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

– 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, kidneys (pyelonephritis), lower urinary tract (cystitis, urethritis), genital organs and pelvic organs (endometritis, salpingitis, oophoritis, cervicitis, parametritis, prostatitis, colpitis, orchitis, epididymitis).

Pharmacological effect

Combiflox is a combination drug, the effect of which is determined by the components included in its composition.

Ornidazole is an antiprotozoal and antimicrobial agent, a derivative of 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 reduced 5-nitro group of ornidazole interacts with DNA in microbial cells, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.

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., Clostridium spp. Aerobic microorganisms are not sensitive to ornidazole.

Ofloxacin is a broad-spectrum antimicrobial agent from the group of fluoroquinolones that acts on the bacterial enzyme DNA gyrase, which ensures supercoiling, etc. 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 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 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 insensitive: Nocardia asteroides, anaerobic bacteria (including Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile), Enterococcus spp., most Streptococcus spp., does not affect Treponema pallidum.

Special instructions

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

To prevent urine hyperconcentration and subsequent crystalluria, adequate hydration is recommended during treatment.

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

Rarely, tendinitis can lead to tendon rupture (mostly the Achilles tendon), especially in older patients. If signs of tendinitis occur, you should immediately stop treatment, immobilize the Achilles tendon and consult an orthopedist. During the treatment period, ethanol should not be consumed.

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

During treatment, the course of myasthenia gravis may worsen and attacks of porphyria may increase in predisposed patients.

When used simultaneously with drugs that prolong the QT interval, class IA and III antiarrhythmics, tricyclic and tetracyclic antidepressants, antipsychotics, macrolides, antifungals, some antihistamines, incl. astemizole, terfenadine, ebastine) systematic ECG monitoring is necessary.

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

In patients with impaired liver or kidney function, monitoring of plasma concentrations of ofloxacin is necessary. In severe renal failure, the risk of toxic effects increases (reducing dose adjustment is required).

When using the drug, both while taking it and 2-3 weeks after stopping treatment, diarrhea caused by Clistridium difficile (pseudomembranous colitis) may develop. In mild cases, it is sufficient to discontinue treatment and use ion exchange resins (colestyramine, colestipol); in severe cases, replacement of loss of fluid, electrolytes and protein, and the appointment of vancomcin, bacitracin or metronidazole are indicated.

You should not use medications that inhibit intestinal motility.

Active ingredient

Ornidazole, Ofloxacin

Composition

1 tablet contains ornidazole 500 mg,

ofloxacin 200 mg

Pregnancy

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

Contraindications

— epilepsy (including history);
– decreased seizure threshold (including after traumatic brain injury, stroke or inflammatory processes in the central nervous system;
– tendon damage due to previous treatment with fluoroquinolones;
– age up to 18 years;
— pregnancy;
– lactation period;
– hypersensitivity to ofloxacin, ornidazole, other fluoroquinolones and imidazole derivatives, components of the drug Combiflox.
With caution: cerebral atherosclerosis, cerebrovascular accidents (history), chronic renal failure, liver disease, liver failure, organic diseases of the central nervous system (including multiple sclerosis), predisposition to convulsive reactions, myasthenia gravis, hepatic porphyria, glucose-6-phosphate dehydrogenase deficiency, diabetes mellitus, congenital long Q-T interval syndrome, diseases heart failure (heart failure, myocardial infarction, bradycardia), history of psychosis and other mental disorders; simultaneous use of drugs that prolong the QT interval (class IA and III antiarrhythmics, tricyclic and tetracyclic antidepressants, neuroleptics, macrolides, antifungals, some antihistamines, including astemizole, terfenadine, ebastine), drugs for general anesthesia from the group of barbiturates, drugs that lower blood pressure; electrolyte imbalance (for example, with hypokalemia, hypomagnesemia), old age, alcoholism.

Side Effects

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

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

From the musculoskeletal system: tendonitis, myalgia, arthralgia, tenosynovitis, tendon rupture, pain in the limbs, muscle rigidity, rhabdomyolysis, muscle weakness.

From the senses: impaired color perception, diplopia, taste disturbances, perversion of taste sensations, disturbances of smell, hearing and balance.

From the cardiovascular system: tachycardia, increase or decrease in blood pressure, collapse, prolongation of the QT interval, ventricular arrhythmia, incl. ventricular tachysystolic arrhythmia of the “pirouette” type.

Allergic reactions: skin rash, itching, urticaria, allergic pneumonitis, allergic nephritis, eosinophilia, fever, angioedema, bronchospasm; exudative erythema multiforme (including Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell’s syndrome), photosensitivity, vasculitis, anaphylactic shock, itching of the external genitalia in women.

From the skin: pinpoint hemorrhages (petechiae), bullous hemorrhagic dermatitis, papular rash with crust, indicating vascular damage (vasculitis).

From the hematopoietic organs: 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: intestinal dysbiosis, superinfection, hypoglycemia (in patients with diabetes), vaginitis, chest pain, fatigue, asthenia, general weakness, photosensitivity, vaginal discharge, nosebleeds, thirst, weight loss, pharyngitis, rhinitis, dry cough, acute attack of porphyria (in patients with porphyria).

Interaction

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

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

When administered concomitantly with glucocorticosteroids, the risk of tendon rupture increases, especially in the elderly.
When prescribed with drugs that alkalinize urine (carbonic anhydrase inhibitors, citrates, sodium bicarbonate), the risk of crystalluria and nephrotoxic effects increases. When administered simultaneously with hypoglycemic agents, both hypo- and hyperglycemia are possible, and therefore it is necessary to monitor the concentration of glucose in the blood plasma.

When used simultaneously with drugs that prolong the QT interval, class IA and III antiarrhythmics, tricyclic and tetracyclic antidepressants, antipsychotics, macrolides, antifungals, some antihistamines, incl. astemizole, terfenadine, ebastine) may prolong the QT interval. Food products and antacids containing aluminum, calcium, magnesium or iron salts reduce the absorption of ofloxacin by forming insoluble complexes (the time interval between the administration of these drugs should be at least 2 hours).

Ornidazole:

Enhances the effect of indirect coumarin anticoagulants and prolongs the muscle relaxant effect of vecuronium bromide.
Compatible with ethanol (does not inhibit acetaldehyde dehydrogenase) unlike other imidazole derivatives (metronidazole).

Overdose

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

Treatment: gastric lavage, symptomatic therapy (diazepam for seizures).

Storage conditions

In a place protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Manufacturer

Micro Labs Ltd, India