Ofloksin

Ofloksin – antibacterial agent of group of ftorkhinolon.

Form of release and structure

Dosage forms:

• Tablets, film coated: almost white or white color, a round biconvex form, with an engraving "200" on one party and dividing risky – on another; internal structure at a break – white or almost white (in blisters: on 7 pieces, in a cardboard pack 2 blisters; on 10 pieces, in a cardboard pack 1 or 2 blisters);
• Solution for infusions: transparent light liquid with a flavovirent shade (on 100 ml in glass colourless bottles, in a cardboard pack 1 bottle).

Active ingredient of Ofloksin – ofloxacin:

• 1 tablet – 0,2 g;
• 1 bottle of solution – 0,2 g.

Auxiliary components:

• Tablets: povidone 25, lactoses monohydrate, кросповидон, starch corn, magnesium stearate, half-oxameasures, talc;
• Solution: dinatrium эдетат a dihydrate, Acidum hydrochloricum concentrated sodium chloride, water for injections.

In addition as a part of a cover of tablets: macrogoal 6000, gipromelloza 2910/5, titanium dioxide, talc.

Indications to use

Ofloksin's use is shown at treatment of the infectious and inflammatory pathologies caused by microorganisms, sensitive to drug:

• Bronchitis, pneumonia;
• Meningitis;
• Sinusitis, average otitis, pharyngitis, laryngitis;
• Infections of joints and bones;
• Infectious diseases of skin, soft tissues;
• Infectious and inflammatory diseases of digestive tract, biliary tract and other abdominal organs;
• Endometritis, oophoritis, salpingitis, cervicitis, prostatitis, parametritis;
• Pyelonephritis, cystitis, urethritis;
• Gonorrhea;
• Infections of generative organs (orchitis, colpitis, epididymite);
• Clamidiosis.

To patients with a neutropenia and other disturbances of the immune status drug is appointed for prevention of infections.

Besides, solution is applied at treatment of a septicaemia.

Contraindications

• Epilepsy (including the anamnesis);
• Deficit glyukozo-6-fosfatdegidrogenazy;
• Reduction of the threshold of convulsive activity of a brain, including states after the had stroke, a craniocereberal injury or processes of an inflammation in the central nervous system (CNS);
• Age up to 18 years;
• Period of pregnancy and breastfeeding;
• Hypersensitivity to drug components.

With care Ofloksin sick with atherosclerosis of vessels of a brain, the instruction in the anamnesis is recommended to appoint to disturbances of cerebral circulation, organic lesions of TsNS, a chronic renal failure.

Besides, it is contraindicated to patients to appoint tablets with damage of sinews after the previous therapy of a hinolonama, and when lengthening on an electrocardiography of an interval of QT it is necessary to take with caution.

Route of administration and dosage

Tablets, film coated
Pill is taken to food or during meal, inside, swallowing entirely and washing down with enough water.

The doctor appoints a dose and duration of administration of drug on the basis of clinical indications, considering severity of a condition of the patient, a type of an infection and functional parameters of a liver and kidneys.

The recommended daily dose can make from 0,2 to 0,6 g therefore the dose to 0,4 g a day is taken for 1 time, it is desirable in the morning, and more than 0,4 g divide a dose into two equal parts and accept 2 times a day at regular intervals. Duration of therapy is 7-10 days.

At severe forms of infectious pathologies or at the excess weight of the patient the daily dose can be raised to 0,8 g.

At treatment of uncomplicated infections of lower parts of urinary tract appoint 0,2 g a day for 3-5 days, at gonorrhea – 0,4 g once.

Initial treatment by Ofloksin in the form of solution for infusions after improvement of a condition of the patient can be continued by reception of tablets in the same dose.

Contraindicated simultaneous use with antacids.

Solution for infusions
Solution is entered intravenously kapelno.

The dose is appointed individually taking into account weight of a current and localization of an infection, sensitivity of microorganisms, a clinical condition of the patient, function of kidneys and a liver.

Treatment begin with single slow introduction 0,2 g of drug within 0,5-1 hours. After improvement of a condition of the patient transfer to reception of tablets in the same daily dose.

The recommended dosing:

• Infections of urinary tract: on 0,1 g 1-2 times a day;
• Infections of generative organs and kidneys: on 0,1-0,2 g 2 times a day;
• Respiratory infections, fish soup, throat and nose (pharyngitis, sinusitis, average otitis, laryngitis), soft tissues and skin, bones and joints, abdominal cavity, septic infections: on 0,2 g 2 times a day, for achievement of therapeutic effect a dose it is possible to raise to 0,4 g 2 times a day;
• Prevention of infections at the expressed decrease in immunity: 0,2 g mixed from 5% by glucose solution, infusion duration – 0,5 hours (it is necessary to mix solutions just before introduction).

The single dose of Ofloksin for treatment of patients with functional disorder of kidneys (the clearance of creatinine (CC) of 50-20 ml/min.) has to correspond 1/2 from average recommended and be applied 1-2 times a day. At KK less than 20 ml/min. appoint a single dose of 0,2 g, further – every other day on 0,1 g a day.

At a hemodialysis and peritoneal dialysis – on 0,1 g of 1 times a day.

For patients with a liver failure the daily dose should not exceed 0,4 g.

Side effects

• Alimentary system: nausea, vomiting, anorexia, diarrhea, meteorism, gastralgia and other abdominal pains, pseudomembranous coloenteritis, increase in activity of liver enzymes, cholestatic jaundice, hyperbilirubinemia;
• Cardiovascular system: lowering of arterial pressure (ABP), vasculitis, tachycardia, collapse;
• Nervous system: headache, spasms, uncertainty of movements, dizziness, tremor, paresthesias and numbness of extremities, increase in intracranial pressure, intensive and/or dreadful dreams, uneasiness, psychotic reactions, phobias, hyperexcitability, depression, hallucinations, confusion of consciousness;
• System of a hemopoiesis: anemia, agranulocytosis, leukopenia, pancytopenia, thrombocytopenia, aplastic and hemolitic anemia;
• Sense bodys: disturbances of sense of smell, taste, hearing, balance, diplopia, disturbance of color perception;
• Musculoskeletal system: tendosinovit, mialgiya, a tendinitis, arthralgias, a rupture of a sinew;
• Urinary system: a renal failure, increase in level of concentration of urea in blood, acute intersticial nephrite, a giperkreatininemiya;
• Dermatological reactions: petechias (dot hemorrhages), violent hemorrhagic dermatitis, photosensitization, papular rash;
• Allergic reactions: fever, itch, skin rash, small tortoiseshell, allergic pneumonitis, eosinophilia, allergic nephrite, Quincke's edema, Stephens-Johnson's syndrome, bronchospasm, mnogoformny exudative erythema, Lyell's disease, acute anaphylaxis;
• Others: superinfection, dysbacteriosis, at a diabetes mellitus – a hypoglycemia, a vaginitis.

Besides, Ofloksin can cause side effects characteristic of one of drug forms:

• Tablets: from the alimentary system – hepatitis, a musculoskeletal system – muscular weakness, рабдомиолиз;
• Solution for infusions: reactions in an injection site in the form of pain, reddening, thrombophlebitis.

Special instructions

At pneumococcal pneumonia and acute tonsillitis Ofloksin is not shown for use.

Treatment duration drug should not exceed 2 months.

The patient needs to avoid influence of direct sunshine and uviolizing.

At emergence of symptoms of side effect from TsNS, pseudomembranous colitis, development of allergic reactions therapy should be cancelled. For treatment of laboratory confirmed pseudomembranous colitis purpose of peroral forms of Vancomycinum and metronidazole is shown.

Ofloksin's use in rare instances causes development of a tendinitis which can lead to a rupture of sinews (Achilles tendon), is more often at patients of advanced age. Therefore at emergence of a tendinitis carrying out an immobilization of an Achilles tendon and receiving consultation of the orthopedist is required.

Women during treatment are not recommended to use vaginal tampons in connection with big risk of development of candidiasis.

Effect of drug can worsen a current of a myasthenia, at the patients inclined to a porphyria – to promote increase of attacks, at bacteriological diagnosis of tuberculosis – to yield false-negative results.

At a renal failure or a liver regular control of level of maintenance of an ofloksatsin in a blood plasma is required. Because of risk of development of toxic effects patients with a heavy renal and liver failure need dose adjustment.

Alcohol intake during treatment by Ofloksin contraindicated.

Use of solution for infusions in pediatrics is possible only at threat of life of the child when it is impossible to use other, less toxic drugs, after careful assessment of estimated advantage and potential threat of development of side effects. At appointment the average daily dose is recommended of 0,0075 g on 1 kg of weight of the child, the maximum dose should not exceed 0,015 g on 1 kg.

During Ofloksin's use the patient cannot be engaged in potentially dangerous types of activity, including management of vehicles and mechanisms.

Medicinal interaction

At simultaneous use of Ofloksin:

• Cimetidinum, methotrexate, furosemide and medicines blocking canalicular secretion – promote increase in level of concentration of an ofloksatsin in a blood plasma;
• The non-steroidal anti-inflammatory drugs derivative of methylxanthines and a nitroimidazole – increase risk of neurotoxic effects;
• Glucocorticosteroids – promote increase in risk of a rupture of sinews, especially at patients of advanced age;
• Inhibitors of a karboangidraza, sodium bicarbonate, citrates (the drugs alkalizing urine) – increase probability of development of nephrotoxic effects, crystallurias.

At a combination with ofloksatsiny the clearance of theophylline decreases by 25%, the level of maintenance of glibenclamide increases in a blood plasma.

Control of a condition of coagulant system of blood at the accompanying therapy by indirect anticoagulants – antagonists of vitamin K is required.

Products and antacids, calciferous, aluminum, salts of iron or magnesium, reduce absorption of an ofloksatsin therefore the interval between their reception and Ofloksin's reception has to make 2 and more hours.

The risk of lengthening of an interval of QT increases at a combination of tablets to antiarrhytmic drugs of the class IA and III, macroleads, tricyclic antidepressants (the means extending QT interval).

Ofloksin's solution pharmaceutical is compatible from 0,9% solution of sodium of chloride, 5% fructose solution, Ringer's solution, 5% solution of glucose (dextrose), but it cannot be mixed with heparin.

Terms and storage conditions

To store in unavailable to children, the dry place at a temperature of 10-25 °C, – to protect solution from influence of direct sunshine.

Period of validity – 3 years.