Combiflox, pills 500+200mg, 20pcs

Composition

1 tablet contains ornidazole 500 mg,

ofloxacin 200 mg

Pharmacological action

Combiflox is a combined drug, the action 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 consists in 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 the DNA of microbial cells, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.

Active against Trichomonas vaginalis, Giardia lamblia, Entamoeba histolytica, and 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, which acts on the bacterial enzyme DNA gyrase, which provides supercoiling 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 develop resilience), Serratia marcescens.

Anaerobes:  Clostridium perfringens.

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

In most cases, they are 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 act on Treponema pallidum.

Indications

— mixed bacterial infections caused by sensitive gram-positive and gram-negative organisms, in Association with anaerobic microorganisms and/or protozoa; infectious-inflammatory diseases of the abdominal cavity and the biliary tract, kidney (pyelonephritis), lower urinary tract (cystitis, urethritis), genitals and organs of the small pelvis (endometritis, salpingitis, oophoritis, cervicitis, parameters, prostatitis, vaginitis, orchitis, epididymitis).

Use during pregnancy and lactation

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

Contraindications

• -epilepsy (including in the anamnesis);- reduction of the seizure threshold (including after a traumatic brain injury, stroke, or inflammatory processes in the central nervous system;- damage to tendons during previous treatment with fluoroquinolones;— under 18 years of age;— pregnancy; – lactation period; – hypersensitivity to ofloxacin, ornidazole, other fluoroquinolones and imidazole derivatives, components of the drug Combiflox. With caution: atherosclerosis of the cerebral vessels, cerebral circulatory disorders (in the anamnesis), chronic renal failure, liver diseases, 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 Q-T interval prolongation syndrome, heart disease (heart failure, myocardial infarction, bradycardia), psychosis and other mental disorders in the anamnesis; simultaneous use of drugs that prolong the Q-T interval (antiarrhythmic IA and III classes, tricyclic and tetracyclic antidepressants, neuroleptics, macrolides, antifungal, some antihistamines, including astemizole, terfenadine, Ebastinee), general anesthesia products from the barbiturate group, drugs that are not recommended for use in the treatment of heart failure. lowers blood pressure; electrolyte imbalance (for example, with hypokalemia, hypomagnesemia), old age, alcoholism.

Side effects

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

Nervous system disorders:  headache, dizziness, insomnia, nervousness, lack of movement, tremor, convulsions, numbness and paresthesia of the extremities, intense dreams, “nightmare” dreams, anxiety, agitation, phobias, depression, confusion, hallucinations, increased intracranial pressure, insomnia, nervousness, drowsiness, epileptic seizures, extrapyramidal disorders, psychotic reactions with a tendency to addiction suicide, sensory or sensorimotor peripheral neuropathy, impaired coordination of movement, temporary loss of consciousness.

From the musculoskeletal system:  tendinitis, myalgia, arthralgia, tendosynovitis, tendon rupture, limb pain, muscle rigidity, rhabdomyolysis, muscle weakness.

From the side of the senses:  violation of color perception, diplopia, taste disorders, perversion of taste sensations, violations of smell, hearing and balance.

From the cardiovascular system:  tachycardia, increased or decreased blood pressure, collapse, prolongation of the QT interval, ventricular arrhythmia, including ventricular tachysystolic arrhythmia of the “pirouette” type.

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

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

From the side of 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 services:  intestinal dysbiosis, superinfection, hypoglycemia (in patients with diabetes mellitus), vaginitis, chest pain, fatigue, asthenia, general weakness, photosensitization, 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 the serum concentration of cyclosporine.

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

Concomitant use with glucocorticosteroids increases the risk of tendon rupture, especially in the elderly. When prescribed with drugs that alkalize the urine (carbonic anhydrase inhibitors, citrates, sodium bicarbonate), the risk of crystalluria and nephrotoxic effects increases. When administered concomitantly 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 concomitantly with drugs that prolong the Q-T interval (class IA and III antiarrhythmics, tricyclic and tetracyclic antidepressants, neuroleptics, macrolides, antifungal drugs, some antihistamines, including astemizole, terfenadine, Ebastinee), the Q-T interval may be prolonged. Food products, antacids containing aluminum, calcium, magnesium ions or iron salts reduce the absorption of ofloxacin, forming insoluble complexes (the time interval between the appointment of these drugs should be at least 2 hours).

Ornidazole:

Enhances the effect of coumarin-type indirect anticoagulants, prolongs the muscle-relaxing effect of vecuronium bromide. It is compatible with ethanol (does not inhibit acetaldehyde dehydrogenase), unlike other imidazole derivatives (metronidazole).

How to take it, course of use and dosage

Combiflox is taken orally,1 hour before meals or 2 hours after meals, with a sufficient amount of water. Do not break, chew or destroy the tablet.

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

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

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

Overdose

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

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

Special instructions

It is not recommended to be exposed to sunlight, ultraviolet radiation (mercury-quartz lamps, tanning beds).

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

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

Rarely occurring tendinitis can lead to tendon rupture (mainly the Achilles tendon), especially in elderly patients. If signs of tendinitis occur, you should immediately stop treatment, immobilize the Achilles tendon and consult an orthopedic specialist. During the treatment period, you can not use ethanol.

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

Against the background of treatment, the course of myasthenia gravis may worsen, and porphyria attacks may become more frequent in predisposed patients.

When used concomitantly with drugs that prolong the Q-T interval (class IA and III antiarrhythmics, tricyclic and tetracyclic antidepressants, neuroleptics, macrolides, antifungal drugs, some antihistamines, including astemizole, terfenadine, Ebastinee), systematic ECG monitoring is necessary.

It can lead to false negative results in the bacteriological diagnosis of tuberculosis (prevents the release of 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 (reducing dose adjustment is required).

When using the drug, both against the background of 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 cancel treatment and use ion exchange resins (colestyramine, colestipol), in severe cases, compensation for fluid, electrolyte and protein loss is indicated, and the appointment of vancomycin, bacitracin or metronidazole is indicated.

Do not use medications that inhibit intestinal motility.

Form of production

film-coated tablets

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Ornidazole, Ofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Adults as prescribed by a doctor

Indications

Infectious Diseases, Biliary Tract Infections, Cholecystitis, Urethritis, Urinary Tract Infections