Ornidazole, Ofloxacin | Combiflox tablets 500 + 200 mg, 10 pcs.

Release form

film-coated tablets

Packing

10 pcs.

Pharmacological action

Combiflox is a combined drug whose action 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 reduced 5-nitro group of ornidazole interacts with the DNA of microorganism 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 - a broad-spectrum antimicrobial agent from the group of fluoroquinolones, acts on the bacterial enzyme DNA gyrase, which provides supercoiling, etc. 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 resistance), Serratia marcescens.

Anaerobes: Clostridium perfringens.

Others: 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. Ppp.

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 ( , salpingitis, oophoritis, cervicitis, parametritis, prostatitis, colpitis, orchitis, epididymitis).

Contraindications

epilepsy (including a history)

decrease in seizure threshold (including after a head injury, stroke or inflammation in the central nervous system

tendon damage with previous treatment with sperlrdol pregnancy

lactation

hypersensitivity to ofloxacin, ornidazole, other fluoroquinolones and imidazole derivatives, components of the drug

Caution: cerebral arteriosclerosis, cerebrovascular accident (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 deficiency -phosphate dehydrogenase, diabetes mellitus, syndrome of congenital lengthening of the QT interval, heart disease (heart failure, myocardial infarction, bradycardia), psychoses and other mental disorders in the anamnesis TERM taking medicines prolonging the interval QT (IA and III antiarrhythmics of classes, tricyclic and tetracyclic antidepressants, antipsychotics, macrolides, antifungals, antihistamines, some, including astemizole, terfenadine, ebastine) means for general anesthesia from the group consisting of barbiturates, drugs that reduce blood pressure electrolyte imbalance (for example, with hypokalemia, hypomagnesemia), old age, alcoholism.

Composition of

1 tablet contains Ornidazole 500 mg, ofloxacin 200 mg

Dosage and administration

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

Recommended dose - 1 tablet 2 times a day for 7-10 days.

Dosing regimen for chronic renal failure (ofloxacin dose calculation): with KK 50-20 ml / min - 200 mg once every 24 hours, with KK 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 of the

Digestive system: gastralgia, decreased appetite, nausea, vomiting, diarrhea, constipation, flatulence, abdominal pain, increased activity of hepatic transaminases, hyperbilirubinemia, cholestatic jaundice, pseudomembranous mucous colitis, dryness, including hemorrhagic), hepatitis.

From the side of the nervous system: headache, dizziness, insomnia, nervousness, insecurity of movements, tremors, cramps, numbness and paresthesias of the extremities, intense dreams, nightmares, anxiety, agitation, phobias, depression, confusion, hallucinations, increased intracranial pressure insomnia, nervousness, drowsiness, epileptic seizures, extrapyramidal disorders, psychotic reactions with a tendency to suicide, sensory or sensory-motor peripheral neuropathy, impaired coordination of movement, temporary loss of consciousness.

From the musculoskeletal system: tendonitis, myalgia, arthralgia, tendosynovitis, tendon rupture, pain in the extremities, muscle stiffness, rhabdomyolysis, muscle weakness.

On the part of the sensory organs: impaired color perception, diplopia, impaired taste, perversion of taste, impaired smell, hearing and balance.

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

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

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

From the hemopoietic 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 mellitus), vaginitis, chest pain, fatigue, asthenia, general weakness, photosensitivity, vaginal discharge, nosebleeds, thirst, weight loss, pharyngitis, rhinitis, dry cough, acute porphyria attack (in patients with porphyria).

Drug Interactions

It is not recommended to be exposed to sunlight or 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, development of symptoms of peripheral neuropathy, drug withdrawal is necessary.

Rarely occurring tendonitis can lead to rupture of tendons (mainly Achilles tendon), especially in elderly patients. In case of signs of tendonitis, it is necessary to 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 hygienic tampons due to the increased risk of thrush.

Against the background of treatment, the course of myasthenia gravis, frequent porphyria attacks in predisposed patients are possible.

With simultaneous use with drugs that extend the QT interval, antiarrhythmic IA and class III, tricyclic and tetracyclic antidepressants, antipsychotics, macrolides, antifungal, some antihistamines, including astemizole, terfenadine, ebastin) systematic ECG monitoring is necessary.

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

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

When using the drug, as in the background, and 2-3 weeks after the cessation of treatment, the development of diarrhea caused by Clistridium difficile (pseudomembranous colitis) is possible. In mild cases, discontinuation of treatment and the use of ion-exchange resins (colestyramine, colestipol) is sufficient, in severe cases, compensation for loss of fluid, electrolytes and protein, the appointment of vancomcin, bacitracin or metronidazole are indicated.

Do not use drugs that inhibit intestinal motility.

Overdose

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

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

Storage conditions

In a dark place at a temperature of no higher than 25 РC.

Terms and conditions

Prescription

dosage form

tablets

Prescription

Adult prescription