Kombiflox - Instructions For Use, Price, Reviews, Analogs Of Tablets

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Combiflox

Kombiflox: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Kombifloks

ATX code: J01RA

Active ingredient: ornidazole + ofloxacin (ornidazole + ofloxacin)

Manufacturer: Micro Labs Limited (India)

Description and photo updated: 22.11.2018

Prices in pharmacies: from 536 rubles.

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Kombiflox is a combined antiprotozoal drug with antibacterial action.

Release form and composition

Dosage form Kombiflox - film-coated tablets: capsule-shaped, with a dividing line on one side; an orange-colored shell and a yellowish-creamy core stand out in a cross section (in an aluminum blister 3 or 5 pcs., in a cardboard box 1 blister; in an aluminum blister 10 pcs., in a cardboard box 1, 2 or 10 blisters).

Composition of one tablet:

• active ingredients: ornidazole - 500 mg, ofloxacin - 200 mg;
• auxiliary components (core): microcrystalline cellulose, sodium carboxymethyl starch, sodium croscarmellose, colloidal silicon dioxide, talc, magnesium stearate, hypromellose, quinoline yellow dye;
• shell: orange opadry (lactose monohydrate, hypromellose, titanium dioxide, macrogol, triacetin, sunset yellow dye).

Pharmacological properties

Pharmacodynamics

The action of Kombiflox is due to its active ingredients.

Ornidazole, a derivative of 5-nitroimidazole, has antiprotozoal and antimicrobial effects. The biochemical mechanism of action consists in the restoration of the 5-nitro group of ornidazole by intracellular transport proteins of anaerobic and protozoan microorganisms. The reduced 5-nitro group of ornidazole inhibits the synthesis of nucleic acids in bacteria by interacting with deoxyribonucleic acid (DNA) of their cells, which leads to the death of microorganisms.

Ornidazole is active against Giardia intestinalis (Giardia lamblia), Trichomonas vaginalis, Entamoeba histolytica, anaerobes Bacteroides spp. (including Bacteroides ovatus, Bacteroides distasonis, Bacteroides fragilis, Bacteroides vulgatus, Bacteroides thetaiotaomicron), Peptostreptococcus spp., Clostridium spp., Fusobacterium spp.).

Aerobic microorganisms are resistant to the action of ornidazole.

Ofloxacin is an antibiotic of the second generation fluoroquinolone group that has a broad spectrum bactericidal antimicrobial effect. The drug specifically inhibits the bacterial enzyme DNA gyrase, which is necessary in the process of transcription, replication, recombination and repair of bacterial DNA, which leads to unwinding and destabilization of DNA chains and the death of microorganism cells.

Bacteria sensitive to the action of ofloxacin: Neisseria flavescens, Neisseria meningitidis, Neisseria gonorrhoeae, Staphylococcus epidermidis, Staphylococcus aureus, Citrobacter, Escherichia coli, Klebsiella spp. (including Klebsiella pneumonia), Hafnia, Enterobacter spp., Proteus spp. (including Proteus mirabilis, indole-negative and indole-positive Proteus vulgaris), Shigella spp. (including Shigella sonnei), Salmonella spp., Aeromonas hydrophila, Campilobacter jejuni, Yersinia enterocolitica, Vibrio parahaemolyticus, Vibrio cholera, Plesiomonas aeruginosa, Haemophilus influenzae, Serratia spp., Provilionella spp., Chipretia spp., Provilionella spp.., Bordetella pertussis, Bordetella parapertussis, Moraxella catarrhalis, Brucella spp., Staphylococcus spp., Propionibacterium acnes.

Microorganisms with intermittent sensitivity (due to possible acquired resistance) to ofloxacin: Streptococcus pyogenes, Enterococcus faecalis, pneumoniae and viridans, Acinetobacter, Pseudomonas aeruginosa, Serratio marcescens, Mycobacterium tuberuitum Utibacterium, Mycobacterium tuberculosis, Mycobacterium tuberculosis, Mycobacterium tuberculosis, Mycobacterium tuberculosis, Mycobacterium uberculosis, Mycobacterium tuberculosis, Mycobacterium uberculosis, Mycobacterium uberculosi, Gardnerella vaginalis, Listeria monocytogenes, Helicobacter pylori, Corynebacterium spp.

Bacteria that are resistant to ofloxacin in most cases: Nocardia asteroides, anaerobic microorganisms (for example, Peptococcus spp., Bacteroides spp., Peptostreptococcus spp., Clostridium difficile, Fusobacterium spp., Eubacterium spp.).

Ofloxacin has no effect on the following microorganisms: Treponema pallidum, Acinetobacter baumannii, Enterococci (including Enterococcus faecium), methicillin-resistant Staphylococcus spp., Nocardia spp.

Pharmacokinetics

• absorption: ornidazole and ofloxacin after oral administration are well absorbed in the gastrointestinal tract. The bioavailability of ornidazole is 90%, ofloxacin is almost 100%. Plasma proteins bind 13% of ornidazole and 25% of ofloxacin. The time to reach the maximum concentration (T _Cmax) for ornidazole is 3 hours, for ofloxacin - 1 hour;
• distribution: ornidazole is able to penetrate into most body fluids and tissues, has the property of passing through the blood-brain and placental barriers and excreted in breast milk. Ofloxacin is distributed in cells (alveolar macrophages, leukocytes), skin, soft tissues, bones, abdominal and pelvic organs, respiratory system, urine, saliva, bile, and prostatic secretions. Its volume of distribution is approximately 120 liters. Ofloxacin well penetrates the blood-brain and placental barrier, is secreted in breast milk;
• metabolism and excretion: ornidazole is metabolized in the liver, forming the main metabolites - alpha-hydroxymethyl and 2-hydroxymethyl, which have less activity against anaerobic bacteria and Trichomonas vaginalis than unchanged ornidazole. The half-life (T _1/2) of the active substance is approximately 13 hours. After a single oral administration, 85% of ornidazole is excreted in the urine (mainly in the form of metabolites), through the intestines - 20-25%, unchanged - 4%. Ofloxacin is metabolized in the liver (less than 5%) with the formation of two main metabolites - dimethylofloxacin and ofloxacin N-oxide, excreted mainly by the kidneys, unchanged - 80-90% of the dose taken. Approximately 4% of ofloxacin is excreted through the intestine as glucuronides. T _1/2- 6-7 hours. In urine and infected urinary tract, the content of ofloxacin exceeds its content in blood serum by 5–100 times. After a single dose of 200 mg is found in the urine within 20-24 hours. The excretion of ofloxacin may be slowed down by impaired renal / liver function. The active substance does not accumulate.

Indications for use

According to the instructions, Kombiflox is indicated for the treatment of the following mixed bacterial infections caused by sensitive gram-negative and gram-positive microorganisms in association with anaerobic bacteria and / or protozoa:

• infectious and inflammatory diseases of the abdominal cavity and biliary tract;
• kidney infections (pyelonephritis), lower urinary tract infections (urethritis, cystitis);
• infectious lesions of the pelvic organs (prostatitis, endometritis, parametritis, cervicitis, oophoritis, salpingitis), genital organs (orchitis, colpitis, epididymitis).

Contraindications

Absolute:

• epilepsy;
• tendon lesions against the background of previous treatment with fluoroquinolones;
• organic diseases of the central nervous system;
• blood cell abnormalities and pathological changes in the blood;
• pseudoparalytic myasthenia gravis;
• lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• age up to 18 years;
• pregnancy and lactation;
• increased individual sensitivity to ornidazole, ofloxacin, imidazole derivatives or other fluoroquinolones, as well as auxiliary components of the drug.

Relative (the use of Combiflox requires caution):

• predisposition to the development of seizures: with lesions of the central nervous system (disorders of cerebral circulation, in the anamnesis, including severe atherosclerosis of the vessels of the brain, a history of brain trauma); with the simultaneous use of drugs that lower the threshold of seizure readiness of the brain (for example, theophylline, fenbufen or other nonsteroidal anti-inflammatory drugs);
• latent or manifest deficiency of glucose-6-phosphate dehydrogenase;
• renal failure;
• liver dysfunction;
• porphyria;
• diseases / conditions with an increased risk of lengthening the QT interval (electrical systole of the heart): congenital lengthening of the QT interval, heart disease (heart failure, bradycardia, myocardial infarction), uncorrected electrolyte disturbances (hypomagnesemia, hypokalemia), concomitant use of drugs that contribute to lengthening the interval QT (tricyclic antidepressants, class IA and III antiarrhythmics, antipsychotics, macrolides);
• concomitant use of oral hypoglycemic agents (eg glibenclamide) or insulin in patients with diabetes mellitus;
• severe adverse reactions to other quinolones, including neurological disorders;
• alcoholism;
• elderly age.

Instructions for the use of Kombiflox: method and dosage

Kombiflox tablets are taken orally, swallowing whole with a sufficient amount of water, 1 hour before a meal or 2 hours after a meal.

It is recommended to take 1 tablet 2 times a day for 7-10 days.

For patients with chronic renal failure, the following dosage regimens are recommended (dose calculation based on ofloxacin): with creatinine clearance 20-50 ml / min - 200 mg (1 tablet) once every 24 hours; when creatinine clearance less than 20 mL / min, and in hemodialysis and peritoneal dialysis - 100 or 200 mg (¹ / ₂ or 1 tablet) once every 24 or 48 hours.

In severe renal impairment or during dialysis, it is recommended to monitor the concentration of ofloxacin in the blood serum.

In patients with hepatic impairment, the maximum daily dose of Kombiflox should not exceed 400 mg of ofloxacin (2 tablets).

Side effects

Possible side reactions from systems and organs:

• cardiovascular system: palpitations, tachycardia, prolongation of the QT interval, increase or decrease in blood pressure, ventricular arrhythmia of the pirouette type (especially in the presence of risk factors for prolongation of the QT interval);
• blood and lymphatic system: anemia, leukopenia, hemolytic anemia, thrombocytopenia, eosinophilia, agranulocytosis, inhibition of bone marrow hematopoiesis, pancytopenia;
• central nervous system: headache, dizziness, drowsiness, paresthesia, dysgeusia or ageusia (impaired taste perception), parosmia (olfactory disorder), extrapyramidal symptoms, impaired muscle coordination, tremors, muscle stiffness, peripheral sensory neuropathy, seizures, peripheral sensory-motor neuropathy, increased intracranial pressure, temporary loss of consciousness;
• psyche: sleep disorders, agitation, insomnia, nervousness, anxiety, psychotic disturbances (hallucinations), nightmares, confusion, depression, psychotic reactions with a tendency to suicide;
• organ of vision: conjunctivitis, irritation of the mucous membrane of the eye, visual disturbances (disorders of color perception, diplopia), uveitis;
• hearing organ and labyrinthine disorders: ringing in the ears, hearing disorders, vertigo, hearing loss;
• respiratory system, chest and mediastinal organs: shortness of breath, cough, nasopharyngitis, bronchospasm, severe shortness of breath, allergic pneumonitis;
• digestive system: abdominal pain, nausea, vomiting, stomatitis, loss of appetite, dryness of the oral mucosa, metallic taste in the mouth, diarrhea, enterocolitis (in some cases hemorrhagic), dyspepsia, flatulence, constipation, pseudomembranous colitis, pancreatitis;
• liver and biliary tract: increased enzymatic activity of hepatic transaminases, hyperbilirubinemia, cholestatic jaundice, hepatitis (in some cases, severe), in rare cases - severe liver failure (mainly in patients with impaired liver function), including acute liver failure, sometimes fatal;
• kidney and urinary tract: increased serum creatinine concentration, increased blood urea concentration, acute renal failure, acute interstitial nephritis;
• skin and subcutaneous tissues: itching, skin rash, urticaria, pustular rash, hyperhidrosis, hyperemia, exudative erythema multiforme, photosensitivity reactions, toxic epidermal necrolysis (Lyell's syndrome), drug rash, vasculitis (in exceptional cases leading to vascular necrosis), malignant exudative erythema (Stevens-Johnson syndrome), exfoliative dermatitis, acute generalized exanthematous pustulosis;
• musculoskeletal and connective tissue: arthralgia, tendinitis, myalgia, tendon rupture (it can be bilateral and its development is possible within 48 hours from the start of therapy), myopathy and / or rhabdomyolysis, muscle weakness (important for patients with pseudoparalytic myasthenia gravis), rupture / muscle tear, arthritis, ligament rupture;
• metabolism and nutrition: anorexia, hypoglycemia, hyperglycemia, hypoglycemic coma (with diabetes mellitus in the case of the use of hypoglycemic drugs);
• immune system: anaphylactoid reactions, anaphylactic reactions, angioedema, anaphylactic shock, anaphylactoid shock;
• others: intestinal dysbiosis, resistance of pathogenic microorganisms, fungal infections, vaginitis, asthenia, general weakness, fatigue, fever, chest, back, limb pain, weight loss, nosebleeds, thirst, in patients with porphyria - exacerbation of the disease.

Overdose

In case of an overdose of Combiflox, the following symptoms may occur: nausea, erosion of the mucous membrane of the gastrointestinal tract, dizziness, lethargy, confusion / disturbance of consciousness, convulsions, prolongation of the QT interval.

In such cases, gastric lavage and symptomatic therapy are recommended. Antacids can be used to protect the gastrointestinal mucosa. To control the QT interval, it is necessary to systematically monitor the electrocardiogram. There is no specific antidote for ofloxacin. The hemodialysis procedure is effective for removing fractions of the substance.

special instructions

In patients with impaired renal and / or liver function while taking Combiflox, it is necessary to monitor the content of ofloxacin in the blood plasma.

The development of diarrhea, especially severe, persistent and / or with traces of blood, during or after therapy with Combiflox may indicate the occurrence of pseudomembranous colitis. In case of suspicion of pseudomembranous colitis, it is necessary to immediately discontinue treatment and immediately conduct appropriate specific antibiotic therapy (metronidazole, teicoplanin or vancomycin orally). Medicines that help suppress intestinal motility are contraindicated in such clinical situations.

If seizures develop, the drug must be canceled.

While taking Combiflox, as with other antibacterial agents, a secondary infection may develop, associated with the growth of microorganisms resistant to this drug. To confirm or exclude it, it is necessary to re-evaluate the patient's condition. In the event of a secondary infection, appropriate treatment is required.

During the period of antibiotic therapy, the use of alcoholic beverages is not recommended.

Cases of development (sometimes with a rapid onset) of sensory and sensory-motor neuropathy have been reported in patients taking fluoroquinolones, including ofloxacin. If symptoms of neuropathy appear, treatment with Combiflox should be discontinued to minimize the possible risks of developing irreversible disorders.

It is recommended to carefully monitor blood glucose in patients with diabetes.

Inflammation of the tendon tissue (tendinitis), which occurs in some cases during treatment with quinolones, can lead to rupture of tendons, including Achilles, especially in patients taking glucocorticosteroids at the same time and in elderly patients. This side effect can be bilateral and develop within two days of starting therapy. If symptoms of tendonitis occur, Combiflox should be discontinued immediately and, if necessary, appropriate treatment (immobilization) of the damaged tendon should be carried out.

When using quinolones in patients with diagnosed deficiency of glucose-6-phosphate dehydrogenase, hemolytic reactions are possible.

During the period of treatment with Combiflox, due to the risk of developing photosensitization, it is recommended to avoid exposure to direct sunlight and ultraviolet radiation.

In patients receiving therapy with lithium preparations, systematic monitoring of the concentration of lithium, creatinine and electrolytes in the blood plasma should be carried out.

Ofloxacin, like other fluoroquinolones, has an activity that blocks neuromuscular conduction, and can increase muscle weakness in patients with pseudoparalytic myasthenia gravis. Therefore, taking Combiflox for patients with diagnosed pseudoparalytic myasthenia gravis is not recommended.

Patients should be informed that in the event of lesions of the mucous membranes and / or skin reactions, they should immediately consult a specialist before continuing to take Combiflox.

With the simultaneous use of Combiflox with vitamin K antagonists (warfarin, etc.), careful monitoring of blood coagulation is required, since in this case an increase in the value of prothrombin time and / or the development of bleeding is possible.

Since the risk of developing resistance in individual microbial species can vary with geographic and temporal data, local information is required. Therefore, it is necessary to conduct microbiological diagnostics with the isolation of the pathogen and the determination of its sensitivity, especially in the absence of a clinical effect of treatment or in severe infections.

Ofloxacin can inhibit the growth of Mycobacterium tuberculosis and lead to false negative results in the bacteriological diagnosis of tuberculosis.

When determining the level of opiates and porphyrins in the urine during the period of taking ofloxacin, a false positive result is likely. More specific research methods may be required.

In the case of mixed infection caused by Trichomonas vaginalis, including, it is necessary to carry out simultaneous therapy of sexual partners.

Influence on the ability to drive vehicles and complex mechanisms

Since Kombiflox can cause such adverse reactions as dizziness, drowsiness, confusion, it is not recommended to drive vehicles and perform potentially hazardous activities that require increased concentration of attention and a quick psychomotor reaction while taking the tablets.

Application during pregnancy and lactation

Since during therapy with Kombiflox it is impossible to completely exclude the likelihood of damage to the cartilaginous zones of bone growth in the fetus and the child, its use in pregnant and lactating women is contraindicated.

If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Pediatric use

Children and adolescents under 18 years of age are prohibited from prescribing Combiflox.

With impaired renal function

Patients with impaired renal function should take Combiflox with caution. Systematic monitoring of the concentration of ofloxacin in the blood in such patients is necessary.

For violations of liver function

Liver dysfunction is a relative contraindication to the use of Kombiflox.

With the use of fluoroquinolones, cases of fulminant hepatitis have been reported, which led to liver failure (including death). During the period of use of Kombiflox, if symptoms and signs of liver disease appear (jaundice, anorexia, dark urine, abdominal pain, itching), it is recommended to stop taking the drug and consult a doctor.

Use in the elderly

When using Combiflox to treat elderly patients, caution is required.

Drug interactions

The use of ornidazole concurrently with some drugs can lead to the development of the following effects:

• indirect anticoagulants of the coumarin series: enhancement of their action (dose adjustment is required);
• vecuronium bromide: lengthening its muscle relaxant effect;
• ethanol: compatible with ornidazole, which does not inhibit acetaldehyde dehydrogenase, unlike other imidazole derivatives;
• phenobarbital and other inducers of microsomal liver enzymes: a decrease in the time of elimination of ornidazole from blood plasma;
• inhibitors of microsomal liver enzymes (cimetidine): increasing the concentration of ornidazole in the blood plasma.

The interaction of ofloxacin with other drugs can cause the following effects:

• antacids containing aluminum hydroxide, magnesium hydroxide, sucralfate, aluminum phosphate, and preparations containing iron or zinc: decreased absorption of ofloxacin. It is necessary to observe the interval between taking them at least 2 hours;
• vitamin K antagonists (for example, warfarin): an increase in prothrombin time and / or the development of bleeding, including severe;
• glibenclamide: an increase in its concentration in serum. You should carefully monitor the concentration of glucose in the blood and the patient's condition with this combination of drugs;
• insulin and oral hypoglycemic agents: increased risk of hypoglycemia. Close monitoring of blood glucose is required;
• cimetidine, probenecid, methotrexate, furosemide and other drugs excreted from the body by renal tubular secretion: mutual delay in excretion and increase in serum concentrations (especially when using high doses);
• theophylline, fenbufen, non-steroidal anti-inflammatory drugs and other drugs that lower the threshold for seizure activity of the brain: an excessive decrease in the threshold for seizure activity of the brain;
• glucocorticosteroids: increased risk of tendon rupture, especially in elderly patients;
• sodium bicarbonate, carbonic anhydrase inhibitors, other drugs that alkalize urine: increased risk of crystalluria and nephrotic effects;
• tricyclic antidepressants, antipsychotics, macrolides, class IA and III antiarrhythmics and other drugs capable of prolonging the QT interval: excessive prolongation of the QT interval.

Analogs

Analogues of Kombiflox are: Oletetrin, Safotsid, Ornidazole, Ornidazol-Vero, Zanocin, Dancil, Dazolik, Gairo and others.

Terms and conditions of storage

Store in a dark place at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Kombiflox

Reviews of Kombiflox indicate that the drug is a potent antibiotic, which must be used strictly according to medical prescription and extremely carefully. The drug is usually effective against numerous infections, but causes serious side effects, which may, in turn, require appropriate treatment.

In addition, users report that the cost of Combiflox is quite high.

Price for Combiflox in pharmacies

The price for Combiflox per package is approximately: 10 tablets - 690 rubles, 20 tablets - 905 rubles.

Kombiflox: prices in online pharmacies

Drug name Price Pharmacy

Kombiflox 500 mg + 200 mg film-coated tablets 10 pcs. RUB 536 Buy

Kombiflox tablets p.o. 500mg + 200mg 10 pcs. 587 r Buy

Kombiflox 500 mg + 200 mg film-coated tablets 20 pcs. 750 RUB Buy

Kombiflox tablets p.o. 500mg + 200mg 20 pcs. 820 RUB Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!