Combiflox, 500 mg+200 mg 20 pcs

Combiflox is a combination drug, the action of which is due to the components in its composition.

Ornidazole is an antiprotozoal and antimicrobial agent, a derivative of 5-nitroimidazole. The mechanism of action consists in biochemical reduction of the 5-nitrogroup of ornidazole by intracellular transport proteins of anaerobic bacteria and protozoa. The reduced 5-nitrogroup of ornidazole interacts with the DNA of the cells of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of the bacteria.

It is active against Trichomonas vaginalis, Giardia lamblia, Entamoeba histolytica as well as anaerobes Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp. Aerobic microorganisms are not sensitive to ornidazole.

Ofloxacin is a broad-spectrum antimicrobial agent of the group of fluoroquinolones which acts on the bacterial enzyme DNA-gyrase which provides superspiralization and thus stability of bacterial DNA (destabilization of DNA chains leads to their death). It 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 aerogenes, 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 develops resistance), Serratia marcescens.

Anaerobes: Clostridium perfringens.

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

In most cases the following are insensitive: Nocardia asteroides, anaerobic bacteria (including Bacteroides spp., Peptococcus spp, Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile), Enterococcus spp., most Streptococcus spp., has no effect on Treponema pallidum.

Indications

Infectious diseases, Cholecystitis, Biliary tract infections, Urethritis, Urinary tract infections

– mixed bacterial infections caused by sensitive Gram-positive and Gram-negative microorganisms in association with anaerobic microorganisms and/or protozoa;
– infectious and inflammatory diseases of the abdominal cavity and biliary tract, kidney (pyelonephritis), lower urinary tract (cystitis, urethritis), genital and pelvic organs (endometritis, salpingitis, oophoritis, cervicitis, parametritis, prostatitis, colpitis, orchitis, epididymitis).

Active ingredient

Ornidazole, Ofloxacin

Composition

1 tablet contains ornidazole 500 mg,

ofloxacin 200 mg

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How to take, the dosage

Combiflox is taken orally, 1 hour before a meal or 2 hours after a meal with plenty of water. The tablet should not be crushed, chewed or broken.

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

The dosing regimen for CKD (calculation of dosage for ofloxacin): in IQ 50-20 ml/min – 200 mg 1 time every 24 hours, in IQ less than 20 ml/min, in hemodialysis, peritoneal dialysis – 200 mg 1 time every 48 hours.

In case of hepatic impairment, the maximum daily dose is 2 tablets (400 mg ofloxacin).

Interaction

Ofloxacin:
Reduces theophylline clearance by 25% (theophylline dose should be reduced with concomitant use).
Increases plasma concentration of glibenclamide. Increases the serum concentration of cyclosporine.

Cimetidine, furosemide, methotrexate and drugs (drugs) that block tubular secretion increase plasma concentration ofloxacin. When concomitant use with indirect anticoagulants (coumarin derivatives, including warfarin) it is necessary to monitor the clotting system. When prescribed with nonsteroidal anti-inflammatory drugs, nitroimidazole derivatives and methylxanthines the risk of neurotoxic effects, including seizures increases.

Concomitant administration with glucocorticosteroids increases the risk of tendon rupture, especially in the elderly.
When prescribed with drugs that alkalize the urine (carbohydrate inhibitors, citrates, sodium hydrogen carbonate), the risk of crystalluria and nephrotoxic effects increases. When concomitant administration with hypoglycemic agents both hypo- and hyperglycemia are possible, in connection with this it is necessary to monitor the plasma glucose concentration.

In concomitant use with drugs prolonging the Q-T interval: antiarrhythmic of classes IA and III, tricyclic and tetracyclic antidepressants, neuroleptics, macrolides, antifungals, some antihistamines, including astemizole, terfenadine, ebastine) prolongation of Q-T interval is possible. Foods, antacids containing aluminum, calcium, magnesium ions or iron salts decrease absorption of Ofloxacin, forming insoluble complexes (time interval between doses of these drugs should be at least 2 hours).

Ornidazole:

It enhances the effect of indirect coumarin-type anticoagulants, prolongs the myorelaxant effect of vecuronium bromide.
Compatible with ethanol (does not inhibit acetaldehyde dehydrogenase) unlike other imidazole derivatives (metronidazole).

Special Instructions

Exposure to sunlight and ultraviolet light (mercury quartz lamps, tanning beds) is not recommended.

In order to prevent hyperconcentration of urine and subsequent crystalluria, adequate hydration is recommended during treatment.

In case of central nervous system side effects, allergic reactions, pseudomembranous colitis, and development of peripheral neuropathy symptoms, discontinuation of the drug is necessary.

Rarely occurring tendinitis may lead to tendon rupture (mainly Achilles tendon), especially in elderly patients. If signs of tendinitis occur, treatment should be stopped immediately, the Achilles tendon should be immobilized, and an orthopedist should be consulted. Ethanol should not be consumed during treatment.

Women should not use sanitary tampons when using the drug due to the increased risk of thrush.

With the course of treatment it is possible to worsen the course of myasthenia gravis, the frequency of porphyria attacks in predisposed patients.

When concomitant use with drugs prolonging the Q-T interval, tricyclic and tetracyclic antidepressants, neuroleptics, macrolides, antifungals, some antihistamines, including astemizole, terfenadine, ebastine) systematic ECG control is necessary.

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

In patients with hepatic or renal dysfunction it is necessary to monitor the plasma concentration of Ofloxacin. In patients with severe renal impairment the risk of toxic effects increases (decreasing dose adjustment is required).

When using the drug both during treatment and 2-3 weeks after discontinuation of treatment the development of diarrhea caused by Clistridium difficile (pseudomembranous colitis) is possible. In mild cases withdrawal of treatment and use of ion exchange resins (colestiramine, colestipol) is sufficient, in severe cases compensation of loss of fluid, electrolytes and protein, prescription of vancomycin, bacitracin or metronidazole is indicated.

Drugs that inhibit intestinal peristalsis should not be used.

Contraindications

• – epilepsy (including anamnesis);
  – decreased seizure threshold (including after traumatic brain injury, stroke or CNS inflammatory processes; – epilepsy (including in anamnesis;
  – decreased seizure threshold (including after craniocerebral injury, stroke or CNS inflammatory processes;
  – tendon affection in previously treated fluoroquinolones;
  – age <18 years; <
  – pregnancy;
  – lactation;
  – hypersensitivity to ofloxacin, ornidazole, other fluoroquinolones and imidazole derivatives, components of Combiflox.
  With caution: atherosclerosis of cerebral blood vessels, cerebral circulation disorders (in anamnesis), chronic renal insufficiency, liver diseases, liver failure, organic CNS diseases (including multiple sclerosis), predisposition to seizure reactions, myasthenia gravis, hepatic porphyria, glucose-6-phosphate dehydrogenase deficiency, diabetes, congenital Q-T interval prolongation syndrome, heart diseases (heart failure, myocardial infarction, bradycardia), psychosis and other mental disorders in the history; concomitant use of drugs that prolong the Q-T interval (antiarrhythmic drugs of classes IA and III, tricyclic and tetracyclic antidepressants, neuroleptics, macrolides, antifungals, some antihistamines, including

, general anesthetics from the group of barbiturates, drugs that reduce blood pressure; electrolyte imbalance (e.g., hypokalemia, hypomagnesemia), old age, alcoholism.

Side effects

Digestive system disorders: gastralgia, decreased appetite, nausea, vomiting, diarrhea, constipation, flatulence, abdominal pain, increased liver transaminase activity, hyperbilirubinemia, cholestatic jaundice, pseudomembranous colitis, dry oral mucosa, colitis (including hemorrhagic), hepatitis.

Nervous system disorders: Headache, dizziness, insomnia, nervousness, uncertainty of movements, tremors, seizures, numbness and paresthesias of extremities, intense dreams, “nightmares” dreams, anxiety, state of agitation, phobias, depression, confusion, hallucinations, increased intracranial pressure, insomnia, nervousness, somnolence, epileptic seizures, extrapyramidal disorders, psychotic reactions with suicidal tendencies, sensory or sensory-motor peripheral neuropathy, movement coordination disorders, temporary loss of consciousness.

Musculoskeletal system disorders: tendinitis, myalgia, arthralgia, tenosynovitis, tendon rupture, pain in extremities, muscle rigidity, rhabdomyolysis, muscle weakness.

Sensory organs: color perception disorders, diplopia, taste disorders, perversion of the sense of taste, disorders of smell, hearing and balance.

Cardiovascular system disorders: tachycardia, increased or decreased BP, collapse, prolongation of QT interval, ventricular arrhythmia, including pirouette-type ventricular tachysystolic arrhythmia.

Allergic reactions: skin rash, pruritus, urticaria, allergic pneumonitis, allergic nephritis, eosinophilia, fever, angioneurotic edema, bronchospasm; erythema multiforme (including erythema exudative syndrome).Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell’s syndrome), photosensitization, vasculitis, anaphylactic shock, female genital itching.

Skin disorders: petechial hemorrhages (petechiae), bullous hemorrhagic dermatitis, papular rash with crust, indicating vascular lesions (vasculitis).

Hematopoietic organs: leukopenia, agranulocytosis, anemia (including aplastic and hemolytic), thrombocytopenia, pancytopenia.

Urinary system disorders: acute interstitial nephritis, renal dysfunction, hypercreatininemia, increased concentration of urea, dysuria, urinary retention, acute renal failure.

Other: intestinal dysbacteriosis, superinfection, hypoglycemia (in diabetic patients), vaginitis, chest pain, fatigue, asthenia, general weakness, photosensitization, vaginal discharge, nasal bleeding, thirst, weight loss, pharyngitis, rhinitis, dry cough, acute onset of porphyria (in patients with porphyria).

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Overdose

Symptoms: dizziness, confusion, lethargy, disorientation, drowsiness, vomiting, epileptiform seizures, depression, peripheral neuritis.

Treatment: gastric lavage, symptomatic therapy (diazepam in convulsions).

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Pregnancy use

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

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