Combiflox, 500 mg+200 mg 10 pcs

Infectious diseases, Biliary tract infections, Cholecystitis, 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 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).

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Active ingredient

Ornidazole, Ofloxacin

Composition

1 tablet contains:

acting ingredients:

ornidazole 500 mg,

ofloxacin 200 mg

How to take, the dosage

Overly, 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 according to ofloxacin): in creatinine clearance (CK) 50-20 ml/min 200 mg once every 24 hours, in CK less than 20 ml/min, in hemodialysis, peritoneal dialysis 200 mg once every 48 hours.

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

Interaction

Ofloxacin

Antacids containing aluminum hydroxide, sucralfate, magnesium hydroxide, aluminum phosphate or drugs containing zinc, iron. Reduce absorption of Ofloxacin. When using the above drugs and ofloxacin, approximately two-hour intervals between doses should be observed.

Vitamin K antagonists. Increased values of PV/ INR and/or development of bleeding (including severe bleeding) have been reported in patients with concomitant use of ofloxacin and vitamin K antagonists (e.g., warfarin). When concomitant use of vitamin K antagonists it is necessary to monitor the clotting system.

Glibenclamide. Ofloxacin may slightly increase serum concentrations of glibenclamide when used concomitantly. Concomitant use ofloxacin and glibenclamide recommends careful monitoring of patients and blood glucose concentrations.

Other hypoglycemic drugs for oral administration and insulin. Ofloxacin increases the risk of hypoglycemia; closer monitoring of blood glucose concentrations is required.

Probenecid, cimetidine, furosemide or methotrexate. When using quinolones together with drugs eliminated by renal tubular secretion (such as probenecid, cimetidine, furosemide, methotrexate) mutual retardation of excretion and increased serum concentrations (especially in case of high doses) are possible.

The drugs that may decrease the threshold of seizure activity of the brain, such as theophylline, phenbufen and other similar NSAIDs. No pharmacokinetic interactions between ofloxacin and theophylline have been established in clinical studies. However, a significant decrease in cerebral seizure threshold is possible with concomitant use of quinolones with drugs that reduce cerebral seizure threshold (theophylline, phenbufen and other similar NSAIDs).

The GCS. Concomitant use with GCS increases the risk of tendon rupture, especially in older patients.

The drugs that may prolong the QT interval. Ofloxacin as well as other fluoroquinolones should be used with caution in patients receiving medications which may prolong QT interval (antiarrhythmic medications of classes IA and III, tricyclic antidepressants, macrolides, neuroleptics).

The drugs that alkalize the urine (carboangidrase inhibitors, citrates, sodium bicarbonate). When prescribing with drugs that alkalize the urine (carboanhydrase inhibitors, citrates, sodium bicarbonate), the risk of crystalluria and nephrotoxic effects increases.

Ornidazole

Enhances the effect of indirect coumarin anticoagulants, which requires appropriate dose adjustment.

Longens the myorelaxant effect of vecuronium bromide.

Compatible with ethanol (does not inhibit acetaldehyde dehydrogenase) unlike other imidazole derivatives (metronidazole).

Phenobarbital or other inducers of microsomal liver enzymes decrease T1/2 of ornidazole from blood plasma.

Hepatic microsomal enzyme inhibitors (e.g., cimetidine) increase the plasma concentration of ornidazole.

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 during the use of 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);
• reduction of seizure threshold (including after traumatic brain injury, stroke, or CNS inflammatory processes;
• tendon disorders from previous treatment with fluoroquinolones.
• craniocerebral trauma, stroke or CNS inflammation;
• tendon involvement in previous fluoroquinolone treatment;
• age below 18 years of age;
• pregnancy;
• lactation period;
• hypersensitivity to ofloxacin, ornidazole, other fluoroquinolones and imidazole derivatives, components of the drug.

With caution: cerebral atherosclerosis, cerebral blood 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, includingincluding astemizole, terfenadine, ebastine), drugs for general anesthesia from the group of barbiturates, BP-lowering drugs, electrolyte imbalance (e.g. hypokalemia, hypomagnesemia), older 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.

Others: 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).

Overdose

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

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

Pregnancy use

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