensations, impaired sense of smell, hearing and balance.

    From the cardiovascular system: tachycardia, increase or decrease in blood pressure, collapse, lengthening interval QT, ventricular arrhythmia, incl. arrhythmia ventricular tachysystolic type "pirouette".

    Allergic reactions: skin rash, itching, hives, allergic pneumonitis, allergic nephritis, eosinophilia, fever, angioedema, bronchospasm; erythema multiforme (including Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell's syndrome), photosensitivity, vasculitis, anaphylaxis, pruritus external genitalia in women.

    From the skin: point hemorrhages (petechiae), bullous hemorrhagic dermatitis, papular rash with a cortex, indicative of vascular lesions (vasculitis).

    From the hematopoiesis: leukopenia, agranulocytosis, anemia (including aplastic and hemolytic), thrombocytopenia, pancytopenia.

    From the urinary system: acute interstitial nephritis, impaired renal function, hypercreatininemia, increased urea concentration, dysuria, urinary retention, acute renal failure.

    Other: dysbacteriosis of the intestine, superinfection, hypoglycemia (in patients with diabetes mellitus), vaginitis, chest pain, fatigue, asthenia, general weakness, photosensitivity, vaginal discharge, epistaxis, thirst, weight loss, pharyngitis, rhinitis, dry cough, acute attack porphyria (in patients with porphyria).

    Overdose:

    Symptoms: dizziness, confusion, inhibition, disorientation, drowsiness, vomiting, epileptiform cramps, depression, peripheral neuritis.

    Treatment: gastric lavage, symptomatic therapy (diazepam - with convulsions).
    Interaction:

    Ofloxacin:

    Reduces the clearance of theophylline by 25% (with simultaneous use should reduce the dose of theophylline).

    Increases the concentration of glibenclamide in plasma.

    Increases serum concentration of cyclosporine.

    Cimetidine, furosemide, methotrexate and medicines (LC), blocking tubular secretion, increase the concentration of ofloxacin in blood plasma.

    When taken concomitantly with indirect anticoagulants (coumarin derivatives, including warfarin) it is necessary to control the blood coagulation system. When administered with non-steroidal anti-inflammatory drugs, derivatives of nitroimidazole and methylxanthines, the risk of developing neurotoxic effects, including convulsions, increases.

    At simultaneous appointment with glucocorticosteroids, the risk of rupture of tendons increases, especially in the elderly.

    When appointed with AC, alkalizing urine (carbonic anhydrase inhibitors, citrates, sodium hydrogen carbonate), the risk of crystalluria and nephrotoxic effects increases. With a simultaneous appointment with hypoglycemic agents, both hypo- and hyperglycemia are possible, and in this connection it is necessary to monitor the concentration of glucose in the blood plasma.

    With simultaneous application with drugs that extend the interval Q-T antiarrhythmic IA and class III, tricyclic and tetracyclic antidepressants, antipsychotics, macrolides, antifungals, antihistamines, some, including astemizole, terfenadine, ebastine) it is possible to extend the interval Q-T.

    Food products, antacids containing ions of aluminum, calcium, magnesium or iron salts, reduce the absorption of ofloxacin, forming insoluble complexes (the time interval between the administration of these LC should be at least 2 hours).

    Ornidazole:

    Strengthens the effect of indirect anticoagulants coumarinic series, prolongs the miorelaksiruyuschee effect of vecuronium bromide.

    Compatible with ethanol (does not inhibit acetaldehyde dehydrogenase), unlike other imidazole derivatives (metronidazole).

    Special instructions:

    It is not recommended to be exposed to sunlight, ultraviolet rays (mercury quartz lamps, solarium).

    To prevent the hyperconcentration of urine and subsequent crystalluria, during the treatment it is recommended to conduct adequate hydration.

    In case of side effects from the central nervous system, allergic reactions, pseudomembranous colitis, the development of peripheral neuropathy symptoms, the drug must be discontinued.

    Rarely developing tendonitis can lead to rupture of tendons (mainly Achilles tendon), especially in elderly patients. In case of signs of tendonitis, it is necessary immediately to stop treatment, to immobilize the Achilles tendon and consult an orthopedist.

    During the period of treatment can not be consumed ethanol.

    When using the drug, women are not recommended to use hygiene tampons due to the increased risk of thrush development.

    Against the backdrop of treatment, myasthenia flow may worsen, and porphyria attacks may be more frequent in predisposed patients.

    With simultaneous application with drugs that extend the interval Q-T antiarrhythmic IA and class III, tricyclic and tetracyclic antidepressants, antipsychotics, macrolides, antifungals, antihistamines, some, including astemizole, terfenadine, ebastine) requires systematic ECG monitoring.

    Can lead to false-negative results in the bacteriological diagnosis of tuberculosis (prevents the isolation Mycobacterium tuberculosis).

    In patients with impaired liver or kidney function, it is necessary to monitor the concentration of ofloxacin in plasma. With severe renal insufficiency, the risk of toxic effects increases (a decreasing dose adjustment is required).

    When using the drug, both on the background of taking and 2-3 weeks after discontinuation of treatment, it is possible to develop diarrhea caused by Clistridium difficile (pseudomembranous colitis). In mild cases, it is sufficient to discontinue treatment and apply ion-exchange resins (colestramine, colestipol), in severe cases, compensation for loss of fluid, electrolytes and protein, the appointment of vancomycin, bacitracin or metronidazole is indicated.

    Do not use drugs that inhibit the intestinal peristalsis.


    Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    Film coated tablets 500 mg + 200 mg.

    Packaging:10 tablets per blister Aluminum / Aluminum; 1, 2 or 10 blisters together with instructions for use in a cardboard pack.
    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use the product after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000836
    Date of registration:10.10.2011
    The owner of the registration certificate:Micro Labs LimitedMicro Labs Limited India
    Manufacturer: & nbsp
    Representation: & nbspMICRO LABS LIMITED MICRO LABS LIMITED India
    Information update date: & nbsp27.12.2012
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